The following data is part of a premarket notification filed by Advanced Technology Laboratories, Inc. with the FDA for Q Lab Software.
| Device ID | K021966 |
| 510k Number | K021966 |
| Device Name: | Q LAB SOFTWARE |
| Classification | System, Image Processing, Radiological |
| Applicant | ADVANCED TECHNOLOGY LABORATORIES, INC. 22100 BOTHELL-EVERETT HWY. P.O. BOX 3003 Bothell, WA 98041 -3003 |
| Contact | Sarah Baxter |
| Correspondent | Mark Job 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 | 2002-06-17 |
| Decision Date | 2002-07-02 |
| Summary: | summary |