The following data is part of a premarket notification filed by Dataview Imaging Intl., Inc. with the FDA for Image Transport Series Ii.
Device ID | K925963 |
510k Number | K925963 |
Device Name: | IMAGE TRANSPORT SERIES II |
Classification | System, Image Processing, Radiological |
Applicant | DATAVIEW IMAGING INTL., INC. SIXTH FLOOR 1001 PENNSYLVANIA AVE. N.W. Washington, DC 20004 |
Contact | Von Oehsen |
Correspondent | Von Oehsen DATAVIEW IMAGING INTL., INC. SIXTH FLOOR 1001 PENNSYLVANIA AVE. N.W. Washington, DC 20004 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-11-25 |
Decision Date | 1995-02-03 |