Clearance Summary
ERGO IMAGING SYSTEM received FDA 510(k) clearance under submission number K123408, sponsored by Digirad Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2013-01-15.
- Submission: K123408
- Applicant / Sponsor: Digirad Corp.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.1100
- Decision date: 2013-01-15
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.