The following data is part of a premarket notification filed by Philips Healthcare Group with the FDA for Qlab Quantification Software.
| Device ID | K120525 |
| 510k Number | K120525 |
| Device Name: | QLAB QUANTIFICATION SOFTWARE |
| Classification | System, Image Processing, Radiological |
| Applicant | PHILIPS HEALTHCARE GROUP 3000 MINUTEMAN ROAD Andover, MA 01810 -7324 |
| Contact | Penny Greco |
| 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 | 2012-02-22 |
| Decision Date | 2012-03-09 |
| Summary: | summary |