FDA.reportPublic FDA data

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
138
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00628341930239Positioning AidsCDR Systems Inc12019-12-31
00841439114100Posifix® HeadrestMEDTEC, INC.3050012026-04-23
00841439114605WedgeMEDTEC, INC.107101MR2025-10-22
07640178061811pearltecPearl Technology AGProFoam Head Support2025-07-28
00850043319047Hyperfine Foam Head PadHyperfine Operations, Inc.810-11108-002023-01-25
00850043319146Head StabilizerHyperfine Operations, 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