ShapeIT (SI014135)— 510(k) K241611

Substantially Equivalent

Imds Operations B.V.

FDA 510(k) clearance K241611 for ShapeIT (SI014135), Substantially Equivalent on 2024-09-03. Applicant: Imds Operations B.V..

Clearance details

Applicant: Imds Operations B.V.
Product code: Code DQY
Advisory panel: Cardiovascular
Date received: 2024-06-05
Decision date: 2024-09-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Roden, NL

Download summary PDF View on FDA.gov ↗

Adverse events under product code DQY

product code DQY

Death: 464
Injury: 4,489
Malfunction: 13,721
Other: 2
Total: 18,676

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.