The following data is part of a premarket notification filed by Lorad Medical Systems, Inc. with the FDA for Rt-125 Rough Terrain Mobile X-ray Unit.
| Device ID | K894643 |
| 510k Number | K894643 |
| Device Name: | RT-125 ROUGH TERRAIN MOBILE X-RAY UNIT |
| Classification | System, X-ray, Mobile |
| Applicant | LORAD MEDICAL SYSTEMS, INC. EAGLE ROAD, COMMERCE PARK Danbury, CT 06810 |
| Contact | Ed Mcdermott |
| Correspondent | Ed Mcdermott LORAD MEDICAL SYSTEMS, INC. EAGLE ROAD, COMMERCE PARK Danbury, CT 06810 |
| Product Code | IZL |
| CFR Regulation Number | 892.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-24 |
| Decision Date | 1989-12-14 |