510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K091009Substantially Equivalent

My Labs25 Gold/mylab30 Gold Cardiovascular Model 7340, My Lab70/my Lab70xvision/mylab60, Model 6150

Esaote S.p.A., Carmel IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K091009 is the FDA 510(k) clearance record for MY LABS25 GOLD/MYLAB30 GOLD CARDIOVASCULAR MODEL 7340, MY LAB70/MY LAB70XVISION/MYLAB60, MODEL 6150, a class II device, cleared for Esaote, S.p.A. on under FDA product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic). FDA records list 69 510(k) clearances for Esaote, S.p.A., from to . As of , FDA records show no recalls naming K091009.

Clearance record

Decision date
Received
(39 days to decision)
Product code
IYN System, Imaging, Pulsed Doppler, Ultrasonic
Regulation
21 CFR 892.1550
Device class
Class II
Review panel
Radiology
Applicant
Esaote, S.p.A. 11460 N.Meridian St.,, Carmel IN
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code IYN

Trailing 12 months
50 clearances under product code IYN in the twelve months to November 2026, May 2026 the highest month at 11.
Show the numbers
Monthly 510(k) clearances under FDA product code IYN, trailing twelve months
MonthClearances
December 20256
January 20264
February 20261
March 20266
April 20263
May 202611
June 20263
July 20266
August 20263
September 20263
October 20264
November 20260