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FDA 510(k)

SYNGO TRUED SOFTWARE

K-Number: K101749 · 2010-08-16

ApplicantSiemens Medical Solutions
Decision Date2010-08-16
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SYNGO TRUED SOFTWARE is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Medical Solutions. It received FDA 510(k) clearance on 2010-08-16 under 510(k) number K101749. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYNGO TRUED SOFTWARE?

SYNGO TRUED SOFTWARE is a medical device that received FDA 510(k) clearance on 2010-08-16. The listed applicant is Siemens Medical Solutions. The 510(k) number is K101749.

When did SYNGO TRUED SOFTWARE receive FDA 510(k) clearance?

SYNGO TRUED SOFTWARE received FDA 510(k) clearance on 2010-08-16, under 510(k) number K101749.

Who is the listed applicant for SYNGO TRUED SOFTWARE?

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

What is the FDA product code for SYNGO TRUED SOFTWARE?

The FDA product code for SYNGO TRUED SOFTWARE is LLZ.

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Other records listing Siemens 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.

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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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