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Device Explorer · FDA GUDID · GMDN 61132

Radiological headrest

A non-sterile device intended to facilitate adequate positioning and immobilization of the patient's head and neck for reproducible positioning during diagnostic imaging procedures, image-guided surgical or interventional procedures, and/or radiation therapy p

US‑registered devices99in commercial distribution
Companies12labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription84%Rx‑only share
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Share of device records

Medtec, Inc.6364%
Guangdong Meicen Medical Equipment Co., Ltd.1010%
Qfix55%
Monteris Medical Inc44%
Pearl Technology Ag44%
Sat Pad Inc.33%
Domico Med-Device, Llc33%
Maquet Gmbh22%

Top labelers

CompanyDevicesShare
Medtec, Inc.6364%
Guangdong Meicen Medical Equipment Co., Ltd.1010%
Qfix55%
Monteris Medical Inc44%
Pearl Technology Ag44%
Sat Pad Inc.33%
Domico Med-Device, Llc33%
Maquet Gmbh22%
Hyperfine Operations, Inc.22%
Pinestar Technology, Inc.11%
Ge Medical Systems Israel, Functional Imaging11%
Cdr Systems Inc11%

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

Brand names on the register (sample)

MeicenHead restRigid head restHead StabilizerHyperfine Foam Head PadPinestar Technology IncNeck & Brachial Plexus SatPad™ SetBrachial Plexus SatPad™Neck SatPad™Headrest - Timo size F with baseHeadrest - Timo size B with baseHeadrest - Timo size C with baseHeadrest - Timo size A with baseHeadrest - TIMO Size A, B, C, FHeadrest - Timo Size FHeadrest - Timo size E

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, medical100
LNHSystem, nuclear magnetic resonance imaging58
IWYHolder, Head, Radiographic11
IWEMonitor, Patient Position, Light-Beam10
IWYHolder, head, radiographic10
MOSCoil, Magnetic Resonance, Specialty4

GMDN & GCC registration

  • GMDN code 61132 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 84% · 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

Length (Inch) · 48Width (Inch) · 37Length (Centimeter) · 22Width (Centimeter) · 20

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

How many radiological headrest products are registered in the US?

99 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Radiological headrest", from 12 companies. The largest labeler is Medtec, Inc. with 64% of records.

Which FDA product codes apply?

IYE (Accelerator, linear, medical), LNH (System, nuclear magnetic resonance imaging), IWY (Holder, Head, Radiographic), IWE (Monitor, Patient Position, Light-Beam)

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.

How do I get quotes?

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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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