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Niobe MNS Omega ES Omega

by Stereotaxis, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

1 closed

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberM58800100620010 UDI-DI Date23 Apr 2026ListedStatusListed GUDID: in commercial distribution

Recalls

1 recall · FDA

    • Terminated Z-0430-2021 FDA Class II initiated 21 Sep 2020 on shared 510(k) K192775

    There is a potential for fire in the inside computer cabinet.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Niobe MNS Omega
Generic Name
Cardiac mapping system workstation
Model / Ref / Catalog
ES Omega, 001-006200-1
Primary DI / UDI-DI
M58800100620010
510(k) Number
FDA Product Code
NDQ
GMDN Term
Cardiac mapping system workstation
Device Class
Class II
Regulation Number
870.1290
GUDID distribution status
In Commercial Distribution

Other devices from Stereotaxis, Inc.

See all devices from Stereotaxis, Inc. →

Properties

  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No