Clearance Summary
TYPE 633 COMPUTED RADIOGRAPHY (CR) FILM received FDA 510(k) clearance under submission number K862415, sponsored by Parexel Intl. 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 1986-07-01.
- Submission: K862415
- Applicant / Sponsor: Parexel Intl. Corp.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.1840
- Decision date: 1986-07-01
Classification & Regulation
This clearance is catalogued under FDA product code IWZ and 21 CFR 892.1840, within the Radiology review panel as a Class I device.