DeviceClearance

RadAlly— 510(k) K213660

Substantially Equivalent

Imaging Wave, LLC

FDA 510(k) clearance K213660 for RadAlly, Substantially Equivalent on 2023-03-31. Applicant: Imaging Wave, LLC. Device class: 2.

Clearance details

Applicant
Imaging Wave, LLC
Product code
Code LLZ
Device class
Class 2
Regulation
21 CFR 892.2050
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Abbreviated
Location
Forrest Hills, NY, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code LLZ

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Adverse events under product code LLZ

product code LLZ
Death
13
Total
13

Source: openFDA MAUDE database, through . 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.