X-Ray Generating System Tf 1000

by General Medical Merate S.P.A. Italy 510(k)

510(k) K881386

Product code IZO

Regulatory status

as of 25 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK881386	Date8 Jul 1988Cleared	StatusActive

Coverage

1 jurisdiction

Active
Not covered

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Specification

510(k) · synced 22 Oct 2026

510(k) Number: K881386
FDA Product Code: IZO
FDA applicant: General Medical Merate S.P.A

Device Class: Class I
Regulation: 21 CFR Part 892.1700
Advisory Committee: Radiology
FDA Decision: SESE Substantially Equivalent

Other devices from General Medical Merate S.P.A.

Telescop Synchro Stitching

Class I
Lem Plus 150 Ts

Class I
CS01MS

Class I
Lem Plus 150 Ml

Class I
Lem Plus Ic

Class I
Lem Plus 180 Ml

Class I

See all devices from General Medical Merate S.P.A. →

Properties & raw data

Show properties, registry sources and raw records

Sources (1)

FDA 510(k) K881386 24 fields · synced 22 Oct 2026