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Panels › Radiology › Product code KPS · Class 2

System, Tomography, Computed, Emission

Regulation 892.1200

9510(k)s in 12 months (473 all time)
9recalls in 12 months (450 all time)
435recalls that name a 510(k)
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Top companies in KPS

Company510(k)sRecalls
Siemens Medical Solutions USA, Inc.46137
Philips Medical Systems (Cleveland), Inc.20110
GE Healthcare1275
Ge Medical Systems Israel, Functional Imaging239
GE Medical Systems2713
Adac Laboratories350
Shanghai United Imaging Healthcare Co., Ltd.1814
Philips Medical Systems028
Cti Pet Systems, Inc.184
Trionix Research Laboratory, Inc.161
Decided510(k)Device and applicantCode
May 2, 1990K900892MICRODELTA, GATED SINGLE PHOTON (SPECT) PACKAGE
Siemens Gammasonics, Inc.
KPS
Apr 4, 1990K901019DIACAM GAMMA CAMERA SYSTEM
Siemens Gammasonics, Inc.
KPS
Dec 22, 1989K896458ASPECT GAMMA CAMERA
Digital Scintigraphics, Inc.
KPS
Nov 15, 1989K894056POSITRON EMISSION COMPUTED TOMOGRAPH SET-1400W
Shimadzu Medical Systems
KPS
Nov 2, 1989K894998MODIFIED POSICAM SYSTEM MODEL 6.5
Positron
KPS
Aug 23, 1989K892358PEGASYS NUCLEAR MEDICINE IMAGING COMPUTER
Adac Laboratories
KPS
Jul 20, 1989K892875BIAD NUCLEAR IMAGING SYSTEM
Trionix Research Laboratory, Inc.
KPS
Apr 17, 1989K891266NEUROFOCAL COLLIMATOR
Siemens Gammasonics, Inc.
KPS
Apr 13, 1989K890100PENN-PET SCANNER
Ugm Medical Systems, Inc.
KPS
Dec 22, 1988K884349ADAC VIEWPOINT (ADDITIONAL SOFTWARE)
Adac Laboratories
KPS
Nov 16, 1988K875378SINGLE PHOTON SET 031 & AZ-701-NTS-SP EMISSION
Shimadzu Precision Instruments, Inc.
KPS
Jan 19, 1988K873775TRIAD NUCLEAR IMAGING SYSTEM
Trionix Research Laboratory, Inc.
KPS
Jul 10, 1987K862511TOMOMATIC 232
Medimatic
KPS
Apr 16, 1986K861252NON-CIRCULAR ORBITING OPTION
Siemens Gammasonics, Inc.
KPS
Sep 20, 1985K850416TOMOMATIC 564
M.I.D., Inc.
KPS
Sep 3, 1985K852239POSICAM TM(MODEL 3.2,4.3,6.5)
Position Corp.
KPS
Nov 21, 1984K843366SUPERPETT
Scanditronix, Inc.
KPS
Apr 10, 1981K810589NEURO-ECAT
Eg&G Ortec, Inc.
KPS
Jan 15, 1981K802801GE RT/PLAN MAGNETIC TAPE DRIVE OPTION
General Electric Co.
KPS
Sep 17, 1979K791055ADAC TOMOGRAPHY OPTION
Adac Laboratories
KPS
Feb 15, 1979K790169TOMOGRAPHIC PROGRAMS
Cmsi
KPS
Nov 3, 1978K781753TOMOGSCANNER 2
Tomogscanner OK , Ltd.
KPS
Feb 28, 1977K770220RADIONUCLIDE COMPUTED TOMOGRAPHY SYS.
G.D. Searle and Co.
KPS

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