510(k) · Cleared
ClearedGenesis
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 Jan 18, 2013 as substantially equivalent to K955019 (Dornier Medtech America, Inc., 1995) and 1 other predicate after a 130-day review. Its family tree reaches back 9 generations to 1980. 4 later devices descend from it.
- Decided
- Jan 18, 2013
- Review
- 130 days
- Class
- Class II
- Product code
- JAA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K801623 (1980). 59 ancestors in all. 4 later devices descend from it, 3 citing it directly.
- Root · 9 generations backK801623 Cavitron Ultrasonic Surg. Aspir. CusaCavitron Corp. · 1980
- 5 generations between
- 3 generations backK061054 Axiom Aristos FX PlusSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- 2 generations backK062623 Axiom Luminos DRFSiemens Medical Solutions USA, Inc. · 2007 · Recalled
- 1 generation backK101491 Uroskop OmniaSiemens Medical Solutions USA, Inc. · 2010 · Recalled
- This deviceK122768 GenesisDornier Medtech America, Inc. · 2013
- Descendant · cites it directly · 2 of its ownK133434 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
- Descendant · cites it directly · 0 of its ownK130729 Extra Corporeal Shockwave LithotripterDornier Medtech Systems · 2013
Show all 9 generations
- Root · 9 generations backK801623 Cavitron Ultrasonic Surg. Aspir. CusaCavitron Corp. · 1980
- 8 generations backK962952 Olympus Ultrasonic Surgical System (Usu)Olympus Optical, Co. · 1996
- 7 generations backK972114 Olympus Sonosurg SystemThe Olympus Optical Co. · 1998
- 6 generations backK981993 Olympus Integrated Endosurgery System EndoalphaThe Olympus Optical Co. · 1998
- 5 generations backK994231 Siemens Integrated Operating System (Sios)Siemens Medical Corp. · 2000
- 4 generations backK052202 Axiom Artis - Modular Angiographic SystemSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- 3 generations backK061054 Axiom Aristos FX PlusSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- 2 generations backK062623 Axiom Luminos DRFSiemens Medical Solutions USA, Inc. · 2007 · Recalled
- 1 generation backK101491 Uroskop OmniaSiemens Medical Solutions USA, Inc. · 2010 · Recalled
- This deviceK122768 GenesisDornier Medtech America, Inc. · 2013
Most influential descendants
Showing 4 of 4 · See all- K133434Genesis IIDornier Medtech America, Inc. · 2014 · cites it directly2descendants
- K151485GenesisDornier Medtech America, Inc. · 2015 · cites it directly1descendant
- K220871NautilusDornier Medtech America, Inc. · 2022 · 2 generations on0descendants
- K130729Extra Corporeal Shockwave LithotripterDornier Medtech Systems · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K801623 | Cavitron Ultrasonic Surg. Aspir. Cusa | Cavitron Corp. | 1980 | — |
| −8 | K962952 | Olympus Ultrasonic Surgical System (Usu) | Olympus Optical, Co. | 1996 | — |
| −7 | K972114 | Olympus Sonosurg System | The Olympus Optical Co. | 1998 | — |
| −6 | K981993 | Olympus Integrated Endosurgery System Endoalpha | The Olympus Optical Co. | 1998 | — |
| −5 | K994231 | Siemens Integrated Operating System (Sios) | Siemens Medical Corp. | 2000 | — |
| −4 | K052202 | Axiom Artis - Modular Angiographic System | Siemens Medical Solutions USA, Inc. | 2006 | 29 |
| −3 | K061054 | Axiom Aristos FX Plus | Siemens Medical Solutions USA, Inc. | 2006 | 3 |
| −2 | K062623 | Axiom Luminos DRF | Siemens Medical Solutions USA, Inc. | 2007 | 20 |
| −1 | K101491 | Uroskop Omnia | Siemens Medical Solutions USA, Inc. | 2010 | 12 |
| 0 (this device) | K122768 | Genesis | Dornier Medtech America, Inc. | 2013 | — |
| +1 | K133434 | Genesis II | Dornier Medtech America, Inc. | 2014 | — |
| +1 | K151485 | Genesis | Dornier Medtech America, Inc. | 2015 | — |
| +2 | K220871 | Nautilus | Dornier Medtech America, Inc. | 2022 | — |
| +1 | K130729 | Extra Corporeal Shockwave Lithotripter | Dornier Medtech Systems | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 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 | 2 | 0 |
| 2002 | 4 | 0 |
| 2004 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 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? (2)
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 |
|---|---|---|---|
| * | K955019 | Urotract ISummary page 1…GENESIS Device Common Name /Image-intensified fluoroscopic x-ray system (Product Code: JAA) Classification Name: Predicate Device(s): Dornier Urotract (K955019) Siemens Uroskop Omni@ (K1 01491) General Device The Dornier GENESIS is an Image Intensif… | 1995 |
| * | K101491 | Uroskop OmniaSummary page 1…uoroscopic x-ray system (Product Code: JAA) Classification Name: Predicate Device(s): Dornier Urotract (K955019) Siemens Uroskop Omni@ (K1 01491) General Device The Dornier GENESIS is an Image Intensified Fluoroscopic X-ray Description: System (i.… | 2010 |
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 33 years and passes through 6 companies; a new generation was cleared every 2.0 years on median.
- 20 of the 59 ancestors have a recall of any class.
- Of its descendants, K133434 (Dornier Medtech America, Inc., 2014) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K955019.
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. 2013, 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 is intended for use in a wide field of applications, including all general examinations in urology and gynecology, as well as endloscopic 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/K122768 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122768: Genesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122768
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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