Consulting Wallah › Device Explorer › Other devices › Radiological breast positioner, non-wearable
Device Explorer · FDA GUDID · GMDN 40899

Radiological breast positioner, non-wearable

A device that is specifically designed to ensure adequate positioning and immobilization of the female patient's breast(s) and chest during diagnostic imaging procedures, image-guided surgical or interventional procedures, and/or radiation therapy procedures.

US‑registered devices101in commercial distribution
Companies8labelers on GUDID
Single‑use9%of device records
Sterile0%labelled sterile
Prescription96%Rx‑only share
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Share of device records

Medtec, Inc.4141%
Hologic, Inc.3030%
Qfix1717%
Aktina Corp.66%
Sat Pad Inc.33%
Usa Instruments, Inc.22%
Digirad Corporation11%
Quality Electrodynamics Llc11%

Top labelers

CompanyDevicesShare
Medtec, Inc.4141%
Hologic, Inc.3030%
Qfix1717%
Aktina Corp.66%
Sat Pad Inc.33%
Usa Instruments, Inc.22%
Digirad Corporation11%
Quality Electrodynamics Llc11%

Company = labeler of record on GUDID. 8 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Breast Imaging AccessoryBreast Pad Insert H SatPad™Breast Pad Insert SatPad™16 Channel Breast SatPad™Opti Handle Thermoplastic AdapterPortrait Head & Neck Mask Adapter for Access SupPortrait Head Only Mask Adapter for Access SupinAccess Wrist SupportAccess Arm SupportPro Posifix® Headrest AdapterMolded Hand GripThorawedge™ LocatorEvolve Slant BoardEvolve Bottom BoardPro HandlePro Wing Board™

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, medical65
OTEDigital breast tomosynthesis23
LNHSystem, nuclear magnetic resonance imaging16
JAICouch, radiation therapy, powered10
IZHSystem, x-ray, mammographic9
IYEAccelerator, Linear, Medical8

GMDN & GCC registration

  • GMDN code 40899 · non‑implantable
  • Single‑use 9% · sterile 0% · Rx‑only 96% · 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) · 25Length (Centimeter) · 24Width (Inch) · 17Width (Centimeter) · 14Height (Centimeter) · 5Height (Inch) · 2

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

How many radiological breast positioner, non-wearable products are registered in the US?

101 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Radiological breast positioner, non-wearable", from 8 companies. The largest labeler is Medtec, Inc. with 41% of records.

Which FDA product codes apply?

IYE (Accelerator, linear, medical), OTE (Digital breast tomosynthesis), LNH (System, nuclear magnetic resonance imaging), JAI (Couch, radiation therapy, powered)

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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