510(k) K233336
K233336 is an FDA 510(k) premarket notification submitted by Acula Technology Corp. for the device "21.3 3MP Color LCD Display UMD3-21B01 (MD3-21B01)". The FDA issued a decision of Substantially Equivalent on May 21, 2024. The device falls under product code PGY (Display, Diagnostic Radiology), a Class II device regulated under 21 CFR 892.2050. Acula Technology Corp. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 21, 2024
- Date Received
- September 29, 2023
- 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.