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 |