The following data is part of a premarket notification filed by Philips Healthcare (cleveland) with the FDA for Ingenuity Digital Pet/ct.
| Device ID | K123599 |
| 510k Number | K123599 |
| Device Name: | INGENUITY DIGITAL PET/CT |
| Classification | System, Tomography, Computed, Emission |
| Applicant | PHILIPS HEALTHCARE (CLEVELAND) 595 MINER RD. Cleveland, OH 44143 |
| Contact | Michael S Preto |
| Correspondent | Michael S Preto PHILIPS HEALTHCARE (CLEVELAND) 595 MINER RD. Cleveland, OH 44143 |
| Product Code | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-11-21 |
| Decision Date | 2013-07-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838059559 | K123599 | 000 |