The following data is part of a premarket notification filed by Sanders Data Systems, Llc. with the FDA for Qlva Plus.
| Device ID | K963859 |
| 510k Number | K963859 |
| Device Name: | QLVA PLUS |
| Classification | System, Image Processing, Radiological |
| Applicant | SANDERS DATA SYSTEMS, LLC. 3980 BIBBITS DR. Palo Alto, CA 94303 |
| Contact | William Sanders |
| Correspondent | William Sanders SANDERS DATA SYSTEMS, LLC. 3980 BIBBITS DR. Palo Alto, CA 94303 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-26 |
| Decision Date | 1996-12-18 |