Product code IYB
- Device name
- Tube Mount, X-Ray, Diagnostic
- Medical specialty
- Radiology
- Device class
- 1
- Regulation number
- 892.1770
- 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 |
|---|---|---|---|
| K935123 | SUPERSTAND 300 | Wuestec Medical, Inc. | 1996-03-27 |
| K946261 | MTS-007, STS-008, SSMTS-010, EURO-40, 72, SUPER EURO 4072, 5000 | Scott Imaging Intl., Inc. | 1995-02-15 |
| K941017 | F/C/W TUBESTAND | Acoma Medical Imaging, Inc. | 1994-07-29 |
| K941004 | CTS SYSTEM | Acoma Medical Imaging, Inc. | 1994-07-29 |
| K940442 | MPR-814 | Xri, Inc. | 1994-06-09 |
| K935004 | MODEL ALPHA TS-2 | Dpa Consulting, Inc. | 1993-12-13 |
| K933253 | SUPERSTAND 3000 | Wuestec Medical, Inc. | 1993-08-16 |
| K925716 | BENNETT OVERHEAD TUBE CRANE MODEL NO. B-OTC | Bennett X-Ray Corp. | 1992-12-17 |
| K925170 | SHIMADZU X-RAY TUBE STAND BH-100 SERIES | Shimadzu Medical Systems | 1992-12-07 |
| K920727 | CEILING TUBE SUPPORT CH-30X | Shimadzu Medical Systems | 1992-04-16 |
| K914944 | BENNETT OVERHEAD TUBE CRANE MODEL NO. B-OTC | Bennett X-Ray Corp. | 1991-12-02 |
| K914348 | ER-1000 CATHERIZATION C-ARM SYSTEMS | Shimadzu Medical Systems | 1991-11-01 |
| K911563 | INVENTOR RT/EXPLORER TRAUMA UNIT | Continental X-Ray Corp. | 1991-10-23 |
| K912696 | TRAUMA VIEW RAD SYST MODEL #B-TRV/STRET MOBIL TABL | Bennett X-Ray Corp. | 1991-09-16 |
| K900234 | PFM-90 CEILING TUBE SUPPORT | Fischer Imaging Corp. | 1990-02-26 |
| K895188 | SHIMADZU X-RAY TUBE STAND FH-31 | Shimadzu Medical Systems | 1989-09-22 |
| K893653 | RADIOGRAPHIC CEILING TUBE SUPPORT CTS15 | Fischer Imaging Corp. | 1989-06-23 |
| K893652 | RADIOGRAPHIC FLOOR MOUNTED TUBESTAND FM 60 | Fischer Imaging Corp. | 1989-06-23 |
| K883664 | LUM VASCULAR PROCEDURE SYSTEM #B5200A | General Electric Co. | 1988-11-07 |
| K883864 | RADKOR SFR-70 | Radkor, Inc. | 1988-10-19 |
| K881701 | RADKOR SFC-21 | Radkor, Inc. | 1988-09-08 |
| K882563 | RADKOR, CST-18 | Radkor, Inc. | 1988-07-08 |
| K880530 | CEILING MOUNTED RADIOGRAPHIC SYSTEM TRAUMEX | Fischer Imaging Corp. | 1988-03-03 |
| K880528 | OVERHEAD TUBE MOUNT CASCADE II | Fischer Imaging Corp. | 1988-02-29 |
| K873283 | MODEL C2-5000 OVERHEAD TUBE SUPPORT | Transworld X-Ray Corp. | 1987-09-10 |
| K870856 | COSMOS | Pausch Corp. | 1987-03-30 |
| K862827 | FCW TUBE STAND | Garrels X-Ray Products, Inc. | 1986-08-01 |
| K862734 | CEILSTAND, MULTISTAND R & S AND THE BUCKYSTAND | D&R X-Ray Products, Inc. | 1986-08-01 |
| K861995 | MODEL RS-3 RADIOGRAPHIC STAND | Medicor USA , Ltd. | 1986-06-19 |
| K852952 | TRAUMA STAND | Xre Corp. | 1985-09-26 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08809832900302 | SST-4100S | SHINYOUNG FOR M CO.,LTD. | 2026-05-27 |
| 00198953054949 | NA | GE Hualun Medical Systems Co., Ltd | 2025-09-30 |
| 00195278901880 | NA | GE Hualun Medical Systems Co., Ltd | 2025-06-09 |
| 00860008892768 | Foot and Ankle Stand | OXOS Medical, Inc. | 2025-06-02 |
| 08800011103088 | DRGEM | DRGEM Corporation | 2024-10-24 |
| 08800011103170 | DRGEM | DRGEM Corporation | 2024-10-24 |
| 08800011103163 | DRGEM | DRGEM Corporation | 2024-10-24 |
| 08800011103132 | DRGEM | DRGEM Corporation | 2024-10-24 |
| 08800011103125 | DRGEM | DRGEM Corporation | 2024-10-24 |
| 08800011103095 | DRGEM | DRGEM Corporation | 2024-10-24 |
| 08809832900258 | SD-3100 | SHINYOUNG FOR M CO.,LTD. | 2024-04-04 |
| B884SVMS4000 | VMS 400 | Pausch, L.L.C. | 2024-02-16 |
| 08809832900234 | SS-2100 | SHINYOUNG FOR M CO.,LTD. | 2023-11-20 |
| 08809832900074 | LSS-2000 | SHINYOUNG FOR M CO.,LTD. | 2023-11-20 |
| 08809832900098 | SST-3100 | SHINYOUNG FOR M CO.,LTD. | 2023-11-20 |
| 08809832900104 | SST-3001 | SHINYOUNG FOR M CO.,LTD. | 2023-11-20 |
| 08809832900227 | SS-2100 | SHINYOUNG FOR M CO.,LTD. | 2023-11-20 |
| 05999116100269 | F100 TS99N TUBE MOUNT | CONTROL-X Medical Kereskedelmi és Szolgáltató Zártkörűen Működő Részvénytársaság | 2023-08-15 |
| D678A63890 | Provecta HD Single Post Mounting Plate | AIR TECHNIQUES, INC. | 2023-07-11 |
| D678A63410 | "Provecta HD 16"" Center to Center Wall Mounting Plate" | AIR TECHNIQUES, INC. | 2023-07-11 |
| D678A63301 | Provecta HD 16" Center to Center Wall Mounting Plate | AIR TECHNIQUES, INC. | 2023-07-11 |
| D678A63361 | Provecta HD Single Post Mounting Plate | AIR TECHNIQUES, INC. | 2023-07-11 |
| B884S10000110R0 | Paxis 100 Auto | Pausch, L.L.C. | 2023-05-12 |
| B884S10000110L0 | Paxis 100 Auto | Pausch, L.L.C. | 2023-05-03 |
| S10000110R0 | Paxis 100 Auto | Pausch, L.L.C. | 2023-05-03 |
| B884S100002000 | Paxis 200 | Pausch, L.L.C. | 2022-12-23 |
| B884S04201000R0 | Cirrus | Pausch, L.L.C. | 2022-12-23 |
| B884S04201000L0 | Cirrus | Pausch, L.L.C. | 2022-12-23 |
| 04260491620064 | N/A | Pausch Medical GmbH | 2017-06-08 |
| 08714729841852 | Localization Generator Mount | BOSTON SCIENTIFIC CORPORATION | 2017-02-22 |