The following data is part of a premarket notification filed by Absolute X-ray Corp. with the FDA for X-ray Generating System, Tf 800.
| Device ID | K881387 |
| 510k Number | K881387 |
| Device Name: | X-RAY GENERATING SYSTEM, TF 800 |
| Classification | Generator, High-voltage, X-ray, Diagnostic |
| Applicant | ABSOLUTE X-RAY CORP. 23-06 31 AVE. Long Island City, NY 11106 |
| Contact | George S Pavel |
| Correspondent | George S Pavel ABSOLUTE X-RAY CORP. 23-06 31 AVE. Long Island City, NY 11106 |
| Product Code | IZO |
| CFR Regulation Number | 892.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-04-01 |
| Decision Date | 1988-07-08 |