510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K071996Substantially Equivalent

Mylab30, Model 7300

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

K071996 is the FDA 510(k) clearance record for MYLAB30, MODEL 7300, a class II device, cleared for Esaote, S.p.A. on under FDA product code IYO (System, Imaging, Pulsed Echo, Ultrasonic). FDA records list 69 510(k) clearances for Esaote, S.p.A., from to . As of , FDA records show no recalls naming K071996.

Clearance record

Decision date
Received
(8 days to decision)
Product code
IYO System, Imaging, Pulsed Echo, Ultrasonic
Regulation
21 CFR 892.1560
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 IYO

Trailing 12 months
10 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 20262
November 20260