510(k) K201599
K201599 is an FDA 510(k) premarket notification submitted by Shenzhen Beacon Display Technology Co., Ltd. for the device "2MP Color/Monochrome LCD Monitors C22S+, C22SP+/G22S+, G22SP+, G23S+, G23SP+". The FDA issued a decision of Substantially Equivalent on July 2, 2020. The device falls under product code PGY (Display, Diagnostic Radiology), a Class II device regulated under 21 CFR 892.2050. Shenzhen Beacon Display Technology Co., Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 2, 2020
- Date Received
- June 12, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Display, Diagnostic Radiology
- Device Class
- Class II
- Regulation Number
- 892.2050
- Review Panel
- RA
- Submission Type
The device is intended for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners.