FDA.report

Radiological headrest

Definition
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 procedures. The device is in the form of a frame, cushion, or preformed pad that is intended to directly contact the head, and which may be customizable for single-patient use. This is a reusable device.
GUDID devices
135
Last updated
2025-08-05 15:50:56

Related Product Codes

CodeDeviceSpecialtyClassDevices
IYEAccelerator, Linear, MedicalRadiology283
LNHSystem, Nuclear Magnetic Resonance ImagingRadiology225
IWYHolder, Head, RadiographicRadiology120
MOSCoil, Magnetic Resonance, SpecialtyRadiology24
IXQTable, Radiographic, Stationary TopRadiology22
KXJTable, RadiologicRadiology21

Representative GUDID Devices

Primary DIBrandCompanyModelPublished
07640178061811pearltecPearl Technology AGProFoam Head Support2025-07-28
00850043319047Hyperfine Foam Head PadHyperfine Operations, Inc.810-11108-002023-01-25
00850043319146Head StabilizerHYPERFINE RESEARCH, INC.900-11022-002024-12-11
00841439114858Headrest - TIMO Size A, B, C, D, E, FMEDTEC, INC.MTTIMO22024-12-04
00841439114865Headrest - Timo Size AMEDTEC, INC.MTTIMO2A2024-12-04
00841439114872Headrest - Timo size BMEDTEC, INC.MTTIMO2B2024-12-04
00841439114889Headrest - Timo size CMEDTEC, INC.MTTIMO2C2024-12-04
00841439114896Headrest - Timo size DMEDTEC, INC.MTTIMO2D2024-12-04
00841439114902Headrest - Timo size EMEDTEC, INC.MTTIMO2E2024-12-04
00841439114919Headrest - Timo Size FMEDTEC, INC.MTTIMO2F2024-12-04
00841439114926Headrest - TIMO Size A, B, C, FMEDTEC, INC.MTTIMO2L2024-12-04
00841439114933Headrest - Timo size A with baseMEDTEC, INC.MTTIMO2AL2024-12-04
00841439114940Headrest - Timo size B with baseMEDTEC, INC.MTTIMO2BL2024-12-04
00841439114957Headrest - Timo size C with baseMEDTEC, INC.MTTIMO2CL2024-12-04
00841439114964Headrest - Timo size F with baseMEDTEC, INC.MTTIMO2FL2024-12-04
00841439114971Headrest - Timo size B with baseMEDTEC, INC.MTTIMO2BBB2024-12-04
00841439114988Headrest - Timo size F with baseMEDTEC, INC.MTTIMO2FBB2024-12-04
00841439114612WedgeMEDTEC, INC.107102MR2024-07-09
00841439114629SpacerMEDTEC, INC.107103MR2024-07-09
00841439114636SpacerMEDTEC, INC.107104MR2024-07-09
00841439114643Wedge and Spacer SetMEDTEC, INC.107106MR2024-07-09
10841962109588Neuro Head HolderQfix80020462016-09-13
10841962109595DSA-2Q Head HolderQfix80020482016-09-13
10841962109601DSA-2T Head HolderQfix80020492016-09-13
10841962109618DSA-3Q Head HolderQfix80025052016-09-13
00841439114056Positioning CushionMEDTEC, INC.3012052023-06-09
00841439114063Positioning CushionMEDTEC, INC.3012042023-06-09
00841439114070Positioning CushionMEDTEC, INC.3012032023-06-09
00841439114087Positioning CushionMEDTEC, INC.3012022023-06-09
00841439114094Positioning CushionMEDTEC, INC.3012012022-11-15
10841962119372Nurofit Premiere™QfixXT-4000-012022-10-18
04046768028906Rigid head restMAQUET GmbH100282A02022-09-22
04046768132962Head restMAQUET GmbH118052A02022-09-22
07640178060012Crania AdultPearl Technology AGCrania Adult2022-05-11
07640178060029Crania ChildPearl Technology AGCrania Child2022-05-11
07640178060081CT HeadFixPearl Technology AGCT HeadFix2022-05-11
10841962118740Nurofit™ Head SupportQfixXT-4000-012022-03-11
00841439113448Solstat™ Immobilization SystemMEDTEC, INC.CHS142021-05-22
10841962111192Neuro Head HolderQfix80020462021-05-10
00841439113714Solstice™ MR SRS Immobilization SystemMEDTEC, INC.CHS18MR2021-05-01
00810050243599ScancoatDOMICO MED-DEVICE, LLC119-SCB2020-10-16
00810050243490N/ADOMICO MED-DEVICE, LLC94112020-09-24
00810050242134NADOMICO MED-DEVICE, LLC90072020-09-24
00810050243223N/ADOMICO MED-DEVICE, LLC94032020-09-24
00850021301125Pinestar Technology IncPINESTAR TECHNOLOGY, INC.DAT-HH2020-07-23
00841439113233Solstice™ MR SRS Immobilization SystemMEDTEC, INC.CHS03MR2020-07-10
00841439113240Solstice™ MR SRS Immobilization SystemMEDTEC, INC.CHS04MR2020-07-10
00841439100899Positioning CushionMEDTEC, INC.3010082017-08-02
00840682138383NM600G E MEDICAL SYSTEMS ISRAEL LTD.HEAD HOLDER2018-04-09
10628341930236Positioning AidsCDR Systems Inc12019-12-31
00841439100950Posifix® HeadrestMEDTEC, INC.3010252017-08-02
00841439100967Posifix® HeadrestMEDTEC, INC.3010262017-08-02
00841439100974Posifix® HeadrestMEDTEC, INC.3010272017-08-02
00841439101278Posifix® HeadrestMEDTEC, INC.3012342017-08-02
00841439101322Posifix® HeadrestMEDTEC, INC.3050002017-08-02
00841439102268Posifix® HeadrestMEDTEC, INC.305000BLK2017-08-02
00841439107003Prone-Lok™ Positioning CushionMEDTEC, INC.MTPLC012017-08-02
00841439109991Posifix® HeadrestMEDTEC, INC.301025BLK2017-08-02
00841439110386Posifix® HeadrestMEDTEC, INC.301027A2017-08-02
00841439100844Positioning CushionMEDTEC, INC.3010012017-08-02
00841439100851Positioning CushionMEDTEC, INC.3010022017-08-02
00841439100868Positioning CushionMEDTEC, INC.3010032017-08-02
00841439100875Positioning CushionMEDTEC, INC.3010042017-08-02
00841439100882Positioning CushionMEDTEC, INC.3010052017-08-02
00841439100929Positioning CushionMEDTEC, INC.3010222017-08-02
00841439100936Positioning CushionMEDTEC, INC.3010232017-08-02
00841439100943Positioning CushionMEDTEC, INC.3010242017-08-02
00841439100998Positioning CushionMEDTEC, INC.3010302017-08-02
00841439101001Positioning CushionMEDTEC, INC.3010322017-08-02
00841439101018Positioning CushionMEDTEC, INC.3010332017-08-02
00841439101025Positioning CushionMEDTEC, INC.3010342017-08-02
00841439101353Positioning CushionMEDTEC, INC.4025252017-08-02
00841439102220Positioning CushionMEDTEC, INC.301002BLK2017-08-02
00841439102237Positioning CushionMEDTEC, INC.301003BLK2017-08-02
00841439102244Positioning CushionMEDTEC, INC.301004BLK2017-08-02
00841439102251Positioning CushionMEDTEC, INC.301005BLK2017-08-02
00841439102350Customizable Head SupportMEDTEC, INC.CHS012017-08-02
00841439102367Customizable Head SupportMEDTEC, INC.CHS022017-08-02
00841439104385Individual Head SupportMEDTEC, INC.MTIHS012017-08-02
00841439104392Individual Head SupportMEDTEC, INC.MTIHS022017-08-02