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

SHIMADZU CEILING TUBE SUPPORT CH-30GH

K Number: K990715 · Decision Apr 16, 1999
Classifications
1
FEI Numbers
81
Registration Numbers
81
Same Product Code
355
Applicant Total
49
Review Days
43

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Basic Information

Device Name
SHIMADZU CEILING TUBE SUPPORT CH-30GH
K Number
K990715
Device Class
FDA class 2
Clearance Type
Abbreviated
Regulation Number
892.1680
Medical Specialty
Radiology
Decision
Substantially Equivalent
Statement or Summary
Statement
Applicant
Shimadzu Corp.
Date Received
March 4, 1999
Decision Date
April 16, 1999
Product Code
KPR
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
KPR System, X-Ray, Stationary

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K Number Device Name
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K101036 SHIMADZU COLLIMATOR R-20J
K090578 SHIMADZU COLLIMATOR R-30H
K090268 SHIMADZU MOBILE X-RAY SYSTEM MOBILE ART EVOLUTION
K080701 SHIMADZU MOBILE X-RAY SYSTEM MOBILEDART EVOLUTION
K072006 DAR-9400F
K071717 GE OEC ALTITUDE
K062360 BRANSIST SAFIRE
Search all 49 clearances from Shimadzu Corp. →