510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K123535Substantially Equivalent

Ilab Ultrasound Imaging System

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

K123535 is the FDA 510(k) clearance record for ILAB ULTRASOUND IMAGING SYSTEM, a class II device, cleared for Boston Scientific Corp on under FDA product code IYO (System, Imaging, Pulsed Echo, Ultrasonic). FDA records list 1,110 510(k) clearances for Boston Scientific Corp, from to . As of , FDA records show no recalls naming K123535.

Clearance record

Decision date
Received
(60 days to decision)
Product code
IYO System, Imaging, Pulsed Echo, Ultrasonic
Regulation
21 CFR 892.1560
Device class
Class II
Review panel
Radiology
Applicant
Boston Scientific Corp 47215 Lakeview, Fremont CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code IYO

Trailing 12 months
9 clearances under product code IYO in the twelve months to November 2026, February 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code IYO, trailing twelve months
MonthClearances
December 20250
January 20260
February 20262
March 20261
April 20262
May 20260
June 20261
July 20261
August 20260
September 20261
October 20261
November 20260