510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K854085Substantially Equivalent

Omni Plane System

Xre Corp., Littleton MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K854085 is the FDA 510(k) clearance record for OMNI PLANE SYSTEM, a class II device, cleared for Xre Corp. on under FDA product code IXR (Table, Radiographic, Tilting). FDA records list 19 510(k) clearances for Xre Corp., from to . As of , FDA records show no recalls naming K854085.

Clearance record

Decision date
Received
(21 days to decision)
Product code
IXR Table, Radiographic, Tilting
Regulation
21 CFR 892.1980
Device class
Class II
Review panel
Radiology
Applicant
Xre Corp. 300 Foster St., Littleton MA
Third party review
No

Clearances, product code IXR

Trailing 12 months

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

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