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FDA 510(k)

DR 800 with DSA, DR 800

K-Number: K212145 · 2021-08-31

ApplicantAgfa N.V.
Decision Date2021-08-31
Product CodeJAA
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DR 800 with DSA, DR 800 is a medical device manufactured by Agfa N.V.. It received FDA 510(k) clearance on 2021-08-31 under approval number K212145. The device is classified under product code JAA. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DR 800 with DSA, DR 800?

DR 800 with DSA, DR 800 is a medical device that received FDA 510(k) clearance on 2021-08-31. It is manufactured by Agfa N.V.. The 510(k) number is K212145.

When was DR 800 with DSA, DR 800 approved by the FDA?

DR 800 with DSA, DR 800 received FDA 510(k) clearance on 2021-08-31, under approval number K212145.

What company makes DR 800 with DSA, DR 800?

DR 800 with DSA, DR 800 is manufactured by Agfa N.V..

What is the FDA product code for DR 800 with DSA, DR 800?

The FDA product code for DR 800 with DSA, DR 800 is JAA.

Other Devices by Agfa N.V.

K191884DR 100s K183275DR 800 with Tomosynthesis K193262DR 600 with Tomosynthesis K213469VALORY K211790DX-D Imaging Package with XD Detectors

Related Devices (Code: JAA)

K161019Uroview FDPausch Medical GmbH K160301Platinum dRF Imaging SystemApelem-Dms Group K163210Philips CombiDiagnost R90Philips Medical Systems Dmc GmbH K173395MECALL CLISIS SYSTEMS, Discovery RF180General Medical Merate S.P.A K180651Uroview FD IIPausch Medical GmbH K180589DR 800 with MUSICA DynamicAgfa Healthcare N.V.

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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