Clearance Summary
ERGO IMAGING SYSTEM received FDA 510(k) clearance under submission number K100838, sponsored by Digirad Corp.. The device was reviewed via the Special premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2010-04-23.
- Submission: K100838
- Applicant / Sponsor: Digirad Corp.
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.1100
- Decision date: 2010-04-23
Classification & Regulation
This clearance is catalogued under FDA product code IYX and 21 CFR 892.1100, within the Radiology review panel as a Class I device.