510(k) · Cleared
ClearedGenesis II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dornier Medtech America, Inc. · JAA System, X-Ray, Fluoroscopic, Image-Intensified
Cleared on Nov 26, 2014 as substantially equivalent to K122768 (Dornier Medtech America, Inc., 2013) and 2 other predicates after a 383-day review. Its family tree reaches back 10 generations to 1980. 2 later devices descend from it.
- Decided
- Nov 26, 2014
- Review
- 383 days
- Class
- Class II
- Product code
- JAA
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 10 generations to K801623 (1980). 64 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 10 generations backK801623 Cavitron Ultrasonic Surg. Aspir. CusaCavitron Corp. · 1980
- 6 generations between
- 3 generations backK062623 Axiom Luminos DRFSiemens Medical Solutions USA, Inc. · 2007 · Recalled
- 2 generations backK101491 Uroskop OmniaSiemens Medical Solutions USA, Inc. · 2010 · Recalled
- 1 generation backK122768 GenesisDornier Medtech America, Inc. · 2013
- This deviceK133434 Genesis IIDornier Medtech America, Inc. · 2014
- Descendant · cites it directly · 1 of its ownK151485 GenesisDornier Medtech America, Inc. · 2015
- Descendant · 2 generations on · 0 of its ownK220871 NautilusDornier Medtech America, Inc. · 2022
Show all 10 generations
- Root · 10 generations backK801623 Cavitron Ultrasonic Surg. Aspir. CusaCavitron Corp. · 1980
- 9 generations backK962952 Olympus Ultrasonic Surgical System (Usu)Olympus Optical, Co. · 1996
- 8 generations backK972114 Olympus Sonosurg SystemThe Olympus Optical Co. · 1998
- 7 generations backK981993 Olympus Integrated Endosurgery System EndoalphaThe Olympus Optical Co. · 1998
- 6 generations backK994231 Siemens Integrated Operating System (Sios)Siemens Medical Corp. · 2000
- 5 generations backK052202 Axiom Artis - Modular Angiographic SystemSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- 4 generations backK061054 Axiom Aristos FX PlusSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- 3 generations backK062623 Axiom Luminos DRFSiemens Medical Solutions USA, Inc. · 2007 · Recalled
- 2 generations backK101491 Uroskop OmniaSiemens Medical Solutions USA, Inc. · 2010 · Recalled
- 1 generation backK122768 GenesisDornier Medtech America, Inc. · 2013
- This deviceK133434 Genesis IIDornier Medtech America, Inc. · 2014
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K801623 | Cavitron Ultrasonic Surg. Aspir. Cusa | Cavitron Corp. | 1980 | — |
| −9 | K962952 | Olympus Ultrasonic Surgical System (Usu) | Olympus Optical, Co. | 1996 | — |
| −8 | K972114 | Olympus Sonosurg System | The Olympus Optical Co. | 1998 | — |
| −7 | K981993 | Olympus Integrated Endosurgery System Endoalpha | The Olympus Optical Co. | 1998 | — |
| −6 | K994231 | Siemens Integrated Operating System (Sios) | Siemens Medical Corp. | 2000 | — |
| −5 | K052202 | Axiom Artis - Modular Angiographic System | Siemens Medical Solutions USA, Inc. | 2006 | 29 |
| −4 | K061054 | Axiom Aristos FX Plus | Siemens Medical Solutions USA, Inc. | 2006 | 3 |
| −3 | K062623 | Axiom Luminos DRF | Siemens Medical Solutions USA, Inc. | 2007 | 20 |
| −2 | K101491 | Uroskop Omnia | Siemens Medical Solutions USA, Inc. | 2010 | 12 |
| −1 | K122768 | Genesis | Dornier Medtech America, Inc. | 2013 | — |
| 0 (this device) | K133434 | Genesis II | Dornier Medtech America, Inc. | 2014 | — |
| +1 | K151485 | Genesis | Dornier Medtech America, Inc. | 2015 | — |
| +2 | K220871 | Nautilus | Dornier Medtech America, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1984 | 1 | 0 |
| 1986 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1991 | 4 | 0 |
| 1992 | 2 | 0 |
| 1993 | 3 | 0 |
| 1994 | 1 | 0 |
| 1995 | 13 | 0 |
| 1996 | 4 | 0 |
| 1997 | 4 | 0 |
| 1999 | 3 | 0 |
| 2000 | 3 | 0 |
| 2001 | 4 | 0 |
| 2002 | 4 | 0 |
| 2004 | 2 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2022 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JAA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new JAA device
- #1 K253103 Nexus DRF Digital X-ray Imaging Systemscore 13.2 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K122768 | GenesisSummary page 4…Image Intensified Fluoroscopic X-ray System Classification Name (21 CFR 892.1650, Product Code JAA) Predicate Device(s): Dornier Genesis (K122768) Dornier Gemini (K121656) Dornier Urotract (K955019) General De… | 2013 |
| * | K121656 | Gemini LithotripterSummary page 4…sification Name (21 CFR 892.1650, Product Code JAA) Predicate Device(s): Dornier Genesis (K122768) Dornier Gemini (K121656) Dornier Urotract (K955019) General Device Description: The Dornier Genesis II is an Image Int… | 2012 |
| * | K955019 | Urotract ISummary page 4…JAA) Predicate Device(s): Dornier Genesis (K122768) Dornier Gemini (K121656) Dornier Urotract (K955019) General Device Description: The Dornier Genesis II is an Image Intensified Fluoroscopic X-ray System. It is intended for use… | 1995 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K151485 | Genesis | 2015 | 1 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 34 years and passes through 6 companies; a new generation was cleared every 2.0 years on median.
- 20 of the 64 ancestors have a recall of any class.
- Of its descendants, K151485 (Dornier Medtech America, Inc., 2015) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K122768.
How does its category compare?
All JAA devicesJAA System, X-Ray, Fluoroscopic, Image-Intensified: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · JAA
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JAA
89in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JAA
4in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JAA
33in 2025
MAUDE reports naming product code JAA, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 35 | 9,517 |
| 2008 | 6 | 18 | 21 | 9,484 |
| 2009 | 0 | — | 18 | 12,040 |
| 2010 | 1 | — | 6 | 5,803 |
| 2011 | 4 | 48 | 7 | 14,000 |
| 2012 | 1 | — | 2 | 11,684 |
| 2013 | 6 | 129 | 3 | 13,706 |
| 2014 | 6 | 276 | 1 | 10,265 |
| 2015 | 3 | 197 | 1 | 2,922 |
| 2016 | 2 | — | 7 | 35 |
| 2017 | 1 | — | 3 | 56 |
| 2018 | 3 | 30 | 1 | 36 |
| 2019 | 6 | 49 | 2 | 49 |
| 2020 | 4 | 39 | 2 | 39 |
| 2021 | 6 | 104 | 2 | 35 |
| 2022 | 1 | — | 5 | 34 |
| 2023 | 2 | — | 9 | 41 |
| 2024 | 3 | 89 | 2 | 25 |
| 2025 | 2 | — | 4 | 33 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133434 · printed Nov 5, 2026
Cite this page
510(k) Report. “K133434: Genesis II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K133434
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026