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FDA 510(k)

GAMMA CAMERAS -GXA-301 & GCA-402

K-Number: K771599 · 1977-09-20

ApplicantToshiba Medical Systems
Decision Date1977-09-20
Product CodeIYX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

GAMMA CAMERAS -GXA-301 & GCA-402 is the device name listed in this FDA 510(k) record. The listed applicant is Toshiba Medical Systems. It received FDA 510(k) clearance on 1977-09-20 under 510(k) number K771599. The device is classified under product code IYX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GAMMA CAMERAS -GXA-301 & GCA-402?

GAMMA CAMERAS -GXA-301 & GCA-402 is a medical device that received FDA 510(k) clearance on 1977-09-20. The listed applicant is Toshiba Medical Systems. The 510(k) number is K771599.

When did GAMMA CAMERAS -GXA-301 & GCA-402 receive FDA 510(k) clearance?

GAMMA CAMERAS -GXA-301 & GCA-402 received FDA 510(k) clearance on 1977-09-20, under 510(k) number K771599.

Who is the listed applicant for GAMMA CAMERAS -GXA-301 & GCA-402?

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

What is the FDA product code for GAMMA CAMERAS -GXA-301 & GCA-402?

The FDA product code for GAMMA CAMERAS -GXA-301 & GCA-402 is IYX.

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Related Devices (Code: IYX)

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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.

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