Data / Medical devices / New Zealand / Lunit International Limited
Lunit International Limited: FDA-registered device maker in Wellington Central, New Zealand, 2 510(k) clearances
Lunit International Limited is registered with the FDA (registration 3009117933) in Wellington Central, New Zealand. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated July 27, 2021. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3009117933
- Address
- Level 4, 1 Victoria Street, Wellington Central, New Zealand, 6011
- Owner or operator
- Lunit Inc. (10034313)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- December 3, 2013
- Registered through
- 2027
- Brand names listed
- Volpara Live, Volpara Scorecard
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Instrument, Quality-Assurance, Radiologic | LHO | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 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 |
|---|---|---|---|---|---|---|
| July 27, 2021 | K211279 | Volpara Imaging Software | LLZ | Substantially Equivalent | Volpara Health Technologies Limited | accessdata.fda.gov |
| January 7, 2016 | K153427 | Volpara Imaging Software | LLZ | Substantially Equivalent | Matakina Technology, Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Image Processing, Radiological
- All makers of Instrument, Quality-Assurance, Radiologic
Updated July 27, 2021. 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.