510(k) K241499
K241499 is an FDA 510(k) premarket notification submitted by Acula Technology Corp. for the device "21.3 5MP Color LCD Display UMD5-21B01". The FDA issued a decision of Substantially Equivalent on June 13, 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
- June 13, 2024
- Date Received
- May 28, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
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.