The following data is part of a premarket notification filed by Galil Medical Inc. with the FDA for Visual-ice Mri Cryoblation Console, Visual-ice Mri Junction Box Assembly, Visual-ice Mri Mobile Connection Panel.
| Device ID | K173037 |
| 510k Number | K173037 |
| Device Name: | Visual-ICE MRI Cryoblation Console, Visual-ICE MRI Junction Box Assembly, Visual-ICE MRI Mobile Connection Panel |
| Classification | Unit, Cryosurgical, Accessories |
| Applicant | Galil Medical Inc. 4364 Round Lake Road Arden Hills, MN 55112 |
| Contact | Lynne Davies |
| Correspondent | Lynne Davies Galil Medical Inc. 4364 Round Lake Road Arden Hills, MN 55112 |
| Product Code | GEH |
| CFR Regulation Number | 878.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-28 |
| Decision Date | 2017-11-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00859019006332 | K173037 | 000 |
| 00859019006325 | K173037 | 000 |
| 00859019006318 | K173037 | 000 |