FDA.reportPublic FDA data

Artemis

Primary DI
00860009734814
Brand
Artemis
Company
Eigen Health Services LLC
Model
2.0
Catalog number
900-20000-00
Device description
3D workstation for Transrectal/transperineal biopsy navigation and planning of the prostate.
Published
2026-01-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
GEHUnit, Cryosurgical, Accessories
QTZRadiological Image Processing Software For Ablation Therapy Planning And Evaluation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEHUnit, Cryosurgical, AccessoriesGeneral, Plastic Surgery2
QTZRadiological Image Processing Software For Ablation Therapy Planning And EvaluationRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860009734814PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860009734814008600097348148600097348140860009734814

GMDN Terms#

Term, Definition table
TermDefinition
Rectal ultrasound navigational image processorA mobile, mains electricity (AC-powered) device intended to be used in conjunction with an ultrasound imaging system and rectal ultrasound transducer to display two- and three-dimensional (3-D) ultrasound images of tissues (e.g., the prostate). It consists of a personal computer (PC) based workstation which processes data from the ultrasound imaging system, and a mechanical assembly intended to mount and track the rectal ultrasound transducer to generate a real-time 3-D image. Depending on specific software, packages may also allow for biopsy navigation and further image processing/data management.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
117062155
Device count
1
Serial number
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860009734807ProFuse1.0900-07000-002026-01-28
00860009734821Artemis-TPOS1.0900-20000-022026-01-28
00860009734838Artemis with ProFuse2.0 HD900-20000-012024-12-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10840143902666cryoICE® SystemATRICURE, INC.GEH2026-05-27
10840143902673cryoICE® SystemATRICURE, INC.GEH2026-05-27
10840143902680cryoICE® SystemATRICURE, INC.GEH2026-05-27
10840143902697cryoICE® SystemATRICURE, INC.GEH2026-05-27
10840143902703cryoICE® SystemATRICURE, INC.GEH2026-05-27
10840143902710cryoICE® SystemATRICURE, INC.GEH2026-05-27
10840143902727cryoICE® SystemATRICURE, INC.GEH2026-05-27
10840143902734cryoICE® SystemATRICURE, INC.GEH2026-05-27
30840143904343cryoICE® SystemATRICURE, INC.GEH2026-05-27
30840143912164AtriCure® cryoICE® BOXATRICURE, INC.GEH2026-05-27
04050147024694ErbeErbe Elektromedizin GmbHGEH2026-05-26
08800073100148TargetCool-eRecensMedical, Inc.GEH2026-05-14
04056869991771myAblation GuideSiemens Healthcare GmbHQTZ2026-05-11
06974083413115CryoThinMedinux (Tianjin) Technologies Co., Ltd.GEH2026-04-23
06974083413122CryoThinMedinux (Tianjin) Technologies Co., Ltd.GEH2026-04-23
06974083413313CryoThinMedinux (Tianjin) Technologies Co., Ltd.GEH2026-04-23
06974083413320CryoThinMedinux (Tianjin) Technologies Co., Ltd.GEH2026-04-23
06974083413337CryoThinMedinux (Tianjin) Technologies Co., Ltd.GEH2026-04-23
06974083413412CryoThinMedinux (Tianjin) Technologies Co., Ltd.GEH2026-04-23
06974083413528CryoThinMedinux (Tianjin) Technologies Co., Ltd.GEH2026-04-23
06974083413221CryoThinMedinux (Tianjin) Technologies Co., Ltd.GEH2026-04-22
06974083410718CryoThinMedinux (Tianjin) Technologies Co., Ltd.GEH2026-04-01
06974083413214CryoThinMedinux (Tianjin) Technologies Co., Ltd.GEH2026-04-01
06974083413511CryoThinMedinux (Tianjin) Technologies Co., Ltd.GEH2026-04-01
06974083413818CryoThinMedinux (Tianjin) Technologies Co., Ltd.GEH2026-04-01
00850009343352MIMMIM SOFTWARE INC.QTZ2026-01-30
00850009343710MIMMIM SOFTWARE INC.QTZ2026-01-30
00860009734821Artemis-TPOSEigen Health Services LLCGEH2026-01-28
00860009734821Artemis-TPOSEigen Health Services LLCQTZ2026-01-28
00194346615124EquateWAL-MART STORES, INC.GEH2025-12-22