FDA.reportPublic FDA data

Tissue specimen x-ray system IVD

Definition
An assembly of devices designed to produce an x-ray image of a tissue sample (e.g., stereotactic biopsy cores taken during mammographic procedures) and/or an amputated body part, by generating and controlling x-ray beams and recording the absorption patterns of the x-rays. The system typically includes a cabinet where the specimen is placed and a screen; the image is generated via digital imaging methods.
GUDID devices
19
Last updated
2026-07-30 21:32:00

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
06979294740036TrueViewCompAI MedTech (Suzhou) Co., Ltd.Core 100Pro-US2026-07-22
06979294740043TrueViewCompAI MedTech (Suzhou) Co., Ltd.200 Pro-US2026-07-22
05060508820017CoreLiteCIRDAN IMAGING LIMITED12020-03-31
05060508820062Solas ORCIRDAN IMAGING LIMITED12026-05-05
25420045516622FAXITRON COREHologic, Inc.04-41262023-04-11
25420045516646FAXITRON MAMMOTOMEHologic, Inc.120-8076042023-04-11
B619X20Q9XPERT20KubtecXPERT 202025-03-26
B619X40QF0XPERT40KubtecXPERT 402025-03-26
B619X42QK0XPERT42KubtecXPERT 422025-03-26
B619X80LAR0XPERT80LKubtecXPERT 80L2025-03-26
B619X80QT0XPERT80KubtecXPERT 802025-03-26
B619X84R3XPERT84KubtecXPERT842025-03-26
00860007231605Clarix Imaging CorpsClarix Imaging CorporationVSI-12024-08-01
15420045516656FAXITRON WEDGEHologic, Inc.120-8076002023-05-25
06974970580074TrueViewCompAI Healthcare (Suzhou) Co.,ltd200 Pro-US2023-05-17
06974970580081TrueViewCompAI Healthcare (Suzhou) Co.,ltdCore 100Pro-US2023-05-17
15420045516625FAXITRON COREHologic, Inc.04-41262023-04-11
15420045516649FAXITRON MAMMOTOMEHologic, Inc.120-8076042023-04-11
15420045514898FAXITRON ULTRAFOCUSHologic, Inc.ULTRAFOCUS 23x292022-07-12