# K133434: Genesis II

- Pathway: 510(k) (Traditional)
- Applicant: Dornier Medtech America, Inc.
- Decided: Nov 26, 2014 after 383 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: 10 generations back to K801623 (1980). 64 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 67 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122768: Genesis, Dornier Medtech America, Inc. (2013) Summary page 4.
- K121656: Gemini Lithotripter, Dornier Medtech America, Inc. (2012) Summary page 4.
- K955019: Urotract I, Dornier Medtech America, Inc. (1995) Summary page 4.

## Most influential descendants
- K151485: Genesis (2015), 1 descendant of its own
- K220871: Nautilus (2022), 0 descendants of its own

## Indications for use
The Dornier GENESIS II 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/K133434
Methodology: https://510kreport.com/methodology