FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

LIAC

K Number: K110840 · Decision Apr 17, 2012
Classifications
1
FEI Numbers
114
Registration Numbers
114
Same Product Code
733
Applicant Total
1
Review Days
389

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
LIAC
K Number
K110840
Device Class
FDA class 2
Clearance Type
Abbreviated
Regulation Number
892.5050
Medical Specialty
Radiology
Decision
Substantially Equivalent
Statement or Summary
Statement
Applicant
Sordina S.P.A.
Date Received
March 25, 2011
Decision Date
April 17, 2012
Product Code
IYE
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
IYE Accelerator, Linear, Medical

Similar 510(k) Clearances

Other 510(k) clearances with the same product code (IYE), ordered by most recent decision date.

View all