Allmec 90/15
FDA 510(k) K811196 · Tecnomed, Inc.
510(k) numberK811196
Submission
- Device name
- Allmec 90/15
- Applicant
- Tecnomed, Inc.
Mchenry, IL, US - Received
- April 30, 1981
- Decision date
- June 9, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code KXJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K050190 | ApolloKXJ · Abbreviated | Villa Sistemi Medicali S.P.A. | 03/25/2005SE |
| K963905 | Radiographic Itt TableKXJ · Traditional | X-Ray Technologies, Inc. | 11/12/1996SE |
| K955414 | XRT 400KXJ · Traditional | Wuestec Medical, Inc. | 07/24/1996SE |
| K951146 | Imaging TableKXJ · Traditional | Septa Corp. | 05/04/1995SE |
| K950068 | Carbon Fiber Couch InsertKXJ · Traditional | Medtec, Inc. | 04/06/1995SE |
| K950442 | Infrared Exposure Hand SwitchKXJ · Traditional | Medical X-Ray Intl., Inc. | 03/31/1995SE |
| K940696 | Syncra Tilt Option for Angio Diagnost 5KXJ · Traditional | Philips Medical Systems North America, Inc. | 03/16/1994SE |
| K931724 | Electrophysiology (Ep) Table Ep 2000 SeriesKXJ · Traditional | Continental X-Ray Corp. | 06/14/1993SE |
| K926407 | Model Cole TAB-2 Table W/Model Cole SFD-2 SpotfilmKXJ · Traditional | Nucletron-Oldelft Corp. | 03/31/1993SE |
| K922098 | CAG-02AKXJ · Traditional | Toshiba America Medical Systems, In.C | 07/27/1992SE |
More from Toshiba America Medical Systems, In.C
| 510(k) | Device | Decision |
|---|---|---|
| K892226 | Tec 6340 90/15 Radiographic/Fluoroscopic TableIXR · Traditional | 04/26/1989SE |
| K854203 | Tec 2720 Mamex DC MagIZH · Traditional | 03/06/1986SE |
| K827126 | Technomed Generator, Radiographic, 3 Phase · Traditional | 03/05/1982SE |
| K827124 | Ralco Collimator, Automatic, Radiographic · Traditional | 03/05/1982SE |
| K820307 | Tecnomed Generator, Radiograph., 3 PhaseIZO · Traditional | 03/05/1982SE |
| K820306 | Ralco Collimator, Automatic RadiographicKPW · Traditional | 03/05/1982SE |
| K827125 | Ralco Collimators, Manual, Radiographic · Traditional | 03/04/1982SE |
| K820305 | Ralco Collimators, Manual RadiographicKPW · Traditional | 03/04/1982SE |
| K811197 | Superix 120IZF · Traditional | 06/09/1981SE |
| K811195 | ArgostatIYB · Traditional | 06/09/1981SE |
Questions and answers
When was Allmec 90/15 cleared by the FDA?
Allmec 90/15 (K811196) received a 510(k) decision of Substantially Equivalent on June 9, 1981, 40 days after the submission was received.
What is the product code of K811196?
The FDA product code is KXJ – Table, Radiologic, a Class II (moderate risk) device regulated under 21 CFR 892.1980.