The following data is part of a premarket notification filed by Altek Corp. with the FDA for The X-ray Digitizer, Altek Model Act20020-bl.
| Device ID | K895442 |
| 510k Number | K895442 |
| Device Name: | THE X-RAY DIGITIZER, ALTEK MODEL ACT20020-BL |
| Classification | System, Simulation, Radiation Therapy |
| Applicant | ALTEK CORP. 12210 PLUM ORCHARD DR. Silver Spring, MD 20904 |
| Contact | Thomas A Rainone |
| Correspondent | Thomas A Rainone ALTEK CORP. 12210 PLUM ORCHARD DR. Silver Spring, MD 20904 |
| Product Code | KPQ |
| CFR Regulation Number | 892.5840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-09-08 |
| Decision Date | 1989-12-14 |