The following data is part of a premarket notification filed by Ge Healthcare with the FDA for Fullcard Analysis.
| Device ID | K061587 |
| 510k Number | K061587 |
| Device Name: | FULLCARD ANALYSIS |
| Classification | System, Tomography, Computed, Emission |
| Applicant | GE HEALTHCARE 3000 N. GRANDVIEW BLVD. Waukesha, WI 53188 |
| Contact | Larry A Kroger |
| Correspondent | Neil E Devine, Jr. INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2006-06-08 |
| Decision Date | 2006-06-23 |
| Summary: | summary |