The following data is part of a premarket notification filed by Digirad Corp. with the FDA for Notebook Imager.
Device ID | K961104 |
510k Number | K961104 |
Device Name: | NOTEBOOK IMAGER |
Classification | Camera, Scintillation (gamma) |
Applicant | DIGIRAD CORP. 14900 SWEITZER LN. SUITE 200 Laurel, MD 20707 |
Contact | James M Howard |
Correspondent | James M Howard DIGIRAD CORP. 14900 SWEITZER LN. SUITE 200 Laurel, MD 20707 |
Product Code | IYX |
CFR Regulation Number | 892.1100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-03-20 |
Decision Date | 1997-05-28 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
NOTEBOOK IMAGER 75202360 not registered Dead/Abandoned |
Digirad Corporation 1996-11-22 |