Atlas FDA

PHILIPS PLUS COMPUTED TOMOGRAPHY SYSTEM

FDA 510(k) clearance K033326 · decided 2003-10-29

Clearance details

K-number
K033326
Device name
PHILIPS PLUS COMPUTED TOMOGRAPHY SYSTEM
Applicant
Philips Medical Systems, Inc.
Decision
Substantially Equivalent
Date received
2003-10-16
Decision date
2003-10-29
Days to decision
13 days
Clearance type
Traditional
Product code
JAK
Device class
2
Regulation number
892.1750
Medical specialty
Radiology
Advisory committee
Radiology
Location
Cleveland, OH, US
Third-party review
Yes
Expedited review
No

+ Add to Predicate Builder ◉ Watch Philips Medical Systems

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
BodyTom Elite (NL4000) (K253450)NeuroLogica Corp., a Samsung Company2026-07-28
CardIQ Suite (K253770)GE Medical Systems SCS2026-07-21
Enhanced Boundary for PCCT (K253560)Ge Medical Systems, LLC2026-06-24
Respiratory Gating for Scanners (2.1) (K253026)Varian Medical Systems, Inc.2026-06-04
Aquilion ONE (TSX-308A/TSX-306A) V2.0 (K253596)Canon Medical Systems Corporation2026-05-20
Spectral CT Verida Family (K253649)Philips Medical Systems Technologies , Ltd.2026-03-27
True Definition DL (K253686)Ge Healthcare Japan Corporation2026-03-23
CT Rembra RT; CT Areta RT; CT Rembra (K252992)Philips Healthcare (Suzhou) Co., Ltd.2026-03-23
Photonova Spectra, Photonova Spectra Select (K253520)Ge Medical Systems, LLC2026-03-20
SOMATOM X.cite; SOMATOM X.ceed (K253574)Siemens Medical Solutions USA, Inc.2026-03-20
Aquilion ServeSP (TSX-307B) V2.0 (K260078)Canon Medical Systems Corporation2026-03-13
Extremity CT Imaging System (K252249)Mars Bioimaging , Ltd.2026-03-13

Recalls involving this device

RecordFirmDate
Philips CT systems labeled as the following: 1. Brilliance CT 40 Channel, Model Number: 72 recall (Z-2595-2025)Philips North America Llc2025-09-19
Philips CT systems labeled as the following: 1. Ingenuity Core128 / Elite China, Model Num recall (Z-2602-2025)Philips North America Llc2025-09-19
Philips CT systems labeled as the following: 1. Ingenuity CT Family Brazil, Model Number: recall (Z-2603-2025)Philips North America Llc2025-09-19
Philips CT systems labeled as the following: 1. CT 6000, Model Number: 728307. recall (Z-2604-2025)Philips North America Llc2025-09-19
Brilliance 64 Computed Tomography X-ray system recall (Z-0544-2016)Philips Medical Systems (Cleveland) Inc2015-12-24
Ingenuity Core Computed Tomography X-ray system recall (Z-0547-2016)Philips Medical Systems (Cleveland) Inc2015-12-24
Ingenuity Core 128 Computed Tomography X-ray system recall (Z-0548-2016)Philips Medical Systems (Cleveland) Inc2015-12-24
Ingenuity CT Computed Tomography X-ray system recall (Z-0549-2016)Philips Medical Systems (Cleveland) Inc2015-12-24
Brilliance 64 Computed Tomography X-Ray System, Model number 728231, running version 2.6.0 recall (Z-0409-2016)Philips Medical Systems (Cleveland) Inc2015-12-10
Computed Tomography X-ray Systems Brilliance CT 64-channel with Essence technology. Intend recall (Z-2254-2015)Philips Medical Systems (Cleveland) Inc2015-07-24
Computed Tomography X-ray Systems Ingenuity Core. Intended to produce cross-sectional imag recall (Z-2257-2015)Philips Medical Systems (Cleveland) Inc2015-07-24
Computed Tomography X-ray Systems Ingenuity Core 128. Intended to produce cross-sectional recall (Z-2258-2015)Philips Medical Systems (Cleveland) Inc2015-07-24
Computed Tomography X-ray Systems Ingenuity CT scanners. Intended to produce cross-section recall (Z-2259-2015)Philips Medical Systems (Cleveland) Inc2015-07-24
Head Holder shipped with Ingenuity Core Computed Tomography X-ray Systems. Intended to pro recall (Z-2203-2015)Philips Medical Systems (Cleveland) Inc2015-07-22
Head Holder shipped with Ingenuity Core 128 Computed Tomography X-ray Systems. Intended to recall (Z-2204-2015)Philips Medical Systems (Cleveland) Inc2015-07-22
Head Holder shipped with Ingenuity CT Computed Tomography X-ray Systems recall (Z-2205-2015)Philips Medical Systems (Cleveland) Inc2015-07-22
Brilliance CT 64 channel with Essence, Technology (Uninterruptible Power Supply (UPS) acce recall (Z-1761-2015)Philips Medical Systems (Cleveland) Inc2015-06-11
Brilliance CT 40 - Slices (Uninterruptible Power Supply (UPS) accessory devices) Computed recall (Z-1762-2015)Philips Medical Systems (Cleveland) Inc2015-06-11
Ingenuity Flex (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography recall (Z-1770-2015)Philips Medical Systems (Cleveland) Inc2015-06-11
Ingenuity Core (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography recall (Z-1771-2015)Philips Medical Systems (Cleveland) Inc2015-06-11
Ingenuity Core 128 (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomogra recall (Z-1772-2015)Philips Medical Systems (Cleveland) Inc2015-06-11
Ingenuity CT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X- recall (Z-1773-2015)Philips Medical Systems (Cleveland) Inc2015-06-11
Brilliance CT 64. Computed Tomography X-ray systems intended to produce cross-sectional im recall (Z-1649-2015)Philips Medical Systems (Cleveland) Inc2015-05-22
Brilliance CT 40. Computed Tomography X-ray systems intended to produce cross-sectional im recall (Z-1650-2015)Philips Medical Systems (Cleveland) Inc2015-05-22
Ingenuity CT. Computed Tomography X-ray systems intended to produce cross-sectional images recall (Z-1657-2015)Philips Medical Systems (Cleveland) Inc2015-05-22
Computed Tomography X-ray Systems (Brilliance CT 64-channel w/Essence technology, Brillian recall (Z-1359-2015)Philips Medical Systems (Cleveland) Inc2015-04-01
Various Brilliance and Ingenuity Computed Tomography X-ray systems; one unit per package P recall (Z-0979-2015)Philips Medical Systems (Cleveland) Inc2015-01-15
The Ingenuity CT, Ingenuity Core, and Ingenuity Core128 scanners are Computed Tomography X recall (Z-2711-2014)Philips Medical Systems (Cleveland) Inc2014-09-29
Brilliance CT System 6/10/16/16P/40 configuration. No packaging, sold as single unit. Comp recall (Z-2709-2014)Philips Medical Systems (Cleveland) Inc2014-09-26
The Brilliance 64 and Ingenuity CT are Computed Tomography X-Ray Systems intended to produ recall (Z-2664-2014)Philips Medical Systems (Cleveland) Inc2014-09-18
IntelliSpace Portal (ISP) DX/HX/EX, IntelliSpace Portal (ISP) IX, and IntelliSpace Portal recall (Z-2237-2014)Philips Medical Systems (Cleveland) Inc2014-08-14
Philips Medical Systems Computed Tomography X-ray systems (Brilliance CT series, iCT, iCT recall (Z-1722-2014)Philips Medical Systems (Cleveland) Inc2014-06-04
IntelliSpace Portal (ISP), (ISP DX/HX/EX, Model number 881001; ISP IX, Model number 881030 recall (Z-1678-2014)Philips Medical Systems (Cleveland) Inc2014-06-02
Brilliance CT 16, Brilliance CT 64, Brilliance CT Big Bore Oncology, Brilliance CT Big Bor recall (Z-1461-2014)Philips Medical Systems (Cleveland) Inc2014-04-16
Ingenuity Core 128, Computed Tomography X-ray systems, Philips Medical Systems (Cleveland) recall (Z-1464-2014)Philips Medical Systems (Cleveland) Inc2014-04-16
Brilliance iCT, Brilliance 64 and Brilliance Big Bore The Brilliance iCT, Brilliance 64 an recall (Z-0791-2014)Philips Medical Systems (Cleveland) Inc2014-01-29
Brilliance CT 6, M/N 728256; Brilliance CT 16 M/N 728246; Brilliance CT 40, M/N 728235 & B recall (Z-2210-2013)Philips Medical Systems (Cleveland) Inc2013-09-16
Computed Tomography X-ray systems Product Usage: The Brilliance CT 64, Ingenuity Core, and recall (Z-1646-2013)Philips Medical Systems (Cleveland) Inc2013-07-02
MAQUET Getinge Group Mobile Operating Table YUNO OTN GA 1433.01 EN 05. The YUNO OTN is use recall (Z-1622-2013)Maquet Cardiovascular Us Sales, Llc2013-07-01
Brilliance CT 64, Ingenuity CT, Ingenuity Core, and Ingenuity Core128 scanners are whole b recall (Z-1588-2013)Philips Medical Systems (Cleveland) Inc2013-06-25
Brilliance 64 and Ingenuity Computed Tomography X-Ray Systems The Brilliance 64 and Ingenu recall (Z-0950-2013)Philips Medical Systems (Cleveland) Inc2013-03-14
Brilliance 6, 10, 16, 40, 64, Big Bore and the iCT, iCT SP, Ingenuity CT and MX8000 Dual v recall (Z-0945-2013)Philips Medical Systems (Cleveland) Inc2013-03-13
Brilliance 64 and Ingenuity CT Computed Tomography X-Ray Scanning Systems: Brilliance 64 - recall (Z-0674-2013)Philips Medical Systems (Cleveland) Inc2013-01-15
The Brilliance 6, 10, 16, 40, 64 and CT Big Bore are Computed Tomography X-Ray Systems The recall (Z-2245-2012)Philips Medical Systems (Cleveland) Inc2012-08-22
The Brilliance 64 and Ingenuity CT are whole body Computed Tomography X-Ray Systems intend recall (Z-2223-2012)Philips Medical Systems (Cleveland) Inc2012-08-17
Philips Brilliance 6, 16, 40, 64, Big Bore, iCT and iCT SP are Computed Tomography X-Ray S recall (Z-2035-2012)Philips Medical Systems (Cleveland) Inc2012-07-19
Intellispace Portal software Product Usage: Intellispace Portal is a multimodality thin-cl recall (Z-2000-2012)Philips Medical Systems (Cleveland) Inc2012-07-12
IntelliSpace Portal software and Extended Brillance Workspace software Intellispace Portal recall (Z-1987-2012)Philips Medical Systems (Cleveland) Inc2012-07-11
Intellispace Portal software. Intellispace Portal is a multimodality thin client applicati recall (Z-1988-2012)Philips Medical Systems (Cleveland) Inc2012-07-11
Brilliance 40 - Model #72835, and Brilliance 64 - Model #728231, and Ingenuity - Model #72 recall (Z-1691-2012)Philips Medical Systems (Cleveland) Inc2012-05-30

PMA approvals by this applicant

RecordFirmDate
HeartStart OnSite Defibrillator (Model M5066A) and HeartStart Home Defibrillator (Model M5068A) (P160029/S028)Philips Medical Systems, Inc.2025-06-20
HeartStart Home Defibrillator (M5068A) and HeartStart Onsite Defibrillator (M5066A) (P160029/S027)Philips Medical Systems, Inc.2025-06-09
HeartStart FR3 Defibrillator (P160028/S006)Philips Medical Systems, Inc.2025-05-09
HeartStart Home Defibrillator, HeartStart OnSite Defibrillator, HeartStart HS1 SMART Pads, Adult (M5071A), HeartStart HS (P160029/S026)Philips Medical Systems, Inc.2024-12-12
HeartStart FR3 Primary Battery (989803150161) (P160028/S005)Philips Medical Systems, Inc.2024-09-11
HeartStart HS1 Onsite Defibrillator (M5066A), HeartStart HS1 Home Defibrillator (M5068A) (P160029/S024)Philips Medical Systems, Inc.2024-02-21
HeartStart OnSite Defibrillator, HeartStart Home Defibrillator, HeartStart HS1 SMART Pads, Adult, HeartStart HS1 SMART P (P160029/S022)Philips Medical Systems, Inc.2024-01-23
HeartStart OnSite Defibrillator and HeartStart Home Defibrillator (P160029/S023)Philips Medical Systems, Inc.2024-01-05