The following data is part of a premarket notification filed by Radiological Engineering, Inc. with the FDA for Rei-90/90 Radiographic Table.
| Device ID | K854478 |
| 510k Number | K854478 |
| Device Name: | REI-90/90 RADIOGRAPHIC TABLE |
| Classification | Table, Radiographic, Tilting |
| Applicant | RADIOLOGICAL ENGINEERING, INC. 2160 LITTLETON RD. North Ft. Myers, FL 33903 |
| Contact | Ralph Frizzle |
| Correspondent | Ralph Frizzle RADIOLOGICAL ENGINEERING, INC. 2160 LITTLETON RD. North Ft. Myers, FL 33903 |
| Product Code | IXR |
| CFR Regulation Number | 892.1980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-11-07 |
| Decision Date | 1986-04-17 |