The following data is part of a premarket notification filed by Shimadzu Medical Systems with the FDA for Mc125l-50 Shimadzu Mobile X-ray System.
| Device ID | K893637 |
| 510k Number | K893637 |
| Device Name: | MC125L-50 SHIMADZU MOBILE X-RAY SYSTEM |
| Classification | System, X-ray, Mobile |
| Applicant | SHIMADZU MEDICAL SYSTEMS 101 WEST WALNUT ST. Gardenia, CA 90248 |
| Contact | De Mint |
| Correspondent | De Mint SHIMADZU MEDICAL SYSTEMS 101 WEST WALNUT ST. Gardenia, CA 90248 |
| Product Code | IZL |
| CFR Regulation Number | 892.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-05-12 |
| Decision Date | 1989-07-20 |