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Device Explorer · FDA GUDID · GMDN 61128

Stereotactic radiosurgical/radiotherapy arch head frame

A non-sterile device intended to be used to position and immobilize a patient’s head for reproducible positioning during radiation treatment planning, stereotactic radiotherapy (SRT), and stereotactic radiosurgery (SRS), on all parts of the brain, head, and ne

US‑registered devices62in commercial distribution
Companies3labelers on GUDID
Single‑use15%of device records
Sterile0%labelled sterile
Prescription65%Rx‑only share
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Share of device records

3C-Medical Intelligence Gmbh3252%
Aktina Corp.2744%
Medtec, Inc.35%

Top labelers

CompanyDevicesShare
3C-Medical Intelligence Gmbh3252%
Aktina Corp.2744%
Medtec, Inc.35%

Company = labeler of record on GUDID. 3 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Fraxion™FraxionBodyFIXtrUpoint ARCH™PositionPro Head CradlePositionPro Pitch/Roll BaseboardArmAssist, PositionProShoulderAssist, PositionProArch Kit, PositionProPositionPro Subcranial Head SupportPositionPro Cranial Head SupportPinPoint Nose Bridge StabilizerPinPoint Head and Neck SystemPinPoint LINAC-based Cranial SRS SystemPinPoint Radiosurgery Immobilization System, ElePinPoint Radiosurgery Immobilization System, Exa

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
IYEAccelerator, Linear, Medical80
IYEAccelerator, linear, medical6

GMDN & GCC registration

  • GMDN code 61128 · non‑implantable
  • Single‑use 15% · sterile 0% · Rx‑only 65% · OTC 0%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Width (Inch) · 3Length (Inch) · 3

Use these as the dimensions to specify in a tender line.

How many stereotactic radiosurgical/radiotherapy arch head frame products are registered in the US?

62 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Stereotactic radiosurgical/radiotherapy arch head frame", from 3 companies. The largest labeler is 3C-Medical Intelligence Gmbh with 52% of records.

Which FDA product codes apply?

IYE (Accelerator, Linear, Medical), IYE (Accelerator, linear, medical)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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