DR 600 with Tomosynthesis— 510(k) K193262

Substantially Equivalent

Agfa N.V.

FDA 510(k) clearance K193262 for DR 600 with Tomosynthesis, Substantially Equivalent on 2020-03-09. Applicant: Agfa N.V.. Device class: 2.

Clearance details

Applicant: Agfa N.V.
Product code: Code IZF
Device class: Class 2
Regulation: 21 CFR 892.1740
Advisory panel: Radiology
Date received: 2019-11-26
Decision date: 2020-03-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mortsel, BE

Download summary PDF View on FDA.gov ↗

Recent devices under product code IZF

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