510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K063493Substantially Equivalent

I Review Software(accessory to) Ilab Ultrasound Imaging System) Version1.0

Boston Scientific Corporation, Fremont CA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K063493 is the FDA 510(k) clearance record for I REVIEW SOFTWARE(ACCESSORY TO) ILAB ULTRASOUND IMAGING SYSTEM) VERSION1.0, a class II device, cleared for Boston Scientific Corp on under FDA product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic). FDA records list 1,110 510(k) clearances for Boston Scientific Corp, from to . As of , FDA records show one recall naming K063493.

Clearance record

Decision date
Received
(31 days to decision)
Product code
IYN System, Imaging, Pulsed Doppler, Ultrasonic
Regulation
21 CFR 892.1550
Device class
Class II
Review panel
Radiology
Applicant
Boston Scientific Corp 47900 Bayside Pkwy., Fremont CA
510(k) summary
Summary PDF
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