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Stage 2.4

by Spintech, Inc.

Stage 2.4 (REF 200009) is a Class II device made by Spintech, Inc., cleared under FDA 510(k) K223079 on 28 Oct 2022 and listed in FDA GUDID since 23 Jul 2026 (UDI-DI 00866463000496), 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) K223079

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 Number00866463000496 UDI-DI Date23 Jul 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK223079 Date28 Oct 2022DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K223079 decided 28 Oct 2022 Active
  • FDA GUDID UDI-DI 00866463000496 listed 23 Jul 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K223079
  2. Listed FDA GUDID 00866463000496

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Stage
Generic name
MRI system application software
Model / Ref / Catalog
2.4, REF 200009
Primary DI / UDI-DI
00866463000496
510(k) Number
FDA product code
LLZ, LNH
GMDN term
MRI system application software
Device class
Class II
Regulation number
892.2050, 892.1000
GUDID distribution status
In Commercial Distribution

Similar devices

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

Other devices from Spintech, Inc.

See all devices from Spintech, Inc. →

Properties

  • Prescription use
  • Serial number
Other properties (13, all answered No)