510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K903238Substantially Equivalent

Afga Video Imager, Various Models

Enhanced Imaging Technologies, Inc., Orangeburg NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K903238 is the FDA 510(k) clearance record for AFGA VIDEO IMAGER, VARIOUS MODELS, a class II device, cleared for Enhanced Imaging Technologies, Inc. on under FDA product code LMC (Camera, Multi Format, Radiological). FDA records list 4 510(k) clearances for Enhanced Imaging Technologies, Inc., from to . As of , FDA records show no recalls naming K903238.

Clearance record

Decision date
Received
(107 days to decision)
Product code
LMC Camera, Multi Format, Radiological
Regulation
21 CFR 892.2040
Device class
Class II
Review panel
Radiology
Applicant
Enhanced Imaging Technologies, Inc. One Ramland Rd., Orangeburg NY
Third party review
No

Clearances, product code LMC

Trailing 12 months

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

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