FDA.reportPublic FDA data

Radiographic image marker, manual

Definition
An object that is manually configured and physically placed within the field of view of a medical or dental diagnostic imaging system [e.g., x-ray, magnetic resonance imaging (MRI), or nuclear medicine] and leaves identifying marks on either films or digital images created using various diagnostic imaging modalities. It can be positioned either on a patient's body, or next to a patient, or be affixed to the film cassette or holder. It is made from materials compatible with the imaging system with which it is intended to be used. Typically used to imprint information on the images related to image acquisition parameters and/or patient identification, and to record anatomical information.
GUDID devices
395
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00190376073088BattalionALPHATEC SPINE, INC.274202020-06-17
00811801031120BattalionALPHATEC SPINE, INC.CI-100952020-09-19
00811801031496BattalionALPHATEC SPINE, INC.CI-101262020-09-19
00811801031830ZodiacALPHATEC SPINE, INC.CI-100472020-09-19
00811801035104General InstrumentsALPHATEC SPINE, INC.CI-10235-102020-09-19
00811801035111General InstrumentsALPHATEC SPINE, INC.CI-10235-202020-09-19
00811801035616BattalionALPHATEC SPINE, INC.CI-105272020-09-19
00811801036040General InstrumentsALPHATEC SPINE, INC.CI-102722020-09-19
00811801037245General InstrumentsALPHATEC SPINE, INC.CI-104302020-09-19
00815212026737ORTHO-KEYIzi Medical Products, LLC2010-05-ORTHO2023-06-06
00840180500378General InstrumentsALPHATEC SPINE, INC.CI-10579-102020-11-04
00840180500385General InstrumentsALPHATEC SPINE, INC.CI-10579-202020-11-04
00840348526264AADCOAADCO MEDICAL, INC.N-1052022-12-16
00840348526271AADCOAADCO MEDICAL, INC.N-2142022-12-16
00840348526288AADCOAADCO MEDICAL, INC.N-2152022-12-16
00840348526295AADCOAADCO MEDICAL, INC.N-2162022-12-16
00840348526301AADCOAADCO MEDICAL, INC.N-216A2022-12-16
00840348526318AADCOAADCO MEDICAL, INC.N-2212022-12-16
00840348526325AADCOAADCO MEDICAL, INC.N-2232022-12-16
00840348526332AADCOAADCO MEDICAL, INC.N-2242022-12-16
00840348526349AADCOAADCO MEDICAL, INC.N-2252022-12-16
00840348526370AADCOAADCO MEDICAL, INC.N-2992022-12-16
00840967151182BattalionALPHATEC SPINE, INC.274372020-06-17
00841685104238A. Titan InstrumentsA. TITAN INSTRUMENTS, INC.RM2023-01-25
00841690197164OMNIBoticsOmni Life Science, Inc.RM-100052023-01-10
00841690197171OMNIBoticsOmni Life Science, Inc.RM-100042023-01-10
00841690199748OMNIBoticsOmni Life Science, Inc.RM-100032023-01-10
00841690199755OMNIBoticsOmni Life Science, Inc.RM-100022023-01-10
00841690199779OMNIBoticsOmni Life Science, Inc.RM-100012023-01-10
00841690199953OMNIBoticsOmni Life Science, Inc.RM-100002023-01-10
00854623006006XactSolstice CorporationM15S2021-02-26
00854623006013XactSolstice CorporationM10TT2021-02-26
00854623006020XactSolstice CorporationM23SC2021-02-26
00854623006037XactSolstice CorporationM10LM2021-02-26
00854623006044XactSolstice CorporationM10LT2021-02-10
00854623006051XactSolstice CorporationM15RT2021-02-26
00854623006068XactSolstice CorporationM15RM2021-02-26
00854623006082XactSolstice CorporationM20S2021-02-26
00854623006099XactSolstice CorporationM15SC2021-02-26
00854623006105XactSolstice CorporationM20SC2021-02-26
00854623006112XactSolstice CorporationM10TM2021-02-26
00854623006129XactSolstice CorporationM10R2021-02-26
00854623006136XactSolstice CorporationM15R2021-02-26
00854623006143XactSolstice CorporationM10AC2021-02-26
07640182641641VARIOmulti ScanabutmentThommen Medical AG3.03.7802022-12-29
07640182641665VARIOmulti ScanabutmentThommen Medical AG3.03.7812022-12-29
03613720287971UNiD™ Calibration SphereMEDTRONIC SOFAMOR DANEK, INC.A003000322023-08-20
00815212026683nView 590 Sterile Navigation KitIzi Medical Products, LLC5902023-07-27
00815212026690nView 428 Navigated Surgical ProbeIzi Medical Products, LLC4282023-07-27
00815212026706nView 603 Extra Reflective MarkerIzi Medical Products, LLC6032023-07-27
00815212026713nView 627 Reflective Markers -14Izi Medical Products, LLC6272023-07-27
00815212026744nView 639 Long Micro-Reference ClipIzi Medical Products, LLC6392023-07-27
00815212026751nView 638 Short Micro-Reference ClipIzi Medical Products, LLC6382023-07-27
00815212026720ORTHO-KEYIzi Medical Products, LLC2010-05-ORTHO2023-06-06
00840180515235General InstrumentALPHATEC SPINE, INC.CI-11232-102023-03-30
00840180515242General InstrumentALPHATEC SPINE, INC.CI-11232-202023-03-30
00841690194552OMNIBoticsOmni Life Science, Inc.NS-262202023-03-27
00841690194569OMNIBoticsOmni Life Science, Inc.NS-261202023-03-27
00190376464862SIGMAALPHATEC SPINE, INC.270-2102022-10-13
00190376464879SIGMAALPHATEC SPINE, INC.270-2202022-10-13
00840180505113General InstrumentALPHATEC SPINE, INC.CI-10759-012022-10-13
00840180505120General InstrumentALPHATEC SPINE, INC.CI-10759-022022-10-13
00840180505519General InstrumentALPHATEC SPINE, INC.CI-10851-202022-10-13
00840180505694General InstrumentALPHATEC SPINE, INC.CI-10789-012022-10-13
00840180505717General InstrumentALPHATEC SPINE, INC.CI-10789-022022-10-13
00840180510469General InstrumentALPHATEC SPINE, INC.CI-110342022-10-13
00840180510933General InstrumentALPHATEC SPINE, INC.CI-11036-202022-10-13
00840180510940General InstrumentALPHATEC SPINE, INC.CI-11036-102022-10-13
D762RAMBELL000Implant-OneImplant Logistics, Inc.RAM-BELL-002022-08-12
D762RAMMARK200Implant-OneImplant Logistics, Inc.RAM-MARK-202022-08-12
008152120266527D SNAP ON SPHERZ - 5 PACKIzi Medical Products, LLCPM8005-7D2021-10-13
00815212025624SPHERZ: ILUMARK NONSTERILE 1010-05Izi Medical Products, LLC1010-052022-05-18
00815212026379ACCELUS SNAP ON SPHERZ - 4 PACKIzi Medical Products, LLC60042022-05-18
00815212026386ACCELUS SNAP ON SPHERZ - 80 PACKIzi Medical Products, LLC60802022-05-18
00190376395210SIGMAALPHATEC SPINE, INC.170-2102022-02-13
00190376395227SIGMAALPHATEC SPINE, INC.170-2202022-02-13
00815212021428SPHERZ: ILUMARK SNAP EASYFIT 2010-05Izi Medical Products, LLC2010-052021-10-15
00815212021589SPHERZ: ILUMARK QUICK TWIST 2021-02Izi Medical Products, LLC2021-022021-10-15
00815212022760SONOWAND MM RADIOGRAPHIC MARKERSIzi Medical Products, LLCMM3002SW2021-10-15
00815212022852MULTI-MODALITY NUCMED-PET MARKERSIzi Medical Products, LLCS-MM30032021-10-15