The following data is part of a premarket notification filed by Hologic, Inc. with the FDA for Securview Dx Diagnostic Workstation, Models Sv-0001, Sv-0002 And Sv-0003.
Device ID | K062107 |
510k Number | K062107 |
Device Name: | SECURVIEW DX DIAGNOSTIC WORKSTATION, MODELS SV-0001, SV-0002 AND SV-0003 |
Classification | System, Image Processing, Radiological |
Applicant | HOLOGIC, INC. 36 APPLE RIDGE ROAD Danbury, CT 06810 |
Contact | Gail Yaeker-daunis |
Correspondent | Gail Yaeker-daunis HOLOGIC, INC. 36 APPLE RIDGE ROAD Danbury, CT 06810 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-07-24 |
Decision Date | 2006-08-18 |
Summary: | summary |