The following data is part of a premarket notification filed by Hitachi Medical Corp. Of America with the FDA for Convergence Cdr For Hitachi Spectradigital V250dsp Gamma Cameras.
| Device ID | K991535 |
| 510k Number | K991535 |
| Device Name: | CONVERGENCE CDR FOR HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERAS |
| Classification | System, Tomography, Computed, Emission |
| Applicant | HITACHI MEDICAL CORP. OF AMERICA 9177 DUTTON DR. Twinsburg, OH 44056 |
| Contact | Gary W Enos |
| Correspondent | Gary W Enos HITACHI MEDICAL CORP. OF AMERICA 9177 DUTTON DR. Twinsburg, OH 44056 |
| Product Code | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-05-03 |
| Decision Date | 1999-07-30 |
| Summary: | summary |