The following data is part of a premarket notification filed by Philips Healthcare with the FDA for Qlab Advanced Quantification Software.
| Device ID | K191647 |
| 510k Number | K191647 |
| Device Name: | QLAB Advanced Quantification Software |
| Classification | Automated Radiological Image Processing Software |
| Applicant | Philips Healthcare 22100 Bothell Everett Highway Bothell, WA 98021 -8431 |
| Contact | Eri Gremi |
| Correspondent | Eri Gremi Philips Healthcare 22100 Bothell Everett Highway Bothell, WA 98021 -8431 |
| Product Code | QIH |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-20 |
| Decision Date | 2019-12-20 |