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Fraxion P10106-120

by 3C-Medical Intelligence GmbH

Fraxion P10106-120 is a medical device (FDA Class II; FDA product code IYE, Accelerator, Linear, Medical) made by 3C-Medical Intelligence GmbH, cleared under FDA 510(k) K112210 on 22 Nov 2011 and listed in FDA GUDID since 23 Aug 2016 (UDI-DI 04056719001452), 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) K112210

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 Number04056719001452 UDI-DI Date23 Aug 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK112210 Date22 Nov 2011DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K112210 decided 22 Nov 2011 Active
  • FDA GUDID UDI-DI 04056719001452 listed 23 Aug 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K112210
  2. Listed FDA GUDID 04056719001452

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Fraxion
Generic name
Stereotactic radiosurgical/radiotherapy arch head frame
Model / Ref / Catalog
P10106-120
Primary DI / UDI-DI
04056719001452
510(k) Number
FDA product code
IYE
GMDN term
Stereotactic radiosurgical/radiotherapy arch head frame
Device class
Class II
Regulation number
892.5050
GUDID distribution status
In Commercial Distribution

Related devices

Category: Stereotactic radiosurgical/radiotherapy arch head frame

Cleared under the same submission (K112210)

Similar devices

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

Other devices from 3C-Medical Intelligence GmbH

See all devices from 3C-Medical Intelligence GmbH →

Properties

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