The following data is part of a premarket notification filed by Ge Medical Systems, Llc. with the FDA for Snapshot Freeze 2.
| Device ID | K183161 |
| 510k Number | K183161 |
| Device Name: | SnapShot Freeze 2 |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | GE Medical Systems, LLC. 3000 N. Grandview Blvd Waukesha, WI 53188 |
| Contact | Laura Turner |
| Correspondent | Laura Turner GE Medical Systems, LLC. 3000 N. Grandview Blvd Waukesha, WI 53188 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-15 |
| Decision Date | 2019-02-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00195278865335 | K183161 | 000 |