The following data is part of a premarket notification filed by Shimadzu Medical Systems with the FDA for X-ray Tube Assembly Circlex1.2ug.
| Device ID | K920731 |
| 510k Number | K920731 |
| Device Name: | X-RAY TUBE ASSEMBLY CIRCLEX1.2UG |
| Classification | Assembly, Tube Housing, 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 | ITY |
| CFR Regulation Number | 892.1760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-02-18 |
| Decision Date | 1992-05-29 |