Atlas FDA

GEMINI RAPTOR

FDA 510(k) clearance K052640 · decided 2005-10-07

Clearance details

K-number
K052640
Device name
GEMINI RAPTOR
Applicant
Philips Medical Systems (Cleveland), Inc.
Decision
Substantially Equivalent
Date received
2005-09-26
Decision date
2005-10-07
Days to decision
11 days
Clearance type
Traditional
Product code
KPS
Device class
2
Regulation number
892.1200
Medical specialty
Radiology
Advisory committee
Radiology
Location
Cleveland, OH, US
Third-party review
Yes
Expedited review
No

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Recalls involving this device

RecordFirmDate
GEMINI PET/CT System, a diagnostic imaging system for fixed or mobile installations that c recall (Z-0197-2016)Philips Medical Systems (Cleveland) Inc2015-11-02
GEMINI LXL CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integr recall (Z-2194-2015)Philips Medical Systems (Cleveland) Inc2015-07-22
GEMINI TF 16 Slice CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family o recall (Z-2195-2015)Philips Medical Systems (Cleveland) Inc2015-07-22
GEMINI TF 64 Slice CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family o recall (Z-2196-2015)Philips Medical Systems (Cleveland) Inc2015-07-22
GEMINI TF Ready CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of i recall (Z-2197-2015)Philips Medical Systems (Cleveland) Inc2015-07-22
GEMINI TF Base CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of in recall (Z-2198-2015)Philips Medical Systems (Cleveland) Inc2015-07-22
Gemini LXL 16 Slice (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomogr recall (Z-1782-2015)Philips Medical Systems (Cleveland) Inc2015-06-11
TruFlight Select PET/CT 16-slice (Uninterruptible Power Supply (UPS) accessory devices) Co recall (Z-1783-2015)Philips Medical Systems (Cleveland) Inc2015-06-11
Ingenuity TF (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X- recall (Z-1785-2015)Philips Medical Systems (Cleveland) Inc2015-06-11
GEMINI TF PET/CT 16 Slice (Uninterruptible Power Supply (UPS) accessory devices) Computed recall (Z-1786-2015)Philips Medical Systems (Cleveland) Inc2015-06-11
GEMINI TF PET/CT 64 Slice (Uninterruptible Power Supply (UPS) accessory devices) Computed recall (Z-1787-2015)Philips Medical Systems (Cleveland) Inc2015-06-11
GEMINI TF Ready (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography recall (Z-1788-2015)Philips Medical Systems (Cleveland) Inc2015-06-11
GEMINI TF PET/CT16: 882470, GEMINI TF PET/CT 64: 882471, GEMINI TF Big Bore: 882476. A dia recall (Z-2037-2014)Philips Medical Systems (Cleveland) Inc2014-07-10
Diagnostic imaging systems (GEMINI LXL Model #882412, TruFlight Select Model #882438, GEMI recall (Z-0932-2014)Philips Medical Systems (Cleveland) Inc2014-02-04
Ingenuity TF PET/CT Diagnostic imaging system for fixed or mobile installations that combi recall (Z-0067-2014)Philips Medical Systems (Cleveland) Inc2013-10-25
Ingenuity TF PET/CT. Diagnostic imaging system that combines Positron Emission Tomography recall (Z-1029-2013)Philips Medical Systems (Cleveland) Inc2013-04-01
Ingenuity TF PET/CT. Diagnostic imaging system recall (Z-0897-2013)Philips Medical Systems (Cleveland) Inc2013-02-28
Philips Medical Systems, GEMINI LXL - Model #882412; GEMINI TF 16 - Model #882470 and Mode recall (Z-0882-2013)Philips Medical Systems (Cleveland) Inc2013-02-26
Positron Emission Tomography (PET) and X-ray Computed Tomography, GEMINI TF 16 PET/CT, GEM recall (Z-2239-2012)Philips Medical Systems (Cleveland) Inc2012-08-22
GEMINI TF 16, 64 & Big Bore Computed Tomography X-Ray Systems, M/N 882470, 882471 & 882476 recall (Z-1369-2012)Philips Medical Systems (Cleveland) Inc2012-04-05
TruFlight Select PET/CT System equipped with software version 3.5.3.10, Model #45980011166 recall (Z-1056-2012)Philips Medical Systems (Cleveland) Inc2012-02-17
GEMINI TF 16 PET/CT System & GEMINI TF 64 PET/CT System, Philips Medical Systems, Clevelan recall (Z-0937-2012)Philips Medical Systems (Cleveland) Inc2012-02-02
GEMINI TF 16 PET/CT System (with software version 3.5.1 and 3.5.1.1), Model # 882470 & GEM recall (Z-0805-2012)Philips Medical Systems (Cleveland) Inc2012-01-18
Philips GEMINI TF16 Diagnostic Imaging Systems, Model Number: 882470, 510(k) #K052640, Ser recall (Z-3199-2011)Philips Medical Systems (Cleveland) Inc2011-09-13
Philips GEMINI TF64 Diagnostic Imaging Systems, Model Number: 882471, 510(k) #K052640, Ser recall (Z-3200-2011)Philips Medical Systems (Cleveland) Inc2011-09-13
Respiratory Gating System, Catalog Number: NPTA540, Model #4535 674 26701, for the followi recall (Z-0287-2010)Philips Medical Systems (Cleveland) Inc2009-11-17
GEMINI PET/CT Systems Upper Patient Pallet for the GEMINI TF, 16, 64, and 16 Base Slice co recall (Z-0261-2010)Philips Medical Systems (Cleveland) Inc2009-11-13
TumorLoc Software Application for the EBW (Extended Brilliance Workstation, Model # 455011 recall (Z-1580-2009)Philips Medical Systems (Cleveland) Inc2009-07-06
Philips Medical Systems, GEMINI TF 16 & 64 slice PET/CT Systems, diagnostic imaging system recall (Z-0461-2008)Philips Medical Systems (Cleveland) Inc2008-01-31
Philips Medical Systems, GEMINI GXL 6, 10, & 16 slice PET/CT Systems, diagnostic imaging s recall (Z-0462-2008)Philips Medical Systems (Cleveland) Inc2008-01-31

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