Gvi Technology Partners
Country not established
- Devices
- 3
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Gvi Technology Partners makes
Gvi Technology Partners manufactures nuclear medicine imaging systems, including the ONEPASS and CLEARVISION series, designed for diagnostic imaging in medical settings. These devices support gamma camera-based imaging for procedures such as bone scans, thyroid studies, and other nuclear medicine applications. The ONEPASS NUCLEAR IMAGING SYSTEM, MODEL 70-500101, is a specific model within this portfolio.
The company’s devices are regulated under the FDA’s 510(k) pathway, with classifications ranging from Class I to Class II. These systems are listed in the FDA’s 510(k) database, indicating their compliance with U.S. regulatory requirements. The manufacturer is based in the United States.
Catalogue
Onepass Nuclear Medicine Imaging System Ref K051402
Regimes: 510(k) Registry: 510(k)Clearvision Nuclear Medicine Imaging System Ref K072191
Regimes: 510(k) Registry: 510(k)Onepass Nuclear Imaging System, Model 70-500101 Ref K023373
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 1 recall initiated by Gvi Technology Partners, initiated on 2004-01-16. By recorded status: 1 terminated. The reasons filed fall into these groups: software or firmware and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2004
- 16 Jan 2004 Z-0527-04 Unclassified (pre-2012) Terminated Due to limitations in the operating software, the acquired scan may not be processed properly.
Frequently asked questions
How many devices does Gvi Technology Partners have in the registry?
The registry currently lists 3 devices for Gvi Technology Partners. Devices recorded under merged duplicate company entries are counted once.
Which registries list Gvi Technology Partners's devices?
Among its 3 most recently registered devices, Gvi Technology Partners has devices listed in FDA 510(k) (3 devices).
What risk classes do Gvi Technology Partners's devices fall under?
Among its 3 most recently registered devices, the classes recorded for Gvi Technology Partners's devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Gvi Technology Partners?
FDA recall records list 1 recall initiated by Gvi Technology Partners, the most recent initiated on 16 Jan 2004. 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 Gvi Technology Partners in the registry?
The most recently registered devices listed for Gvi Technology Partners include ONEPASS NUCLEAR MEDICINE IMAGING SYSTEM, CLEARVISION NUCLEAR MEDICINE IMAGING SYSTEM and ONEPASS NUCLEAR IMAGING SYSTEM, MODEL 70-500101.