The following data is part of a premarket notification filed by Matakina Technologies Limited with the FDA for Volpara Imaging Software.
| Device ID | K152028 |
| 510k Number | K152028 |
| Device Name: | Volpara Imaging Software |
| Classification | System, Image Processing, Radiological |
| Applicant | MATAKINA TECHNOLOGIES LIMITED Level 12, 86 Victoria Street Wellington, NZ 6011 |
| Contact | Ralph Highnam |
| Correspondent | Sheila Pickering SHEILA PICKERING 2081 LONGDEN CIRCLE Losaltos, CA 94024 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-07-22 |
| Decision Date | 2015-10-26 |
| Summary: | summary |