Clearance Summary
ORWO X-RAY FILM received FDA 510(k) clearance under submission number K920539, sponsored by Burkhart Roentgen Intl., Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1992-06-30.
- Submission: K920539
- Applicant / Sponsor: Burkhart Roentgen Intl., Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.1840
- Decision date: 1992-06-30
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.