The following data is part of a premarket notification filed by Continental X-ray Corp. with the FDA for Linear Fr Tomographic System: 0mt 8000, Model No. 6681.270.
| Device ID | K950571 |
| 510k Number | K950571 |
| Device Name: | LINEAR FR TOMOGRAPHIC SYSTEM: 0MT 8000, MODEL NO. 6681.270 |
| Classification | System, X-ray, Tomographic |
| Applicant | CONTINENTAL X-RAY CORP. 2000 SOUTH 25TH AVE. Broadview, IL 60153 |
| Contact | Oscar Khutoryansky |
| Correspondent | Oscar Khutoryansky CONTINENTAL X-RAY CORP. 2000 SOUTH 25TH AVE. Broadview, IL 60153 |
| Product Code | IZF |
| CFR Regulation Number | 892.1740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-01-31 |
| Decision Date | 1995-03-31 |