FDA.reportPublic FDA data

Radiological breast positioner, non-wearable

Definition
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. The device is in the form of a frame, board, cushion, or preformed pad (non-wearable device) and may also be used to facilitate reproducible positioning for serial imaging studies or serial radiation therapy treatments.
GUDID devices
134
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00841962120425Opti Handle Thermoplastic AdapterQfixRT-4546-052026-05-18
00850004813256 Breast Pad Insert SatPad™Sat Pad Inc.12019-06-18
B365702100Prone Breast Immobilization SystemAktina Corp.70-2102019-12-20
00841962120401Portrait Head Only Mask Adapter for Access SupineQfixRT-4546-032025-12-02
00841962120418Portrait Head & Neck Mask Adapter for Access SupineQfixRT-4546-042025-12-02
15420045516236EnvisionHologic, Inc.ASY-146212025-11-13
15420045516243EnvisionHologic, Inc.ASY-146222025-11-13
15420045516250EnvisionHologic, Inc.ASY-146232025-11-13
15420045516267EnvisionHologic, Inc.ASY-146242025-11-13
15420045516274EnvisionHologic, Inc.ASY-146252025-11-13
15420045516281EnvisionHologic, Inc.ASY-146262025-11-13
15420045516304EnvisionHologic, Inc.ASY-146272025-11-13
15420045516311EnvisionHologic, Inc.ASY-146282025-11-13
15420045516328EnvisionHologic, Inc.ASY-146302025-11-13
15420045516335EnvisionHologic, Inc.ASY-146312025-11-13
15420045516342EnvisionHologic, Inc.ASY-156372025-11-13
15420045516359EnvisionHologic, Inc.ASY-157862025-11-13
15420045516366EnvisionHologic, Inc.ASY-157872025-11-13
15420045516373EnvisionHologic, Inc.ASY-157882025-11-13
15420045516380EnvisionHologic, Inc.ASY-157892025-11-13
15420045516397EnvisionHologic, Inc.ASY-157902025-11-13
15420045516403EnvisionHologic, Inc.ASY-157912025-11-13
15420045516410EnvisionHologic, Inc.ASY-157922025-11-13
15420045516427EnvisionHologic, Inc.ASY-157932025-11-13
15420045516434EnvisionHologic, Inc.ASY-157942025-11-13
15420045516441EnvisionHologic, Inc.ASY-161502025-11-13
15420045516458EnvisionHologic, Inc.ASY-161512025-11-13
15420045516465EnvisionHologic, Inc.ASY-161522025-11-13
00841962119504Access Arm SupportQfixRT-4546AA-012025-07-09
00841962119511Access Wrist SupportQfixRT-4546AW-012025-07-09
00841439114599Pro Posifix® Headrest AdapterMEDTEC, INC.OAP1212024-05-16
00841439114490Molded Hand GripMEDTEC, INC.OAP1402024-02-12
10841962108734Quest™QfixRT-45432016-09-13
10841962108758Access™ ProneQfixRT-45442016-09-13
10841962108765Access™ ProneQfixRT-4544-012016-09-13
10841962108772Access 360™QfixRT-4544KV-012016-09-13
10841962108789Access 360™QfixRT-4544KV-022016-09-13
10841962108796Access 360™QfixRT-4544KV-112016-09-13
10841962108802Access 360™QfixRT-4544KV-122016-09-13
10841962108819Access™ SupineQfixRT-45462016-09-13
10841962108826Access™ SupineQfixRT-4546-012016-09-13
10841962108833Access™ SupineQfixRT-4546-022016-09-13
10841962110607Access™ Clearvue™QfixRT-4545CV-172017-12-19
10841962110614Access™ Clearvue™QfixRT-4545CV-202017-12-19
00841439114346Thorawedge™ LocatorMEDTEC, INC.TWI1002023-05-18
00841439114124Pro Wing Board™MEDTEC, INC.OAP2202022-10-14
00841439114131Pro HandleMEDTEC, INC.OAP2212022-10-14
00841439114148Evolve Bottom BoardMEDTEC, INC.OAP2102022-10-14
00841439114155Evolve Slant BoardMEDTEC, INC.OAP2002022-10-14
00841439113875TotalRT All In One PlatformMEDTEC, INC.TRT1002022-05-13
00841439113882Type-S™ Lok-Bar™MEDTEC, INC.MTWBL0012022-05-13
00841439113455C-Qual M™MEDTEC, INC.MTM4102021-08-14
B365112330Silverman AdapterAktina Corp.11-2332021-05-21
B365701000SenoView Prone Breast BoardAktina Corp.70-1002021-05-21
B365608120ArmCradle4Aktina Corp.60-8122021-01-05
10850004813253 Breast Pad Insert SatPad™Sat Pad Inc.12019-06-18
00841439102527HeadrestMEDTEC, INC.MT250SUB52017-08-02
00841439102688C-QualMEDTEC, INC.MT400132017-08-02
00841439107126Thermoplastic FrameMEDTEC, INC.MTRFH22017-08-02
00841439108031Wrist SupportMEDTEC, INC.MTTWSS2017-08-02
00840682138284NAUSA INSTRUMENTS, INC.LATERAL LARGE GRID BREAST BIOPSY PLATE2017-12-01
00840682138291NAUSA INSTRUMENTS, INC.MEDIAL LARGE GRID BREAST BIOPSY PLATE2017-12-01
00814848020195Breast Riser CXQUALITY ELECTRODYNAMICS LLCMAC0001092016-12-09
00815568020151Kobold® Prone Breast BoardKOBOLD, LLC325-0002016-09-23
00850004813263 Breast Pad Insert H SatPad™Sat Pad Inc.12019-12-12
00841439100509Posiboard™MEDTEC, INC.1090202017-08-02
00841439100523Posiboard™MEDTEC, INC.1090302017-08-02
00841439101162Thorawedge™MEDTEC, INC.3010802017-08-02
00841439102565Adapter Plate Box LabelMEDTEC, INC.MT3504002017-08-02
00841439102640C-Qual™MEDTEC, INC.MT4002017-08-02
00841439102695C-Qual™MEDTEC, INC.MT400142017-08-02
00841439108895Wing Board™MEDTEC, INC.MTWB082017-08-02
00841439108901Wing Board™MEDTEC, INC.MTWB092017-08-02
00841439108918Wing Board™MEDTEC, INC.MTWB102017-08-02
00841439110287C-Qual M™MEDTEC, INC.MTM4002017-08-02
00841439110683Monarch™ Overhead Arm PositionerMEDTEC, INC.OAP1102017-08-02
00841439112595Monarch™ Individual Hand GripsMEDTEC, INC.OAP1602019-01-07
00841439100202Arm SupportMEDTEC, INC.1060112017-08-02
00841439100219Arm SupportMEDTEC, INC.1060152017-08-02
00841439100226Arm SupportMEDTEC, INC.1060162017-08-02