The following data is part of a premarket notification filed by Matakina Technology Ltd with the FDA for Volpara Imaging Software.
| Device ID | K153427 |
| 510k Number | K153427 |
| Device Name: | Volpara Imaging Software |
| Classification | System, Image Processing, Radiological |
| Applicant | Matakina Technology LTD Level 12 86 Victoria Street Wellington, NZ 6011 |
| Contact | Ralph Highnam |
| Correspondent | Ralph Highnam Matakina Technology LTD Level 12 86 Victoria Street Wellington, NZ 6011 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-25 |
| Decision Date | 2016-01-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09421904268029 | K153427 | 000 |
| 09421904268128 | K153427 | 000 |
| 09421904268098 | K153427 | 000 |
| 09421904268050 | K153427 | 000 |
| 09421904268258 | K153427 | 000 |
| 09421904268319 | K153427 | 000 |
| 09421904268289 | K153427 | 000 |
| 09421904268241 | K153427 | 000 |