CS-series-FP with Optional ROI Accessory CA-100S
FDA 510(k) K182834 · Omega Medical Imaging, LLC
510(k) numberK182834
Submission
- Device name
- CS-series-FP with Optional ROI Accessory CA-100S
- Applicant
- Omega Medical Imaging, LLC
Sanford, FL, US - Received
- October 9, 2018
- Decision date
- March 29, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
|---|---|---|
| K242488 | Soteria E-ViewJAA · Traditional | 01/06/2025SE |
| K212890 | Nyquist.IQJAA · Traditional | 12/13/2021SE |
| K212336 | Soteria.AIOWB · Traditional | 11/17/2021SE |
| K191713 | CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShield…JAA · Traditional | 10/04/2019SE |
| K171755 | CS-series-FP with MX CFP 3131 or MX CFP 2222 Option Radiographic/Fluoroscopy SystemOWB · Special | 02/09/2018SE |
| K121293 | Cs-Series-Fp with 3030+OPTIONJAA · Traditional | 07/26/2012SE |
| K100102 | Cs-Series-FpOWB · Traditional | 08/31/2010SE |
| K093572 | R650 Qdasm CollimatorIZW · Traditional | 02/03/2010SE |
| K070834 | Cs-Series Fluoroscopy System, CS-10 Through CS-65 (11 Configurations)OWB · Traditional | 05/18/2007SE |
| K062647 | E-View Fluoroscopy System, Model CS-50OWB · Traditional | 10/20/2006SE |
Questions and answers
When was CS-series-FP with Optional ROI Accessory CA-100S cleared by the FDA?
CS-series-FP with Optional ROI Accessory CA-100S (K182834) received a 510(k) decision of Substantially Equivalent on March 29, 2019, 171 days after the submission was received.
What is the product code of K182834?
The FDA product code is JAA – System, X-Ray, Fluoroscopic, Image-Intensified, a Class II (moderate risk) device regulated under 21 CFR 892.1650.