FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Bladder Scanner, Model Name:M5
K Number: K213488
·
Decision Jul 1, 2022
Classifications
1
FEI Numbers
345
Registration Numbers
346
Same Product Code
883
Applicant Total
1
Review Days
242
Basic Information
- Device Name
- Bladder Scanner, Model Name:M5
- K Number
- K213488
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1560
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Suzhou Peaksonic Medical Technology Co., Ltd.
- Date Received
- November 1, 2021
- Decision Date
- July 1, 2022
- Product Code
- IYO
- 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 |
|---|---|---|---|
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (IYO), ordered by most recent decision date.
B-Scan
FDA 510(k)
FDA Class 2
·Radiology
Velacur One (LI-1100)
FDA 510(k)
FDA Class 2
·Radiology
Accuro 3S
FDA 510(k)
FDA Class 2
·Radiology
EchoGuide (Version 1)
FDA 510(k)
FDA Class 2
·Radiology
Portable Liver Elastography Ultrasound Diagnostic System (Liverscan C)
FDA 510(k)
FDA Class 2
·Radiology
SpineUs System
FDA 510(k)
FDA Class 2
·Radiology