The following data is part of a premarket notification filed by Philips Healthcare with the FDA for Qlab Quantification Software Heart Model.
| Device ID | K130159 |
| 510k Number | K130159 |
| Device Name: | QLAB QUANTIFICATION SOFTWARE HEART MODEL |
| Classification | System, Image Processing, Radiological |
| Applicant | PHILIPS HEALTHCARE 3000 MINUTEMAN RD Andover, MA 01810 |
| Contact | Penny Greco |
| Correspondent | Penny Greco PHILIPS HEALTHCARE 3000 MINUTEMAN RD Andover, MA 01810 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-01-23 |
| Decision Date | 2013-05-13 |
| Summary: | summary |