FDA 510(k)

GE VISION NUCLEAR MEDICINE WORKSTATION

K-Number: K012568 · 2001-09-06

Decision Date2001-09-06

Product CodeKPS

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

GE VISION NUCLEAR MEDICINE WORKSTATION is the device name listed in this FDA 510(k) record. The listed applicant is General Electric Co.. It received FDA 510(k) clearance on 2001-09-06 under 510(k) number K012568. 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 GE VISION NUCLEAR MEDICINE WORKSTATION?

GE VISION NUCLEAR MEDICINE WORKSTATION is a medical device that received FDA 510(k) clearance on 2001-09-06. The listed applicant is General Electric Co.. The 510(k) number is K012568.

When did GE VISION NUCLEAR MEDICINE WORKSTATION receive FDA 510(k) clearance?

GE VISION NUCLEAR MEDICINE WORKSTATION received FDA 510(k) clearance on 2001-09-06, under 510(k) number K012568.

Who is the listed applicant for GE VISION NUCLEAR MEDICINE WORKSTATION?

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

What is the FDA product code for GE VISION NUCLEAR MEDICINE WORKSTATION?

The FDA product code for GE VISION NUCLEAR MEDICINE WORKSTATION is KPS.

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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.