4DM
by Invia
510(k) K260879
4DM is a medical device (FDA Class II; FDA product code QIH, Automated Radiological Image Processing Software) made by Invia, cleared under FDA 510(k) K260879 on 10 Sep 2026, 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 | NumberK260879 | Date10 Sep 2026 | StatusActive |
Official records
- FDA 510(k) database K260879
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- QIH
- FDA applicant
- INVIA, LLC
- Device class
- Class II
- Regulation
- 21 CFR Part 892.2050
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
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