The following data is part of a premarket notification filed by Philips Medical Systems(cleveland), Inc. with the FDA for Gemini 16.
| Device ID | K032036 |
| 510k Number | K032036 |
| Device Name: | GEMINI 16 |
| Classification | System, Tomography, Computed, Emission |
| Applicant | PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. 595 MINER RD. Cleveland, OH 44143 |
| Contact | Christof Littwitz |
| Correspondent | Heinz J Steneberg TUV RHEINLAND OF NORTH AMERICA, INC. 12 COMMERCE RD. Newton, CT 06470 |
| Product Code | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2003-07-01 |
| Decision Date | 2003-07-11 |
| Summary: | summary |