Company ยท US
Siemens Gammasonics, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1981 to 1994. Name variants (Inc, Corp, punctuation) are merged.
53510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| IYX | Camera, Scintillation (Gamma) | 11 |
| KPS | System, Tomography, Computed, Emission | 9 |
| LLZ | System, Image Processing, Radiological | 7 |
| IZI | System, X-Ray, Angiographic | 5 |
| JWM | System, Tomographic, Nuclear | 4 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 3 |
| IYZ | Bed, Scanning, Nuclear | 3 |
| LMC | Camera, Multi Format, Radiological | 3 |
| LMD | System, Digital Image Communications, Radiological | 3 |
| ITX | Transducer, Ultrasonic, Diagnostic | 1 |
| IXY | Holder, Radiographic Cassette, Wall-Mounted | 1 |
| JAK | System, X-Ray, Tomography, Computed | 1 |
| JAM | Scanner, Whole Body, Nuclear | 1 |
| KGI | Densitometer, Bone | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 18, 1994 | K934766 | CARBON FIBER PALLET Siemens Gammasonics, Inc. | IYX |
| Dec 15, 1993 | K933664 | POLYTRON T.O.P. (TIME, OPERATION, PERFORMANCE) Siemens Gammasonics, Inc. | IZI |
| Oct 29, 1993 | K933256 | FAN BEAM COLLIMATOR Siemens Gammasonics, Inc. | IYX |
| Oct 20, 1992 | K920319 | SIENET IMAGE DISPLAY WORKSTATIONS, IMAGE ACQUISITI Siemens Gammasonics, Inc. | LLZ |
| Oct 14, 1992 | K923582 | SIENET CAMERA SERVER Siemens Gammasonics, Inc. | LMD |
| Aug 17, 1992 | K922373 | MULTISPECT(TM) 2 DUAL DETECTOR CAMERA SYSTEM Siemens Gammasonics, Inc. | KPS |
| Aug 17, 1992 | K922372 | MULTISPECT(TM) 3 TRIPLE DETECTOR CAMERA SYSTEM Siemens Gammasonics, Inc. | KPS |
| Mar 30, 1992 | K920310 | SIENET ARCHIVE SERVER, ISA I, ISA II STORAGE SERVE Siemens Gammasonics, Inc. | LMD |
| Mar 20, 1992 | K920309 | SIENET DIAGNOSTIC REPORTING CONSOLE Siemens Gammasonics, Inc. | LLZ |
| Nov 27, 1991 | K914313 | HICOR Siemens Gammasonics, Inc. | IZI |
| Nov 22, 1991 | K914350 | ICON COMPUTER SYSTEM Siemens Gammasonics, Inc. | JWM |
| Oct 30, 1991 | K914179 | CARDIOFOCAL COLLIMATOR Siemens Gammasonics, Inc. | KPS |
| Oct 23, 1991 | K913630 | MULTISPECT 2 DUAL DETECTOR CAMERA SYSTEM Siemens Gammasonics, Inc. | KPS |
| Aug 26, 1991 | K913252 | LITEBOX Siemens Gammasonics, Inc. | JAK |
| Aug 2, 1991 | K912481 | ECT CARBON FIBER PALLET, MODIFICATION Siemens Gammasonics, Inc. | IYZ |
| Aug 2, 1991 | K912286 | CARDIAC SPECT PALLET Siemens Gammasonics, Inc. | IYZ |
| Jun 21, 1991 | K905074 | MICRODELTA, TC-99M-MAG3 RENAL PROCESSING PROGRAM Siemens Gammasonics, Inc. | IYX |
| Jun 17, 1991 | K911078 | MULTISPECT 3 TRIPLE DETECTOR CAMERA SYSTEM Siemens Gammasonics, Inc. | KPS |
| Jan 14, 1991 | K905199 | PACSNET RESEARCH TOOLKIT Siemens Gammasonics, Inc. | LMD |
| Jan 9, 1991 | K903315 | ICON Siemens Gammasonics, Inc. | JWM |
| Oct 1, 1990 | K903375 | HICOR Siemens Gammasonics, Inc. | IZI |
| Sep 7, 1990 | K903767 | ECT (EMMISSION COMPUTED TOMOGRAPHY) CARBON FIB PAL Siemens Gammasonics, Inc. | IYZ |
| May 2, 1990 | K900892 | MICRODELTA, GATED SINGLE PHOTON (SPECT) PACKAGE Siemens Gammasonics, Inc. | KPS |
| Apr 19, 1990 | K901158 | LITEBOX DIAGNOSTIC REVIEW WORKSTATION Siemens Gammasonics, Inc. | LLZ |
| Apr 4, 1990 | K901019 | DIACAM GAMMA CAMERA SYSTEM Siemens Gammasonics, Inc. | KPS |
| Nov 15, 1989 | K895668 | DIGICAM LHP (VIDEO INTERFACE OPTION) Siemens Gammasonics, Inc. | LMC |
| Apr 17, 1989 | K891266 | NEUROFOCAL COLLIMATOR Siemens Gammasonics, Inc. | KPS |
| Mar 30, 1989 | K885242 | MICRODELTA II Siemens Gammasonics, Inc. | IYX |
| Feb 28, 1989 | K884995 | SIEMENS PACS/1-B (OPTICAL DISK OPTION) Siemens Gammasonics, Inc. | LLZ |
| Feb 27, 1989 | K883324 | DIGICAM LHP (DIGITAL LASER HIGH PERFORMANCE) Siemens Gammasonics, Inc. | LMC |
| Feb 17, 1989 | K885318 | DIGITRON 3, LV ANALYSIS PROTCOL Siemens Gammasonics, Inc. | LLZ |
| Oct 31, 1988 | K880690 | SIEMENS PACS/I-A Siemens Gammasonics, Inc. | IZI |
| Oct 12, 1988 | K881481 | DIGITRON STENOSIS PROTOCOL Siemens Gammasonics, Inc. | LLZ |
| Sep 14, 1988 | K883072 | DIGITRON 2, DIGITAL SUBSTRACTION ANGIO. SYSTEM Siemens Gammasonics, Inc. | IZI |
| May 29, 1987 | K871778 | DIGISPOT IMAGER Siemens Gammasonics, Inc. | LMC |
| Mar 16, 1987 | K870818 | BODYSCAN Siemens Gammasonics, Inc. | IYX |
| Feb 2, 1987 | K861515 | OSTEOPAK BMD (BONE MINERAL DENSITOMETER) Siemens Gammasonics, Inc. | KGI |
| Jul 25, 1986 | K861429 | DIGITRON 3V,3VA,3VAC,3 HIGH RESOLUTION UPGRADE Siemens Gammasonics, Inc. | LLZ |
| Jun 10, 1986 | K861637 | WEIGHTED ACQUISITION MODULE Siemens Gammasonics, Inc. | IYX |
| Apr 16, 1986 | K861252 | NON-CIRCULAR ORBITING OPTION Siemens Gammasonics, Inc. | KPS |
| Feb 21, 1986 | K860454 | BASICAM S COUNTER BALANCE CAMERA Siemens Gammasonics, Inc. | IXY |
| Apr 10, 1985 | K850463 | BASICAM COUNTER BALANCE CAMERA Siemens Gammasonics, Inc. | IYX |
| Mar 26, 1985 | K850397 | ORBITOR II COUNTER BALANCE CAMERA Siemens Gammasonics, Inc. | IYX |
| Aug 27, 1984 | K842895 | WBA - I.R.I.S. Siemens Gammasonics, Inc. | JAM |
| Aug 9, 1984 | K841905 | DOT-A, DOT-AR PXP-E, PXP-ER Siemens Gammasonics, Inc. | JWM |
| Dec 27, 1983 | K833811 | CARDIAC CAMERA Siemens Gammasonics, Inc. | IYX |
| Sep 29, 1983 | K832737 | ECT PROCESSOR Siemens Gammasonics, Inc. | JWM |
| Mar 5, 1982 | K820124 | INTEGRAL SECTOR MODULE Siemens Gammasonics, Inc. | IYO |
| Nov 20, 1981 | K811842 | IMAGER 2000 REAL TIME SYSTEM Siemens Gammasonics, Inc. | IYO |
| Aug 25, 1981 | K811843 | BIOPSY TRANSDUCER Siemens Gammasonics, Inc. | ITX |
Newest 50 of 53.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||