510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K931279Substantially Equivalent

Acu-Ray

Sterne Equipment Co., Ltd., Brampton, On., CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K931279 is the FDA 510(k) clearance record for ACU-RAY, a class II device, cleared for Sterne Equipment Co., Ltd. on under FDA product code IZL (System, X-Ray, Mobile). FDA records list 6 510(k) clearances for Sterne Equipment Co., Ltd., from to . As of , FDA records show no recalls naming K931279.

Clearance record

Decision date
Received
(240 days to decision)
Product code
IZL System, X-Ray, Mobile
Regulation
21 CFR 892.1720
Device class
Class II
Review panel
Radiology
Applicant
Sterne Equipment Co., Ltd. 7 Research Rd., Brampton, On., CA
510(k) summary
Statement
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