The following data is part of a premarket notification filed by Mckesson Israel Ltd. with the FDA for Mckesson Horizon Cardiology.
| Device ID | K112720 |
| 510k Number | K112720 |
| Device Name: | MCKESSON HORIZON CARDIOLOGY |
| Classification | System, Image Processing, Radiological |
| Applicant | MCKESSON ISRAEL LTD. HANECHOSHET 4 Tel Aviv, IL 69710 |
| Contact | Tomer Levy |
| Correspondent | Tomer Levy MCKESSON ISRAEL LTD. HANECHOSHET 4 Tel Aviv, IL 69710 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2011-09-19 |
| Decision Date | 2012-01-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 80010939070025 | K112720 | 000 |