FDA 510(k)

SUMMIT NUCLEAR VISION FX 20 SERIES GAMMA CAMERA SYSTEMS

K-Number: K935318 · 1994-02-25

Decision Date1994-02-25

Product CodeKPS

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

SUMMIT NUCLEAR VISION FX 20 SERIES GAMMA CAMERA SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is Summit Nuclear. It received FDA 510(k) clearance on 1994-02-25 under 510(k) number K935318. 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 SUMMIT NUCLEAR VISION FX 20 SERIES GAMMA CAMERA SYSTEMS?

SUMMIT NUCLEAR VISION FX 20 SERIES GAMMA CAMERA SYSTEMS is a medical device that received FDA 510(k) clearance on 1994-02-25. The listed applicant is Summit Nuclear. The 510(k) number is K935318.

When did SUMMIT NUCLEAR VISION FX 20 SERIES GAMMA CAMERA SYSTEMS receive FDA 510(k) clearance?

SUMMIT NUCLEAR VISION FX 20 SERIES GAMMA CAMERA SYSTEMS received FDA 510(k) clearance on 1994-02-25, under 510(k) number K935318.

Who is the listed applicant for SUMMIT NUCLEAR VISION FX 20 SERIES GAMMA CAMERA SYSTEMS?

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

What is the FDA product code for SUMMIT NUCLEAR VISION FX 20 SERIES GAMMA CAMERA SYSTEMS?

The FDA product code for SUMMIT NUCLEAR VISION FX 20 SERIES GAMMA CAMERA SYSTEMS is KPS.

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Other records listing Summit Nuclear as applicant

K935273VISION FX 40 & 80 SERIES GAMMA CAMERA K922427SUMMIT NUCLEAR VISION 1024RZ GAMMA CAMERA SYSTEM K922426SUMMIT NUCLEAR VISION T-22 GAMMA CAMERA SYSTEM K920958SUMMIT NUCLEAR VISION NEUROSPECT K912573VISION (NUCLEAR MEDICINE COMPUTER)

Related Devices (Code: KPS)

Official Source

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