The following data is part of a premarket notification filed by Shimadzu Medical Systems with the FDA for Shimadzu X-ray High Voltage Generator Xud150b-10.
| Device ID | K913063 |
| 510k Number | K913063 |
| Device Name: | SHIMADZU X-RAY HIGH VOLTAGE GENERATOR XUD150B-10 |
| Classification | Generator, High-voltage, X-ray, Diagnostic |
| 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 | IZO |
| CFR Regulation Number | 892.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-10 |
| Decision Date | 1991-09-16 |