FDA.reportPublic FDA data

Ashvins variant Diagnostic Workstation, Ashvins variant Image & Web Management

Primary DI
04260648620008
Brand
Ashvins variant Diagnostic Workstation, Ashvins variant Image & Web Management
Company
MedicalCommunications GmbH
Model
Ashvins 2020
Published
2020-12-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
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
04260648620008PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260648620008042606486200084260648620008

GMDN Terms#

Term, Definition table
TermDefinition
Radiology picture archiving and communication system workstationA freestanding, image processing device that is a component of a picture archiving and communication system (PACS) for radiology designed to be networked with a wide variety of diagnostic imaging systems [e.g., x-ray, nuclear medicine, magnetic resonance imaging (MRI) or ultrasound (US), as well as a laboratory or hospital information system (HIS)]. It does not contain controls for the direct operation of a diagnostic imaging system and is designed to receive, archive, and transmit data both on-line and off-line. It is configured to provide limited or extensive capabilities to further process, manipulate and/or view patient images and information collected from diagnostic imaging systems.

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
04260648620039Ashvins2023 (Build 2088)2023-02-24
04260648620046Ashvins variant HEYEX 2 / HEYEX PACS2.62023-02-24
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
07350092810722Sectra Orthopedic PackageSectra ABLLZ2026-09-06
00754016387128ANDIImeka Solutions IncLLZ2026-05-14
00198953059173ViewPointGE Healthcare GmbHLLZ2026-02-27
00817886020677JointsMEDSTRAT, INC.LLZ2026-02-16
00817886020660JointsMEDSTRAT, INC.LLZ2025-08-09
00817886020653JointsMEDSTRAT, INC.LLZ2025-06-27
00817886020646JointsMEDSTRAT, INC.LLZ2025-04-30
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
00817886020578JointsMEDSTRAT, INC.LLZ2024-04-12
00817886020561JointsMEDSTRAT, INC.LLZ2024-02-10
00817886020554JointsMEDSTRAT, INC.LLZ2023-11-13
00350227000520EaglesoftPATTERSON TECHNOLOGY CENTERLLZ2023-10-25
00754016387111ANDIImeka Solutions IncLLZ2023-09-01
00732094223910Welch Allyn, Inc.WELCH ALLYN, INC.NFJ2023-08-24
00817886020516JointsMEDSTRAT, INC.LLZ2023-05-29
00817886020509JointsMEDSTRAT, INC.LLZ2023-04-03
00817886020493JointsMEDSTRAT, INC.LLZ2023-03-06
00195278517340ViewPointGE Healthcare GmbHLLZ2023-02-15
00817886020486JointsMEDSTRAT, INC.LLZ2023-01-20
00670082000511Modus PlanSynaptive Medical IncLLZ2022-12-13
00817886020479JointsMEDSTRAT, INC.LLZ2022-10-29
00817886020462JointsMEDSTRAT, INC.LLZ2022-09-05