FDA.reportPublic FDA data

Ashvins

Primary DI
04260648620039
Brand
Ashvins
Company
MedicalCommunications GmbH
Model
2023 (Build 2088)
Published
2023-02-24
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
04260648620039PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260648620039042606486200394260648620039

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
04260648620053Ashvins2023 (Build 2167)2024-07-09
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
05420060351228TruMatch CMF Titanium 3D Printed SplintsMaterialise NVLLZ2026-10-20
TKRL0001F1540PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001F1B80PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001F34K0PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001F6000PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001F7300PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001F7940PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001F7F80PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001F9F00PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001FF640PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001FLI00PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001KF5I0PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001L0LD0PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001L4120PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001L7FI0PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001L9260PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL000200F30PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL000201K20PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL000202L80PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL000203ID0PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL000205I00PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0002066I0PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL000207330PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL000208K50PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0002098I0PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL000209F30PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL00020D0F0PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL00020F080PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL00020F670PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL00020I510PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20