510(k) K935580
K935580 is an FDA 510(k) premarket notification submitted by Precise Optics for the device "PHF20 20 MOBILE C-ARM IMAGE INTENSIFIER". The FDA issued a decision of Substantially Equivalent on March 16, 1994. The device falls under product code OXO (Image-Intensified Fluoroscopic X-Ray System, Mobile), a Class II device regulated under 21 CFR 892.1650. Precise Optics has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 16, 1994
- Date Received
- November 18, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Image-Intensified Fluoroscopic X-Ray System, Mobile
- Device Class
- Class II
- Regulation Number
- 892.1650
- Review Panel
- RA
- Submission Type
Fluoroscopy of the human body.