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Cake 3.0.0

by Neosoft, LLC

Cake 3.0.0 is a Class II device made by Neosoft, LLC, cleared under FDA 510(k) K080196 on 5 Sep 2008 and listed in FDA GUDID since 1 Aug 2018 (UDI-DI 00864747000231), active as of 22 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 22 Oct 2026

Documents

510(k) K080196

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00864747000231 UDI-DI Date1 Aug 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK080196 Date5 Sep 2008DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K080196 decided 5 Sep 2008 Active
  • FDA GUDID UDI-DI 00864747000231 listed 1 Aug 2018 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K080196
  2. Listed FDA GUDID 00864747000231

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Cake
Generic name
MRI system application software
Model / reference
3.0.0
Primary DI / UDI-DI
00864747000231
510(k) Number
FDA product code
LLZ
GMDN term
MRI system application software
Device class
Class II
Regulation number
892.2050
GUDID distribution status
In Commercial Distribution

Related devices

Category: MRI system application software

Similar devices in this category

Other devices filed under MRI system application software.

Other devices from Neosoft, LLC

Properties

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