510(k) K241245
K241245 is an FDA 510(k) premarket notification submitted by Echo IQ, Ltd. for the device "EchoSolv AS". The FDA issued a decision of Substantially Equivalent on October 4, 2024. The device falls under product code POK (Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer), a Class II device regulated under 21 CFR 892.2060.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 4, 2024
- Date Received
- May 3, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
- Device Class
- Class II
- Regulation Number
- 892.2060
- Review Panel
- RA
- Submission Type
Assist users in characterizing lesions identified on acquired medical images