510(k) K191821
K191821 is an FDA 510(k) premarket notification submitted by Iba Dosimetry GmbH for the device "Blue Phantom PT". The FDA issued a decision of Substantially Equivalent on January 23, 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
- January 23, 2020
- Date Received
- July 8, 2019
- Clearance Type
- Abbreviated
- 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