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..

Clearance details

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

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