AXIOM ARISTOS FX PLUS— 510(k) K061054

Name: FDA 510(k) clearance K061054
Creator: U.S. Food and Drug Administration
Published: 2006-05-09

Substantially Equivalent

Siemens Medical Solutions USA, Inc.

FDA 510(k) clearance K061054 for AXIOM ARISTOS FX PLUS, Substantially Equivalent on 2006-05-09. Applicant: Siemens Medical Solutions USA, Inc.. Device class: 2.

Clearance details

Applicant: Siemens Medical Solutions USA, Inc.
Product code: Code MQB
Device class: Class 2
Regulation: 21 CFR 892.1680
Advisory panel: Radiology
Date received: 2006-04-17
Decision date: 2006-05-09
Decision: Substantially Equivalent
Clearance type: Special
Location: Malvern, PA, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K061054

K-number listed on FDA's recall record

Z-1765-2020 — System AXIOM Aristos FX Plus - A dedicated x-ray system with a flat panel detector which allows the acquisition of x-ray exposures without the use of conventional film/screen systems; and allows radiographic exposures of the whole body including skull, spinal column, chest, abdomen, and extremities. It is not designed for mammography use. Radiographic exposures may be taken with the patient in the sitting, standing, or supine positions.Class II·Terminated·Siemens Medical Solutions USA, Inc·20200406

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K061054.

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Clearance details

Recent devices under product code MQB

More clearances from Siemens Medical Solutions USA, Inc.

Recalls naming K061054