510(k) K912250
K912250 is an FDA 510(k) premarket notification submitted by Theta Systems, Inc. for the device "ISORAD(TM) INTEGRAL BUILDUP PHOTON DIODES". The FDA issued a decision of Substantially Equivalent on November 5, 1991. The device falls under product code IWB (System, Radiation Therapy, Radionuclide), a Class II device regulated under 21 CFR 892.5750. Theta Systems, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 5, 1991
- Date Received
- May 21, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Radiation Therapy, Radionuclide
- Device Class
- Class II
- Regulation Number
- 892.5750
- Review Panel
- RA
- Submission Type