SYNGO DOSIMETRIST WORKSPACE V2.7 MODEL: 1056864— 510(k) K101119

Name: FDA 510(k) clearance K101119
Creator: U.S. Food and Drug Administration
Published: 2010-06-16

Substantially Equivalent

Siemens Medical Solutions USA, Inc.

FDA 510(k) clearance K101119 for SYNGO DOSIMETRIST WORKSPACE V2.7 MODEL: 1056864, Substantially Equivalent on 2010-06-16. Applicant: Siemens Medical Solutions USA, Inc.. Device class: 2.

Clearance details

Applicant: Siemens Medical Solutions USA, Inc.
Product code: Code MUJ
Device class: Class 2
Regulation: 21 CFR 892.5050
Advisory panel: Radiology
Date received: 2010-04-21
Decision date: 2010-06-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Concord, CA, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K101119

K-number listed on FDA's recall record

Z-2075-2014 — Siemens syngo RT Dosimetrist 2.7 system Product Usage: The intended use of syngo Suite for Oncology Systems is as an accessory to the linear accelerator system to aid and support in the planning and delivery of x-ray radiation for the therapeutic treatment of cancer.Class II·Terminated·Siemens Medical Solutions USA, Inc·20140515

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K101119.

Data sourced from openFDA. This site is unofficial and independent of the FDA.

Clearance details

Recent devices under product code MUJ

More clearances from Siemens Medical Solutions USA, Inc.

Recalls naming K101119