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FDA 510(k)

DR 600 with Tomosynthesis

K-Number: K193262 · 2020-03-09

ApplicantAgfa N.V.
Decision Date2020-03-09
Product CodeIZF
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DR 600 with Tomosynthesis is the device name listed in this FDA 510(k) record. The listed applicant is Agfa N.V.. It received FDA 510(k) clearance on 2020-03-09 under 510(k) number K193262. The device is classified under product code IZF. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DR 600 with Tomosynthesis?

DR 600 with Tomosynthesis is a medical device that received FDA 510(k) clearance on 2020-03-09. The listed applicant is Agfa N.V.. The 510(k) number is K193262.

When did DR 600 with Tomosynthesis receive FDA 510(k) clearance?

DR 600 with Tomosynthesis received FDA 510(k) clearance on 2020-03-09, under 510(k) number K193262.

Who is the listed applicant for DR 600 with Tomosynthesis?

The FDA 510(k) record lists Agfa N.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DR 600 with Tomosynthesis?

The FDA product code for DR 600 with Tomosynthesis is IZF.

Other records listing Agfa N.V. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K213469VALORYK212145DR 800 with DSA, DR 800K211790DX-D Imaging Package with XD DetectorsK191884DR 100sK183275DR 800 with Tomosynthesis

Related Devices (Code: IZF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252649TAP2DNano-X Imaging , Ltd.K252133Adaptix Ortho350Adaptix LimitedK250850Nanox.ARC XNano-X Imaging , Ltd.K242395Nanox.ARCNano-X Imaging , Ltd.K222934Nanox.ARCNano-X Imaging , Ltd.K221949Ortho Device, ADAPTIX 3D Orthopedic Imaging SystemPausch Medical GmbH

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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