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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 a medical device manufactured by Agfa N.V.. It received FDA 510(k) clearance on 2020-03-09 under approval 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. It is manufactured by Agfa N.V.. The 510(k) number is K193262.

When was DR 600 with Tomosynthesis approved by the FDA?

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

What company makes DR 600 with Tomosynthesis?

DR 600 with Tomosynthesis is manufactured by Agfa N.V..

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

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

Other Devices by Agfa N.V.

K191884DR 100s K183275DR 800 with Tomosynthesis K213469VALORY K212145DR 800 with DSA, DR 800 K211790DX-D Imaging Package with XD Detectors

Related Devices (Code: IZF)

K183275DR 800 with TomosynthesisAgfa N.V. K213081CLISIS SYSTEMS, Discovery RF180General Medical Merate S.P.A K222934Nanox.ARCNano-X Imaging , Ltd. K221949Ortho Device, ADAPTIX 3D Orthopedic Imaging SystemPausch Medical GmbH K242395Nanox.ARCNano-X Imaging , Ltd. K252133Adaptix Ortho350Adaptix Limited

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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