ULTRASIGHT HD DIGITAL COLPOSCOPY WITH IMAGESENSE TECHNOLOGY— 510(k) K090324

Name: FDA 510(k) clearance K090324
Creator: U.S. Food and Drug Administration
Published: 2010-12-20

Substantially Equivalent

Sti Medical Systems

FDA 510(k) clearance K090324 for ULTRASIGHT HD DIGITAL COLPOSCOPY WITH IMAGESENSE TECHNOLOGY, Substantially Equivalent on 2010-12-20. Applicant: Sti Medical Systems. Device class: 2.

Clearance details

Applicant: Sti Medical Systems
Product code: Code HEX
Device class: Class 2
Regulation: 21 CFR 884.1630
Advisory panel: Obstetrics/Gynecology
Date received: 2009-02-09
Decision date: 2010-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Honolulu, HI, US

Download summary PDF View on FDA.gov ↗

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