Atlas FDA

ACQSIM-MULTISLICE-CT, MODEL 453567042271

FDA 510(k) clearance K033357 · decided 2004-01-09

Clearance details

K-number
K033357
Device name
ACQSIM-MULTISLICE-CT, MODEL 453567042271
Applicant
Philips Medical Systems (Cleveland), Inc.
Decision
Substantially Equivalent
Date received
2003-10-20
Decision date
2004-01-09
Days to decision
81 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
Brilliance CT (computed tomography) scanners, Big Bore configuration, Model number 728243. recall (Z-0400-2016)Philips Medical Systems (Cleveland) Inc2015-12-10
Brilliance CT 40 - Slices(Uninterruptible Power Supply (UPS) accessory devices) Computed T recall (Z-1763-2015)Philips Medical Systems (Cleveland) Inc2015-06-11
Brilliance CT Big Bore Radiology (Uninterruptible Power Supply (UPS) accessory devices) Co recall (Z-1764-2015)Philips Medical Systems (Cleveland) Inc2015-06-11
Brilliance CT Big Bore Oncology. Computed Tomography X-ray systems intended to produce cro recall (Z-1648-2015)Philips Medical Systems (Cleveland) Inc2015-05-22
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
No packaging. The device is a computed tomography scanner. Intended to provide corss secti recall (Z-2678-2014)Philips Medical Systems (Cleveland) Inc2014-09-22
The Brilliance CT Big Bore is a whole-body Computed Tomography X-ray system intended to pr recall (Z-2666-2014)Philips Medical Systems (Cleveland) Inc2014-09-18
Brilliance CT Big Bore Oncology Whole Body Computed Tomography X-Ray System & Brilliance C recall (Z-1745-2014)Philips Medical Systems (Cleveland) Inc2014-06-22
Philips Medical Systems Computed Tomography X-ray systems (Brilliance CT series, iCT, iCT recall (Z-1722-2014)Philips Medical Systems (Cleveland) Inc2014-06-04
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
Computed Tomography X-Ray System (Brilliance CT Big Bore Oncology & Brilliance CT Big Bore recall (Z-0801-2014)Philips Medical Systems (Cleveland) Inc2014-01-21
Brilliance CT Big Bore Oncology, Brilliance CT Big Bore Radiology and Brilliance CT 16 (Ai recall (Z-0013-2014)Philips Medical Systems (Cleveland) Inc2013-10-17
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 Medical Systems, Brilliance Computed Tomography (CT) X-Ray Scanners, Big Bore, Mod recall (Z-0880-2013)Philips Medical Systems (Cleveland) Inc2013-02-26
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
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
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
Brilliance Big Bore Model #728243 and #728244, Philips Medical Systems. Computed Tomograph recall (Z-0946-2012)Philips Medical Systems (Cleveland) Inc2012-02-03
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 Big Bore CT (Computed Tomography) System, 510 (k) #K033357, Model #728243, Seri recall (Z-0777-2012)Philips Medical Systems (Cleveland) Inc2012-01-17
Brilliance Big Bore Computed Tomography X-Ray System, 510(k) #K033357, Model Number: 72824 recall (Z-0334-2012)Philips Medical Systems (Cleveland) Inc2011-12-01
Brilliance Big Bore Computed Tomography X-Ray System, Model Number: 728243. The units subj recall (Z-2207-2011)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
Respiratory Gating System, Catalog #NPTA540, Model #4535 674 26701, which includes: Pulmon recall (Z-0286-2010)Philips Medical Systems (Cleveland) Inc2009-11-17
Respiratory Gating System, Catalog Number: NPTA540, Model #4535 674 26701, for the followi recall (Z-0287-2010)Philips Medical Systems (Cleveland) Inc2009-11-17
Vertical drive brake (on patient supports). Used on certain Philips Medical Systems MX ser recall (Z-0597-2009)Philips Medical Systems (Cleveland) Inc2009-01-16
Respiratory Gating System which includes: Pulmonary Digital Assembly Kit and Pulmonary Too recall (Z-0132-2009)Philips Medical Systems (Cleveland) Inc2008-10-28
Philips Medical Systems, Cardiac Viewer or Pulmonary Viewer Application that can run on al recall (Z-0366-2008)Philips Medical Systems (Cleveland) Inc2007-12-29
The Brilliance CT Big Bore is a whole body computed tomography X-Ray system. The malfuncti recall (Z-0121-2008)Philips Medical Systems (Cleveland) Inc2007-11-07
Brilliance(a) CT 6 slice, Model #4535 670 73191. Brilliance(a) CT 10 Slice, Model 4535 670 recall (Z-0014-2007)Philips Medical Systems (Cleveland) Inc2007-09-26
Brilliance CT System, Big Bore Configuration, Model #728243. (version 2.2.1) recall (Z-0636-2007)Philips Medical Systems (Cleveland) Inc2007-03-17

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