510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
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K022858Substantially Equivalent

Supernova Diagnostic Ultrasound Scanning System

Novasonics, Inc., Mountain Vies CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K022858 is the FDA 510(k) clearance record for SUPERNOVA DIAGNOSTIC ULTRASOUND SCANNING SYSTEM, a class II device, cleared for Novasonics, Inc. on under FDA product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic). FDA records list one 510(k) clearance for Novasonics, Inc. As of , FDA records show no recalls naming K022858.

Clearance record

Decision date
Received
(9 days to decision)
Product code
IYN System, Imaging, Pulsed Doppler, Ultrasonic
Regulation
21 CFR 892.1550
Device class
Class II
Review panel
Radiology
Applicant
Novasonics, Inc. 1061 Terra Bella Ave., Mountain Vies CA
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code IYN

Trailing 12 months
55 clearances under product code IYN in the twelve months to October 2026, May 2026 the highest month at 11.
Show the numbers
Monthly 510(k) clearances under FDA product code IYN, trailing twelve months
MonthClearances
November 20256
December 20256
January 20264
February 20261
March 20266
April 20263
May 202611
June 20263
July 20266
August 20263
September 20263
October 20263