510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K183275Substantially Equivalent

DR 800 with Tomosynthesis

Agfa N.V., Mortsel, BE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K183275 is the FDA 510(k) clearance record for DR 800 with Tomosynthesis, a class II device, cleared for Agfa N.V. on under FDA product code IZF (System, X-Ray, Tomographic). FDA records list 6 510(k) clearances for Agfa N.V., from to . As of , FDA records show 3 recalls naming K183275.

Clearance record

Decision date
Received
(70 days to decision)
Product code
IZF System, X-Ray, Tomographic
Regulation
21 CFR 892.1740
Device class
Class II
Review panel
Radiology
Applicant
Agfa N.V. Septestraat 27, Mortsel, BE
510(k) summary
Summary PDF
Third party review
No

Clearances, product code IZF

Trailing 12 months
2 clearances under product code IZF in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code IZF, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20261
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260