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510(k) K121948

CR 10-X DIGITIZER by Agfa Healthcare N.V. — Product Code MQB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 20, 2012
Date Received
July 3, 2012
Clearance Type
Special
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Solid State X-Ray Imager (Flat Panel/Digital Imager)
Device Class
Class II
Regulation Number
892.1680
Review Panel
RA
Submission Type

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Other clearances for product code MQB

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  • K243443 — EXPD 4343N1; EXPD 4343N; EXPD 4343U1; EXPD 4343NU; EXPD 4343NP; EXPD 3643N1; EXP (March 19, 2025)
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  • K244010 — ExamVue Apex (February 24, 2025)
  • K243171 — Yushan X-Ray Flat Panel Detector (December 19, 2024)
  • K241319 — SKR 3000 (November 21, 2024)