Data / Medical devices / Denmark / TracInnovations A/S
TracInnovations A/S: FDA-registered device maker in Ballerup Hovedstaden, Denmark, 2 510(k) clearances
TracInnovations A/S is registered with the FDA (registration 3019844073) in Ballerup Hovedstaden, Denmark. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated August 29, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3019844073
- Address
- Brydehusvej 13, Ballerup Hovedstaden, Denmark, 2750
- Owner or operator
- TracInnovations A/S (10082007)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- June 7, 2021
- Registered through
- 2026
- Brand names listed
- TCL3 Motion Tracking System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Nuclear Magnetic Resonance Imaging | LNH | 2 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| August 29, 2022 | K221785 | TCL3 Motion Tracking System | LNH | Substantially Equivalent | Tracinnovations A/S | accessdata.fda.gov |
| April 28, 2021 | K203451 | TCL3 Motion Tracking System | LNH | Substantially Equivalent | Tracinnovations Aps | accessdata.fda.gov |
Compare with other makers
Updated August 29, 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.