510(k) DEN170022
- Device
- QuantX
- Applicant
- Quantitative Insights, Inc.
- 510(k) number
- DEN170022
- Product code
- POK
- Decision
- Unknown (DENG)
- Decision date
- 2017-07-19
- Date received
- 2017-04-07
- Regulation
- 892.2060
- Classification name
- Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Robert Tomek
- Address
- 1452 E 53rd St. Chicago IL US 60615 60615
FDA Registration Numbers#
- 3017604664
- 3040335643
- 3007301305
- 3022983474
- 3033588305
- 3034527804
- 3016585383
- 3010119782
- 3044622018
- 3017210169
- 3029937167
- 3015478020
- 3011205675
- 3032008018
Source Documents#
510(k) summary PDF not indicated by FDA
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