Nautilus
by Technix SpA
Nautilus is a Class II device made by Technix SpA, cleared under FDA 510(k) K220871 on 18 Apr 2022 and listed in FDA GUDID since 6 Nov 2024 (UDI-DI 08053307590196), active as of 21 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number08053307590196 | Date6 Nov 2024 | StatusListed |
| United States | FDA 510(k)SESE | NumberK220871 | Date18 Apr 2022 | StatusActive |
Official records
- AccessGUDID record 08053307590196
- FDA 510(k) database K220871
Across registries
- FDA 510(k) K220871 decided 18 Apr 2022 Active
- FDA GUDID UDI-DI 08053307590196 listed 6 Nov 2024 Listed
Timeline
- Cleared FDA 510(k) K220871
- Listed FDA GUDID 08053307590196
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Stationary general-purpose fluoroscopic x-ray system, digital
- Model / reference
- NAUTILUS
- Description
- Fixed equipment for radioscopy and radiography Brand: Dornier MedTech America, Inc
- Primary DI / UDI-DI
- 08053307590196
- 510(k) Number
- FDA product code
- JAA
- GMDN term
- Stationary general-purpose fluoroscopic x-ray system, digital
- Device class
- Class II
- Regulation number
- 892.1650
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Stationary general-purpose fluoroscopic x-ray system, digital.