510(k) K231353
K231353 is an FDA 510(k) premarket notification submitted by ArteryFlow Technology Co., Ltd. for the device "AccuCTP Pro". The FDA issued a decision of Substantially Equivalent on September 14, 2023. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. ArteryFlow Technology Co., Ltd. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 14, 2023
- Date Received
- May 10, 2023
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Image Processing, Radiological
- Device Class
- Class II
- Regulation Number
- 892.2050
- Review Panel
- RA
- Submission Type