Aplio 500/400/300 Diagnostic Ultrasound System

Q: What is the product code of K121422?

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

FDA 510(k) K121422 · Toshiba Medical Systems Coporation, Japan

Substantially Equivalent

510(k) numberK121422

Submission

Device name: Aplio 500/400/300 Diagnostic Ultrasound System
Applicant: Toshiba Medical Systems Coporation, Japan
Tustin, CA, US
Received: May 14, 2012
Decision date: August 16, 2012
Decision: Substantially Equivalent (SESE)
Type: Special 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 Aplio 500/400/300 Diagnostic Ultrasound System cleared by the FDA?

Aplio 500/400/300 Diagnostic Ultrasound System (K121422) received a 510(k) decision of Substantially Equivalent on August 16, 2012, 94 days after the submission was received.

What is the product code of K121422?

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