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FDA 510(k)

SOMATOM DEFINITION, MODEL AS/AS+

K-Number: K081022 · 2008-06-02

ApplicantSiemens Medical Solutions USA, Inc.
Decision Date2008-06-02
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SOMATOM DEFINITION, MODEL AS/AS+ 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 2008-06-02 under 510(k) number K081022. 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 SOMATOM DEFINITION, MODEL AS/AS+?

SOMATOM DEFINITION, MODEL AS/AS+ is a medical device that received FDA 510(k) clearance on 2008-06-02. The listed applicant is Siemens Medical Solutions USA, Inc.. The 510(k) number is K081022.

When did SOMATOM DEFINITION, MODEL AS/AS+ receive FDA 510(k) clearance?

SOMATOM DEFINITION, MODEL AS/AS+ received FDA 510(k) clearance on 2008-06-02, under 510(k) number K081022.

Who is the listed applicant for SOMATOM DEFINITION, MODEL AS/AS+?

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 SOMATOM DEFINITION, MODEL AS/AS+?

The FDA product code for SOMATOM DEFINITION, MODEL AS/AS+ is JAK.

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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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