Sonata 3-D Imaging Accessory, Model 3DS

Q: What is the product code of K042620?

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) K042620 · Tetrad Corp.

Substantially Equivalent

510(k) numberK042620

Submission

Device name: Sonata 3-D Imaging Accessory, Model 3DS
Applicant: Tetrad Corp.
Englewood, CO, US
Received: September 27, 2004
Decision date: December 23, 2004
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 Sonata 3-D Imaging Accessory, Model 3DS cleared by the FDA?

Sonata 3-D Imaging Accessory, Model 3DS (K042620) received a 510(k) decision of Substantially Equivalent on December 23, 2004, 87 days after the submission was received.

What is the product code of K042620?

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