510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K942367Substantially Equivalent

Axt 1400 Spotfilm Device

Applied X-Ray Technologies, Inc., Denver CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K942367 is the FDA 510(k) clearance record for AXT 1400 SPOTFILM DEVICE, a class II device, cleared for Applied X-Ray Technologies, Inc. on under FDA product code IXL (Device, Spot-Film). FDA records list 3 510(k) clearances for Applied X-Ray Technologies, Inc., from to . As of , FDA records show no recalls naming K942367.

Clearance record

Decision date
Received
(19 days to decision)
Product code
IXL Device, Spot-Film
Regulation
21 CFR 892.1670
Device class
Class II
Review panel
Radiology
Applicant
Applied X-Ray Technologies, Inc. 2727 W. 92nd Ave.,, Denver CO
510(k) summary
Statement
Third party review
No

Clearances, product code IXL

Trailing 12 months

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

FDA records show no clearances under product code IXL in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code IXL, 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