Gx-Elevator
FDA 510(k) K894188 · Gendex Corp.
510(k) numberK894188
Submission
- Device name
- Gx-Elevator
- Applicant
- Gendex Corp.
Franklin Park, IL, US - Received
- June 16, 1989
- Decision date
- October 3, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code IZZ
| 510(k) | Device | Applicant | Decision |
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| 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 |
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| K952598 | Gx-Pan Panoramic Dental X-Ray SystemGEX · Traditional | 06/29/1995SE |
| K945682 | Processor, Radiographic-Film, Automatic, DentalEGY · Traditional | 02/09/1995SE |
| K935046 | GX-770 X-Ray Control, Model 46-404600G4EHD · Traditional | 02/18/1994SE |
| K925094 | Visualix Radiographic Image Detecting and ProcessEHD · Traditional | 09/29/1993SE |
| K931001 | Oralix DCEHD · Traditional | 09/14/1993SE |
| K932675 | GXP Dental X-Ray ProcessorEGN · Traditional | 07/26/1993SE |
| K922165 | ATC725, ATC525, and AP300IZO · Traditional | 07/27/1992SE |
| K920189 | Gx-C CephalometerEAG · Traditional | 04/28/1992SE |
| K890083 | GX-2000 Stationary X-Ray GeneratorIZO · Traditional | 03/31/1989SE |
| K873982 | Gx-Mobile X-Ray UnitIZL · Traditional | 10/30/1987SE |
Questions and answers
When was Gx-Elevator cleared by the FDA?
Gx-Elevator (K894188) received a 510(k) decision of Substantially Equivalent on October 3, 1989, 109 days after the submission was received.
What is the product code of K894188?
The FDA product code is IZZ – Table, Radiographic, Non-Tilting, Powered, a Class II (moderate risk) device regulated under 21 CFR 892.1980.