The following data is part of a premarket notification filed by Sanders Data Systems, Llc. with the FDA for Qca Plus.
Device ID | K915542 |
510k Number | K915542 |
Device Name: | QCA 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 | 1991-12-10 |
Decision Date | 1992-01-24 |
Summary: | summary |