Clearance Summary
INVENTOR RT/EXPLORER TRAUMA UNIT received FDA 510(k) clearance under submission number K911563, sponsored by Continental X-Ray 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 1991-10-23.
- Submission: K911563
- Applicant / Sponsor: Continental X-Ray Corp.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.1770
- Decision date: 1991-10-23
Classification & Regulation
This clearance is catalogued under FDA product code IYB and 21 CFR 892.1770, within the Radiology review panel as a Class I device.