CS 8100 3D— 510(k) K133406

Substantially Equivalent

Trophy

FDA 510(k) clearance K133406 for CS 8100 3D, Substantially Equivalent on 2014-03-14. Applicant: Trophy. Device class: 2.

Clearance details

Applicant: Trophy
Product code: Code OAS
Device class: Class 2
Regulation: 21 CFR 892.1750
Advisory panel: Radiology
Date received: 2013-11-06
Decision date: 2014-03-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marne La Vallee Cedex 2, FR

Download summary PDF View on FDA.gov ↗

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Recalls naming K133406

K-number listed on FDA's recall record

Z-1378-2015 — CS 8100 3D, CATALOG # (s): 5311162, 5311188. Intended to produce complete or segmented tomographic digital panoramic X-ray images and three-dimensional digital X-ray images of the dentomaxillo-facial area to be used at the direction of healthcare professionals as diagnostic support for pediatric and adult patient.Class II·Terminated·Carestream Health, Inc.·20150108

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K133406.

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