NA Comfort EC710

by Alltech Medical Systems America, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00853704006010 UDI-DI	Date17 Oct 2017Listed	StatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Generic Name: Full-body MRI system, superconducting magnet
Model / Reference: Comfort EC710

Primary DI / UDI-DI: 00853704006010
FDA Product Code: LNH
GMDN Term: Full-body MRI system, superconducting magnet

Device Class: Class II
Regulation Number: 892.1000
GUDID distribution status: In Commercial Distribution

Other devices from Alltech Medical Systems America, Inc.

Comfort EC710

Class II
Echostar Comfort 1.5T MRI

Class II
EchoStar Spica 1.5T MR System

Class II
Alltech Echostar 1.5 T MR System

Class II

Properties

Prescription Use
Serial Number
Manufacturing Date

Other properties (11)

Sterile: No
Single Use: No
Implantable: No
Contains Latex: No
Over-the-Counter: No
Convenience Kit: No
Combination Product: No
HCT/P: No
Premarket Exempt: No
Lot / Batch Number: No
Expiration Date: No