The following data is part of a premarket notification filed by Spectrum X-ray Corp. with the FDA for Digital Cradle.
| Device ID | K840463 |
| 510k Number | K840463 |
| Device Name: | DIGITAL CRADLE |
| Classification | Cradle, Patient, Radiologic |
| Applicant | SPECTRUM X-RAY CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KXH |
| CFR Regulation Number | 892.1830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-02-02 |
| Decision Date | 1984-02-21 |