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FDA 510(k)

OSTEO CT FOR THE SOMATOM AR FAMILY AND PLUS 4 CT SYSTEMS

K-Number: K971054 · 1997-06-13

ApplicantSiemens Medical Solutions USA, Inc.
Decision Date1997-06-13
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

OSTEO CT FOR THE SOMATOM AR FAMILY AND PLUS 4 CT SYSTEMS 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 1997-06-13 under 510(k) number K971054. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OSTEO CT FOR THE SOMATOM AR FAMILY AND PLUS 4 CT SYSTEMS?

OSTEO CT FOR THE SOMATOM AR FAMILY AND PLUS 4 CT SYSTEMS is a medical device that received FDA 510(k) clearance on 1997-06-13. The listed applicant is Siemens Medical Solutions USA, Inc.. The 510(k) number is K971054.

When did OSTEO CT FOR THE SOMATOM AR FAMILY AND PLUS 4 CT SYSTEMS receive FDA 510(k) clearance?

OSTEO CT FOR THE SOMATOM AR FAMILY AND PLUS 4 CT SYSTEMS received FDA 510(k) clearance on 1997-06-13, under 510(k) number K971054.

Who is the listed applicant for OSTEO CT FOR THE SOMATOM AR FAMILY AND PLUS 4 CT SYSTEMS?

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 OSTEO CT FOR THE SOMATOM AR FAMILY AND PLUS 4 CT SYSTEMS?

The FDA product code for OSTEO CT FOR THE SOMATOM AR FAMILY AND PLUS 4 CT SYSTEMS is JAK.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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