The following data is part of a premarket notification filed by Visus Technology Transfer Gmbh with the FDA for Jive X Software.
Device ID | K053183 |
510k Number | K053183 |
Device Name: | JIVE X SOFTWARE |
Classification | System, Image Processing, Radiological |
Applicant | VISUS TECHNOLOGY TRANSFER GMBH 20406 EARL STREET Torrance, CA 90503 |
Contact | Stephen Neushul |
Correspondent | Stephen Neushul VISUS TECHNOLOGY TRANSFER GMBH 20406 EARL STREET Torrance, CA 90503 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-11-14 |
Decision Date | 2006-02-16 |