Delta4 Phantom+ MR (PMMA), Delta4 Phantom+ MR (PW)— 510(k) K183606

Name: FDA 510(k) clearance K183606
Creator: U.S. Food and Drug Administration
Published: 2019-04-08

Substantially Equivalent

Scandidos AB

FDA 510(k) clearance K183606 for Delta4 Phantom+ MR (PMMA), Delta4 Phantom+ MR (PW), Substantially Equivalent on 2019-04-08. Applicant: Scandidos AB. Device class: 2.

Clearance details

Applicant: Scandidos AB
Product code: Code IYE
Device class: Class 2
Regulation: 21 CFR 892.5050
Advisory panel: Radiology
Date received: 2018-12-26
Decision date: 2019-04-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Uppsala, SE

Download summary PDF View on FDA.gov ↗

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Adverse events under product code IYE

product code IYE

Malfunction: 455
Other: 3
Total: 458

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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