The following data is part of a premarket notification filed by Shimadzu Medical Systems with the FDA for Positron Emission Computed Tomograph Set-1400w.
| Device ID | K894056 |
| 510k Number | K894056 |
| Device Name: | POSITRON EMISSION COMPUTED TOMOGRAPH SET-1400W |
| Classification | System, Tomography, Computed, Emission |
| 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 | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-06-07 |
| Decision Date | 1989-11-15 |