510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K945957Substantially Equivalent

Ausonics Opus 2 Realtime Ultrasound Scanner

Kleinfeld, Kaplan and Becker, Washington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K945957 is the FDA 510(k) clearance record for AUSONICS OPUS 2 REALTIME ULTRASOUND SCANNER, a class II device, cleared for Kleinfeld, Kaplan and Becker on under FDA product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic). FDA records list 2 510(k) clearances for Kleinfeld, Kaplan and Becker, from to . As of , FDA records show no recalls naming K945957.

Clearance record

Decision date
Received
(496 days to decision)
Product code
IYN System, Imaging, Pulsed Doppler, Ultrasonic
Regulation
21 CFR 892.1550
Device class
Class II
Review panel
Radiology
Applicant
Kleinfeld, Kaplan and Becker 1140 Nineteenth St., NW, Washington DC
510(k) summary
Statement
Third party review
No

Clearances, product code IYN

Trailing 12 months
53 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 20261