510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K012663Substantially Equivalent

Easy Moving Mobile X-Ray Unit (Model Sm-HF)

Sedecal USA, Inc, Deer Field IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K012663 is the FDA 510(k) clearance record for EASY MOVING MOBILE X-RAY UNIT (MODEL SM-HF), a class II device, cleared for Sedecal USA, Inc. on under FDA product code IZL (System, X-Ray, Mobile). FDA records list 3 510(k) clearances for Sedecal USA, Inc., from to . As of , FDA records show one recall naming K012663.

Clearance record

Decision date
Received
(18 days to decision)
Product code
IZL System, X-Ray, Mobile
Regulation
21 CFR 892.1720
Device class
Class II
Review panel
Radiology
Applicant
Sedecal USA, Inc. P.O. Box 7007, Deer Field IL
510(k) summary
Summary
Third party review
No

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