UROSKOP OMNIA— 510(k) K101491
Substantially EquivalentSiemens Medical Solutions USA, Inc.
FDA 510(k) clearance K101491 for UROSKOP OMNIA, Substantially Equivalent on 2010-06-30. Applicant: Siemens Medical Solutions USA, Inc.. Device class: 2.
Clearance details
- Applicant
- Siemens Medical Solutions USA, Inc.
- Product code
- Code JAA
- Device class
- Class 2
- Regulation
- 21 CFR 892.1650
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Mavern, PA, US
Recent devices under product code JAA
view allMore clearances from Siemens Medical Solutions USA, Inc.
view allAdverse events under product code JAA
product code JAA- Other
- 1
- Total
- 1
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K101491
K-number listed on FDA's recall record- Z-1981-2025 — UROSKOP Omnia. Model Number: 10094910
- Z-1982-2025 — UROSKOP Omnia Max. Model Number: 10762473
- Z-0805-2021 — Uroskop Omnia, Model no. 10094910 - Product Usage: a solid state detector fluoroscopic X-ray system, primarily for urological applications (functional x-ray diagnosis, endourology and minimal invasive urology/surgery).
- Z-0984-2019 — Uroskop Omnia -fluoroscopic X-ray system Model # 10094910 The Uroskop Omnia is a solid state detector fluoroscopic X-ray system, primarily for urological applications (functional x-ray diagnosis, endourology and minimal invasive urology/surgery).
- Z-1670-2015 — SIEMENS Uroskop Omnia Max ; a solid state detector fluoroscopic X-Ray system, primarily for urological applications (functional x-ray diagnostic, 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 but not limited to: Querying and retrieving patient history information and/or previous diagnosis and images from other modalities, including X-ray examinations of the urogenital area, Ultrasound examinations, Endourological interventions, Percutaneous interventions, Laparoscopy, Application of fistula, Simple procedures, Extracorporeal shock wave lithotripsy, Uroflow/urodynamics, Pediatric radiological and therapeutic applications.
- Z-0004-2015 — Siemens Uroskop Omnia Max system The Uroskop Omnia is a solid state detector fluoroscopic X-Ray system, primarily for urological applications (functional x-ray diagnostic, 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 but not limited to: "Querying and retrieving patient history information and/or previous diagnosis and images from other modalities; "X-ray examinations of the urogenital area "Ultrasound examinations "Endourological interventions "Percutaneous interventions "Laparoscopy "Application of fistula "Simple procedures "Extracorporeal shock wave lithotripsy "Uroflow/urodynamics "Pediatric radiological and therapeutic applications
- Z-2292-2014 — Siemens Luminos dRF, Ysio or Uroskop Omnia systems. The Axiom Luminos dRF is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies.
- Z-0140-2014 — Siemens RAD Fluoro Uro system (Luminos dRF and Uroskop Omnia with software version VD10A/G Image intensified Fluoroscopic X-ray system
- Z-0374-2014 — (Siemens Rad Fluoro Uro Systems) Ysio, Luminos Agile, Luminos dRF, and Uroskop Omnia systems with software version VC10 Image intensified fluoroscopic x-ray system
- Z-1845-2014 — Siemens RAD Fluoro Uro System (Ysio, Luminos dRF, and Uroskop Omnia) with software versions VB10G. Product Usage: Image Intensified Fluoroscopic X-ray system
- Z-0016-2014 — Siemens RAD Fluoro Uro Systems - Luminos dRF, Ysio and Uroskop Omnia with software versions VB10D, VB10F, VB10C and VB10E. Fluroscopic X-Ray Systems
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K101491.
Data sourced from openFDA. This site is unofficial and independent of the FDA.