The following data is part of a premarket notification filed by Medis Medical Imaging Systems, B.v. with the FDA for Qcu Analytical Software Package.
| Device ID | K011582 |
| 510k Number | K011582 |
| Device Name: | QCU ANALYTICAL SOFTWARE PACKAGE |
| Classification | System, Image Processing, Radiological |
| Applicant | MEDIS MEDICAL IMAGING SYSTEMS, B.V. POORTGEBOUW RIJNSBURGERWEG 10 Leiden, NL 2333 Aa |
| Contact | J.j. Hollander |
| Correspondent | J.j. Hollander MEDIS MEDICAL IMAGING SYSTEMS, B.V. POORTGEBOUW RIJNSBURGERWEG 10 Leiden, NL 2333 Aa |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-05-23 |
| Decision Date | 2001-07-31 |
| Summary: | summary |