FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
X-CUBE 70
K Number: K211299
·
Decision Aug 9, 2021
Classifications
1
FEI Numbers
211
Registration Numbers
211
Same Product Code
1117
Applicant Total
12
Review Days
103
Basic Information
- Device Name
- X-CUBE 70
- K Number
- K211299
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1550
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Alpinion Medical Systems Co., Ltd.
- Date Received
- April 28, 2021
- Decision Date
- August 9, 2021
- Product Code
- IYN
- 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 |
|---|---|---|---|
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (IYN), ordered by most recent decision date.
Sonosite LX Ultrasound System
FDA 510(k)
FDA Class 2
·Radiology
Vivid Pioneer
FDA 510(k)
FDA Class 2
·Radiology
EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems
FDA 510(k)
FDA Class 2
·Radiology
6600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70)
FDA 510(k)
FDA Class 2
·Radiology
TE Air Diagnostic Ultrasound System
FDA 510(k)
FDA Class 2
·Radiology
Voluson Performance 16; Voluson Performance 18
FDA 510(k)
FDA Class 2
·Radiology
Other Clearances by Alpinion Medical Systems Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K223564 | X-CUBE 50, X-CUBE 60 | Apr 17, 2023 | Substantially Equivalent |
| K221093 | X-CUBE 70, X-CUBE 90 | Oct 14, 2022 | Substantially Equivalent |
| K220857 | X-CUBE 50, X-CUBE 60 | Oct 13, 2022 | Substantially Equivalent |
| K213523 | X-CUBE i8, X-CUBE i9 | Jan 28, 2022 | Substantially Equivalent |
| K211300 | X-CUBE 90 | Aug 9, 2021 | Substantially Equivalent |
| K200449 | X-Cube 90 | Jul 10, 2020 | Substantially Equivalent |
| K200450 | X-Cube 70 | Jul 10, 2020 | Substantially Equivalent |
| K182594 | E-CUBE i7 | Jan 24, 2019 | Substantially Equivalent |
| K182845 | minisono | Dec 27, 2018 | Substantially Equivalent |
| K181617 | E-CUBE 8 | Oct 11, 2018 | Substantially Equivalent |