HYPER DLR
FDA 510(k) clearance K193210 · decided 2020-08-04
Clearance details
- K-number
- K193210
- Device name
- HYPER DLR
- Applicant
- Shanghai United Imaging Healthcare Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2019-11-21
- Decision date
- 2020-08-04
- Days to decision
- 257 days
- Clearance type
- Traditional
- Product code
- KPS
- Device class
- 2
- Regulation number
- 892.1200
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Shanghai, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.