The following data is part of a premarket notification filed by Sterling Diagnostic Imaging, Inc. with the FDA for Linx Networking System.
Device ID | K964250 |
510k Number | K964250 |
Device Name: | LINX NETWORKING SYSTEM |
Classification | System, Digital Image Communications, Radiological |
Applicant | STERLING DIAGNOSTIC IMAGING, INC. P.O. BOX 6101 BUILDING 600/MAILBOX 630 Newark, DE 19714 -6101 |
Contact | Jean E Bartlett |
Correspondent | Jean E Bartlett STERLING DIAGNOSTIC IMAGING, INC. P.O. BOX 6101 BUILDING 600/MAILBOX 630 Newark, DE 19714 -6101 |
Product Code | LMD |
CFR Regulation Number | 892.2020 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-10-24 |
Decision Date | 1996-12-18 |
Summary: | summary |