550 TXT TREATMENT TABLE— 510(k) K050422

Name: FDA 510(k) clearance K050422
Creator: U.S. Food and Drug Administration
Published: 2005-03-18

Substantially Equivalent

Siemens Medical Solutions USA, Inc.

FDA 510(k) clearance K050422 for 550 TXT TREATMENT TABLE, Substantially Equivalent on 2005-03-18. Applicant: Siemens Medical Solutions USA, Inc.. Device class: 2.

Clearance details

Applicant: Siemens Medical Solutions USA, Inc.
Product code: Code JAI
Device class: Class 2
Regulation: 21 CFR 892.5770
Advisory panel: Radiology
Date received: 2005-02-18
Decision date: 2005-03-18
Decision: Substantially Equivalent
Clearance type: Special
Location: Concord, CA, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K050422

K-number listed on FDA's recall record

Z-0787-2014 — PRIMUS, ONCOR, ARTISTE Linac systems with component 550 TxT Treatment Table. TT-A, TT-D, TT-M or TT-S Table tops. Manufactured by: SIEMENS AG, MEDICAL SOLUTIONS Roentgenstrasse 19-21 Kemnath, GERMANY 95478 The intended use of the SIEMENS branded, ARTISTE", ONCOR" and PRIMUS" family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.Class II·Terminated·Siemens Medical Solutions USA, Inc·20131205

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K050422.

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

Clearance details

Recent devices under product code JAI

More clearances from Siemens Medical Solutions USA, Inc.

Recalls naming K050422