Trionix Research Laboratory, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 16
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Trionix Research Laboratory, Inc. makes
Trionix Research Laboratory, Inc. manufactures nuclear imaging systems and processing software for cardiac and nuclear medicine applications, including single-photon emission computed tomography (SPECT) systems and ejection fraction analysis tools. Their portfolio includes detector options, collimators, and imaging packages designed for myocardial perfusion imaging (MIBI) and other diagnostic procedures. Systems like the BIAD, TRIAD, MONAD, and EAGLE are tailored for nuclear imaging, while specialized software processes imaging data for clinical assessment.
The company’s devices are classified as Class II under FDA regulations and are listed in the FDA’s 510(k) database. These systems are intended for use in the United States, where they undergo premarket notification review to demonstrate substantial equivalence to predicate devices. No additional registries or international authorizations are referenced in the provided data.
Catalogue
Search and filter all 16 devicesFDA recalls
FDA recall records list 1 recall initiated by Trionix Research Laboratory, Inc., initiated on 2006-08-01. By recorded status: 1 terminated. The reasons filed fall into these groups: other reasons as filed. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2006
- 1 Aug 2006 Z-0193-2007 Unclassified (pre-2012) Terminated The ball screw on the unit which supports the detector head (which weighs approximately 800 lbs.) could snap resulting in the detector head dropping on the patient.
Frequently asked questions
How many devices does Trionix Research Laboratory, Inc. have in the registry?
The registry currently lists 16 devices for Trionix Research Laboratory, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Trionix Research Laboratory, Inc.'s devices?
Among its 16 most recently registered devices, Trionix Research Laboratory, Inc. has devices listed in FDA 510(k) (16 devices).
What risk classes do Trionix Research Laboratory, Inc.'s devices fall under?
Among its 16 most recently registered devices, the classes recorded for Trionix Research Laboratory, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Trionix Research Laboratory, Inc.?
FDA recall records list 1 recall initiated by Trionix Research Laboratory, Inc., the most recent initiated on 2006-08-01. 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 Trionix Research Laboratory, Inc. in the registry?
The most recently registered devices listed for Trionix Research Laboratory, Inc. include GATED MIBI 3-D EJECTION FRACTION PROCESSING, VISIONPRO, BIAD NUCLEAR IMAGING SYSTEM and TRIAD NUCLEAR IMAGING SYSTEM.