FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇷 Türkiye
General Radiography X-ray System (Model: GR10X 40K), General Radiography X-ray System (Model: GR10X 50K)
K Number: K220149
·
Decision Apr 19, 2022
Classifications
1
FEI Numbers
81
Registration Numbers
81
Same Product Code
355
Applicant Total
1
Review Days
90
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
- General Radiography X-ray System (Model: GR10X 40K), General Radiography X-ray System (Model: GR10X 50K)
- K Number
- K220149
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1680
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Xera Medical Systems & Technology , Ltd.
- Date Received
- January 19, 2022
- Decision Date
- April 19, 2022
- 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