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

FILMLESS CLINIC

K Number: K031704 · Decision Jul 31, 2003
Classifications
1
FEI Numbers
609
Registration Numbers
609
Same Product Code
2221
Applicant Total
2
Review Days
59

Basic Information

Device Name
FILMLESS CLINIC
K Number
K031704
Device Class
FDA class 2
Clearance Type
Abbreviated
Regulation Number
892.2050
Medical Specialty
Radiology
Decision
Substantially Equivalent
Statement or Summary
Statement
Applicant
CONNECT IMAGING, INC.
Date Received
June 2, 2003
Decision Date
July 31, 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 CONNECT IMAGING, INC.

K Number Device Name
K061972 CONNECT IMAGING PACS