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 |