Gemini 16

• • Terminated Z-0197-2016 FDA Class II ·initiated 1 May 2008 ·on shared 510(k) K032036

  The reason for this inspection is to determine if the Spindle Block Servo Controllers on the CT subsystem of potentially affected GEMINI PET/CT systems are susceptible to premature failure.

• • Terminated Z-1418-05 FDA Unclassified (pre-2012) ·initiated 11 Mar 2005 ·on shared 510(k) K032036

  When two product applications called Flip and Secondary Capture are used together, it is possible for image orientation labels to be incorrect.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

1. 11 Jul 2003 Cleared FDA 510(k) K032036
2. 11 Mar 2005 Recall initiated FDA recalls Z-1418-05
3. 1 May 2008 Recall initiated FDA recalls Z-0197-2016

510(k) Number

K032036 ↗

FDA product code

KPS

Device class

Class II

Regulation

21 CFR Part 892.1200

Advisory committee

Radiology

FDA decision

SESE Substantially Equivalent

Other devices filed under FDA product code KPS (System, Tomography, Computed, Emission).

• BIOGRAPH MCT FAMILY by SIEMENS MEDICAL SOLUTIONS USA, INC.
• HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERA SYSTEM WITH THICK NAL(TI) CRYSTAL by Hitachi Medical Corp. of America
• MPOWER, MODEL 712 SERIES by Positron Corp.
• Imaging system of positron emission and X-ray computed tomography (DigitMI 930) by Raysolution Healthcare Co., Ltd.
• Biograph Horizon PET/CT and Biograph mCT PET/CT and Biograph mCT Flow PET/CT by SIEMENS MEDICAL SOLUTIONS USA, INC.
• Hybrid3D by Hermes Medical Solutions AB
• CARDIAC TRIAD NEW DETECTOR OPTION by Trionix Research Laboratory, Inc.
• CEDARS-SINAI BPGS AND MOCO by Smv America
• ISOCAM II (DUAL HEAD GAMMA CAMERA) by Independent Scintilation Imaging Systems, Inc.
• IMAGENPRO by Cardiovascular Imaging Technologies

• IQon Spectral CT Open recall

  Class II

  FDA 510(k) K163711 Active Cleared 5 Apr 2017

• Philips CT Big Bore Open recall

  Class II

  FDA 510(k) K171850 Active Cleared 9 Nov 2017

• Philips 459801630821 Open recall

  Class II

  FDA 510(k) K170086 Active Cleared 9 Feb 2017 GUDID on market

• Pinnacle Radiation Therapy Planning System 18.0 Open recall

  Class II

  FDA 510(k) K170086 Active Cleared 9 Feb 2017 GUDID on market

See all devices from Philips Medical Systems (Cleveland), Inc. →