Ultrasight HD Digital Colposcopy with Imagesense Technology

FDA 510(k) K090324 · Sti Medical Systems

Substantially Equivalent

510(k) numberK090324

Submission

Device name
Ultrasight HD Digital Colposcopy with Imagesense Technology
Applicant
Sti Medical Systems
Honolulu, HI, US
Received
February 9, 2009
Decision date
December 20, 2010
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
HEX – Colposcope (And Colpomicroscope)
Device class
Class II (moderate risk)
Regulation
21 CFR 884.1630
Specialty
Obstetrics/Gynecology

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Questions and answers

When was Ultrasight HD Digital Colposcopy with Imagesense Technology cleared by the FDA?

Ultrasight HD Digital Colposcopy with Imagesense Technology (K090324) received a 510(k) decision of Substantially Equivalent on December 20, 2010, 679 days after the submission was received.

What is the product code of K090324?

The FDA product code is HEX – Colposcope (And Colpomicroscope), a Class II (moderate risk) device regulated under 21 CFR 884.1630.