DigiX FDX
FDA 510(k) clearance K162529 · decided 2017-03-03
Clearance details
- K-number
- K162529
- Device name
- DigiX FDX
- Applicant
- Allengers Medical Systems Limited
- Decision
- Substantially Equivalent
- Date received
- 2016-09-09
- Decision date
- 2017-03-03
- Days to decision
- 175 days
- Clearance type
- Traditional
- Product code
- KPR
- Device class
- 2
- Regulation number
- 892.1680
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Derabassi, Distt Mohali, IN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.