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LIAC 12 MeV

by Sit Sordina Iort Technologies Spa

LIAC 12 MeV (900050002) is a Class II device made by Sit Sordina Iort Technologies Spa, cleared under FDA 510(k) K110840 on 17 Apr 2012 and listed in FDA GUDID since 12 Sep 2016 (UDI-DI 08057014730067), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K110840

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08057014730067 UDI-DI Date12 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Abbreviated NumberK110840 Date17 Apr 2012DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K110840 decided 17 Apr 2012 Active
  • FDA GUDID UDI-DI 08057014730067 listed 12 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K110840
  2. Listed FDA GUDID 08057014730067

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Liac
Generic name
Linear accelerator system
Model / Ref / Catalog
12 MeV, 900050002
Primary DI / UDI-DI
08057014730067
510(k) Number
FDA product code
IYE
GMDN term
Linear accelerator system
Device class
Class II
Regulation number
892.5050
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code IYE (Accelerator, Linear, Medical).

Other devices from Sit Sordina Iort Technologies Spa

See all devices from Sit Sordina Iort Technologies Spa →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)