Assembly, Tube Housing, X-Ray, Diagnostic
FDA product code ITY · Class I (low risk) · 21 CFR 892.1760 · Radiology
40510(k) clearances
0PMA approvals
0recalls
Manufacturers
- Shimadzu Medical Systems 4
- Inmark Corp. 4
- X-Ray Tube Corp. 3
- Comet Ltd. C/O Radiology Resources, Inc. 3
- Siemens Corp. 2
- General Electric Co. 2
- Mrx-Ray Tube Corp. 2
- M. D. Products 1
- Dynarad Corp. 1
- Advantech 1
- Hofmann 1
- American Canadian Products, Inc. 1
- Meicor, Inc. 1
- Inland Tube Corp. 1
- Eureka X-Ray Tube Corp. 1
- North American Imaging, Inc. 1
- Absolute X-Ray Corp. 1
- Reactor Experiments, Inc. 1
- Victoreen, Inc. 1
- Cgr Medical Corp. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K000052 | X-Ray Monoblock, Monoblock XRS-60-330ITY · Traditional | Dynarad Corp. | 02/10/2000SE |
| K933162 | MRX-750ITY · Traditional | Mrx Corp. | 10/07/1993SE |
| K923094 | MolybdenumITY · Traditional | Southeastern Medical Diagnostics, Inc. | 03/04/1993SE |
| K923141 | Philips Pre-Filter OptionITY · Traditional | Philips Medical Systems, Inc. | 01/21/1993SE |
| K921129 | MRX-700ITY · Traditional | Mrx-Ray Tube Corp. | 10/05/1992SE |
| K921130 | MRX-865ITY · Traditional | Mrx-Ray Tube Corp. | 09/10/1992SE |
| K921316 | MG-1001 Tube Housing AssemblyITY · Traditional | Magma Corp. | 06/22/1992SE |
| K920731 | X-Ray Tube Assembly CIRCLEX1.2UGITY · Traditional | Shimadzu Medical Systems | 05/29/1992SE |
| K920724 | High Speed Rotation Starter SA-50ITY · Traditional | Shimadzu Medical Systems | 04/27/1992SE |
| K920723 | High Speed Rotation Starter SA-40ITY · Traditional | Shimadzu Medical Systems | 04/27/1992SE |
| K920387 | CIRCLEXO.3T X-Ray Tube AssemblyITY · Traditional | Shimadzu Medical Systems | 04/14/1992SE |
| K913987 | OR340 Intraoperative Ultrasound Biopsy Needle GuidITY · Traditional | Codman & Shurtleff, Inc. | 04/13/1992SE |
| K913301 | MCS 50MO X-Ray Tube Insert/Mxs 50MO Tube Hou AssemITY · Traditional | Comet North America, Inc. | 08/28/1991SE |
| K912338 | Tube Housing AssembliesITY · Traditional | Comet Ltd. C/O Radiology Resources, Inc. | 08/07/1991SE |
| K911695 | Various X-Ray TubesITY · Traditional | Comet Ltd. C/O Radiology Resources, Inc. | 06/19/1991SE |
| K910308 | X-Ray Tube Housing Assembly Polarix II Gen/Xo 110ITY · Traditional | Inmark Corp. | 03/27/1991SE |
| K910842 | DI2000/HS-45-150 X-Ray Tube InsertITY · Traditional | Comet Ltd. C/O Radiology Resources, Inc. | 03/06/1991SE |
| K910276 | X-Ray Tube Housing Assembly Soredex Dc/Cir 51ITY · Traditional | Inmark Corp. | 03/06/1991SE |
| K904182 | R-800-SFITY · Traditional | Advantech | 11/13/1990SE |
| K900367 | Hofmann-Nagel (Hofna) X-Ray TubesITY · Traditional | Hofmann | 02/26/1990SE |
| K894742 | Reloading of X-Ray Tube Housing Assem., VariousITY · Traditional | Inmark Corp. | 10/27/1989SE |
| K894413 | X-Ray Tube Housing Assembly, Various ModelsITY · Traditional | Inmark Corp. | 09/22/1989SE |
| K882939 | Niobi-X Radiation Reduction FilterITY · Traditional | American Canadian Products, Inc. | 11/04/1988SE |
| K882323 | Meicor X-Ray Tube, Models MC1000, MC1500, MC2000ITY · Traditional | Meicor, Inc. | 06/30/1988SE |
| K873314 | Toshiba, Smit RoentgenITY · Traditional | Inland Tube Corp. | 11/02/1987SE |
| K871227 | Les Rad FilterITY · Traditional | M. D. Products | 06/29/1987SE |
| K870071 | Toshiba, Smit RoentgenITY · Traditional | North American Imaging, Inc. | 01/21/1987SE |
| K864042 | Mammographic Model CXR 51 MO-6'/0.6 SHITY · Traditional | Absolute X-Ray Corp. | 10/27/1986SE |
| K860760 | Erbium X-Ray FilterITY · Traditional | Reactor Experiments, Inc. | 06/10/1986SE |
| K860504 | 36-101 XDS111 Xenon Delivery/Trap SystemITY · Traditional | Victoreen, Inc. | 04/04/1986SE |
| K840135 | CrisaITY · Traditional | X-Ray Tube Corp. | 03/23/1984SE |
| K834306 | Phasix-High Frequency GeneratorITY · Traditional | Cgr Medical Corp. | 12/29/1983SE |
| K833847 | CrisaITY · Traditional | X-Ray Tube Corp. | 12/12/1983SE |
| K833238 | CrisaITY · Traditional | X-Ray Tube Corp. | 10/28/1983SE |
| K812915 | MX 125ITY · Traditional | General Electric Co. | 11/24/1981SE |
| K810190 | Opti 110/12/50HSGITY · Traditional | Siemens Corp. | 03/02/1981SE |
| K781524 | Maxiray 125 Tube UnitITY · Traditional | General Electric Co. | 10/17/1978SE |
| K781540 | Opti 110/12/50 HSGITY · Traditional | Siemens Corp. | 09/14/1978SE |
| K770336 | X-Ray Tube, Rotating AnodeITY · Traditional | Litton Medical Systems | 03/01/1977SE |
| K760604 | Eureka X-Scan 150 X-Ray Tube Housing As.ITY · Traditional | Eureka X-Ray Tube Corp. | 09/13/1976SE |