The following data is part of a premarket notification filed by Continental X-ray Corp. with the FDA for Inventor Rt/explorer Trauma Unit.
| Device ID | K911563 |
| 510k Number | K911563 |
| Device Name: | INVENTOR RT/EXPLORER TRAUMA UNIT |
| Classification | Tube Mount, X-ray, Diagnostic |
| Applicant | CONTINENTAL X-RAY CORP. 2000 SOUTH 25TH AVE. Broadview, IL 60153 |
| Contact | James M Taylor |
| Correspondent | James M Taylor CONTINENTAL X-RAY CORP. 2000 SOUTH 25TH AVE. Broadview, IL 60153 |
| Product Code | IYB |
| CFR Regulation Number | 892.1770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-04-08 |
| Decision Date | 1991-10-23 |