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Dornier MedTech Nautilus XRAY Imaging System

by Dornier MedTech America, Inc.

Dornier MedTech Nautilus XRAY Imaging System is a Class II device made by Dornier MedTech America, Inc., cleared under FDA 510(k) K220871 on 18 Apr 2022 and listed in FDA GUDID since 27 Jul 2023 (UDI-DI 00810116023240), 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) K220871

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 Number00810116023240 UDI-DI Date27 Jul 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK220871 Date18 Apr 2022DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K220871 decided 18 Apr 2022 Active
  • FDA GUDID UDI-DI 00810116023240 listed 27 Jul 2023 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K220871
  2. Listed FDA GUDID 00810116023240

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Dornier MedTech
Generic name
Mobile uro-gynaecological fluoroscopic x-ray system, digital
Model / Ref / Catalog
Nautilus XRAY Imaging System, NAUTILUS
Primary DI / UDI-DI
00810116023240
510(k) Number
FDA product code
JAA
GMDN term
Mobile uro-gynaecological fluoroscopic x-ray system, digital
Device class
Class II
Regulation number
892.1650
GUDID distribution status
In Commercial Distribution

Related devices

Category: Mobile uro-gynaecological fluoroscopic x-ray system, digital

Cleared under the same submission (K220871)

Similar devices

Other devices filed under FDA product code JAA (System, X-Ray, Fluoroscopic, Image-Intensified).

Other devices from Dornier MedTech America, Inc.

See all devices from Dornier MedTech America, Inc. →

Properties

  • Prescription use
  • Lot / batch number
  • Serial number
Other properties (12, all answered No)