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 |