The following data is part of a premarket notification filed by Change Healthcare Israel Ltd. with the FDA for Mckesson Cardiology.
| Device ID | K181080 |
| 510k Number | K181080 |
| Device Name: | McKesson Cardiology |
| Classification | System, Image Processing, Radiological |
| Applicant | Change Healthcare Israel Ltd. HaRokmim 26 Holon, IL 5885849 |
| Contact | Nadia Marchant |
| Correspondent | Paul Sumner Change Healthcare Technologies LLC 5995 Windward Parkway Alpharetta, GA 30005 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-04-24 |
| Decision Date | 2018-05-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 17540262090024 | K181080 | 000 |
| 17540262090017 | K181080 | 000 |
| 17540262090048 | K181080 | 000 |
| 17540262090055 | K181080 | 000 |
| 17540262090031 | K181080 | 000 |