Axis Nano Opthalmic Biometer Ultrasound System

FDA 510(k) K102027 · Quantel Medical S.A.

Substantially Equivalent

510(k) numberK102027

Submission

Device name
Axis Nano Opthalmic Biometer Ultrasound System
Applicant
Quantel Medical S.A.
Bozeman, MT, US
Received
July 19, 2010
Decision date
December 22, 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
IYO – System, Imaging, Pulsed Echo, Ultrasonic
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1560
Specialty
Radiology

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Questions and answers

When was Axis Nano Opthalmic Biometer Ultrasound System cleared by the FDA?

Axis Nano Opthalmic Biometer Ultrasound System (K102027) received a 510(k) decision of Substantially Equivalent on December 22, 2010, 156 days after the submission was received.

What is the product code of K102027?

The FDA product code is IYO – System, Imaging, Pulsed Echo, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1560.