Classic 4-WAY Elevating Table
FDA 510(k) K912474 · Continental X-Ray Corp.
510(k) numberK912474
Submission
- Device name
- Classic 4-WAY Elevating Table
- Applicant
- Continental X-Ray Corp.
Broadview, IL, US - Received
- June 3, 1991
- Decision date
- September 16, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Other 510(k)s with product code IZZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K971452 | Multix Top/Pro Radiographic X-Ray TableIZZ · Traditional | Siemens Medical Solutions USA, Inc. | 05/14/1997SE |
| K952701 | Med-Tron SPECT Imaging TableIZZ · Traditional | Med-Tron Products, Inc. | 07/06/1995SE |
| K951315 | Catheterization Table KS-60IZZ · Traditional | Shimadzu Medical Systems | 05/11/1995SE |
| K951053 | Angiorex CAT-350BIZZ · Traditional | Toshiba America Medical Systems, In.C | 04/06/1995SE |
| K943926 | Rapido 2000 Automatic Radiographic TableIZZ · Traditional | Philips Medical Systems (Cleveland), Inc. | 11/28/1994SE |
| K930273 | AlphaIZZ · Traditional | Raymax Medical Corp. | 07/13/1993SE |
| K924444 | B-4 Four-Way Radiographic TableIZZ · Traditional | Control-X, Inc. | 02/05/1993SE |
| K925174 | Shimadzu Radiographic Table BK-100IZZ · Traditional | Shimadzu Medical Systems | 11/27/1992SE |
| K921501 | Deluxe C Arm Radiological Table, Model #056-004IZZ · Traditional | Biodan Medical Systems, Ltd. | 05/15/1992SE |
| K920732 | Catherization KS-50IZZ · Traditional | Shimadzu Medical Systems | 04/16/1992SE |
More from Shimadzu Medical Systems
| 510(k) | Device | Decision |
|---|---|---|
| K972442 | Ceiling Mounted Lateral Positioner, Model No. 6896.002JAA · Traditional | 09/11/1997SE |
| K962140 | ICT-2000, Integrated C-Arm/Table Multipurpose Radiographic/Fluoroscopic Positioning…JAA · Traditional | 07/25/1996SE |
| K961690 | Cardioarc Series: Positioner C-Arm Models No. 6896.001 and 6896.105JAA · Traditional | 06/27/1996SE |
| K954581 | Arc SeriesIZI · Traditional | 12/21/1995SE |
| K950571 | Linear FR Tomographic System: 0MT 8000, Model No. 6681.270IZF · Traditional | 03/31/1995SE |
| K942175 | Linear Tomographic System: PMT 6000IZF · Traditional | 08/17/1994SE |
| K942100 | Model TM Ep High Voltage GeneratorIZO · Traditional | 06/07/1994SE |
| K934686 | Molybdenum/Rhodium FiltersIZO · Traditional | 05/26/1994SE |
| K931724 | Electrophysiology (Ep) Table Ep 2000 SeriesKXJ · Traditional | 06/14/1993SE |
| K925934 | Wall Bucky Holders Lt. & Rt. Hand, & Center MountIXY · Traditional | 03/04/1993SE |
Questions and answers
When was Classic 4-WAY Elevating Table cleared by the FDA?
Classic 4-WAY Elevating Table (K912474) received a 510(k) decision of Substantially Equivalent on September 16, 1991, 105 days after the submission was received.
What is the product code of K912474?
The FDA product code is IZZ – Table, Radiographic, Non-Tilting, Powered, a Class II (moderate risk) device regulated under 21 CFR 892.1980.