FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Discovery XR656 HD
K Number: K172869
·
Decision Oct 20, 2017
Classifications
1
FEI Numbers
81
Registration Numbers
81
Same Product Code
355
Applicant Total
12
Review Days
30
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Discovery XR656 HD
- K Number
- K172869
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 892.1680
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ge Hualun Medical Systems Co. , Ltd.
- Date Received
- September 20, 2017
- Decision Date
- October 20, 2017
- Product Code
- KPR
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KPR | System, X-Ray, Stationary | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KPR), ordered by most recent decision date.
DRE Duo
FDA 510(k)
FDA Class 2
·Radiology
AeroDR TX c02
FDA 510(k)
FDA Class 2
·Radiology
DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector, Lux HD 43 detector
FDA 510(k)
FDA Class 2
·Radiology
uDR Arria & uDR Aris
FDA 510(k)
FDA Class 2
·Radiology
uDR Aurora CX
FDA 510(k)
FDA Class 2
·Radiology
Definium Tempo Select
FDA 510(k)
FDA Class 2
·Radiology
Other Clearances by Ge Hualun Medical Systems Co. , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K253269 | OEC One CFD | Nov 26, 2025 | Substantially Equivalent |
| K250788 | Definium Tempo Select | Aug 28, 2025 | Substantially Equivalent |
| K240828 | OEC One ASD | Dec 27, 2024 | Substantially Equivalent |
| K242678 | Definium Pace Select ET | Oct 1, 2024 | Substantially Equivalent |
| K231892 | Definium Pace Select | Sep 12, 2023 | Substantially Equivalent |
| K191699 | Discovery XR656 HD with VolumeRad | Jul 24, 2019 | Substantially Equivalent |
| K182626 | OEC One | Nov 16, 2018 | Substantially Equivalent |
| K173612 | Optima XR646 HD | Dec 11, 2017 | Substantially Equivalent |
| K172700 | OEC One | Nov 9, 2017 | Substantially Equivalent |
| K171800 | OEC Elite MiniView | Jul 12, 2017 | Substantially Equivalent |