4DM— 510(k) K260879

Name: FDA 510(k) clearance K260879
Creator: U.S. Food and Drug Administration
Published: 2026-09-10

Substantially Equivalent

INVIA, LLC

FDA 510(k) clearance K260879 for 4DM, Substantially Equivalent on 2026-09-10. Applicant: INVIA, LLC. Device class: 2.

Summary

4DM is INVIA's nuclear cardiology software, used to process and quantify SPECT and PET myocardial perfusion studies. It's filed under QIH, automated radiological image processing software.

Class II, 21 CFR 892.2050. The Radiology panel reviewed it as a Traditional 510(k).

INVIA filed from Ann Arbor, Michigan. 4DM has been used in nuclear cardiology labs for years, so this is most likely a new version. Review took 177 days (March 17 to September 10, 2026). The record doesn't say what changed.

Clearance details

Applicant: INVIA, LLC
Product code: Code QIH
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2026-03-17
Decision date: 2026-09-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ann Arbor, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code QIH

view all

K261795 — Quicktome Software Suite2026-09-10
K251417 — ReVISION 22026-09-09
K260525 — NextMR Spine2026-09-04
K260811 — Heartvue.Proton2026-08-26
K261595 — Ceevra Reveal 42026-08-25

Data sourced from openFDA. This site is unofficial and independent of the FDA.