The following data is part of a premarket notification filed by Philips Ultrasound, Inc. with the FDA for Qlab Quantification.
| Device ID | K070792 |
| 510k Number | K070792 |
| Device Name: | QLAB QUANTIFICATION |
| Classification | System, Image Processing, Radiological |
| Applicant | PHILIPS ULTRASOUND, INC. 22100 BOTHELL EVERETT HWY. P.O. BOX 3003 Bothell, WA 98041 |
| Contact | Lynn Harmer |
| 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 | 2007-03-22 |
| Decision Date | 2007-04-06 |
| Summary: | summary |