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FDA 510(k)

SOMATOM DEFINITION

K-Number: K052216 · 2005-09-08

ApplicantSiemens Medical Systems, Inc.
Decision Date2005-09-08
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SOMATOM DEFINITION is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Medical Systems, Inc.. It received FDA 510(k) clearance on 2005-09-08 under 510(k) number K052216. 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?

SOMATOM DEFINITION is a medical device that received FDA 510(k) clearance on 2005-09-08. The listed applicant is Siemens Medical Systems, Inc.. The 510(k) number is K052216.

When did SOMATOM DEFINITION receive FDA 510(k) clearance?

SOMATOM DEFINITION received FDA 510(k) clearance on 2005-09-08, under 510(k) number K052216.

Who is the listed applicant for SOMATOM DEFINITION?

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

What is the FDA product code for SOMATOM DEFINITION?

The FDA product code for SOMATOM DEFINITION is JAK.

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Other records listing Siemens Medical Systems, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K123540SYNGO CT PULMO 3DK123541SYNGO.CT NEURO PERFUSIONK122909SYNGO SINGLE SOURCE DUAL ENGERYK122471SOMATOM DEFINITIONK120579SOMATOM DEFINITION EDGEK121072SOMATOM DEFINITION FLASH

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Related Devices (Code: 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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