X-Ray Equipment (Various Types)
FDA 510(k) K895730 · Continental X-Ray Corp.
510(k) numberK895730
Submission
- Device name
- X-Ray Equipment (Various Types)
- Applicant
- Continental X-Ray Corp.
Chicago, IL, US - Received
- September 22, 1989
- Decision date
- November 6, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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|---|---|---|---|
| K253103 | Nexus DRF Digital X-ray Imaging SystemJAA · Traditional | Varex Imaging Corporation | 05/29/2026SE |
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| K242488 | Soteria E-ViewJAA · Traditional | Omega Medical Imaging, LLC | 01/06/2025SE |
| K242948 | Adora DRFi (04550010)JAA · Traditional | Nrt X-Ray A/S | 12/23/2024SE |
| K233380 | TRIDENT Mobile Fluoroscopy SystemJAA · Traditional | Dornier Medtech America | 06/26/2024SE |
| K233945 | ProxiDiagnost N90 / Precision CRF (706110, 706400)JAA · Special | Philips Medical Systems Dmc GmbH | 01/11/2024SE |
| K232910 | CombiDiagnost R90JAA · Special | Philips Medical Systems Dmc GmbH | 10/19/2023SE |
| K232526 | XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5JAA · Special | Canon Medical Systems Corporation | 09/12/2023SE |
| K220871 | NautilusJAA · Special | Dornier Medtech America, Inc. | 04/18/2022SE |
| K212890 | Nyquist.IQJAA · Traditional | Omega Medical Imaging, LLC | 12/13/2021SE |
More from Omega Medical Imaging, LLC
| 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 X-Ray Equipment (Various Types) cleared by the FDA?
X-Ray Equipment (Various Types) (K895730) received a 510(k) decision of Substantially Equivalent on November 6, 1989, 45 days after the submission was received.
What is the product code of K895730?
The FDA product code is JAA – System, X-Ray, Fluoroscopic, Image-Intensified, a Class II (moderate risk) device regulated under 21 CFR 892.1650.