FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Venue 50
K Number: K152758
·
Decision Nov 18, 2015
Classifications
1
FEI Numbers
211
Registration Numbers
211
Same Product Code
1117
Applicant Total
4
Review Days
55
Basic Information
- Device Name
- Venue 50
- K Number
- K152758
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1550
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIAGNOSTICS
- Date Received
- September 24, 2015
- Decision Date
- November 18, 2015
- 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