510(k) K201798
K201798 is an FDA 510(k) premarket notification submitted by Iba Dosimetry GmbH for the device "myQA iON". The FDA issued a decision of Substantially Equivalent on July 17, 2020. The device falls under product code LHN (System, Radiation Therapy, Charged-Particle, Medical), a Class II device regulated under 21 CFR 892.5050. Iba Dosimetry GmbH has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 17, 2020
- Date Received
- June 30, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- System, Radiation Therapy, Charged-Particle, Medical
- Device Class
- Class II
- Regulation Number
- 892.5050
- Review Panel
- RA
- Submission Type