510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K202514Substantially Equivalent

EchoS Family

Echolight S.p.A., Lecce, IT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K202514 is the FDA 510(k) clearance record for EchoS Family, a class II device, cleared for Echolight S.P.A on under FDA product code MUA (Bone Sonometer). FDA's definition for product code MUA reads: "A bone sonometer is a device that transmits ultrasound energy into the human body to measure acoustic properties of bone that indicate overall bone health and fracture risk. The primary components of the device are a voltage generator, a...". FDA records list 3 510(k) clearances for Echolight S.P.A, from to . As of , FDA records show no recalls naming K202514.

Clearance record

Decision date
Received
(178 days to decision)
Product code
MUA Bone Sonometer
Regulation
21 CFR 892.1180
Device class
Class II
Review panel
Radiology
Applicant
Echolight S.P.A Via Raffaello Sanzio, 18, Lecce, IT
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MUA

Trailing 12 months

FDA records hold no clearances under product code MUA in the trailing twelve months.

FDA records show no clearances under product code MUA in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MUA, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260