Softvue
by Delphinus Medical Technologies 2 variants
510(k) K123209
Softvue is a Class II device made by Delphinus Medical Technologies, cleared under FDA 510(k) K123209 on 19 Dec 2013, 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 | NumberK123209 | Date19 Dec 2013 | StatusActive |
Official records
- FDA 510(k) database K123209
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- Withdrawn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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