The following data is part of a premarket notification filed by Sterling Diagnostic Imaging, Inc. with the FDA for Sterling Diagnostic Imaging Direct Radiography.
Device ID | K973206 |
510k Number | K973206 |
Device Name: | STERLING DIAGNOSTIC IMAGING DIRECT RADIOGRAPHY |
Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
Applicant | STERLING DIAGNOSTIC IMAGING, INC. P.O. BOX 6101 BUILDING 600/MAILBOX 630 Newark, DE 19714 -6101 |
Contact | Elaine H Kindell |
Correspondent | Elaine H Kindell STERLING DIAGNOSTIC IMAGING, INC. P.O. BOX 6101 BUILDING 600/MAILBOX 630 Newark, DE 19714 -6101 |
Product Code | MQB |
CFR Regulation Number | 892.1680 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-08-26 |
Decision Date | 1997-12-04 |
Summary: | summary |