The following data is part of a premarket notification filed by Hitachi Medical Corp. Of America with the FDA for Hitachi Spectradigital Series Gamma Camera Systems.
| Device ID | K954143 |
| 510k Number | K954143 |
| Device Name: | HITACHI SPECTRADIGITAL SERIES GAMMA CAMERA SYSTEMS |
| Classification | System, Tomography, Computed, Emission |
| Applicant | HITACHI MEDICAL CORP. OF AMERICA 660 WHITE PLAINS RD. Tarrytown, NY 10591 |
| Contact | Gary W Enos |
| Correspondent | Gary W Enos HITACHI MEDICAL CORP. OF AMERICA 660 WHITE PLAINS RD. Tarrytown, NY 10591 |
| Product Code | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-01 |
| Decision Date | 1995-12-22 |