EZFluence (RADEZ V2)
Radformation, Inc. · Radiology
Open FDA's page for this record- Third party flag
- N
- City
- New York
- Advisory committee description
- Radiology
- Address 1
- 261 Madison Ave.
- Address 2
- 9th Floor
- Statement or summary
- Summary
- Product code
- IYE
- Zip code
- 10016
- Applicant
- Radformation, Inc.
- Decision date
- 2026-08-31
- Decision code
- SESE
- Country code
- US
- Device name
- EZFluence (RADEZ V2)
- Advisory committee
- RA
- Contact
- Jennifer Wampler
- K number
- K261718
- State
- NY
- Date received
- 2026-05-26
- Review advisory committee
- RA
- Postal code
- 10016
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- Harmonized identifiers (openFDA)
- Device name
- Accelerator, Linear, Medical
- Medical specialty description
- Radiology
- Regulation number
- 892.5050
- Device class
- 2
- Registration number
- 3003803149, 3013410552, 3010625741, 9681134, 3009649442, 9614584, 3006405073, 9710332, 1647149, 3001722928, 3004580128, 3009754495, 3004363352, 3009894282, 1450662, 3031194398, 3002808157, 3007165183, 1530561, 3009302839, 3003873069, 8043933, 3015621321, 3033484057, 3009140718, 1722661, 3006621300, 1651102, 3042022819, 3022719374, 3015548663, 1721113, 3003094912, 3026961165, 3006981798, 1219183, 3009039068, 3004832819, 9617016, 3016591365 +75 more
- FEI number
- 1000143606, 3003803149, 3013410552, 3010625741, 3002807880, 3009649442, 3006405073, 3001722928, 3003251135, 3004580128, 3009754495, 3004363352, 3009894282, 1000227792, 1000518731, 3000253133, 1450662, 3031194398, 3002808157, 3007165183, 3009302839, 3002619595, 3003873069, 3015621321, 3002619738, 3033484057, 3009140718, 3006621300, 3042022819, 3022719374, 3015548663, 1721113, 3007360740, 3003094912, 3026961165, 3006981798, 1219183, 3009039068, 3004832819, 3016591365 +75 more