Cardiac CX
FDA 510(k) K883985 · Fischer Imaging Corp.
510(k) numberK883985
Submission
- Device name
- Cardiac CX
- Applicant
- Fischer Imaging Corp.
Denver, CO, US - Received
- September 20, 1988
- Decision date
- November 21, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code JAA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253103 | Nexus DRF Digital X-ray Imaging SystemJAA · Traditional | Varex Imaging Corporation | 05/29/2026SE |
| K251650 | Insight Enhanced DRF (EN-1002-01)JAA · Traditional | Imaging Engineering, LLC | 09/16/2025SE |
| 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 |
|---|---|---|
| K042095 | MammotestIZH · Traditional | 10/29/2004SE |
| K021113 | MammopathMWP · Traditional | 06/13/2002SE |
| K981414 | LC PositionerJAA · Traditional | 07/16/1998SE |
| K973400 | Mammotest Adapter DriverIZH · Traditional | 11/10/1997SE |
| K964806 | MD-1835IXL · Traditional | 03/04/1997SE |
| K961207 | Ep-X BiplaneJAA · Traditional | 08/20/1996SE |
| K961022 | Tangent Vi TableIXR · Traditional | 05/03/1996SE |
| K950291 | Digital 625HFIZO · Traditional | 03/23/1995SE |
| K945619 | Athena HFXIZH · Traditional | 03/23/1995SE |
| K944150 | Micro X-65 HFIZO · Traditional | 09/16/1994SE |
Questions and answers
When was Cardiac CX cleared by the FDA?
Cardiac CX (K883985) received a 510(k) decision of Substantially Equivalent on November 21, 1988, 62 days after the submission was received.
What is the product code of K883985?
The FDA product code is JAA – System, X-Ray, Fluoroscopic, Image-Intensified, a Class II (moderate risk) device regulated under 21 CFR 892.1650.