510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K870563Substantially Equivalent

X-Ray Apron

X-Tech, Ltd., Newburyport MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K870563 is the FDA 510(k) clearance record for X-RAY APRON, a class I device, cleared for X-Tech, Ltd. on under FDA product code EAJ (Apron, Leaded). FDA records list one 510(k) clearance for X-Tech, Ltd. As of , FDA records show no recalls naming K870563.

Clearance record

Decision date
Received
(9 days to decision)
Product code
EAJ Apron, Leaded
Regulation
21 CFR 892.6500
Device class
Class I
Review panel
Radiology
Applicant
X-Tech, Ltd. P.O. Box 6069, Newburyport MA
Third party review
No

Clearances, product code EAJ

Trailing 12 months

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

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