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510(k) K212145

DR 800 with DSA, DR 800 by Agfa N.V. — Product Code JAA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 31, 2021
Date Received
July 9, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Fluoroscopic, Image-Intensified
Device Class
Class II
Regulation Number
892.1650
Review Panel
RA
Submission Type

Other clearances by Agfa N.V.

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  • K191884 — DR 100s (August 9, 2019)
  • K183275 — DR 800 with Tomosynthesis (February 1, 2019)

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  • K220871 — Nautilus (April 18, 2022)
  • K212890 — Nyquist.IQ (December 13, 2021)
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