Clearance Summary
SCRIBE(TM) DIAGNOSTIC IMAGING WORKSTATION received FDA 510(k) clearance under submission number K945428, sponsored by Multi-Dimensional Imaging, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1995-03-09.
- Submission: K945428
- Applicant / Sponsor: Multi-Dimensional Imaging, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2050
- Decision date: 1995-03-09
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.