Data / Medical devices / Canada / Densitas Inc.
Densitas Inc.: FDA-registered device maker in Halifax Nova Scotia, Canada, 2 510(k) clearances
Densitas Inc. is registered with the FDA (registration 3014343888) in Halifax Nova Scotia, Canada. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated February 19, 2020. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3014343888
- Address
- #66, 1344 Summer Street Suite 311B, Halifax Nova Scotia, Canada, B3H 0A8
- Owner or operator
- Densitas Inc (10057237)
- Roles
- Manufacturer
- First device listed
- March 12, 2018
- Registered through
- 2026
- Brand names listed
- Dose Software, Pressure Software, Quality Software, Verify Software, densitas intelliMammo, intelliMammo Navigator, intelliMammo densityAI, intelliMammo intelliPGMI
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Instrument, Quality-Assurance, Radiologic | LHO | 1 | Manufacturer | accessdata.fda.gov |
| 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 |
|---|---|---|---|---|---|---|
| February 19, 2020 | K192973 | densitas densityai | LLZ | Substantially Equivalent | Densitas, Inc. | accessdata.fda.gov |
| February 23, 2018 | K170540 | DM-Density | LLZ | Substantially Equivalent | Densitas, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Image Processing, Radiological
- All makers of Instrument, Quality-Assurance, Radiologic
Updated February 19, 2020. 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.