510(k) DEN170022
DEN170022 is an FDA 510(k) premarket notification submitted by Quantitative Insights, Inc. for the device "QuantX". The FDA issued a decision of De Novo granted on Jul 19, 2017. 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. Quantitative Insights, Inc. has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- DENG (De Novo granted)
- Decision Date
- Jul 19, 2017
- Date Received
- Apr 7, 2017
- Clearance Type
- Direct
- 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
- 510(k)
Assist users in characterizing lesions identified on acquired medical images