Clearance Summary
DICOM VIDEO received FDA 510(k) clearance under submission number K132183, sponsored by Bar Code Computer, Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2013-10-03.
- Submission: K132183
- Applicant / Sponsor: Bar Code Computer, Ltd.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2030
- Decision date: 2013-10-03
Classification & Regulation
This clearance is catalogued under FDA product code LMA and 21 CFR 892.2030, within the Radiology review panel as a Class II device.