FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IMACOR ZURA EVO IMAGING SYSTEM
K Number: K142054
·
Decision Sep 29, 2014
Classifications
1
FEI Numbers
348
Registration Numbers
349
Same Product Code
892
Applicant Total
3
Review Days
62
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
- IMACOR ZURA EVO IMAGING SYSTEM
- K Number
- K142054
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1560
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Imacor, Inc.
- Date Received
- July 29, 2014
- Decision Date
- September 29, 2014
- 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.
ARTHUR
FDA 510(k)
FDA Class 2
·Radiology
EdgeFlow UW20
FDA 510(k)
FDA Class 2
·Radiology
Accuro XV
FDA 510(k)
FDA Class 2
·Radiology
QT Scanner 2000 Model A
FDA 510(k)
FDA Class 2
·Radiology
IntraSight Plus
FDA 510(k)
FDA Class 2
·Radiology
Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro)
FDA 510(k)
FDA Class 2
·Radiology