FDA.reportPublic FDA data

Radiological image marker, implantable

Definition
A device intended to be implanted within the body, either temporarily or permanently, to create identifying marks that can be seen on radiographic film or digital images. It is typically in the form of a wire, needle, bead, clip, stent-like tube, washer or fluid, and used to locate and delineate a tumour, lesion, or other site of interest. It is made from materials compatible with the imaging system with which it is intended to be used [e.g., magnetic resonance imaging (MRI), x-ray, or nuclear medicine]; it may be intended for use during radiotherapy procedures.
GUDID devices
794
Last updated
2026-07-30 21:31:47

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00841439109755Fiducial Marker KitMEDTEC, INC.MTNW8878512017-08-02
00841439109779Fiducial Marker KitMEDTEC, INC.MTNW8878532017-08-02
00841439109793Fiducial MarkersMEDTEC, INC.MTNW8878552017-08-02
04250195600806TUMARKSOMATEX Medical Technologies GmbH2715502015-10-27
04250195600813TUMARK ProfessionalSOMATEX Medical Technologies GmbH2715602015-10-30
04250195600820TUMARK ProfessionalSOMATEX Medical Technologies GmbH2715652015-10-30
04250195600837TulocSOMATEX Medical Technologies GmbH2716602021-10-28
04250195600844TulocSOMATEX Medical Technologies GmbH2716612021-10-28
04250195600851TulocSOMATEX Medical Technologies GmbH2716632021-10-28
04250195600899Lung Marker SystemSOMATEX Medical Technologies GmbH2720122021-10-28
04250195600905Lung Marker SystemSOMATEX Medical Technologies GmbH2720152021-10-28
04250195601605MRI TulocSOMATEX Medical Technologies GmbH6016492021-10-28
04250195601612MRI TulocSOMATEX Medical Technologies GmbH6016512021-10-28
04250195602046Tuloc PremiumSOMATEX Medical Technologies GmbH2718802021-10-28
04250195602053Tuloc PremiumSOMATEX Medical Technologies GmbH2718812021-10-28
04250195602060Tuloc PremiumSOMATEX Medical Technologies GmbH2718832021-10-28
04250195602183TUMARK FlexSOMATEX Medical Technologies GmbH2715702015-11-03
04250195602190TUMARK FlexSOMATEX Medical Technologies GmbH2715722015-11-03
04250195602206TUMARK FlexSOMATEX Medical Technologies GmbH2715742015-11-03
04250195602213TUMARK FlexSOMATEX Medical Technologies GmbH2715762015-11-03
04250195602268TUMARK ProfessionalSOMATEX Medical Technologies GmbH2715592015-10-30
04250195602275TUMARK ProfessionalSOMATEX Medical Technologies GmbH2715572015-10-30
04250195602282TUMARK Professional X-ShapeSOMATEX Medical Technologies GmbH2715492015-10-30
04250195602350Tumark MRISOMATEX Medical Technologies GmbH6015702015-10-30
04250195603005Q-Wire SystemSOMATEX Medical Technologies GmbH2714632021-10-28
04250195603029Q-Wire SystemSOMATEX Medical Technologies GmbH2714622021-10-28
04250195603036Q-Wire SystemSOMATEX Medical Technologies GmbH2714642021-10-28
04250195603081TUMARK QSOMATEX Medical Technologies GmbH2715002015-10-30
04250195607126Tumark Professional Q-ShapeSOMATEX Medical Technologies GmbH2715482015-10-30
04250195607140Tumark Professional X-ShapeSOMATEX Medical Technologies GmbH2715512015-11-03
04250195607836Tumark VisionSOMATEX Medical Technologies GmbH2715902016-11-25
04250195611086Tumark VisionSOMATEX Medical Technologies GmbH2715892016-11-25
04250195611109Tumark Professional Q-ShapeSOMATEX Medical Technologies GmbH2715552017-01-11
04250195611123Tumark Professional X-ShapeSOMATEX Medical Technologies GmbH3512102017-02-17
04250195611130Tumark Professional X-ShapeSOMATEX Medical Technologies GmbH3512122017-02-17
04250195611147Tumark Professional Q-ShapeSOMATEX Medical Technologies GmbH3512202017-02-17
04250195611154Tumark Professional Q-ShapeSOMATEX Medical Technologies GmbH3512222017-02-17
04250195611161Tumark VisionSOMATEX Medical Technologies GmbH3512302017-02-17
04250195611178Tumark VisionSOMATEX Medical Technologies GmbH3512322017-02-17
04250195611208TUMARK FlexSOMATEX Medical Technologies GmbH3512502017-02-17
04250195611215TUMARK FlexSOMATEX Medical Technologies GmbH3512522017-02-17
04250195611222Tumark® Vision for Eviva® StandardSOMATEX Medical Technologies GmbHTumark-E13-S-Vision2018-11-26
04250195611239Tumark® Vision for Eviva® PetiteSOMATEX Medical Technologies GmbHTumark-E13-P-Vision2018-11-26
04250195611246Tumark® Professional X for Eviva® StandardSOMATEX Medical Technologies GmbHTumark-E13-S-X2018-11-26
04250195611253Tumark® Professional X for Eviva® PetiteSOMATEX Medical Technologies GmbHTumark-E13-P-X2018-11-26
04250195611260Tumark® Professional Q for Eviva® StandardSOMATEX Medical Technologies GmbHTumark-E13-S-Q2018-11-26
04250195611277Tumark® Professional Q for Eviva® PetiteSOMATEX Medical Technologies GmbHTumark-E13-P-Q2018-11-26
04250195611284Tumark® Vision for Brevera® StandardSOMATEX Medical Technologies GmbHTumark-BREV-S-Vision2018-11-26
04250195611291Tumark® Vision for Brevera® PetiteSOMATEX Medical Technologies GmbHTumark-BREV-P-Vision2018-11-26
04250195611307Tumark® Professional X for Brevera® StandardSOMATEX Medical Technologies GmbHTumark-BREV-S-X2018-11-26
04250195611314Tumark® Professional X for Brevera® PetiteSOMATEX Medical Technologies GmbHTumark-BREV-P-X2018-11-26
04250195611321Tumark® Professional Q for Brevera® StandardSOMATEX Medical Technologies GmbHTumark-BREV-S-Q2018-11-26
04250195611338Tumark® Professional Q for Brevera® PetiteSOMATEX Medical Technologies GmbHTumark-BREV-P-Q2018-11-26
04250195611345Tumark EyeSOMATEX Medical Technologies GmbH2715102018-01-05
04250195611369Tumark EyeSOMATEX Medical Technologies GmbH2715122017-12-19
04250195611383Duo System StereoSOMATEX Medical Technologies GmbH2719912018-06-27
04250195611406Duo System StereoSOMATEX Medical Technologies GmbH2719922018-06-27
04250195611468Tumark Vision MRISOMATEX Medical Technologies GmbH6015902018-12-01
04250195611550TuflexSOMATEX Medical Technologies GmbH2716402020-08-31
04250195611574TuflexSOMATEX Medical Technologies GmbH2716412020-08-31
04250195611598TuflexSOMATEX Medical Technologies GmbH2716422020-08-31
04250195611611TuflexSOMATEX Medical Technologies GmbH2716432020-08-31
04250195611635Tuflex PremiumSOMATEX Medical Technologies GmbH2716502020-08-31
04250195611659Tuflex PremiumSOMATEX Medical Technologies GmbH2716512020-08-31
04250195611673Tuflex PremiumSOMATEX Medical Technologies GmbH2716522020-08-31
04250195611697Tumark SpheraSOMATEX Medical Technologies GmbH2715302021-07-30
04250195611710Tumark SpheraSOMATEX Medical Technologies GmbH2715322021-07-30
04250195611802Tumark SpheraSOMATEX Medical Technologies GmbH3512702021-10-08
04250195611819Tumark SpheraSOMATEX Medical Technologies GmbH3512722021-10-08
04250195611826Tumark ConicSOMATEX Medical Technologies GmbH3512602021-10-01
04250195611833Tumark ConicSOMATEX Medical Technologies GmbH3512622021-10-01
04250195611925Tumark ProfessionalSOMATEX Medical Technologies GmbH3512802022-05-16
04250195611932Tumark ProfessionalSOMATEX Medical Technologies GmbH3512822022-05-16
04250195612045Tumark® Vision for Eviva® StandardSOMATEX Medical Technologies GmbHTUMARK-E13-S-V-022023-08-28
04250195612052Tumark® Vision for Eviva® PetiteSOMATEX Medical Technologies GmbHTUMARK-E13-P-V-022023-08-28
04250195612069Tumark® Professional X for Eviva® StandardSOMATEX Medical Technologies GmbHTUMARK-E13-S-X-022023-08-28
04250195612076Tumark® Professional X for Eviva® PetiteSOMATEX Medical Technologies GmbHTUMARK-E13-P-X-022023-08-28
04250195612083Tumark® Professional Q for Eviva® StandardSOMATEX Medical Technologies GmbHTUMARK-E13-S-Q-022023-08-28
04250195612090Tumark® Professional Q for Eviva® PetiteSOMATEX Medical Technologies GmbHTUMARK-E13-P-Q-022023-08-28
04250195612106Tumark® Vision for Brevera® StandardSOMATEX Medical Technologies GmbHTUMARK-BREV-S-V-022023-08-28