ERGO IMAGING SYSTEM— 510(k) K100838

Substantially Equivalent

Digirad Corp.

FDA 510(k) clearance K100838 for ERGO IMAGING SYSTEM, Substantially Equivalent on 2010-04-23. Applicant: Digirad Corp.. Device class: 1.

Clearance details

Applicant: Digirad Corp.
Product code: Code IYX
Device class: Class 1
Regulation: 21 CFR 892.1100
Advisory panel: Radiology
Date received: 2010-03-24
Decision date: 2010-04-23
Decision: Substantially Equivalent
Clearance type: Special
Location: Poway, CA, US

Download summary PDF View on FDA.gov ↗

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