The following data is part of a premarket notification filed by Mckesson Medical Imaging Company with the FDA for Horizon Medical Imaging.
| Device ID | K043146 |
| 510k Number | K043146 |
| Device Name: | HORIZON MEDICAL IMAGING |
| Classification | System, Image Processing, Radiological |
| Applicant | MCKESSON MEDICAL IMAGING COMPANY 130-10711 CAMBIE ROAD Richmond, B.c., CA V6x 3g5 |
| Contact | Robert Macneil |
| Correspondent | Neil E Devine ENTELA, INC. 3033 MADISON AVENUE, SE Grand Rapids, MI 49548 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2004-11-15 |
| Decision Date | 2005-01-04 |
| Summary: | summary |