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HepaFatSmart v2.0.0

by Resonance Health Analysis Services Pty, Ltd.

HepaFatSmart v2.0.0 is a Class II device made by Resonance Health Analysis Services Pty, Ltd., cleared under FDA 510(k) K231459 on 20 Jun 2023 and listed in FDA GUDID since 29 Apr 2024 (UDI-DI 09355529000095), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

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) K231459

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 Number09355529000095 UDI-DI Date29 Apr 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) from GUDID NumberK231459 Date20 Jun 2023IssuedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K231459 decided 20 Jun 2023 Active
  • FDA GUDID UDI-DI 09355529000095 listed 29 Apr 2024 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K231459
  2. Listed FDA GUDID 09355529000095

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
HepaFatSmart
Generic name
MRI system application software
Model / Ref / Catalog
v2.0.0
Primary DI / UDI-DI
09355529000095
510(k) Number
FDA product code
LNH
GMDN term
MRI system application software
Device class
Class II
Regulation number
892.1000
GUDID distribution status
In Commercial Distribution

Related devices

Category: MRI system application software

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Other devices filed under MRI system application software.

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Properties

  • Prescription use
Other properties (14, all answered No)