The following data is part of a premarket notification filed by Philips Ultrasound Inc. with the FDA for Qlab Advanced Quantification Software.
| Device ID | K181264 |
| 510k Number | K181264 |
| Device Name: | QLAB Advanced Quantification Software |
| Classification | System, Image Processing, Radiological |
| Applicant | Philips Ultrasound Inc. 3000 Minuteman Road 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 | 2018-05-14 |
| Decision Date | 2018-06-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838090736 | K181264 | 000 |
| 00884838084322 | K181264 | 000 |