Tube Mount, X-Ray, Diagnostic
Regulation 892.1770
0510(k)s in 12 months (40 all time)
1recalls in 12 months (13 all time)
5recalls that name a 510(k)
Top companies in IYB
| Company | 510(k)s | Recalls |
|---|---|---|
| Fischer Imaging Corp. | 5 | 2 |
| Shimadzu Medical Systems | 4 | 0 |
| Siemens Medical Solutions USA, Inc | 0 | 4 |
| Bennett X-Ray Corp. | 3 | 0 |
| Del Medical Systems Group | 0 | 3 |
| Radkor, Inc. | 3 | 0 |
| Acoma Medical Imaging, Inc. | 2 | 0 |
| General Electric Co. | 2 | 0 |
| Medicor USA , Ltd. | 2 | 0 |
| SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION | 0 | 2 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 13, 2025 | SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION Ceiling Type X-Ray Tube Support Models CH-200 and CH-200M
used with RADspeed, SonialVision and FLUOROspeed Systems
The ceiling type x-ray tube support CH-200 is used to hold the X-ray tube and
collim Open, Classified |
IYB | None listed |
| Jul 31, 2023 | SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION Over-Head Ceiling Tube Support, CH-200, CH-200M, Used with RadSpeed and RadSpeed PRO, Sonial Vision safire, Versa and G4 units, FluoroSpeed 300 and X1 units Open, Classified |
IYB | None listed |
| Jun 29, 2018 | Siemens Medical Solutions USA, Inc 3D V, model. no.
7042042
7042059
3070021
Product Usage:
The ceiling stand is used to hold the X-ray tube and / or the detector and is moveable on a ceiling rail system in three axis. The tube and / Terminated |
IYB | None listed |
| Jun 29, 2018 | Siemens Medical Solutions USA, Inc 3D TOP Ceiling Stand, model no. 3070039
3074486
3070013
3070021
Product Usage:
The ceiling stand is used to hold the X-ray tube and / or the detector and is moveable on a ceiling rail system in three Terminated |
IYB | None listed |
| Dec 1, 2014 | Summit Industries Inc. The J700 Floor Mounted Tube Stand (FMTS) is intended to support and position the diagnostic x-ray tube housing assembly for a medical radiographic procedure. The product consists of a vertical column Terminated |
IYB | K850198 |
| Jun 30, 2009 | Del Medical Systems Group Ceiling Tube Mount Ceiling Tube Mount (CTM)/Digital Ceiling Tube Mount (DCTM) with 5 inch or 10 inch Column Extensions; a radiographic x-ray tube suspension system designed to facilitate a wide range Terminated |
IYB | None listed |
| Jul 6, 2006 | Siemens Medical Solutions USA, Inc 3D-I/III Ceiling Stand. Diagnostic x-ray tube mount Terminated |
IYB | None listed |
| Dec 31, 2005 | Siemens Medical Solutions USA, Inc 3D TOP Ceiling Stand. X-Ray System model number 8773673 Terminated |
IYB | K802200 |
| May 11, 2005 | Del Medical Systems Group Tube Stand for the Dynarad Phantom Mobile X-Ray System; Del Medical Systems, 11550 West King Street, Franklin Park, IL 60131 Terminated |
IYB | None listed |
| May 3, 2005 | Fischer Imaging Corporation VersaRad Generator Terminated |
IYB | K880530 |
| Jul 20, 2004 | Fischer Imaging Corporation VersaRad/Traumex General Radiographic System. Terminated |
IYB | K880530 |
| Jul 20, 2004 | Del Medical Systems Group DCTM Digital Ceiling Tube Mount, model DCTM; a fully counter-balanced radiographic x-ray tube suspension system designed to facilitate a wide range of procedures; Manufactured by Del Medical Imaging C Terminated |
IYB | None listed |
| Jan 8, 2004 | General Electric Med Systems Performix X-ray Tube - Performix ADV, Performix Ultra, Solarix 630. Terminated |
IYB | K013561 K023988 |
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