Data / Medical devices / United States / Resonance Technology, Inc.
Resonance Technology, Inc.: FDA-registered device maker in Northridge, CA, United States, 1 510(k) clearance
Resonance Technology, Inc. is registered with the FDA (registration 2029299) in Northridge, CA, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated March 22, 2000. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2029299
- FEI number
- 1000306474
- Address
- 18121 Parthenia ST., Northridge, CA, United States, 91325
- Owner or operator
- RESONANCE TECHNOLOGY, INC. (9010564)
- Roles
- Manufacturer
- First device listed
- November 7, 2007
- Registered through
- 2026
- Brand names listed
- Cinema Vision, M.R. Vision 2000 Ultra Audio Visual, SereneSound, Visual Stim Digital
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Nuclear Magnetic Resonance Imaging | LNH | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 22, 2000 | K994351 | M.R. VISION 2000 ULTRA AUDIO VISUAL SYSTEM / COMMANDER X6 SYSTEM | LNH | Substantially Equivalent | Resonance Technology, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| May 14, 2007 | 47834 | Not yet classified | Terminated | Headset Model Number RTC-2K for use with the Serene Sound Digital MRI Compatible High Fidelity Stereo Sound System. | Potential safety concerns - Use of this product with a MRI may result in the headset's cord overheating and patients experiencing burns to the skin. | accessdata.fda.gov |
Compare with other makers
Updated September 2, 2008. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.