FDA 510(k)

GE DISCOVERY NM/CT 570C

K-Number: K083504 · 2008-12-12

Decision Date2008-12-12

Product CodeKPS

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

GE DISCOVERY NM/CT 570C is the device name listed in this FDA 510(k) record. The listed applicant is Ge Medical Systems F.I. Haifa. It received FDA 510(k) clearance on 2008-12-12 under 510(k) number K083504. 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 DISCOVERY NM/CT 570C?

GE DISCOVERY NM/CT 570C is a medical device that received FDA 510(k) clearance on 2008-12-12. The listed applicant is Ge Medical Systems F.I. Haifa. The 510(k) number is K083504.

When did GE DISCOVERY NM/CT 570C receive FDA 510(k) clearance?

GE DISCOVERY NM/CT 570C received FDA 510(k) clearance on 2008-12-12, under 510(k) number K083504.

Who is the listed applicant for GE DISCOVERY NM/CT 570C?

The FDA 510(k) record lists Ge Medical Systems F.I. Haifa as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GE DISCOVERY NM/CT 570C?

The FDA product code for GE DISCOVERY NM/CT 570C is KPS.

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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.