Medical Device Manufacturer · US , Twinsburg , OH

Smv America - FDA 510(k) Cleared Devices

7 submissions · 7 cleared · Since 1997

Recent clearances: CEDARS-SINAI BPGS AND MOCO, QPS (QUANTITATIVE PERFUSION SPECT), QGS (QUANTITATIVE GATED SPECT), DS DS I-SERIES

View 7 510(k) Devices ↓

7

Total

7

Cleared

0

Denied

FDA 510(k) Regulatory Record - Smv America Radiology ✕

7 devices

1-7 of 7

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

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