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Stage 1.1

by Spintech, Inc.

Stage 1.1, a MRI system application software (FDA Class II) made by Spintech, Inc., was cleared under FDA 510(k) K210843 on 29 Jun 2021 and listed in FDA GUDID on 6 Oct 2021 (UDI-DI 00866463000410); the registry lists it as not in commercial distribution (GUDID) as of 22 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 22 Oct 2026

Documents

510(k) K210843

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 Number00866463000410 UDI-DI Date6 Oct 2021ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK210843 Date29 Jun 2021DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K210843 decided 29 Jun 2021 Active
  • FDA GUDID UDI-DI 00866463000410 listed 6 Oct 2021 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K210843
  2. Listed FDA GUDID 00866463000410

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  • Withdrawn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 / reference
1.1
Primary DI / UDI-DI
00866463000410
510(k) Number
FDA product code
LNH, LLZ
GMDN term
MRI system application software
Device class
Class II
Regulation number
892.1000, 892.2050
GUDID distribution status
Not in Commercial Distribution

Similar devices

Other devices filed under FDA product code LNH (System, Nuclear Magnetic Resonance Imaging).

Other devices from Spintech, Inc.

See all devices from Spintech, Inc. →

Properties

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