Hydradjust IV Urological Table
FDA 510(k) K943581 · Mallinckrodt Group, Inc.
510(k) numberK943581
Submission
- Device name
- Hydradjust IV Urological Table
- Applicant
- Mallinckrodt Group, Inc.
Cincinnati, OH, US - Received
- July 22, 1994
- Decision date
- January 4, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Other 510(k)s with product code IXR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K000412 | Vision R/F Tilting TableIXR · Traditional | Villa Sistemi Medicali S.P.A. | 04/24/2000SE |
| K973039 | Legacy/Legacy-D TableIXR · Traditional | GE Medical Systems | 10/16/1997SE |
| K971128 | CAP-35B Iii/Cine 275IXR · Traditional | Jamieson Film Co. | 04/28/1997SE |
| K970640 | Philips Easy DiagnostIXR · Traditional | Philips Medical Systems North America, Inc. | 03/21/1997SE |
| K965105 | Electrophysiology Tilt Table Model #9660IXR · Traditional | U.S. Imaging Tables, Inc. | 01/30/1997SE |
| K965096 | Fluoroview Series Fluoroscopic TablesIXR · Traditional | U.S. Imaging Tables, Inc. | 01/27/1997SE |
| K963851 | Tilting Radiographic Table (Remote)IXR · Traditional | Acoma Medical Imaging, Inc. | 01/23/1997SE |
| K961022 | Tangent Vi TableIXR · Traditional | Fischer Imaging Corp. | 05/03/1996SE |
| K954356 | Compax 90/15EIXR · Traditional | General Electric Co. | 10/07/1995SE |
| K953557 | Surgical C-Arm Table, 9610IXR · Traditional | U.S. Imaging Tables, Inc. | 09/26/1995SE |
More from U.S. Imaging Tables, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K945053 | LF CT Hig Pressure CathetersFOZ · Traditional | 05/19/1995SE |
| K945140 | Uro-FloLJH · Traditional | 03/08/1995SE |
| K943122 | Surgical DrapesKKX · Traditional | 09/07/1994SE |
| K934664 | HydragownFYA · Traditional | 05/24/1994SE |
| K920742 | Hydrajust IV Urological TableIXR · Traditional | 04/27/1992SE |
| K912944 | CT 8000 Digital Injection SystemDXT · Traditional | 02/04/1992SE |
| K913264 | Hydraview 1000 Digital Image Process/Stor DeviceLLZ · Traditional | 11/01/1991SE |
| K905789 | Franklin 9000 Wall StandKPX · Traditional | 05/20/1991SE |
| K904147 | Hugh Young II Urological X-Ray SystemKPR · Traditional | 12/13/1990SE |
| K904146 | Neuro Vision Radiographic X-Ray SystemKPR · Traditional | 12/13/1990SE |
Questions and answers
When was Hydradjust IV Urological Table cleared by the FDA?
Hydradjust IV Urological Table (K943581) received a 510(k) decision of Substantially Equivalent on January 4, 1995, 166 days after the submission was received.
What is the product code of K943581?
The FDA product code is IXR – Table, Radiographic, Tilting, a Class II (moderate risk) device regulated under 21 CFR 892.1980.