FDA.reportPublic FDA data

PROMAP LITE – 3D PROSTATE SUITE

Primary DI
03665134000714
Brand
PROMAP LITE – 3D PROSTATE SUITE
Company
KOELIS
Model
KSOF-2602
Device description
ProMap Lite is designed to display medical images of different modalities, prepare these images for an ultrasound-guided prostate procedure, and review the images and data generated during an ultrasound-guided prostate procedure.
Published
2022-07-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ITXTransducer, Ultrasonic, Diagnostic
IYNSystem, Imaging, Pulsed Doppler, Ultrasonic
IYOSystem, Imaging, Pulsed Echo, Ultrasonic
LLZSystem, Image Processing, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITXTransducer, Ultrasonic, DiagnosticRadiology2
IYNSystem, Imaging, Pulsed Doppler, UltrasonicRadiology2
IYOSystem, Imaging, Pulsed Echo, UltrasonicRadiology2
LLZSystem, Image Processing, RadiologicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170521000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170521000TRINITY/3D PROSTATE SUITEKoelis2017-05-30IYN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03665134000714PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03665134000714036651340007143665134000714

GMDN Terms#

Term, Definition table
TermDefinition
Image segmentation application softwareAn application software program intended to convert large volumes of slice-based images into manageable three-dimensional (3-D) models of anatomical structures. It is typically used in an electrophysiology (EP) procedure (e.g., a cardiac mapping) to accept DICOM3 images from computed tomography (CT) and magnetic resonance imaging (MRI) scanners. Once the images are imported, a 3-D model can be extracted in a process called segmentation (the isolation of an object of interest) for easy viewing and manipulation during the EP procedure. This device is typically identified by a proprietary name and "version" or "upgrade" number.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+33(0)458176811qra@koelis.com

Regulatory Flags#

DUNS number
290318455
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03665134000011Disposable guide for 3D endocavity end-fireKDNG002018-07-20
03665134000820Reusable guideGPK-4902025-04-24
03665134000059Reusable guideGPK-4902020-07-17
03665134000165NAIL rangeNAIL.142023-04-04
03665134000158NAIL rangeNAIL.182023-04-04
03665134000219transP - Reusable Guid Perine Grid 14GKRNG.EL1.142020-07-17
03665134000226transP - Reusable Guid Perine Grid 18GKRNG.EL1.182020-07-17
03665134000233transP - Reusable Guid Perine Nail 18GKRNG.EL2.182020-07-17
03665134000240transP - Reusable Guid Perine Nail 14GKRNG.EL2.142020-07-17
03665134000257transP - perine full grid 18GKRNG.EL4.182020-07-17
03665134000264transP - perine full grid 14GKRNG.EL4.142020-07-17
03665134000776Steady ProKSP.SUPP.TR2022-10-06
03665134000912Steady ProKSP.SUPP.TP22024-06-03
03665134000745Steady ProKSP.SUPP.TP2022-10-06
03665134000271transP - Perine Adaptater KRGA.EL52020-07-17
03665134000288CON LEAD 18GKRNG.AB.182023-04-05
03665134000295CON LEAD 14GKRNG.AB.142023-04-05
03665134000127transP - Reusable Guid Perine Grid 14GKRNG.EL1.14-52020-07-17
03665134000301LIN LEAD 18GKRNG.LN.182023-04-05
03665134000318LIN LEAD 14GKRNG.LN.142023-04-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841517112684C5-1FUJIFILM SONOSITE, INC.ITX2026-08-07
00841517112684C5-1FUJIFILM SONOSITE, INC.IYO2026-08-07
00841517112684C5-1FUJIFILM SONOSITE, INC.IYN2026-08-07
00850059977637TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-08-07
00850059977644TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-08-07
00850059977651TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-08-07
00850059977668TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-08-07
00850059977675TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-08-07
75401622522125Synthesis Vision ViewerSynthesis Health Intelligence IncLLZ2026-08-07
00198953246405Xeleris V Processing and Review SystemG E MEDICAL SYSTEMS ISRAEL LTD.LLZ2026-08-03
00860011624349IntraOpVSPXironetic LLCLLZ2026-08-03
00862234000337Mosaic ViewerVirtual Radiologic CorporationLLZ2026-07-31
09358140000093Quicktome Software SuiteOmniscient Neurotechnology Pty Ltd (o8t)LLZ2026-07-30
00841436122078Biopsy BracketCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00841436122900Biopsy BracketCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00841436124294Biopsy BracketCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00841436125420Tracking BracketCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-27
00841436125895Needle Guide Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00841436126052Biopsy BracketCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00841436126212Tracking Bracket Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-27
00841436126229Tracking BracketCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-27
00841436126328Tracking BracketCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-27
00841436126403Needle Guide Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00841436126410Needle Guide BracketCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00841436126588Tracking Bracket Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-27
00841436126595Tracking BracketCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-27
00850059977521TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-06-26
00850059977538TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-06-26
00850059977545TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-06-26
00850059977552TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-06-26