The following data is part of a premarket notification filed by Shimadzu Corp. with the FDA for Shimadzu Ceiling Tube Support Ch-30gx.
| Device ID | K934005 |
| 510k Number | K934005 |
| Device Name: | SHIMADZU CEILING TUBE SUPPORT CH-30GX |
| Classification | System, X-ray, Stationary |
| Applicant | SHIMADZU CORP. 101 WEST WALNUT ST. Gardena, CA 90248 -3130 |
| Contact | Kiyoshi Kume |
| Correspondent | Kiyoshi Kume SHIMADZU CORP. 101 WEST WALNUT ST. Gardena, CA 90248 -3130 |
| Product Code | KPR |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-08-18 |
| Decision Date | 1993-11-24 |