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FDA 510(k)

SYNGO.CT CORONARY ANALYSIS

K-Number: K100637 · 2010-05-26

ApplicantSiemens AG Medical Solutions
Decision Date2010-05-26
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SYNGO.CT CORONARY ANALYSIS is the device name listed in this FDA 510(k) record. The listed applicant is Siemens AG Medical Solutions. It received FDA 510(k) clearance on 2010-05-26 under 510(k) number K100637. 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 SYNGO.CT CORONARY ANALYSIS?

SYNGO.CT CORONARY ANALYSIS is a medical device that received FDA 510(k) clearance on 2010-05-26. The listed applicant is Siemens AG Medical Solutions. The 510(k) number is K100637.

When did SYNGO.CT CORONARY ANALYSIS receive FDA 510(k) clearance?

SYNGO.CT CORONARY ANALYSIS received FDA 510(k) clearance on 2010-05-26, under 510(k) number K100637.

Who is the listed applicant for SYNGO.CT CORONARY ANALYSIS?

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

What is the FDA product code for SYNGO.CT CORONARY ANALYSIS?

The FDA product code for SYNGO.CT CORONARY ANALYSIS is JAK.

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Other records listing Siemens AG Medical Solutions 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.

K123920SYNGO.VIAK120331SYNGO CT DYNAMIC ANGIOK111079SYNGO.VIA WEB VIEWERK101666SYNGO. PLAZA VA20AK093612SYNGO.PLAZAK092067ABVS WORKPLACE

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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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