SoftVue
by Delphinus Medical Technologies 2 variants
510(k) K142517
SoftVue is a Class II device made by Delphinus Medical Technologies, cleared under FDA 510(k) K142517 on 31 Oct 2014, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK142517 | Date31 Oct 2014 | StatusActive |
Official records
- FDA 510(k) database K142517
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- IYO
- FDA applicant
- Delphinus Medical Technologies, Inc.
- Device class
- Class II
- Regulation
- 21 CFR Part 892.1560
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
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