The following data is part of a premarket notification filed by Shimadzu Corp. with the FDA for Shimadzu Ceiling Tube Support Ch-30gh.
| Device ID | K990715 |
| 510k Number | K990715 |
| Device Name: | SHIMADZU CEILING TUBE SUPPORT CH-30GH |
| Classification | System, X-ray, Stationary |
| Applicant | SHIMADZU CORP. 20101 SOUTH VERMONT AVE. Torrance, CA 90502 -1328 |
| Contact | Michael Fishback |
| Correspondent | Michael Fishback SHIMADZU CORP. 20101 SOUTH VERMONT AVE. Torrance, CA 90502 -1328 |
| Product Code | KPR |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-04 |
| Decision Date | 1999-04-16 |