The following data is part of a premarket notification filed by Alan Penn & Associates., Inc. with the FDA for Cadimas Version 1.0.
| Device ID | K052023 |
| 510k Number | K052023 |
| Device Name: | CADIMAS VERSION 1.0 |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | ALAN PENN & ASSOCIATES., INC. 6319 MASSACHUSETTS AVENUE Bethesda, MD 20816 -1139 |
| Contact | Roger H Schneider |
| Correspondent | Roger H Schneider ALAN PENN & ASSOCIATES., INC. 6319 MASSACHUSETTS AVENUE Bethesda, MD 20816 -1139 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-07-26 |
| Decision Date | 2005-12-08 |
| Summary: | summary |