Omnitron Intl., Inc.
United StatesFDA applicant, unverified
- Devices
- 7
What Omnitron Intl., Inc. makes
Omnitron Intl., Inc. manufactures applicators and catheters for targeted radiation therapy, including gynecological applicators, needle applicators (18 and 21 gauge), and intraluminal catheters for bronchial delivery. Their portfolio also includes radionuclide applicators with remote control capabilities and modifications for radioactive implants, such as the IR-192 implant. The company produces devices designed for precise internal radiation treatment in oncology settings.
The company’s devices are classified under Class II in the U.S. regulatory framework and are listed under FDA 510(k) clearance. Their products are intended for use in the United States, where they comply with U.S. medical device regulations.
Catalogue
Omnitron Gyn Applicator System Ref K913908
Regimes: 510(k) Registry: 510(k)Omnitron Needle Applicators 18 And 21 Gauge Ref K920431
Regimes: 510(k) Registry: 510(k)Ir-192 Implant -- Modification Ref K923130
Regimes: 510(k) Registry: 510(k)Pulmocath Intrabronchial Catheter Ref K901615
Regimes: 510(k) Registry: 510(k)Ir-192 Implant, Modification Ref K915253
Regimes: 510(k) Registry: 510(k)Omnicath Implanted Catheter And Depot Ref K911775
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Omnitron Intl., Inc. have in the registry?
The registry currently lists 7 devices for Omnitron Intl., Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Omnitron Intl., Inc.'s devices?
Among its 7 most recently registered devices, Omnitron Intl., Inc. has devices listed in FDA 510(k) (7 devices).
What risk classes do Omnitron Intl., Inc.'s devices fall under?
Among its 7 most recently registered devices, the classes recorded for Omnitron Intl., Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Omnitron Intl., Inc. in the registry?
The most recently registered devices listed for Omnitron Intl., Inc. include OMNITRON GYN APPLICATOR SYSTEM, OMNITRON NEEDLE APPLICATORS 18 AND 21 GAUGE, IR-192 IMPLANT -- MODIFICATION and PULMOCATH INTRABRONCHIAL CATHETER.