AVIEW Aorta Metrics 2.0
AVIEW Aorta Metrics 2.0 is a Class II device made by Coreline Soft Co., Ltd., cleared under FDA 510(k) K260391 on 16 Oct 2026 and listed in FDA GUDID since 29 Oct 2026 (UDI-DI 08800025300374), active as of 9 Nov 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number08800025300374 | Date29 Oct 2026 | StatusListed |
| United States | FDA 510(k)SESE | NumberK260391 | Date16 Oct 2026 | StatusActive |
Official records
- AccessGUDID record 08800025300374
- FDA 510(k) database K260391
Across registries
- FDA 510(k) K260391 decided 16 Oct 2026 Active
- FDA GUDID UDI-DI 08800025300374 listed 29 Oct 2026 Listed
Timeline
- Cleared FDA 510(k) K260391
- Listed FDA GUDID 08800025300374
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- AVIEW Aorta Metrics
- Generic name
- Radiological PACS-dedicated management software
- Model / reference
- 2.0
- Primary DI / UDI-DI
- 08800025300374
- 510(k) Number
- FDA product code
- JAK
- GMDN term
- Radiological PACS-dedicated management software
- Device class
- Class II
- Regulation number
- 892.1750
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code JAK (System, X-Ray, Tomography, Computed).
- CT MAX, CATALOG NO. B7940 HA by General Electric Co.
- OMNIMEDICAL QUAD I by Omnimedical
- SURGETICS ENTACT ENDONASAL NAVIGATION SYSTEM by Praxim
- CAC Software by Imbio, LLC
- LUNG NODULE ASSESSMENT AND COMPARISON OPTION by Philips Medical Systems (Cleveland), Inc.
- Operator Console by GE Hangwei Medical Systems Company Ltd.
- AirDrive EZ XT-5100-P by Qfix
- SOMATOM go.Up, SOMATOM go.Now by SIEMENS MEDICAL SOLUTIONS USA, INC.
- OmniTom Elite with PCD by Neurologica Corporation
- DELTASCAN 2060 CT SCANNER by Technicare Corp.