510(k) K203733
K203733 is an FDA 510(k) premarket notification submitted by Jvckenwood Corporation for the device "12MP Color Digital Mammography LCD Monitor CL-S1200". The FDA issued a decision of Substantially Equivalent on Jun 29, 2021. The device falls under product code PGY (Display, Diagnostic Radiology), a Class II device regulated under 21 CFR 892.2050. Jvckenwood Corporation has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 29, 2021
- Date Received
- Dec 21, 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.