The following data is part of a premarket notification filed by Philips Healthcare with the FDA for Qlab Advanced Quantification Software 13.
| Device ID | K190913 |
| 510k Number | K190913 |
| Device Name: | QLAB Advanced Quantification Software 13 |
| Classification | System, Image Processing, Radiological |
| Applicant | Philips Healthcare 22100 Bothell Everett Highway Bothell, WA 98021 -8431 |
| Contact | Arti Arvind |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2019-04-08 |
| Decision Date | 2019-06-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838091672 | K190913 | 000 |