The following data is part of a premarket notification filed by Imnet Systems, Inc. with the FDA for Imnet Dicom Network Agent.
Device ID | K972366 |
510k Number | K972366 |
Device Name: | IMNET DICOM NETWORK AGENT |
Classification | System, Digital Image Communications, Radiological |
Applicant | IMNET SYSTEMS, INC. 3015 WINDWARD PLAZA WINDWARD FAIRWAYS II Alpharetta, GA 30202 |
Contact | Wi8lliam G Bain |
Correspondent | Wi8lliam G Bain IMNET SYSTEMS, INC. 3015 WINDWARD PLAZA WINDWARD FAIRWAYS II Alpharetta, GA 30202 |
Product Code | LMD |
CFR Regulation Number | 892.2020 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-06-25 |
Decision Date | 1997-09-23 |