Prudent 1717, Prudent 1417, Prudent 1212— 510(k) K211108

Name: FDA 510(k) clearance K211108
Creator: U.S. Food and Drug Administration
Published: 2021-06-04

Substantially Equivalent

Pixxgen Corporation

FDA 510(k) clearance K211108 for Prudent 1717, Prudent 1417, Prudent 1212, Substantially Equivalent on 2021-06-04. Applicant: Pixxgen Corporation. Device class: 2.

Clearance details

Applicant: Pixxgen Corporation
Product code: Code MQB
Device class: Class 2
Regulation: 21 CFR 892.1680
Advisory panel: Radiology
Date received: 2021-04-14
Decision date: 2021-06-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Anyang-Si, KR

Download summary PDF View on FDA.gov ↗

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