Clearance Summary
NOTEBOOK IMAGER received FDA 510(k) clearance under submission number K961104, 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 1997-05-28.
- Submission: K961104
- Applicant / Sponsor: Digirad Corp.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.1100
- Decision date: 1997-05-28
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.