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MREplus 3.0.0WIN

by Resoundant

MREplus 3.0.0WIN is a Class II device made by Resoundant, cleared under FDA 510(k) K183193 on 1 Aug 2019 and listed in FDA GUDID since 1 Apr 2021 (UDI-DI 00850011790014), active (FDA 510(k)), not in commercial distribution (GUDID) as of 23 Oct 2026.

Active United States. Also listed in GUDID (US), not in commercial distribution.

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K183193

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850011790014 UDI-DI Date1 Apr 2021ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK183193 Date1 Aug 2019DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K183193 decided 1 Aug 2019 Active
  • FDA GUDID UDI-DI 00850011790014 listed 1 Apr 2021 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K183193
  2. Listed FDA GUDID 00850011790014

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
MREplus
Generic name
MRI system application software
Model / reference
MREplus 3.0.0WIN
Primary DI / UDI-DI
00850011790014
510(k) Number
FDA product code
LLZ
GMDN term
MRI system application software
Device class
Class II
Regulation number
892.2050
GUDID distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe

Similar devices

Other devices filed under FDA product code LLZ (System, Image Processing, Radiological).

Other devices from Resoundant

See all devices from Resoundant →

Properties

  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (12, all answered No)