FDA Device Registration & Listing · Mysore Karnataka, IN · Registration 3009001657
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| KPR | System, X-Ray, Stationary | Radiology | Class 2 | 892.1680 | 2022-04-21 |
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | Cardiovascular | Class 2 | 870.2300 | 2022-12-07 |
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | Cardiovascular | Class 2 | 870.2300 | 2022-12-07 |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | Anesthesiology | Class 2 | 868.1400 | 2022-12-07 |
| DQA | Oximeter | Cardiovascular | Class 2 | 870.2700 | 2022-12-07 |
| MNR | Ventilatory Effort Recorder | Anesthesiology | Class 2 | 868.2375 | 2022-12-07 |
| EHD | Unit, X-Ray, Extraoral With Timer | Dental | Class 2 | 872.1800 | 2012-12-05 |
| EHD | Unit, X-Ray, Extraoral With Timer | Dental | Class 2 | 872.1800 | 2017-08-17 |
| EHD | Unit, X-Ray, Extraoral With Timer | Dental | Class 2 | 872.1800 | 2011-04-13 |
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | Cardiovascular | Class 2 | 870.2300 | 2022-12-07 |
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | Cardiovascular | Class 2 | 870.2300 | 2022-11-21 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | Cardiovascular | Class 2 | 870.1130 | 2022-11-21 |
| OXO | Image-Intensified Fluoroscopic X-Ray System, Mobile | Radiology | Class 2 | 892.1650 | 2018-06-13 |
| OWB | Interventional Fluoroscopic X-Ray System | Radiology | Class 2 | 892.1650 | 2018-06-13 |
| DQA | Oximeter | Cardiovascular | Class 2 | 870.2700 | 2022-12-07 |
| NHO | Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration) | Anesthesiology | Class 2 | 868.1500 | 2022-12-06 |
| DRS | Transducer, Blood-Pressure, Extravascular | Cardiovascular | Class 2 | 870.2850 | 2022-12-06 |
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | Cardiovascular | Class 2 | 870.2300 | 2022-12-06 |
| NHQ | Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration) | Anesthesiology | Class 2 | 868.1500 | 2022-12-06 |
| CBQ | Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) | Anesthesiology | Class 2 | 868.1500 | 2022-12-06 |
| CBR | Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) | Anesthesiology | Class 2 | 868.1700 | 2022-12-06 |
| MNR | Ventilatory Effort Recorder | Anesthesiology | Class 2 | 868.2375 | 2022-12-06 |
| FLL | Continuous Measurement Thermometer | General Hospital | Class 2 | 880.2910 | 2022-12-06 |
| KRB | Probe, Thermodilution | Cardiovascular | Class 2 | 870.1915 | 2022-12-06 |
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | Cardiovascular | Class 2 | 870.2300 | 2022-12-06 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | Cardiovascular | Class 2 | 870.1130 | 2022-12-06 |
| CCL | Analyzer, Gas, Oxygen, Gaseous-Phase | Anesthesiology | Class 2 | 868.1720 | 2022-12-06 |
| DSF | Recorder, Paper Chart | Cardiovascular | Class 1 | 870.2810 | 2022-12-06 |
| DQA | Oximeter | Cardiovascular | Class 2 | 870.2700 | 2022-12-06 |
| CBS | Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) | Anesthesiology | Class 2 | 868.1620 | 2022-12-06 |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | Anesthesiology | Class 2 | 868.1400 | 2022-12-06 |
| NHP | Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) | Anesthesiology | Class 2 | 868.1500 | 2022-12-06 |
| DSJ | Alarm, Blood-Pressure | Cardiovascular | Class 2 | 870.1100 | 2022-12-06 |
| DXG | Computer, Diagnostic, Pre-Programmed, Single-Function | Cardiovascular | Class 2 | 870.1435 | 2022-12-06 |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | Anesthesiology | Class 2 | 868.1400 | 2022-12-07 |
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K201670 | Siemens Medical Solutions USA, Inc. | YSIO X.pree | 2020-10-21 |
| K123106 | Samsung Electronics Co., Ltd. | DIGITAL DIAGNOSTIC X-RAY SYSTEM MODEL XGEO GU60A | 2013-06-20 |
| K203340 | Siemens Medical Solutions USA, Inc. | MULTIX Impact C | 2021-01-06 |
| K230241 | Sg Healthcare Co, Ltd. | Jumong General | 2023-02-23 |
| K071802 | Mammendorfer Institut Fur Physik Und Medizin GmbH | TESLA GUARD, MODEL EFT G04 | 2007-11-09 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-0002-2009 | GE Medical Systems, LLC | 2 | Revolution XR/d system control room PC model 5117866-2 with Software collector 5115434 |
| Z-0002-2015 | Siemens Medical Solutions USA, Inc | 2 | Siemens Ysio Max system
The Ysio Max is a radiographic system used in hospitals, clinics, and medical practices. Ysio Max enables radiographic and tomographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. It can also be used for intravenous, small interventions (like biopsy, punctures, etc.) and emergency (trauma, critical ill) applications. Exposures may be taken with the patient sitting, standing, or in the prone position. The Ysio Max system is not meant for mammography. The Ysio Max uses integrated or portable digital detectors for generating diagnostic images by converting x-rays into electronic signals. Ysio Max is also designed to be used with conventional film/screen or Computed Radiography (CR) cassettes. |
| Z-0003-2009 | GE Medical Systems, LLC | 2 | Revolution XR/d systems with control room PC model 5117866-2 with Software collector 5194381. GE Healthcare, 3000 North Grandview, Waukesha, WI 53188.
Intended for use in generating Tomographic images of human anatomy. |
| Z-0003-2015 | Siemens Medical Solutions USA, Inc | 2 | Siemens AXIOM Luminos dRF Max systems
The Axiom Luminos dRF is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a digital flat detector, it can perform a range of applications including general R/F, angiography and pediatric examinations. The Axiom Luminos dRF is a device intended to visualize anatomical structures by converting a pattern of X-ray into a visible image. |
| Z-0004-2015 | Siemens Medical Solutions USA, Inc | 2 | 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 |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3023190435 | XERA Medikal Sistemleri ve Teknoloji Ltd. Sti. | Yenimahalle Ankara, TR |
| 3011825597 | FAIR MEDICAL CO.,LTD | Kashiwa Chiba, JP |
| 3009715136 | SG HEALTHCARE CO LTD | Moga-myeon, Icheon-si Gyeonggi, KR |
| 3005810333 | BAY SHORE MEDICAL EQUIPMENT, LLC | Manorville, NY, US |
| 3008284470 | GE Healthcare (China) Co., Ltd. | Beijing, CN |
3009001657 when referencing this establishment in official correspondence.