Anatech X-Ray Generator
FDA 510(k) K904114 · Continental X-Ray Corp.
510(k) numberK904114
Submission
- Device name
- Anatech X-Ray Generator
- Applicant
- Continental X-Ray Corp.
Broadview, IL, US - Received
- September 6, 1990
- Decision date
- January 3, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code IZO
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|---|---|---|---|
| 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 |
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| 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 Anatech X-Ray Generator cleared by the FDA?
Anatech X-Ray Generator (K904114) received a 510(k) decision of Substantially Equivalent on January 3, 1991, 119 days after the submission was received.
What is the product code of K904114?
The FDA product code is IZO – Generator, High-Voltage, X-Ray, Diagnostic, a Class I (low risk) device regulated under 21 CFR 892.1700.