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

INTEGRADWEB BY DYNAMIC IMAGING, INC.

K Number: K031311 · Decision Jun 20, 2003
Classifications
1
FEI Numbers
609
Registration Numbers
609
Same Product Code
2221
Applicant Total
2
Review Days
57

Basic Information

Device Name
INTEGRADWEB BY DYNAMIC IMAGING, INC.
K Number
K031311
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
892.2050
Medical Specialty
Radiology
Decision
Substantially Equivalent
Statement or Summary
Summary
Applicant
DYNAMIC IMAGING INC.
Date Received
April 24, 2003
Decision Date
June 20, 2003
Product Code
LLZ
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
LLZ System, Image Processing, Radiological

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Other Clearances by DYNAMIC IMAGING INC.

K Number Device Name
K042313 INTEGRADWEB MPR/MIP