Futurus 2001 X-Ray Generator
FDA 510(k) K902637 · Acoma Medical Imaging, Inc.
510(k) numberK902637
Submission
- Device name
- Futurus 2001 X-Ray Generator
- Applicant
- Acoma Medical Imaging, Inc.
Wheeling, IL, US - Received
- June 14, 1990
- Decision date
- August 3, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code IZO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K954666 | MPH50, MPH65, and MPH80IZO · Traditional | GE Medical Systems | 11/24/1995SE |
| K953582 | HFX350, 30KW, 300MA, 1 or 3 Phase Radiographic & Fluoroscopic X-Ray GeneratorIZO · Traditional | Varian Canada, Inc. | 09/26/1995SE |
| K953831 | N 800 HFIZO · Traditional | Nucletron-Oldelft Corp. | 09/08/1995SE |
| K952822 | Shimadzu X-Ray High Viltage Generator AHD150GIZO · Traditional | Shimadzu Corp. | 07/12/1995SE |
| K952265 | Milestonw 350/450/550HF, PCX N350/450/550HF, Top-X 350/450/550HF Radiographic X-Ray…IZO · Traditional | Control-X, Inc. | 07/06/1995SE |
| K950883 | Polydoros SX 65 and 80IZO · Traditional | Siemens Medical Solutions USA, Inc. | 04/03/1995SE |
| K950694 | Compact-XIZO · Traditional | Electromed Intl., Ltd. | 03/31/1995SE |
| K950291 | Digital 625HFIZO · Traditional | Fischer Imaging Corp. | 03/23/1995SE |
| K950041 | Sii 360 AprIZO · Traditional | Scott Imaging Intl., Inc. | 03/21/1995SE |
| K950040 | Sii 525 AprIZO · Traditional | Scott Imaging Intl., Inc. | 03/21/1995SE |
More from Scott Imaging Intl., Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K981227 | Symphony 360 Remote Control TableJAA · Traditional | 06/30/1998SE |
| K981131 | Pathfinder Mobile C ArmOXO · Abbreviated | 06/26/1998SE |
| K963851 | Tilting Radiographic Table (Remote)IXR · Traditional | 01/23/1997SE |
| K944952 | Angiographic SystemIZI · Traditional | 02/17/1995SE |
| K941017 | F/C/W TubestandIYB · Traditional | 07/29/1994SE |
| K941004 | CTS SystemIYB · Traditional | 07/29/1994SE |
| K925598 | Buckymatic Automatic Chest Film ChangerKPX · Traditional | 02/01/1993SE |
| K921116 | PX-100 Portable X-Ray GeneratorIZL · Traditional | 10/05/1992SE |
| K921425 | SCD-105 and SCD-125 Capacitor Discharge Mobile X-RIZL · Traditional | 08/27/1992SE |
| K900562 | Trans X 100 Chest Film ChangerKPR · Traditional | 04/10/1990SE |
Questions and answers
When was Futurus 2001 X-Ray Generator cleared by the FDA?
Futurus 2001 X-Ray Generator (K902637) received a 510(k) decision of Substantially Equivalent on August 3, 1990, 50 days after the submission was received.
What is the product code of K902637?
The FDA product code is IZO – Generator, High-Voltage, X-Ray, Diagnostic, a Class I (low risk) device regulated under 21 CFR 892.1700.