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

KONICA LI 10 AND 10A LASER IMAGER

K Number: K920769 · Decision May 6, 1992
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
120
Applicant Total
5
Review Days
90

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Basic Information

Device Name
KONICA LI 10 AND 10A LASER IMAGER
K Number
K920769
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
892.2040
Medical Specialty
Radiology
Decision
Substantially Equivalent
Statement or Summary
Statement
Applicant
Konica Corp.
Date Received
February 6, 1992
Decision Date
May 6, 1992
Product Code
LMC
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
LMC Camera, Multi Format, Radiological

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Other Clearances by Konica Corp.

K Number Device Name
K992586 KONICA LASER IMAGER, DRYPRO MODEL 722
K990359 KONICA DIRECT DIGITIZER, MODEL DD-341
K980873 KONICA DIRECT DIGITIZER REGIUS MODEL 330
K920558 KONICA DIRECT DIGITIZER KD-1000