510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K952891Substantially Equivalent

Cronex Low Absorption Cassette

The du Pont Co., Newark DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K952891 is the FDA 510(k) clearance record for CRONEX LOW ABSORPTION CASSETTE, a class II device, cleared for The DU Pont Co. on under FDA product code IXA (Cassette, Radiographic Film). FDA records list 13 510(k) clearances for The DU Pont Co., from to . As of , FDA records show no recalls naming K952891.

Clearance record

Decision date
Received
(20 days to decision)
Product code
IXA Cassette, Radiographic Film
Regulation
21 CFR 892.1850
Device class
Class II
Review panel
Radiology
Applicant
The DU Pont Co. Bldg. 500 Mail Box 514, Newark DE
510(k) summary
Summary
Third party review
No

Clearances, product code IXA

Trailing 12 months

FDA records hold no clearances under product code IXA in the trailing twelve months.

FDA records show no clearances under product code IXA in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code IXA, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260