FDA 510(k)

VCAR OPTION TO VISION FX-80 GAMMA CAMERA AND POWER STATION

K-Number: K963273 · 1997-03-11

Decision Date1997-03-11

Product CodeKPS

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

VCAR OPTION TO VISION FX-80 GAMMA CAMERA AND POWER STATION is the device name listed in this FDA 510(k) record. The listed applicant is Smv America. It received FDA 510(k) clearance on 1997-03-11 under 510(k) number K963273. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VCAR OPTION TO VISION FX-80 GAMMA CAMERA AND POWER STATION?

VCAR OPTION TO VISION FX-80 GAMMA CAMERA AND POWER STATION is a medical device that received FDA 510(k) clearance on 1997-03-11. The listed applicant is Smv America. The 510(k) number is K963273.

When did VCAR OPTION TO VISION FX-80 GAMMA CAMERA AND POWER STATION receive FDA 510(k) clearance?

VCAR OPTION TO VISION FX-80 GAMMA CAMERA AND POWER STATION received FDA 510(k) clearance on 1997-03-11, under 510(k) number K963273.

Who is the listed applicant for VCAR OPTION TO VISION FX-80 GAMMA CAMERA AND POWER STATION?

The FDA 510(k) record lists Smv America as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VCAR OPTION TO VISION FX-80 GAMMA CAMERA AND POWER STATION?

The FDA product code for VCAR OPTION TO VISION FX-80 GAMMA CAMERA AND POWER STATION is KPS.

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Other records listing Smv America as applicant

K010509CEDARS-SINAI BPGS AND MOCO K003358QPS (QUANTITATIVE PERFUSION SPECT), QGS (QUANTITATIVE GATED SPECT)K002553DS DS I-SERIES K001681POSITRACE DUAL MODE PET/CT ONCOLOGY SYSTEM K991565TAC-2, TRANSMISSION ATTENUATION CORRECTION AND DST, DST-XL GAMMA CAMERAS AND VISION POWER STATION COMPUTER, FOR USE IN S K972686VCAR OPTION TO THE DST AND DST-XL GAMMA CAMERAS AND VISION POWERSTATION COMPUTER

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Related Devices (Code: KPS)

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.