Smv America - FDA 510(k) Cleared Devices
Recent clearances: TAC-2, TRANSMISSION ATTENUATION CORRECTION AND DST, DST-XL GAMMA CAMERAS AND VISION POWER STATION COMPUTER, FOR USE IN S, VCAR OPTION TO THE DST AND DST-XL GAMMA CAMERAS AND VISION POWERSTATION COMPUTER, VCAR OPTION TO VISION FX-80 GAMMA CAMERA AND POWER STATION
7
Total
7
Cleared
0
Denied
FDA 510(k) Regulatory Record - Smv America Radiology ✕
7 devices
Cleared
Apr 27, 2001
CEDARS-SINAI BPGS AND MOCO
Radiology
65d
Cleared
Jan 19, 2001
QPS (QUANTITATIVE PERFUSION SPECT), QGS (QUANTITATIVE GATED SPECT)
Radiology
85d
Cleared
Sep 15, 2000
DS DS I-SERIES
Radiology
29d
Cleared
Aug 25, 2000
POSITRACE DUAL MODE PET/CT ONCOLOGY SYSTEM
Radiology
85d
Cleared
Aug 02, 1999
TAC-2, TRANSMISSION ATTENUATION CORRECTION AND DST, DST-XL GAMMA CAMERAS AND...
Radiology
89d
Cleared
Oct 14, 1997
VCAR OPTION TO THE DST AND DST-XL GAMMA CAMERAS AND VISION POWERSTATION COMPUTER
Radiology
89d
Cleared
Mar 11, 1997
VCAR OPTION TO VISION FX-80 GAMMA CAMERA AND POWER STATION
Radiology
203d