The following data is part of a premarket notification filed by Philips Medical Systems (cleveland), Inc. with the FDA for Philips Multislice Ct System With Low Dose Ct Lung Cancer.
| Device ID | K153444 |
| 510k Number | K153444 |
| Device Name: | Philips Multislice CT System With Low Dose CT Lung Cancer |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. 595 MINER ROAD Cleveland, OH 44143 |
| Contact | Michael Chilbert |
| Correspondent | Michael Chilbert PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. 595 MINER ROAD Cleveland, OH 44143 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-27 |
| Decision Date | 2016-04-08 |
| Summary: | summary |