The following data is part of a premarket notification filed by Shimadzu Corp. with the FDA for Shimazu Whole Body X-ray Ct Scanner Sct-4800tf/gr.
| Device ID | K942731 |
| 510k Number | K942731 |
| Device Name: | SHIMAZU WHOLE BODY X-RAY CT SCANNER SCT-4800TF/GR |
| Classification | Generator, High-voltage, X-ray, Diagnostic |
| 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 | IZO |
| CFR Regulation Number | 892.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-05-19 |
| Decision Date | 1994-10-13 |