# K220871: Nautilus

- Pathway: 510(k) (Special)
- Applicant: Dornier Medtech America, Inc.
- Decided: Apr 18, 2022 after 24 days
- Product code: JAA (System, X-Ray, Fluoroscopic, Image-Intensified)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K801623 (1980). 66 ancestors in all.
No later device cites it as a predicate yet.
0 of 67 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151485: Genesis, Dornier Medtech America, Inc. (2015) Summary page 4.

## Indications for use
The Dornier Nautilus is an image intensified, fluoroscopic x-ray system that is intended for use in a wide field of applications, including all general examinations in urology and gynecology, as well as endoscopic and contrast examinations, imaging with radiography and/or fluoroscopy on patients in either the horizontal or vertical position.

Source page: https://510kreport.com/device/K220871
Methodology: https://510kreport.com/methodology