Clearance Summary
X-RAY MONOBLOCK, MONOBLOCK XRS-60-330 received FDA 510(k) clearance under submission number K000052, sponsored by Dynarad Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2000-02-10.
- Submission: K000052
- Applicant / Sponsor: Dynarad Corp.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.1760
- Decision date: 2000-02-10
Classification & Regulation
This clearance is catalogued under FDA product code ITY and 21 CFR 892.1760, within the Radiology review panel as a Class I device.