Dynarad Corp.
United StatesFDA 510(k) applicant, unverified
- Devices
- 9
What Dynarad Corp. makes
Dynarad Corp. manufactures diagnostic X-ray systems, including monoblock units like the FACTS MONOBLOCK and X-RAY MONOBLOCK (XRS-60-330), as well as high-voltage generators (e.g., HF-110A, 9150A) and beam-limiting devices. Their portfolio also includes diagnostic tube housings, control assemblies, and specialized units such as the PHANTOM and NOVA XM2. Additional products include standalone high-voltage assemblies (e.g., 1100F, 1170) and the ALPHA II diagnostic X-ray system.
The company’s devices are classified under FDA’s Class I and Class II categories, with regulatory submissions recorded in the FDA’s 510(k) clearance database. These products are intended for diagnostic imaging and fall under U.S. medical device regulations. The manufacturer is based in the United States.
Catalogue
Facts Monoblock Ref K981267
510(k) 510(k)Hf-110A Ref K932353
510(k) 510(k)Phantom Ref K941363
510(k) 510(k)X-Ray Monoblock, Monoblock Xrs-60-330 Ref K000052
510(k) 510(k)9150A, 1100F Ref K932355
510(k) 510(k)Nova XM2 Ref K932356
510(k) 510(k)- 510(k) 510(k)
Alpha Ii Ref K931725
510(k) 510(k)9170, 1170 Ref K932354
510(k) 510(k)
Frequently asked questions
How many devices does Dynarad Corp. have in the registry?
The registry currently lists 9 devices for Dynarad Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Dynarad Corp.'s devices?
Among its 9 most recently registered devices, Dynarad Corp. has devices listed in FDA 510(k) (9 devices).
What risk classes do Dynarad Corp.'s devices fall under?
Among its 9 most recently registered devices, the classes recorded for Dynarad Corp.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Dynarad Corp. in the registry?
The most recently registered devices listed for Dynarad Corp. include FACTS MONOBLOCK, HF-110A, PHANTOM and X-RAY MONOBLOCK, MONOBLOCK XRS-60-330.