Octopaque Universal
FDA 510(k) K942916 · Octostop, Inc.
510(k) numberK942916
Submission
- Device name
- Octopaque Universal
- Applicant
- Octostop, Inc.
Montreal, Qc., CA - Received
- June 21, 1994
- Decision date
- September 8, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Other 510(k)s with product code IXQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K973842 | Carbon Fiber Conformal Couch TopIXQ · Traditional | Medtec, Inc. | 12/05/1997SE |
| K960083 | Movable Cantilevered Radiographic Table XRT 100, 200 & 300IXQ · Traditional | Wuestec Medical, Inc. | 07/24/1996SE |
| K954225 | Med-Tec Hand GripIXQ · Traditional | Medtec, Inc. | 11/14/1995SE |
| K946262 | Euro, SCST, Sccft Atlas Radiologic TablesIXQ · Traditional | Scott Imaging Intl., Inc. | 02/15/1995SE |
| K942190 | ID100 Mobile Fluoroscopic Examining TableIXQ · Traditional | Image Diagnostics, Inc. | 08/17/1994SE |
| K913425 | Dial-A-Rad Porta Rad TableIXQ · Traditional | Dial-A-Rad | 11/24/1992SE |
| K923775 | R-Made Head/Arm SupportIXQ · Traditional | R-Made, Inc. | 10/20/1992SE |
| K920729 | Bucky Table BK-12IXQ · Traditional | Shimadzu Medical Systems | 04/27/1992SE |
| K914351 | Clinitron C-10IXQ · Traditional | Ssi Medical Services, Inc. | 02/14/1992SE |
| K912382 | Military Radiographic Flat Table, Cat # T-9130IXQ · Traditional | Continental X-Ray Corp. | 10/10/1991SE |
More from Continental X-Ray Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K972766 | Pivoting Compensating Filters for the HeadKPR · Traditional | 08/14/1997SE |
| K963941 | The Pharaoh Compensating FilterKPR · Traditional | 11/27/1996SE |
| K953246 | OctorollKXH · Traditional | 09/29/1995SE |
| K952871 | Ridges PlusKPR · Traditional | 07/20/1995SE |
| K940306 | Octostop Compensating FiltersKPR · Traditional | 09/06/1994SE |
| K935444 | Octostop(R) Chair (New ModelIXR · Traditional | 09/02/1994SE |
| K930124 | Variant of Octostop and OctopaqueKXH · Traditional | 02/09/1994SE |
| K930357 | Accessory to Universal OctopaqueKXH · Traditional | 07/13/1993SE |
| K926069 | Wrist TractionKPR · Traditional | 01/21/1993SE |
| K913711 | Gentle SlopeKPR · Traditional | 10/14/1992SE |
Questions and answers
When was Octopaque Universal cleared by the FDA?
Octopaque Universal (K942916) received a 510(k) decision of Substantially Equivalent on September 8, 1994, 79 days after the submission was received.
What is the product code of K942916?
The FDA product code is IXQ – Table, Radiographic, Stationary Top, a Class II (moderate risk) device regulated under 21 CFR 892.1980.