Holder, Radiographic Cassette, Wall-mounted

Device Code: 5317

Product Code(s): IXY

Device Classification Information

Device Type ID5317
Device NameHolder, Radiographic Cassette, Wall-mounted
Regulation DescriptionWall-mounted Radiographic Cassette Holder.
Regulation Medical SpecialtyRadiology
Review PanelRadiology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(K) Exempt
CFR Regulation Number892.1880 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeIXY
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID5317
DeviceHolder, Radiographic Cassette, Wall-mounted
Product CodeIXY
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionWall-mounted Radiographic Cassette Holder.
CFR Regulation Number892.1880 [🔎]
Device Problems
Material Torqued
1
Total Device Problems 1
Recalls
Manufacturer Recall Class Date Posted
1
Claymount Assembli
II Jun-30-2014
2
Claymount Assembli
II Jun-30-2014
3
Del Medical, Inc.
II Feb-05-2016
4
Konica Minolta Healthcare, Americas, Inc.
II Dec-21-2018
TPLC Last Update: 2019-04-02 21:04:13

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