EZFluence
Accelerator, Linear, Medical
Radformation, Inc.
The following data is part of a premarket notification filed by Radformation, Inc. with the FDA for Ezfluence.
Pre-market Notification Details
| Device ID | K171352 |
| 510k Number | K171352 |
| Device Name: | EZFluence |
| Classification | Accelerator, Linear, Medical |
| Applicant | Radformation, Inc. 335 Madison Avenue 16th Floor New York, NY 10017 |
| Contact | Kurt Sysock |
| Correspondent | Kurt Sysock Radformation, Inc. 335 Madison Avenue 16th Floor New York, NY 10017 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-05-09 |
| Decision Date | 2017-12-01 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860001672718 | K171352 | 000 |
Trademark Results [EZFluence]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 EZFLUENCE 97305806 not registered Live/Pending |
Radformation, Inc. 2022-03-10 |
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