The following data is part of a premarket notification filed by Volpara Health Technologies Limited with the FDA for Volpara Imaging Software.
| Device ID | K211279 |
| 510k Number | K211279 |
| Device Name: | Volpara Imaging Software |
| Classification | System, Image Processing, Radiological |
| Applicant | Volpara Health Technologies Limited Level 14-15, Simpl House, 40 Mercer Street, Wellington Central Wellington, NZ 6011 |
| Contact | Ralph Highnam |
| Correspondent | Ralph Highnam Volpara Health Technologies Limited Level 14-15, Simpl House, 40 Mercer Street, Wellington Central Wellington, NZ 6011 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-04-27 |
| Decision Date | 2021-07-27 |