CS 8100 CS 8100 ACCESS— 510(k) K120975

Substantially Equivalent

Trophy

FDA 510(k) clearance K120975 for CS 8100 CS 8100 ACCESS, Substantially Equivalent on 2012-06-22. Applicant: Trophy. Device class: 2.

Clearance details

Applicant: Trophy
Product code: Code MUH
Device class: Class 2
Regulation: 21 CFR 872.1800
Advisory panel: Dental
Date received: 2012-04-02
Decision date: 2012-06-22
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 K120975

K-number listed on FDA's recall record

Z-1377-2015 — CS 8100, CATALOG # (s): 5303045, 5311129, 5303060, 5303110 Intended to produce complete or segmented tomographic digital panoramic X-ray images to be used at the direction of healthcare professionals of the dento-maxillo-facial region of the human anatomy 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 K120975.

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