The following data is part of a premarket notification filed by Spectrum X-ray Corp. with the FDA for Spectrum Mark I Special Procedures Table.
| Device ID | K931563 |
| 510k Number | K931563 |
| Device Name: | SPECTRUM MARK I SPECIAL PROCEDURES TABLE |
| Classification | Table, Radiographic, Tilting |
| Applicant | SPECTRUM X-RAY CORP. P.O. BOX 155 RYAN AVE. Westville, NJ 08093 |
| Contact | Robert L Welsh |
| Correspondent | Robert L Welsh SPECTRUM X-RAY CORP. P.O. BOX 155 RYAN AVE. Westville, NJ 08093 |
| Product Code | IXR |
| CFR Regulation Number | 892.1980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-03-30 |
| Decision Date | 1993-08-23 |