Clearance Summary
IMAGESHARE COMPUTED RADIOGRAPHY ACQUISITION STATION AND/OR SOFTWARE(2100{SIKARUS X86}/(1500{WINDOWS NT} received FDA 510(k) clearance under submission number K973421, sponsored by Dejarnette Research Systems. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1997-12-05.
- Submission: K973421
- Applicant / Sponsor: Dejarnette Research Systems
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.2020
- Decision date: 1997-12-05
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.