510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K121948Substantially Equivalent

Cr 10-X Digitizer

AGFA Healthcare Corp., Mortsel, BE / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K121948 is the FDA 510(k) clearance record for CR 10-X DIGITIZER, a class II device, cleared for Agfa Healthcare N.V. on under FDA product code MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager)). FDA records list 39 510(k) clearances for Agfa Healthcare N.V., from to . As of , FDA records show one recall naming K121948.

Clearance record

Decision date
Received
(17 days to decision)
Product code
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Regulation
21 CFR 892.1680
Device class
Class II
Review panel
Radiology
Applicant
Agfa Healthcare N.V. Septestraat 27, Mortsel, BE
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code MQB

Trailing 12 months
3 clearances under product code MQB in the twelve months to October 2026, June 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code MQB, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20262
July 20261
August 20260
September 20260
October 20260