4DM— 510(k) K260879
Substantially EquivalentINVIA, LLC
FDA 510(k) clearance K260879 for 4DM, Substantially Equivalent on 2026-09-10. Applicant: INVIA, LLC. Device class: 2.
Summary
4DM from INVIA is filed under QIH, automated radiological image processing software. The record doesn't describe what the software does.
Class II, 21 CFR 892.2050. The Radiology panel reviewed it as a Traditional 510(k).
INVIA filed from Ann Arbor, Michigan. Review took 177 days (March 17 to September 10, 2026).
Clearance details
- Applicant
- INVIA, LLC
- Product code
- Product code QIH
- Device class
- Class 2
- Regulation
- 21 CFR 892.2050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Ann Arbor, MI, US
Recent devices under product code QIH
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