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radiance 3

by Gmv Soluciones Globales Internet SA

radiance 3 is a Class II device made by Gmv Soluciones Globales Internet SA, cleared under FDA 510(k) K153368 on 16 Feb 2016 and listed in FDA GUDID since 23 Jan 2017 (UDI-DI 08436567540000), 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) K153368

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 Number08436567540000 UDI-DI Date23 Jan 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK153368 Date16 Feb 2016DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K153368 decided 16 Feb 2016 Active
  • FDA GUDID UDI-DI 08436567540000 listed 23 Jan 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K153368
  2. Listed FDA GUDID 08436567540000

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
radiance
Generic name
Radiation therapy software
Model / reference
3
Primary DI / UDI-DI
08436567540000
510(k) Number
FDA product code
MUJ
GMDN term
Radiation therapy software
Device class
Class II
Regulation number
892.5050
GUDID distribution status
In Commercial Distribution

Related devices

Category: Radiation therapy software

Similar devices in this category

Other devices filed under Radiation therapy software.

Other devices from Gmv Soluciones Globales Internet S.A.U.

Properties

  • Prescription use
  • Lot / batch number
Other properties (13, all answered No)