FDA.reportPublic FDA data

Ashvins

Primary DI
04260648620053
Brand
Ashvins
Company
MedicalCommunications GmbH
Model
2023 (Build 2167)
Published
2024-07-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
LLZSystem, Image Processing, Radiological
NFJSystem, Image Management, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2
NFJSystem, Image Management, OphthalmicRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200132000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200132000AshvinsMedicalcommunications GmbH2020-02-18LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260648620053PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260648620053042606486200534260648620053

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmology PACS softwareA software program intended to be used primarily as a picture archiving and communication system (PACS) to allow storage, retrieval, and management of digital images of the eye. It may be web-based or installed on a central server for access by a healthcare professional; some types include features for image analysis.

Regulatory Flags#

DUNS number
314721366
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260648620039Ashvins2023 (Build 2088)2023-02-24
04260648620046Ashvins variant HEYEX 2 / HEYEX PACS2.62023-02-24
04260648620008Ashvins variant Diagnostic Workstation, Ashvins variant Image & Web ManagementAshvins 20202020-12-02
04260648620060Ashvins variant HEYEX 2 / HEYEX PACS2.6.5 (Build 2167)2024-07-09
04260648620077Ashvins variant Ashvins Diagnostic Workstation2023 (Build 2167)2024-07-09
04260648620084Ashvins variant Ashvins Diagnostic Workstation2023 (Build 2088)2024-07-09
04260648620015Ashvins variant HEYEX 2 / HEYEX PACS2.52020-03-27
04260648620022Ashvins 2021 (Build 1920)2021-08-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198953050996SnapShot FreezeGE Medical Systems, L.L.C.LLZ2026-10-19
05745000308385Cercare Medical NeurosuiteCercare Medical A/SLLZ2026-10-17
05745000308392Cercare Medical Neurosuite with Capillary FunctionCercare Medical A/SLLZ2026-10-17
05745000308408Cercare Medical Neurosuite (CMN) Capillary Function with Virtual ExpertCercare Medical A/SLLZ2026-10-17
05745000308361Cercare Oncology Virtual Expert; CMN Capillary Function with Oncology Virtual ExCercare Medical A/SLLZ2026-10-16
75401622502301Synthesis Vision ViewerSynthesis Health Intelligence IncLLZ2026-10-16
00889024713390ROSA® ShoulderOrthosoft IncLLZ2026-10-15
B037FFSMD0Synapse MobilityResolutionMD Inc.LLZ2026-10-15
B037NLIVD0Nicolab Image ViewerResolutionMD Inc.LLZ2026-10-15
B037RESMDD0ResolutionMDResolutionMD Inc.LLZ2026-10-15
00860013868918MICSI-PETMicroStructure Imaging, Inc.LLZ2026-10-14
00745426000059MiPACS V5Medicor ImagingLLZ2026-10-12
75401622522132Synthesis Vision ViewerSynthesis Health Intelligence IncLLZ2026-10-08
00198953200421EchoPACGE Vingmed Ultrasound A/SLLZ2026-10-07
00198953200438EchoPACGE Vingmed Ultrasound A/SLLZ2026-10-07
17540262200126Change Healthcare Stratus Imaging Diagnostic ViewerChange Healthcare Canada CompanyLLZ2026-10-05
00884838120433SmartCTPhilips Medical Systems Nederland B.V.LLZ2026-09-28
04260456230215CHILI PACSCHILI GmbHLLZ2026-09-25
B141MEDISSUITEMRCT20260Medis Suite MRCTMedis Medical Imaging Systems B.V.LLZ2026-09-25
00850025268431Vitrea Advanced VisualizationCanon Medical Informatics, Inc.LLZ2026-09-21
08437021722109ADAS 3DADAS3D MEDICAL S.L.LLZ2026-09-18
07350092810722Sectra Orthopedic PackageSectra ABLLZ2026-09-06
00889024673403NavitrackER®Orthosoft IncLLZ2026-06-26
00754016387128ANDIImeka Solutions IncLLZ2026-05-14
00198953059173ViewPointGE Healthcare GmbHLLZ2026-02-27
05745000308323Cercare Medical Neurosuite with Capillary FunctionCercare Medical A/SLLZ2026-01-30
05745000308330Cercare Medical Neurosuite (CMN) Capillary Function with Virtual ExpertCercare Medical A/SLLZ2026-01-30
00198953076873SenoIrisGE MEDICAL SYSTEMSLLZ2025-11-24
00195278951700EchoPACGE Vingmed Ultrasound A/SLLZ2025-08-08
00195278951717EchoPACGE Vingmed Ultrasound A/SLLZ2025-08-08