The following data is part of a premarket notification filed by Spectrum X-ray Corp. with the FDA for Pentamax 1 Model B Table System.
| Device ID | K870707 |
| 510k Number | K870707 |
| Device Name: | PENTAMAX 1 MODEL B TABLE SYSTEM |
| Classification | Table, Radiographic, Tilting |
| Applicant | SPECTRUM X-RAY CORP. P.O. BOX 155 RYAN AVE. Westville, NJ 08093 |
| Contact | Theresa Mcglone |
| Correspondent | Theresa Mcglone 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 | 1987-02-20 |
| Decision Date | 1987-05-14 |