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FDA 510(k)

JUMBO DIGITAL GAMMACAMERA GCA-90B WI & W2

K-Number: K853470 · 1985-11-19

ApplicantToshiba Medical Systems
Decision Date1985-11-19
Product CodeIYX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

JUMBO DIGITAL GAMMACAMERA GCA-90B WI & W2 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 1985-11-19 under 510(k) number K853470. 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 JUMBO DIGITAL GAMMACAMERA GCA-90B WI & W2?

JUMBO DIGITAL GAMMACAMERA GCA-90B WI & W2 is a medical device that received FDA 510(k) clearance on 1985-11-19. The listed applicant is Toshiba Medical Systems. The 510(k) number is K853470.

When did JUMBO DIGITAL GAMMACAMERA GCA-90B WI & W2 receive FDA 510(k) clearance?

JUMBO DIGITAL GAMMACAMERA GCA-90B WI & W2 received FDA 510(k) clearance on 1985-11-19, under 510(k) number K853470.

Who is the listed applicant for JUMBO DIGITAL GAMMACAMERA GCA-90B WI & W2?

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 JUMBO DIGITAL GAMMACAMERA GCA-90B WI & W2?

The FDA product code for JUMBO DIGITAL GAMMACAMERA GCA-90B WI & W2 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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