Clearance Summary
IMAGES-ON-CALL TELERADIOLOGY SYSTEM received FDA 510(k) clearance under submission number K896095, sponsored by Devices & Services Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1990-02-16.
- Submission: K896095
- Applicant / Sponsor: Devices & Services Co.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.2020
- Decision date: 1990-02-16
Classification & Regulation
This clearance is catalogued under FDA product code LMD and 21 CFR 892.2020, within the Radiology review panel as a Class I device.