Naviscan Pet Systems
Country not established
- Devices
- 1
- FDA recalls
- 2
At a glance
Market reach
- United States
- FDA recalls
What Naviscan Pet Systems makes
Naviscan Pet Systems manufactures the STEREO NAVIGATOR ACCESSORY (STN-1000), a device designed for imaging guidance in veterinary procedures, enhancing precision during medical interventions on animals.
The STN-1000 is classified as a Class II medical device under FDA regulations and is listed in the FDA’s 510(k) clearance registry. The company is based in the United States.
Catalogue
Stereo Navigator Accessory, Stn-1000 Ref K082354
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 2 recalls initiated by Naviscan Pet Systems, the earliest on 2007-08-01 and the most recent on 2008-06-19. By recorded status: 2 terminated. The reasons filed fall into these groups: software or firmware. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2008
- 19 Jun 2008 Z-2229-2008 Unclassified (pre-2012) Terminated This field correction is being initiated as a result of the firm's investigation into a report from a user indicating that the motorized compression exceeded 25 pounds of compression force during the pre-scan positioning of the patient. The investigation identified that a secondary fault protection did not perform as expected.
2007
- 1 Aug 2007 Z-0041-2008 Unclassified (pre-2012) Terminated Naviscan has identified a potential safety issue with all versions of PEM View Software commonly used for analyzing patient images acquired on the PEMFIex product line. 1. The Positron Emission Mammography Standardized Uptake Value (PEMSUV) and distance measurements for the product mentioned above may be inaccurate if a zoomed image has been opened, measurement tools are used, and the applet rema
Frequently asked questions
How many devices does Naviscan Pet Systems have in the registry?
The registry currently lists 1 device for Naviscan Pet Systems. Devices recorded under merged duplicate company entries are counted once.
Which registries list Naviscan Pet Systems's devices?
Among its 1 most recently registered device, Naviscan Pet Systems has devices listed in FDA 510(k) (1 device).
What risk classes do Naviscan Pet Systems's devices fall under?
Among its 1 most recently registered device, the classes recorded for Naviscan Pet Systems's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Naviscan Pet Systems?
FDA recall records list 2 recalls initiated by Naviscan Pet Systems, the most recent initiated on 19 Jun 2008. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Naviscan Pet Systems in the registry?
The most recently registered devices listed for Naviscan Pet Systems include STEREO NAVIGATOR ACCESSORY, STN-1000.