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Device Explorer · FDA GUDID · GMDN 40897

Indexed-immobilization patient positioning system

A assembly of devices used primarily in radiation therapy applications, and consisting of an indexed treatment or imaging table (couch) that contains locking interfaces used to attach various positioning and immobilization devices to numbered or lettered (inde

US‑registered devices794in commercial distribution
Companies9labelers on GUDID
Single‑use1%of device records
Sterile0%labelled sterile
Prescription67%Rx‑only share
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Share of device records

Medtec, Inc.24531%
Klarity Medical Products, Llc22128%
Macromedics B.V.12816%
Qfix9812%
Aktina Corp.415%
Cdr Systems Inc294%
Brainlab Se263%
It-V Medizintechnik Gmbh51%

Top labelers

CompanyDevicesShare
Medtec, Inc.24531%
Klarity Medical Products, Llc22128%
Macromedics B.V.12816%
Qfix9812%
Aktina Corp.415%
Cdr Systems Inc294%
Brainlab Se263%
It-V Medizintechnik Gmbh51%
Elekta Limited10%

Company = labeler of record on GUDID. 9 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Elekta UnityCRANIAL 4PI WEDGE 5 DEG.CRANIAL 4PI STEREOTACTIC MASK 3.2MM (1 PC.)CRANIAL 4PI HEAD SUPPORT WIDECRANIAL 4PI INDEXING PLATECRANIAL 4PI SPACER 20MMCRANIAL 4PI WEDGE 10 DEG.CRANIAL 4PI STEREOTACTIC MASK 3.2MM (5 PCS.)CRANIAL 4PI HEAD SUPPORT STANDARDCRANIAL 4PI HEADREST PLATFORMCRANIAL 4PI HEADREST INLAY H&NCRANIAL 4PI HEADREST INLAY OPENFACECRANIAL 4PI HEADREST INLAY STANDARDCRANIAL 4PI EXTENDED MASK (1 PC.)CRANIAL 4PI EXTENDED MASK (5 PCS.)CRANIAL 4PI OPEN FACE MASK (1 PC.)

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, Medical504
IXQTable, radiographic, stationary top272
IYEAccelerator, linear, medical159
JAICouch, radiation therapy, powered77
JAICouch, Radiation Therapy, Powered33
LNHSystem, Nuclear Magnetic Resonance Imaging31

GMDN & GCC registration

  • GMDN code 40897 · non‑implantable
  • Single‑use 1% · sterile 0% · Rx‑only 67% · 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 (Centimeter) · 89Length (Inch) · 79Width (Inch) · 66Width (Centimeter) · 47Length (Millimeter) · 12Width (Millimeter) · 7

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

How many indexed-immobilization patient positioning system products are registered in the US?

794 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Indexed-immobilization patient positioning system", from 9 companies. The largest labeler is Medtec, Inc. with 31% of records.

Which FDA product codes apply?

IYE (Accelerator, Linear, Medical), IXQ (Table, radiographic, stationary top), IYE (Accelerator, linear, medical), 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.

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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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