510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K881386Substantially Equivalent

X-Ray Generating System Tf 1000

General Medical Merate S.p.A., Long Island City NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K881386 is the FDA 510(k) clearance record for X-RAY GENERATING SYSTEM TF 1000, a class I device, cleared for General Medical Merate S.P.A on under FDA product code IZO (Generator, High-Voltage, X-Ray, Diagnostic). FDA records list 7 510(k) clearances for General Medical Merate S.P.A, from to . As of , FDA records show no recalls naming K881386.

Clearance record

Decision date
Received
(98 days to decision)
Product code
IZO Generator, High-Voltage, X-Ray, Diagnostic
Regulation
21 CFR 892.1700
Device class
Class I
Review panel
Radiology
Applicant
General Medical Merate S.P.A 23-06 31st Ave., Long Island City NY
Third party review
No

Clearances, product code IZO

Trailing 12 months

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

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