FDA.report

VELYS Trauma

Primary DI
04260729622006
Brand
VELYS Trauma
Company
metamorphosis GmbH
Model
10.037.001
Published
2025-12-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
QIHAutomated Radiological Image Processing Software

Product Code Classifications

CodeDeviceSpecialtyClass
QIHAutomated Radiological Image Processing SoftwareRadiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04260729622006PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04260729622006042607296220064260729622006

GMDN Terms

TermDefinition
Basic diagnostic x-ray system application softwareAn individual software program or group of programs, routines or algorithms that add specific image processing and/or analysis capabilities to a general-purpose x-ray imaging system configuration. A basic set of applications programs and routines are included with such computer-controlled imaging systems and they can be upgraded to correct programming errors or to add new system capabilities. Some applications software routines or groups of routine packages must be combined with specific hardware or firmware accessories or configurations in order to function as intended. Applications program packages are typically identified by a proprietary name and "version" or "upgrade" number.

Sterilization Methods

Method

Regulatory Flags

DUNS number
315129327
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 DIBrandCompanyProduct codePublished
08800130400228Neurophet SCALE PETNEUROPHET Inc.QIH2026-05-26
08800130400310Neurophet AQUANEUROPHET Inc.QIH2026-05-26
04068151020076syngo DynamicsSiemens Healthcare GmbHQIH2026-03-19
09369900000857SalixARTRYA USA INC.QIH2026-02-17
09369998252183SalixARTRYA USA INC.QIH2026-02-17
08720892617637LumiNE USAugmedIT B.V.QIH2026-02-13
00860009223660Neosoma Brain MetsNeosoma, Inc.QIH2026-02-10
00860010268087Segmentron ViewerDGNCT LLCQIH2026-01-29
06429810209054SMART PCFDDisior OyQIH2026-01-27
05070003179800CDM InsightsOXFORD BRAIN DIAGNOSTICS LTDQIH2026-01-26
CARDIOVASCCALCT1TeraRecon Cardiovascular.Calcification.CT Terarecon Inc.QIH2026-01-23
08809944936220HERA Z30 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.QIH2026-01-20
00810056991357aprevoCarlsmed, Inc.QIH2026-01-15
00198953109434LOGIQGE Ultrasound Korea Ltd.QIH2026-01-14
00884838129771LVivo View SelectionPhilips Ultrasound LLCQIH2025-12-18
00860003567944Second Opinion 3DPearl Inc.QIH2025-12-12
00860005586394Overjet CBCT AssistOverjet, Inc.QIH2025-12-12
03663999000436AutoDensityEOS IMAGINGQIH2025-12-09
00841517112424Sonosite PXFUJIFILM SONOSITE, INC.QIH2025-11-24
00860011384809ConstellationQ Bio, Inc.QIH2025-10-17
05430002070124FEopsFEopsQIH2025-09-25
E2472110100003A20VistaSoftDÜRR DENTAL SEQIH2025-09-22
04262352353517DS Core DiagnosisZetta25 AGQIH2025-09-05
00884838129276Ultrasound WorkspacePhilips Ultrasound LLCQIH2025-08-29
04068151009460syngo.MI GeneralSIEMENS MEDICAL SOLUTIONS USA, INC.QIH2025-08-13
04068151009453syngo.MM OncologySIEMENS MEDICAL SOLUTIONS USA, INC.QIH2025-08-11
06971576834204uOmnispaceShanghai United Imaging Healthcare Co., Ltd.QIH2025-08-02
06971576834228uOmnispaceShanghai United Imaging Healthcare Co., Ltd.QIH2025-08-02
06971576834259uOmnispaceShanghai United Imaging Healthcare Co., Ltd.QIH2025-08-02
03663999000412VEA AlignEOS IMAGINGQIH2025-08-01