Precision DL— 510(k) K223212

Substantially Equivalent

GE Healthcare

FDA 510(k) clearance K223212 for Precision DL, Substantially Equivalent on 2023-04-27. Applicant: GE Healthcare. Device class: 2.

Clearance details

Applicant: GE Healthcare
Product code: Code KPS
Device class: Class 2
Regulation: 21 CFR 892.1200
Advisory panel: Radiology
Date received: 2022-10-17
Decision date: 2023-04-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tirat Hacarmel, IL

Download summary PDF View on FDA.gov ↗

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