Clearance Summary
SCANNING DIRECTOR received FDA 510(k) clearance under submission number K944585, sponsored by Prentke Romich Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 1995-02-21.
- Submission: K944585
- Applicant / Sponsor: Prentke Romich Co.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.3725
- Decision date: 1995-02-21
Classification & Regulation
This clearance is catalogued under FDA product code IQA and 21 CFR 890.3725, within the Physical Medicine review panel as a Class II device.