The following data is part of a premarket notification filed by Shimadzu Medical Systems with the FDA for Shimadzu Whole Body X-ray Ct Scanner Sct-4500te.
| Device ID | K915623 |
| 510k Number | K915623 |
| Device Name: | SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-4500TE |
| Classification | System, X-ray, Tomography, Computed |
| 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 | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-16 |
| Decision Date | 1992-02-14 |