The following data is part of a premarket notification filed by Matakina Technology Limited with the FDA for Volpara, Version 1.3.
| Device ID | K102556 |
| 510k Number | K102556 |
| Device Name: | VOLPARA, VERSION 1.3 |
| Classification | System, Image Processing, Radiological |
| Applicant | MATAKINA TECHNOLOGY LIMITED Level 6, 86 Victoria Street Wellington, NZ 6142 |
| Contact | Sheila W Pickering |
| Correspondent | Sheila W Pickering MATAKINA TECHNOLOGY LIMITED Level 6, 86 Victoria Street Wellington, NZ 6142 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-07 |
| Decision Date | 2010-10-07 |
| Summary: | summary |