RS-3 Universal Radiographic Working Place
FDA 510(k) K924443 · Control-X, Inc.
510(k) numberK924443
Submission
- Device name
- RS-3 Universal Radiographic Working Place
- Applicant
- Control-X, Inc.
Columbus, OH, US - Received
- September 1, 1992
- Decision date
- February 5, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Other 510(k)s with product code IZF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252649 | TAP2DIZF · Traditional | Nano-X Imaging , Ltd. | 02/02/2026SE |
| K252133 | Adaptix Ortho350IZF · Traditional | Adaptix Limited | 11/06/2025SE |
| K250850 | Nanox.ARC XIZF · Traditional | Nano-X Imaging , Ltd. | 04/16/2025SE |
| K242395 | Nanox.ARCIZF · Traditional | Nano-X Imaging , Ltd. | 12/04/2024SE |
| K222934 | Nanox.ARCIZF · Traditional | Nano-X Imaging , Ltd. | 04/28/2023SE |
| K221949 | Ortho Device, ADAPTIX 3D Orthopedic Imaging SystemIZF · Traditional | Pausch Medical GmbH | 01/26/2023SE |
| K213081 | CLISIS SYSTEMS, Discovery RF180IZF · Traditional | General Medical Merate S.P.A | 10/26/2021SE |
| K193262 | DR 600 with TomosynthesisIZF · Traditional | Agfa N.V. | 03/09/2020SE |
| K183275 | DR 800 with TomosynthesisIZF · Traditional | Agfa N.V. | 02/01/2019SE |
| K132261 | Discovery XR656 with Volumerad (Digital Tomosynthesis)IZF · Traditional | Ge Medical Systems, LLC | 11/18/2013SE |
More from Ge Medical Systems, LLC
| 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 |
| K920349 | PCX 1050HF Radiographic X-Ray GeneratorIZO · Traditional | 02/12/1993SE |
| K924444 | B-4 Four-Way Radiographic TableIZZ · 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 RS-3 Universal Radiographic Working Place cleared by the FDA?
RS-3 Universal Radiographic Working Place (K924443) received a 510(k) decision of Substantially Equivalent on February 5, 1993, 157 days after the submission was received.
What is the product code of K924443?
The FDA product code is IZF – System, X-Ray, Tomographic, a Class II (moderate risk) device regulated under 21 CFR 892.1740.