510(k) K253446
K253446 is an FDA 510(k) premarket notification submitted by Dk Medical Systems Co., Ltd. for the device "AeroDR TX c02". The FDA issued a decision of Substantially Equivalent on April 10, 2026. The device falls under product code KPR (System, X-Ray, Stationary), a Class II device regulated under 21 CFR 892.1680. Dk Medical Systems Co., Ltd. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 10, 2026
- Date Received
- October 2, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, X-Ray, Stationary
- Device Class
- Class II
- Regulation Number
- 892.1680
- Review Panel
- RA
- Submission Type