The following data is part of a premarket notification filed by Ge Medical Systems, Llc with the FDA for Optima Pet/ct 560.
| Device ID | K081496 |
| 510k Number | K081496 |
| Device Name: | OPTIMA PET/CT 560 |
| Classification | System, Tomography, Computed, Emission |
| Applicant | GE MEDICAL SYSTEMS, LLC 3000 N GRANDVIEW BLVD. Waukesha, WI 53188 |
| Contact | David Duersteler |
| Correspondent | Jay Y Kogoma 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 | 2008-05-29 |
| Decision Date | 2008-06-12 |
| Summary: | summary |