Data / Medical devices / Canada / Ramsoft, Inc.
Ramsoft, Inc.: FDA-registered device maker in TORONTO Ontario, Canada, 3 510(k) clearances
Ramsoft, Inc. is registered with the FDA (registration 9680028) in TORONTO Ontario, Canada. It lists 1 device type. The FDA files 3 510(k) clearances under its listings, the newest dated November 17, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9680028
- FEI number
- 3002807975
- Address
- 208-8 King St E, TORONTO Ontario, Canada, M5C 1B5
- Owner or operator
- RAMSOFT, INC. (9006410)
- Roles
- Manufacturer
- First device listed
- September 11, 2003
- Registered through
- 2026
- Brand names listed
- GATEWAY, GATEWAY ROUTER, OMEGAAI, POWERCACHE, POWERREADER, POWERSERVER, RapidResults
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Image Processing, Radiological | LLZ | 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 |
|---|---|---|---|---|---|---|
| November 17, 2022 | K222476 | OmegaAI Image Viewer | LLZ | Substantially Equivalent | Ramsoft, Inc. | accessdata.fda.gov |
| October 31, 2014 | K141881 | RAPIDRESULTS | LLZ | Substantially Equivalent | Ramsoft, Inc. | accessdata.fda.gov |
| September 21, 2005 | K052460 | POWERSERVER, POWERREADER, GATEWAY AND POWERCACHE | LLZ | Substantially Equivalent | Ramsoft, Inc. | accessdata.fda.gov |
Compare with other makers
Updated November 17, 2022. 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.