The following data is part of a premarket notification filed by National Diagnostic Imaging, Inc. with the FDA for Ndi Model Irs-td.
| Device ID | K904676 |
| 510k Number | K904676 |
| Device Name: | NDI MODEL IRS-TD |
| Classification | System, X-ray, Stationary |
| Applicant | NATIONAL DIAGNOSTIC IMAGING, INC. P.O. BOX 5501 5700 GRAND CENTRAL AVENUE Vienna, VA 26105 |
| Contact | A Wood |
| Correspondent | A Wood NATIONAL DIAGNOSTIC IMAGING, INC. P.O. BOX 5501 5700 GRAND CENTRAL AVENUE Vienna, VA 26105 |
| Product Code | KPR |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-10-12 |
| Decision Date | 1991-06-21 |