The following data is part of a premarket notification filed by Philips Ultrasound, Inc. with the FDA for Qlab Quantification Software.
| Device ID | K132165 |
| 510k Number | K132165 |
| Device Name: | QLAB QUANTIFICATION SOFTWARE |
| Classification | System, Image Processing, Radiological |
| Applicant | PHILIPS ULTRASOUND, INC. 3000 MINUTEMAN RD. Andover, MA 01810 |
| 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 | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2013-07-12 |
| Decision Date | 2013-08-09 |
| Summary: | summary |