Device Type ID | 5317 |
Device Name | Holder, Radiographic Cassette, Wall-mounted |
Regulation Description | Wall-mounted Radiographic Cassette Holder. |
Regulation Medical Specialty | Radiology |
Review Panel | Radiology |
Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
Submission Type | 510(K) Exempt |
CFR Regulation Number | 892.1880 [🔎] |
FDA Device Classification | Class 1 Medical Device |
Product Code | IXY |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 5317 |
Device | Holder, Radiographic Cassette, Wall-mounted |
Product Code | IXY |
FDA Device Classification | Class 1 Medical Device |
Regulation Description | Wall-mounted Radiographic Cassette Holder. |
CFR Regulation Number | 892.1880 [🔎] |
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 |