Atlas FDA

BRILLIANCE VOLUME

FDA 510(k) clearance K060937 · decided 2006-06-05

Clearance details

K-number
K060937
Device name
BRILLIANCE VOLUME
Applicant
Philips Medical Systems (Cleveland), Inc.
Decision
Substantially Equivalent
Date received
2006-04-05
Decision date
2006-06-05
Days to decision
61 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
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Philips CT systems labeled as the following: 1. Brilliance iCT SP, Model Number: 728311. recall (Z-2599-2025)Philips North America Llc2025-09-19
Philips Brilliance iCT Computed Tomography X-Ray System; Model # 728306; UDI #s (01)008848 recall (Z-1921-2020)Philips North America, LLC2020-05-06
Philips Brilliance iCT SP Computed Tomography X-Ray System; Model # 728311 recall (Z-1922-2020)Philips North America, LLC2020-05-06
Brilliance iCT Computed Tomography X-ray system recall (Z-0545-2016)Philips Medical Systems (Cleveland) Inc2015-12-24
Brilliance iCT SP Computed Tomography X-ray system recall (Z-0546-2016)Philips Medical Systems (Cleveland) Inc2015-12-24
Computed Tomography X-ray systems Brilliance iCT, Philips Healthcare System. Intended to p recall (Z-2255-2015)Philips Medical Systems (Cleveland) Inc2015-07-24
Computed Tomography X-ray Systems Brilliance iCT SP. Intended to produce cross-sectional i recall (Z-2256-2015)Philips Medical Systems (Cleveland) Inc2015-07-24
Extended Brilliance Workstation (Uninterruptible Power Supply (UPS) accessory devices) Com recall (Z-1767-2015)Philips Medical Systems (Cleveland) Inc2015-06-11
Brilliance iCT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography recall (Z-1768-2015)Philips Medical Systems (Cleveland) Inc2015-06-11
iCT SP (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray sy recall (Z-1769-2015)Philips Medical Systems (Cleveland) Inc2015-06-11
Brilliance iCT Computed Tomography X-ray system recall (Z-1695-2015)Philips Medical Systems (Cleveland) Inc2015-05-29
Brilliance iCT. Computed Tomography X-ray systems intended to produce cross-sectional imag recall (Z-1656-2015)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
Philips Brilliance iCT Computed Tomography X-Ray System Product Usage: The Brilliance iCT/ recall (Z-0236-2015)Philips Medical Systems, Inc.2014-12-16
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
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 iCT and Brilliance iCT SP These systems are intended to produce cross-sectional recall (Z-0831-2014)Philips Medical Systems (Cleveland) Inc2014-01-27
Brilliance iCT & Brilliance iCT SP Computed Tomography X-Ray Systems, Philips Healthcare, recall (Z-0832-2014)Philips Medical Systems (Cleveland) Inc2014-01-27
Brilliance iCT Computed Tomography X-Ray System, Product Usage: The Brilliance iCT is a Co recall (Z-0335-2014)Philips Medical Systems (Cleveland) Inc2013-11-15
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
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
The Brilliance iCT and iCT SP are Computed Tomography X-Ray Systems intended to produce cr recall (Z-1791-2012)Philips Medical Systems (Cleveland) Inc2012-06-08
The Brilliance iCT and iCT SP are Computed Tomography X-Ray Systems intended to produce cr recall (Z-1688-2012)Philips Medical Systems (Cleveland) Inc2012-05-30
Brilliance 40 - Model #72835, and Brilliance 64 - Model #728231, and Ingenuity - Model #72 recall (Z-1691-2012)Philips Medical Systems (Cleveland) Inc2012-05-30
Brilliance Big Bore - Model #728243, and - Model #728244, CT Scanning System is subject to recall (Z-1692-2012)Philips Medical Systems (Cleveland) Inc2012-05-30
Brilliance iCT - Model #728306, and Brilliance iCT SP - Model #728311, CT Scanning System recall (Z-1693-2012)Philips Medical Systems (Cleveland) Inc2012-05-30
IntelliSpace Portal, M/N 881001, IntelliSpace Portal (ISP) is a multimodality (CT, NM, and recall (Z-1337-2012)Philips Medical Systems (Cleveland) Inc2012-03-30
Computed Tomography X-Ray Systems (Brilliance 64, Model Number: 728231; Brilliance Big Bor recall (Z-0845-2012)Philips Medical Systems (Cleveland) Inc2012-01-24
Brilliance iCT Computed Tomography X-Ray System, 510 (k) #K060937, Model #728306, Serial N recall (Z-3208-2011)Philips Medical Systems (Cleveland) Inc2011-09-14
Brilliance iCT SP Computed Tomography X-Ray System, 510 (k) #K060937, Model #728311, Seria recall (Z-3209-2011)Philips Medical Systems (Cleveland) Inc2011-09-14
Brilliance iCT, Computed Tomography X-Ray System, including the Brilliance iCT SP system, recall (Z-2205-2011)Philips Medical Systems (Cleveland) Inc2011-05-19
Vertical Brake Hubs of the Computed Tomography X-Ray Systems under the following Brands an recall (Z-1669-2011)Philips Medical Systems (Cleveland) Inc2011-03-16
Brilliance iCT Heavyweight Gantry Scanner, M/N 728306, S/N: 100016, 100018 -100025 The Bri recall (Z-2460-2010)Philips Medical Systems (Cleveland) Inc2010-09-22

PMA approvals by this applicant

RecordFirmDate
NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000 (P830052/S019)Philips Medical Systems (Cleveland), Inc.1988-07-27
NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000 (P830052/S022)Philips Medical Systems (Cleveland), Inc.1988-07-14
NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000 (P830052/S021)Philips Medical Systems (Cleveland), Inc.1988-07-14
NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000 (P830052/S018)Philips Medical Systems (Cleveland), Inc.1988-06-13
NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000 (P830052/S017)Philips Medical Systems (Cleveland), Inc.1988-05-16
NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000 (P830052/S015)Philips Medical Systems (Cleveland), Inc.1988-05-16
NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000 (P830052/S016)Philips Medical Systems (Cleveland), Inc.1988-04-28
NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000 (P830052/S014)Philips Medical Systems (Cleveland), Inc.1988-04-26