i-Rapha Solution— 510(k) K201296

Substantially Equivalent

Irm, Inc.

FDA 510(k) clearance K201296 for i-Rapha Solution, Substantially Equivalent on 2020-07-09. Applicant: Irm, Inc..

Clearance details

Applicant: Irm, Inc.
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2020-05-15
Decision date: 2020-07-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gangnam-Gu, KR

Download summary PDF View on FDA.gov ↗

Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

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.