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FDA 510(k)

SYNGO DOSIMETRIST WORKSPACE V2.7 MODEL: 1056864

K-Number: K101119 · 2010-06-16

Decision Date2010-06-16
Product CodeMUJ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SYNGO DOSIMETRIST WORKSPACE V2.7 MODEL: 1056864 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 2010-06-16 under 510(k) number K101119. The device is classified under product code MUJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYNGO DOSIMETRIST WORKSPACE V2.7 MODEL: 1056864?

SYNGO DOSIMETRIST WORKSPACE V2.7 MODEL: 1056864 is a medical device that received FDA 510(k) clearance on 2010-06-16. The listed applicant is Siemens Medical Solutions USA, Inc.. The 510(k) number is K101119.

When did SYNGO DOSIMETRIST WORKSPACE V2.7 MODEL: 1056864 receive FDA 510(k) clearance?

SYNGO DOSIMETRIST WORKSPACE V2.7 MODEL: 1056864 received FDA 510(k) clearance on 2010-06-16, under 510(k) number K101119.

Who is the listed applicant for SYNGO DOSIMETRIST WORKSPACE V2.7 MODEL: 1056864?

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 SYNGO DOSIMETRIST WORKSPACE V2.7 MODEL: 1056864?

The FDA product code for SYNGO DOSIMETRIST WORKSPACE V2.7 MODEL: 1056864 is MUJ.

Related Clinical Trials

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.

Other records listing Siemens Medical Solutions USA, 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.

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Related Devices (Code: MUJ)

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.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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