Product code ITY
- Device name
- Assembly, Tube Housing, X-Ray, Diagnostic
- Medical specialty
- Radiology
- Device class
- 1
- Regulation number
- 892.1760
- Review panel
- RA
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K000052 | X-RAY MONOBLOCK, MONOBLOCK XRS-60-330 | Dynarad Corp. | 2000-02-10 |
| K933162 | MRX-750 | Mrx Corp. | 1993-10-07 |
| K923094 | MOLYBDENUM | Southeastern Medical Diagnostics, Inc. | 1993-03-04 |
| K923141 | PHILIPS PRE-FILTER OPTION | Philips Medical Systems, Inc. | 1993-01-21 |
| K921129 | MRX-700 | Mrx-Ray Tube Corp. | 1992-10-05 |
| K921130 | MRX-865 | Mrx-Ray Tube Corp. | 1992-09-10 |
| K921316 | MG-1001 TUBE HOUSING ASSEMBLY | Magma Corp. | 1992-06-22 |
| K920731 | X-RAY TUBE ASSEMBLY CIRCLEX1.2UG | Shimadzu Medical Systems | 1992-05-29 |
| K920724 | HIGH SPEED ROTATION STARTER SA-50 | Shimadzu Medical Systems | 1992-04-27 |
| K920723 | HIGH SPEED ROTATION STARTER SA-40 | Shimadzu Medical Systems | 1992-04-27 |
| K920387 | CIRCLEXO.3T X-RAY TUBE ASSEMBLY | Shimadzu Medical Systems | 1992-04-14 |
| K913987 | OR340 INTRAOPERATIVE ULTRASOUND BIOPSY NEEDLE GUID | Codman & Shurtleff, Inc. | 1992-04-13 |
| K913301 | MCS 50MO X-RAY TUBE INSERT/MXS 50MO TUBE HOU ASSEM | Comet North America, Inc. | 1991-08-28 |
| K912338 | TUBE HOUSING ASSEMBLIES | Comet Ltd. C/O Radiology Resources, Inc. | 1991-08-07 |
| K911695 | VARIOUS X-RAY TUBES | Comet Ltd. C/O Radiology Resources, Inc. | 1991-06-19 |
| K910308 | X-RAY TUBE HOUSING ASSEMBLY POLARIX II GEN/XO 110 | Inmark Corp. | 1991-03-27 |
| K910842 | DI2000/HS-45-150 X-RAY TUBE INSERT | Comet Ltd. C/O Radiology Resources, Inc. | 1991-03-06 |
| K910276 | X-RAY TUBE HOUSING ASSEMBLY SOREDEX DC/CIR 51 | Inmark Corp. | 1991-03-06 |
| K904182 | R-800-SF | Advantech | 1990-11-13 |
| K900367 | HOFMANN-NAGEL (HOFNA) X-RAY TUBES | Hofmann | 1990-02-26 |
| K894742 | RELOADING OF X-RAY TUBE HOUSING ASSEM., VARIOUS | Inmark Corp. | 1989-10-27 |
| K894413 | X-RAY TUBE HOUSING ASSEMBLY, VARIOUS MODELS | Inmark Corp. | 1989-09-22 |
| K882939 | NIOBI-X RADIATION REDUCTION FILTER | American Canadian Products, Inc. | 1988-11-04 |
| K882323 | MEICOR X-RAY TUBE, MODELS MC1000, MC1500, MC2000 | Meicor, Inc. | 1988-06-30 |
| K873314 | TOSHIBA, SMIT ROENTGEN | Inland Tube Corp. | 1987-11-02 |
| K871227 | LES RAD FILTER | M. D. Products | 1987-06-29 |
| K870071 | TOSHIBA, SMIT ROENTGEN | North American Imaging, Inc. | 1987-01-21 |
| K864042 | MAMMOGRAPHIC MODEL CXR 51 MO-6'/0.6 SH | Absolute X-Ray Corp. | 1986-10-27 |
| K860760 | ERBIUM X-RAY FILTER | Reactor Experiments, Inc. | 1986-06-10 |
| K860504 | 36-101 XDS111 XENON DELIVERY/TRAP SYSTEM | Victoreen, Inc. | 1986-04-04 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 16973915530430 | Mingwei | MingWei Medical Technology(Suzhou)Co.,LTD | 2026-01-16 |
| 10850012223167 | Chronos Imaging LLC | CHRONOS IMAGING LLC | 2025-12-29 |
| 00198953042748 | LOGIQ | GE Medical Systems, Ultrasound & Primary Care Diagnostics LLC | 2025-12-05 |
| 08059307491594 | RTM 780 HS | I.A.E. INDUSTRIA APPLICAZIONI ELETTRONICHE SPA | 2025-11-14 |
| 08059307491563 | RTM 77 HS | I.A.E. INDUSTRIA APPLICAZIONI ELETTRONICHE SPA | 2025-11-14 |
| 10850012223136 | Chronos Imaging LLC | CHRONOS IMAGING LLC | 2025-10-31 |
| 00195278723963 | NA | GE Healthcare Japan Corporation | 2025-10-15 |
| 06971564631563 | RADII | Hangzhou Kailong Medical Instruments Co.,Ltd. | 2025-08-30 |
| 06971564630214 | RADII | Hangzhou Kailong Medical Instruments Co.,Ltd. | 2025-08-11 |
| 06971564630160 | RADII | Hangzhou Kailong Medical Instruments Co.,Ltd. | 2025-08-11 |
| 06971564630153 | RADII | Hangzhou Kailong Medical Instruments Co.,Ltd. | 2025-08-11 |
| 00884838127517 | CT XS Tube CPO | Philips Medical Systems DMC GmbH | 2025-07-31 |
| 04580274412397 | Rotating Anode X-ray Tube Assembly | CANON ELECTRON TUBES & DEVICES CO. LTD. | 2025-06-16 |
| 04580274412328 | Rotating Anode X-ray Tube Assembly | CANON ELECTRON TUBES & DEVICES CO. LTD. | 2023-01-26 |
| G252430017660 | Richardson Electronics | Richardson Electronics, Ltd. | 2023-01-11 |
| 06975490630386 | S Spellman High Voltage Electronics Corporation | Spellman High Voltage Electronics(Suzhou Industrial Park) Co., Ltd | 2022-12-08 |
| 06975490630379 | S Spellman High Voltage Electronics Corporation | Spellman High Voltage Electronics(Suzhou Industrial Park) Co., Ltd | 2022-12-08 |
| 00884838113732 | CT8000 | Philips Medical Systems DMC GmbH | 2022-12-08 |
| 00854344007559 | Varex Imaging | VAREX IMAGING CORPORATION | 2021-09-01 |
| 00854344007542 | Varex Imaging | VAREX IMAGING CORPORATION | 2021-09-01 |
| 04580274412311 | Rotating Anode X-ray Tube Assembly | CANON ELECTRON TUBES & DEVICES CO. LTD. | 2021-04-20 |
| 08059307491358 | C30 | I.A.E. INDUSTRIA APPLICAZIONI ELETTRONICHE SPA | 2020-08-24 |
| 04540217061884 | 0.6/1.2P324DK-85 | SHIMADZU CORPORATION | 2020-02-21 |
| 04540217061891 | 0.6/1.2P324DK-85 | SHIMADZU CORPORATION | 2020-02-21 |
| 04540217060788 | 0.7/1.2JG326 D-265 | SHIMADZU CORPORATION | 2019-07-23 |
| 04540217060825 | 0.4/0.7JG326 D-265 | SHIMADZU CORPORATION | 2019-07-23 |
| 04540217061426 | 0.7/1.2JG326 D-265 | SHIMADZU CORPORATION | 2019-07-23 |
| 06971564630603 | RADII | Hangzhou Kailong Medical Instruments Co.,Ltd. | 2018-04-18 |
| 00840682122603 | not applicable | GE MEDICAL SYSTEMS | 2017-09-13 |
| 00840682118460 | Senographe Pristina | GE MEDICAL SYSTEMS | 2016-11-16 |