Diagnostic Ultrasound System

FDA 510(k) K791298 · Xonics Medical Systems, Inc.

Substantially Equivalent

510(k) numberK791298

Submission

Device name
Diagnostic Ultrasound System
Applicant
Xonics Medical Systems, Inc.
Mchenry, IL, US
Received
July 16, 1979
Decision date
September 27, 1979
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

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 Diagnostic Ultrasound System cleared by the FDA?

Diagnostic Ultrasound System (K791298) received a 510(k) decision of Substantially Equivalent on September 27, 1979, 73 days after the submission was received.

What is the product code of K791298?

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