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FDA 510(k)

RADIOTOM 804

K-Number: K844428 · 1985-02-20

ApplicantSiemens Medical Solutions USA, Inc.
Decision Date1985-02-20
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

RADIOTOM 804 is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Medical Solutions USA, Inc.. It received FDA 510(k) clearance on 1985-02-20 under 510(k) number K844428. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RADIOTOM 804?

RADIOTOM 804 is a medical device that received FDA 510(k) clearance on 1985-02-20. The listed applicant is Siemens Medical Solutions USA, Inc.. The 510(k) number is K844428.

When did RADIOTOM 804 receive FDA 510(k) clearance?

RADIOTOM 804 received FDA 510(k) clearance on 1985-02-20, under 510(k) number K844428.

Who is the listed applicant for RADIOTOM 804?

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

What is the FDA product code for RADIOTOM 804?

The FDA product code for RADIOTOM 804 is GEI.

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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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