VTR-12
FDA 510(k) K882176 · Eigen
510(k) numberK882176
Submission
- Device name
- VTR-12
- Applicant
- Eigen
Nevada City, CA, US - Received
- May 24, 1988
- Decision date
- August 11, 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 |
|---|---|---|
| K222222 | Artemis, Artemis TPO, Artemis MXQTZ · Traditional | 10/12/2023SE |
| K173744 | ProFuse CADLLZ · Traditional | 11/21/2018SE |
| K162474 | ArtemisLLZ · Traditional | 10/21/2016SE |
| K082341 | Dsa 2000EXLLZ · Traditional | 08/29/2008SE |
| K081093 | 3-D Imaging WorkstationLLZ · Traditional | 05/01/2008SE |
| K063846 | Eigen Dsa 2000LLZ · Special | 01/26/2007SE |
| K933115 | Digital Disk RecorderLMB · Traditional | 04/07/1994SE |
| K924164 | Digital Disk Recorder W/Dualpath ARCHIVE/30-60 OptJAA · Traditional | 11/23/1992SE |
| K923585 | Digital Fluoro StoreJAA · Traditional | 10/21/1992SE |
| K913012 | Digital Fluoro Store(Dfs) W/Numerical SuffixesJAA · Traditional | 09/23/1991SE |
Questions and answers
When was VTR-12 cleared by the FDA?
VTR-12 (K882176) received a 510(k) decision of Substantially Equivalent on August 11, 1988, 79 days after the submission was received.
What is the product code of K882176?
The FDA product code is JAA – System, X-Ray, Fluoroscopic, Image-Intensified, a Class II (moderate risk) device regulated under 21 CFR 892.1650.