Sirona Medical Radiology Platform

Primary DI
00860011175803
Brand
Sirona Medical Radiology Platform
Company
Sirona Medical, Inc.
Model
Model1
Published
2023-11-14
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
LMDSystem, Digital Image Communications, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2
LMDSystem, Digital Image Communications, RadiologicalRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860011175803PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860011175803008600111758038600111758030860011175803

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
116915707
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 Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00850025268431Vitrea Advanced VisualizationCanon Medical Informatics, Inc.LMD2026-09-21
05415334059139BarcoBarco NVLMD2026-09-21
05415334059924BarcoBarco NVLMD2026-09-21
05415334059931BarcoBarco NVLMD2026-09-21
08437021722109ADAS 3DADAS3D MEDICAL S.L.LLZ2026-09-18
07350092810722Sectra Orthopedic PackageSectra ABLLZ2026-09-06
00754016387128ANDIImeka Solutions IncLLZ2026-05-14
00628105001212Vitrea ReadCanon Medical Informatics A/SLMD2026-04-27
00628105001229Vitrea ReadCanon Medical Informatics A/SLMD2026-04-03
00198953059173ViewPointGE Healthcare GmbHLLZ2026-02-27
00198953076873SenoIrisGE MEDICAL SYSTEMSLLZ2025-11-24
00628105001205Vitrea ReadCanon Medical Informatics A/SLMD2025-11-21
00628105001199Vitrea ReadCanon Medical Informatics A/SLMD2025-08-15
00195278951700EchoPACGE Vingmed Ultrasound A/SLLZ2025-08-08
00195278951717EchoPACGE Vingmed Ultrasound A/SLLZ2025-08-08
00860003424841OrthoGrid Hip TraumaOrthogrid Systems, Inc.LLZ2025-06-24
00628105001182Vitrea ReadCanon Medical Informatics A/SLMD2025-04-04
00884838127746Radiology Operations Command Center ConsolePhilips Medical Systems Nederland B.V.LLZ2025-03-14
00198715251623BrainSpec Coreā„¢ SoftwareBrainSpec Inc.LLZ2025-02-10
00670082000610Modus PlanSynaptive Medical IncLLZ2025-01-17
00628105001168Vitrea ReadCanon Medical Informatics A/SLMD2025-01-10
00628105001175Vitrea ReadCanon Medical Informatics A/SLMD2025-01-10
00195278753472ViewPointGE Healthcare GmbHLLZ2024-07-15
00628105001151Vitrea ReadCanon Medical Informatics A/SLMD2024-05-22
00628105001144Vitrea ReadCanon Medical Informatics A/SLMD2024-04-03
00628105001106Vitrea ReadCanon Medical Informatics A/SLMD2024-01-19