FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ICRCO 3600M
K Number: K122510
·
Decision Apr 26, 2013
Classifications
1
FEI Numbers
40
Registration Numbers
40
Same Product Code
54
Applicant Total
5
Review Days
252
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
- ICRCO 3600M
- K Number
- K122510
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1715
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Icrco, Inc.
- Date Received
- August 17, 2012
- Decision Date
- April 26, 2013
- Product Code
- MUE
- 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 |
|---|---|---|---|
| MUE | Full Field Digital, System, X-Ray, Mammographic | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MUE), ordered by most recent decision date.
MAMMOMAT B.brilliant (11372950)
FDA 510(k)
FDA Class 2
·Radiology
Bellalun 2D (VDMS-1000S)
FDA 510(k)
FDA Class 2
·Radiology
Senographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena Bright
FDA 510(k)
FDA Class 2
·Radiology
HESTIA
FDA 510(k)
FDA Class 2
·Radiology
2430TCA with Xmaru W
FDA 510(k)
FDA Class 2
·Radiology
VIVIX-M
FDA 510(k)
FDA Class 2
·Radiology