510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K012728Substantially Equivalent

E-Scan MRI System

Esaote North America, Inc, Indianapolis IN / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K012728 is the FDA 510(k) clearance record for E-SCAN MRI SYSTEM, a class II device, cleared for Biosound Esaote, Inc. on under FDA product code MOS (Coil, Magnetic Resonance, Specialty). FDA records list 20 510(k) clearances for Esaote North America, Inc, from to . As of , FDA records show no recalls naming K012728.

Clearance record

Decision date
Received
(14 days to decision)
Product code
MOS Coil, Magnetic Resonance, Specialty
Regulation
21 CFR 892.1000
Device class
Class II
Review panel
Radiology
Applicant
Biosound Esaote, Inc. 8000 Castleway Dr., Indianapolis IN
510(k) summary
Summary
Third party review
No

Clearances, product code MOS

Trailing 12 months
9 clearances under product code MOS in the twelve months to October 2026, April 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code MOS, trailing twelve months
MonthClearances
November 20250
December 20250
January 20262
February 20261
March 20261
April 20263
May 20260
June 20260
July 20262
August 20260
September 20260
October 20260