510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K852346Substantially Equivalent

Xiscan Model 1000

Xi Tech, Randolph NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K852346 is the FDA 510(k) clearance record for XISCAN MODEL 1000, a class II device, cleared for Xi Tech on under FDA product code JAA (System, X-Ray, Fluoroscopic, Image-Intensified). FDA records list one 510(k) clearance for Xi Tech. As of , FDA records show no recalls naming K852346.

Clearance record

Decision date
Received
(283 days to decision)
Product code
JAA System, X-Ray, Fluoroscopic, Image-Intensified
Regulation
21 CFR 892.1650
Device class
Class II
Review panel
Radiology
Applicant
Xi Tech 215 - Rte. 10, Randolph NJ
Third party review
No

Clearances, product code JAA

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