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FDA 510(k)

SOMATOM FLASH DS

K-Number: K082220 · 2008-10-10

ApplicantSiemens Medical Solutions USA, Inc.
Decision Date2008-10-10
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SOMATOM FLASH DS 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 2008-10-10 under 510(k) number K082220. 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 FLASH DS?

SOMATOM FLASH DS is a medical device that received FDA 510(k) clearance on 2008-10-10. The listed applicant is Siemens Medical Solutions USA, Inc.. The 510(k) number is K082220.

When did SOMATOM FLASH DS receive FDA 510(k) clearance?

SOMATOM FLASH DS received FDA 510(k) clearance on 2008-10-10, under 510(k) number K082220.

Who is the listed applicant for SOMATOM FLASH DS?

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 FLASH DS?

The FDA product code for SOMATOM FLASH DS 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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