FDA.reportPublic FDA data

EndoNaut (Server) SW

Primary DI
03760262480053
Brand
EndoNaut (Server) SW
Company
THERENVA
Model
1.x.x
Published
2026-05-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LLZSystem, Image Processing, Radiological
OWBInterventional Fluoroscopic X-Ray System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2
OWBInterventional Fluoroscopic X-Ray SystemRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K222070000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222070000EndoNautTherenva Sas2022-10-25OWB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03760262480053PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03760262480053037602624800533760262480053

GMDN Terms#

Term, Definition table
TermDefinition
Radiology DICOM image processing application softwareA software application intended to facilitate management, distribution, and/or viewing of radiological digital imaging and communications in medicine (DICOM) image data; it is not intended for pathological image interpretation (i.e., not intended to detect and localize suspected abnormalities). It may be intended to facilitate image management (e.g., viewing, communication, printing, recording/disc burning) and/or image quality manipulation and quantification (e.g., non-interpretive graphical overlays).

Regulatory Flags#

DUNS number
296780716
Device count
1
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03760262480039EndoNaut WorkstationTS1CA2DS1-22026-05-06
03760262480046EndoNaut (System)1.22026-05-06
03760262480084EndoNaut System MHS1.22026-05-06
03760262480091EndoNaut Server Main Display SW1.x.x2026-05-06
03760262480022EndoNaut (Standalone) SW1.22023-12-11
03760262480015EndoSize3.12016-07-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190376649474CONTOUR3DALPHATEC SPINE, INC.OWB2026-09-25
00190376652313CONTOUR3DALPHATEC SPINE, INC.OWB2026-09-25
00190376652320CONTOUR3DALPHATEC SPINE, INC.OWB2026-09-25
00190376652337CONTOUR3DALPHATEC SPINE, INC.OWB2026-09-25
00190376668307CONTOUR3DALPHATEC SPINE, INC.OWB2026-09-25
04260456230215CHILI PACSCHILI GmbHLLZ2026-09-25
B141MEDISSUITEMRCT20260Medis Suite MRCTMedis Medical Imaging Systems B.V.LLZ2026-09-25
BN981BN002020Bolt NavigationCircinus Medical Technology LLCOWB2026-09-25
BN981BN00202BX101Bolt NavigationCircinus Medical Technology LLCOWB2026-09-25
00850025268431Vitrea Advanced VisualizationCanon Medical Informatics, Inc.LLZ2026-09-21
00850079606081MC2 Portable X-ray SystemOXOS Medical, Inc.OWB2026-09-21
00850079606098EmitterOXOS Medical, Inc.OWB2026-09-21
00850079606104CassetteOXOS Medical, Inc.OWB2026-09-21
08437021722109ADAS 3DADAS3D MEDICAL S.L.LLZ2026-09-18
07350092810722Sectra Orthopedic PackageSectra ABLLZ2026-09-06
00754016387128ANDIImeka Solutions IncLLZ2026-05-14
00198953059173ViewPointGE Healthcare GmbHLLZ2026-02-27
00198953076873SenoIrisGE MEDICAL SYSTEMSLLZ2025-11-24
00860003424841OrthoGrid Hip TraumaOrthogrid Systems, Inc.LLZ2025-06-24
00817886020646JointsMEDSTRAT, INC.LLZ2025-04-30
00884838127746Radiology Operations Command Center ConsolePhilips Medical Systems Nederland B.V.LLZ2025-03-14
00817886020639JointsMEDSTRAT, INC.LLZ2025-03-07
00198715251623BrainSpec Core™ SoftwareBrainSpec Inc.LLZ2025-02-10
00817886020622JointsMEDSTRAT, INC.LLZ2025-02-03
00670082000610Modus PlanSynaptive Medical IncLLZ2025-01-17
00817886020615JointsMEDSTRAT, INC.LLZ2024-12-09
00817886020608JointsMEDSTRAT, INC.LLZ2024-11-01
00817886020592JointsMEDSTRAT, INC.LLZ2024-08-31
00195278753472ViewPointGE Healthcare GmbHLLZ2024-07-15
00817886020585JointsMEDSTRAT, INC.LLZ2024-06-08