510(k) K253861
K253861 is an FDA 510(k) premarket notification submitted by Corify Care S.L for the device "ACORYS MAPPING SYSTEM". The FDA issued a decision of Substantially Equivalent on April 13, 2026. The device falls under product code DQK (Computer, Diagnostic, Programmable), a Class II device regulated under 21 CFR 870.1425.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 13, 2026
- Date Received
- December 3, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Computer, Diagnostic, Programmable
- Device Class
- Class II
- Regulation Number
- 870.1425
- Review Panel
- CV
- Submission Type