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FDA 510(k)

ROTA CAMERA

K-Number: K811715 · 1981-07-20

ApplicantSiemens Gammasonics, Inc.
Decision Date1981-07-20
Product CodeIYX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ROTA CAMERA is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Gammasonics, Inc.. It received FDA 510(k) clearance on 1981-07-20 under 510(k) number K811715. 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 ROTA CAMERA?

ROTA CAMERA is a medical device that received FDA 510(k) clearance on 1981-07-20. The listed applicant is Siemens Gammasonics, Inc.. The 510(k) number is K811715.

When did ROTA CAMERA receive FDA 510(k) clearance?

ROTA CAMERA received FDA 510(k) clearance on 1981-07-20, under 510(k) number K811715.

Who is the listed applicant for ROTA CAMERA?

The FDA 510(k) record lists Siemens Gammasonics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ROTA CAMERA?

The FDA product code for ROTA CAMERA is IYX.

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Other records listing Siemens Gammasonics, Inc. as applicant

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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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