The following data is part of a premarket notification filed by Philips Ultrasound with the FDA for Qlab Quantification Software.
| Device ID | K040227 |
| 510k Number | K040227 |
| Device Name: | QLAB QUANTIFICATION SOFTWARE |
| Classification | System, Image Processing, Radiological |
| Applicant | PHILIPS ULTRASOUND 3000 MINUTEMAN RD. Andover, MA 01810 |
| Contact | Steve Singlar |
| Correspondent | Laura Danielson TUV AMERICA, INC. 1775 OLD HIGHWAY 8 New Brighton, MN 55112 -1891 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2004-02-02 |
| Decision Date | 2004-02-17 |
| Summary: | summary |