PCX 1050HF Radiographic X-Ray Generator
FDA 510(k) K920349 · Control-X, Inc.
510(k) numberK920349
Submission
- Device name
- PCX 1050HF Radiographic X-Ray Generator
- Applicant
- Control-X, Inc.
Columbus, OH, US - Received
- January 24, 1992
- Decision date
- February 12, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
|---|---|---|
| K952265 | Milestonw 350/450/550HF, PCX N350/450/550HF, Top-X 350/450/550HF Radiographic X-Ray…IZO · Traditional | 07/06/1995SE |
| K920347 | Top-X 650HF Radiographic X-RayKPR · Traditional | 05/17/1993SE |
| K924445 | BA-4 Wall Bucky and BA-42 Tilting Wall BuckyIXY · Traditional | 02/19/1993SE |
| K920351 | PCX 650HF Radiographic X-RayIZO · Traditional | 02/12/1993SE |
| K924444 | B-4 Four-Way Radiographic TableIZZ · Traditional | 02/05/1993SE |
| K924443 | RS-3 Universal Radiographic Working PlaceIZF · Traditional | 02/05/1993SE |
| K913577 | Milestone MS 325 Radiographic X-Ray GeneratorIZO · Traditional | 11/05/1991SE |
| K913578 | Milestone MS 525 Radiographic X-Ray GeneratorIZO · Traditional | 11/01/1991SE |
Questions and answers
When was PCX 1050HF Radiographic X-Ray Generator cleared by the FDA?
PCX 1050HF Radiographic X-Ray Generator (K920349) received a 510(k) decision of Substantially Equivalent on February 12, 1993, 385 days after the submission was received.
What is the product code of K920349?
The FDA product code is IZO – Generator, High-Voltage, X-Ray, Diagnostic, a Class I (low risk) device regulated under 21 CFR 892.1700.