510(k) · Cleared
Recalled · Class II · 2025Uroskop Omnia
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solutions USA, Inc. · JAA System, X-Ray, Fluoroscopic, Image-Intensified
Cleared on Jun 30, 2010 as substantially equivalent to K010942 (Siemens Medical Solutions USA, Inc., 2001) and 1 other predicate after a 29-day review. Its family tree reaches back 8 generations to 1980. 11 later devices descend from it. It has been recalled 12 times.
- Decided
- Jun 30, 2010
- Review
- 29 days
- Class
- Class II
- Product code
- JAA
- Recalls
- 12
- Predicates
- 2
Its longest line of descent runs back 8 generations to K801623 (1980). 57 ancestors in all. 11 later devices descend from it, 4 citing it directly.
- Root · 8 generations backK801623 Cavitron Ultrasonic Surg. Aspir. CusaCavitron Corp. · 1980
- 7 generations backK962952 Olympus Ultrasonic Surgical System (Usu)Olympus Optical, Co. · 1996
- 6 generations backK972114 Olympus Sonosurg SystemThe Olympus Optical Co. · 1998
- 5 generations backK981993 Olympus Integrated Endosurgery System EndoalphaThe Olympus Optical Co. · 1998
- 4 generations backK994231 Siemens Integrated Operating System (Sios)Siemens Medical Corp. · 2000
- 3 generations backK052202 Axiom Artis - Modular Angiographic SystemSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- 2 generations backK061054 Axiom Aristos FX PlusSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- 1 generation backK062623 Axiom Luminos DRFSiemens Medical Solutions USA, Inc. · 2007 · Recalled
- This deviceK101491 Uroskop OmniaSiemens Medical Solutions USA, Inc. · 2010
- Descendant · cites it directly · 4 of its ownK122768 GenesisDornier Medtech America, Inc. · 2013
- Descendant · cites it directly · 2 of its ownK161019 Uroview FDPausch Medical GmbH · 2016 · Recalled
- Descendant · 2 generations on · 2 of its ownK133434 Genesis IIDornier Medtech America, Inc. · 2014
- Descendant · cites it directly · 1 of its ownK173639 Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max, Multitom RaxSiemens Medi Cal Solutions, Inc. · 2018 · Recalled
- Descendant · 2 generations on · 1 of its ownK151485 GenesisDornier Medtech America, Inc. · 2015
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K122768GenesisDornier Medtech America, Inc. · 2013 · cites it directly4descendants
- K161019Uroview FDPausch Medical GmbH · 2016 · cites it directly2descendants
- K133434Genesis IIDornier Medtech America, Inc. · 2014 · 2 generations on2descendants
- K173639Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max, Multitom RaxSiemens Medi Cal Solutions, Inc. · 2018 · cites it directly1descendant
- K151485GenesisDornier Medtech America, Inc. · 2015 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K801623 | Cavitron Ultrasonic Surg. Aspir. Cusa | Cavitron Corp. | 1980 | — |
| −7 | K962952 | Olympus Ultrasonic Surgical System (Usu) | Olympus Optical, Co. | 1996 | — |
| −6 | K972114 | Olympus Sonosurg System | The Olympus Optical Co. | 1998 | — |
| −5 | K981993 | Olympus Integrated Endosurgery System Endoalpha | The Olympus Optical Co. | 1998 | — |
| −4 | K994231 | Siemens Integrated Operating System (Sios) | Siemens Medical Corp. | 2000 | — |
| −3 | K052202 | Axiom Artis - Modular Angiographic System | Siemens Medical Solutions USA, Inc. | 2006 | 29 |
| −2 | K061054 | Axiom Aristos FX Plus | Siemens Medical Solutions USA, Inc. | 2006 | 3 |
| −1 | K062623 | Axiom Luminos DRF | Siemens Medical Solutions USA, Inc. | 2007 | 20 |
| 0 (this device) | K101491 | Uroskop Omnia | Siemens Medical Solutions USA, Inc. | 2010 | — |
| +1 | K122768 | Genesis | Dornier Medtech America, Inc. | 2013 | — |
| +1 | K161019 | Uroview FD | Pausch Medical GmbH | 2016 | 1 |
| +2 | K133434 | Genesis II | Dornier Medtech America, Inc. | 2014 | — |
| +1 | K173639 | Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max, Multitom Rax | Siemens Medi Cal Solutions, Inc. | 2018 | 23 |
| +2 | K151485 | Genesis | Dornier Medtech America, Inc. | 2015 | — |
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 | 12 | 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 |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 2 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K010942 | U04Summary page 3…ubstantially equivalent to the commercially available Siemens systems, the UROSKOP U04 and the AXIOM Luminos dRF. The UROSKOP U04 was described in premarket notification K 010942 which received FDA Clearance on April 12, 2001. The AXIOM Luminos dRF was described in premarket notification K.062623 which rece… | 2001 |
| * | K062623 | Axiom Luminos DRFSummary page 2…for image recording and processing. The table design remains unchanged while the new imaging chain is based on the AXIOM Luminos dRF described in premarket notification K 062623 which received FDA Clearance on August 22, 2007. Intended Use The UROSKOP Omnia is a solid state detector fluoroscopic X-ray sy… | 2007 |
What descends from it? (11)
See all 114 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 4, 2025 | Class II | Z-1982-2025 | Device Design | A resistor in the frequency inverter may strongly overheat potentially igniting the plastic housing of the frequency inverter on fire. |
| Jun 4, 2025 | Class II | Z-1981-2025 | Device Design | A resistor in the frequency inverter may strongly overheat potentially igniting the plastic housing of the frequency inverter on fire. |
| Sep 9, 2020 | Class II | Z-0805-2021 | Device Design | After the March 2019 corrective action on the monitor support arm, there is a residual risk of the support arm becoming dislodged in cases when the monitor support arm is used intensely over a long period of time. |
| Feb 8, 2019 | Class II | Z-0984-2019 | Device Design | The swivel arm holding the monitors may become dislodged from the carrying arm. |
| Apr 13, 2015 | Class II | Z-1670-2015 | Software design | Study and all acquired images deleted when using systems with software version VE10E. Acquisitions have to be repeated. Connection with portable detectors (MAX wi-D, MAX mini) is sporadic in image recovery. Pressing undo button on the RAD… |
| Sep 2, 2014 | Class II | Z-0004-2015 | Software design | Two malfunctions posing potential risk to patients were identified with Siemens Ysio Max, AXIOM Luminos dRF Max, Uroskop Omnia Max, and Luminos Agile Max systems with a specific set of serial numbers that will cause lost images due to an… |
| Jul 7, 2014 | Class II | Z-2292-2014 | Device Design | It was discovered that during a RAD examination using Siemens Luminos dRF, Ysio or Uroskop Omnia systems with software version VB10C to VB10F and automatic exposure control, a highly unlikely malfunction can result in longer radiation… |
| Sep 3, 2013 | Class II | Z-0140-2014 | Software design | When using systems operating with software versions VD10A/G during a RAD examination, a malfunction can result in radiation continuing longer than required resulting in an overexposed image that is not of diagnostic quality, prompting… |
| Sep 3, 2013 | Class II | Z-0374-2014 | Software design | A potential malfunction and hazard to patients exists when using the Ysio, Luminos Agile, Luminos dRF, and Uroskop Omnia systems with software version VC10, which may result in radiation continuing longer than required and overexposed… |
| Aug 28, 2013 | Class II | Z-1845-2014 | Software design | When using systems operating with software versions VD10A/G during a RAD examination, a malfunction can result in the image appearing very dark, which may prompt unnecessary repetition of the examination. |
| May 6, 2013 | Class II | Z-0016-2014 | Software design | Siemens has discovered through product monitoring a potential malfunction when using system operating with software versions VB10D, VB10F, VB10C and VB10. During a RAD examination the possibility exists that radiation may continue longer… |
| Feb 15, 2012 | Not classified | Z-1159-2012 | Software design | Firm has become aware of unintended behavior when using Ysio, AXIOM dRF, AXIOM Luminos Agile/TF and Uroskop Omnia with RAD Fluoro Uro function using software version VC10A. Due to an error in the image pipeline, images may display dark… |
The 5 latest of 12 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 30 years and passes through 5 companies; a new generation was cleared every 2.0 years on median.
- 19 of the 57 ancestors have a recall of any class.
- Of its descendants, K122768 (Dornier Medtech America, Inc., 2013) has gone furthest, with 4 descendants of its own.
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. 2010, 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 UROSKOP Omnia is a solid state detector fluoroscopic X-ray system, primarily for urological applications (functional x-ray diagnostics, endourology and minimal invasive urology/surgery). The system, which includes a radiologic/urologic treatment table, may be used for urological, gastroenterological and gynecological treatment, planning and diagnostic procedures including: Querying and retrieving patient history information and/or previous diagnosis…
Read the full statement (177 words)
The UROSKOP Omnia is a solid state detector fluoroscopic X-ray system, primarily for urological applications (functional x-ray diagnostics, endourology and minimal invasive urology/surgery). The system, which includes a radiologic/urologic treatment table, may be used for urological, gastroenterological and gynecological treatment, planning and diagnostic procedures including:
Querying and retrieving patient history information and/or previous diagnosis and images from other modalities.
X-ray examinations of the urogenital and area (e.g. cystoscopy, kidney, bladder, urecter, urethra) including KUB, IVP, vasovesiculography, reflux-cystogram, cystourethrogram, and micturation cystourethrogram combined with uroflow measurements.
Ultrasound examinations (in conjunction with a stand-alone ultrasound system) of the kidncy, bladder, prostate, scrotum.
endourological interventions (e.g. of the urethra, prostate, bladder, sphincter, ostium, kidney and ureter, catheter placement, penile implant placement, transurethral resection of prostate or bladder, alternative treatment of the BPH, brachytherapy, as well as gynecological procedures requiring radiological suppert).
percutaneous interventions (e.g. PCN nephrolithotomy, resection, percutaneous nephrostomy)
laparoscopy (e.g. cholecystectomy, nephrectomy, lymph node dissection, abdominal testis detection/correction, varicocele).
application of fistula (kidney/bladder)
simple procedures (e.g. urethra, testis, phimosis)
intracorporeal shock wave lithotripsy
uroflow/urodynamics
pediatric radiological and therapeutic applications.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K101491 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101491: Uroskop Omnia.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101491
Report an extraction error
Are you the manufacturer?
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