510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K203658Substantially Equivalent

Micro C Medical Imaging System, M01

Oxos Medical Inc, Atlanta GA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K203658 is the FDA 510(k) clearance record for Micro C Medical Imaging System, M01, a class II device, cleared for Oxos Medical, Inc. on under FDA product code IZL (System, X-Ray, Mobile). FDA records list 5 510(k) clearances for Oxos Medical, Inc., from to . As of , FDA records show no recalls naming K203658.

Clearance record

Decision date
Received
(28 days to decision)
Product code
IZL System, X-Ray, Mobile
Regulation
21 CFR 892.1720
Device class
Class II
Review panel
Radiology
Applicant
Oxos Medical, Inc. 1230 Peachtree St. NE, Suite 300, Atlanta GA
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code IZL

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