Clearance Summary
INTEGRATED DIGITAL MEDICAL RECORD (IDMR) received FDA 510(k) clearance under submission number K993338, sponsored by Ibm Israel , 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 1999-12-29.
- Submission: K993338
- Applicant / Sponsor: Ibm Israel , Ltd.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2050
- Decision date: 1999-12-29
Classification & Regulation
This clearance is catalogued under FDA product code LLZ and 21 CFR 892.2050, within the Radiology review panel as a Class II device.