Dioscan

FDA 510(k) K802341 · Sonometrics Systems, Inc.

Substantially Equivalent

510(k) numberK802341

Submission

Device name
Dioscan
Applicant
Sonometrics Systems, Inc.
Mchenry, IL, US
Received
September 26, 1980
Decision date
December 10, 1980
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 Dioscan cleared by the FDA?

Dioscan (K802341) received a 510(k) decision of Substantially Equivalent on December 10, 1980, 75 days after the submission was received.

What is the product code of K802341?

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