VFSS Pro Mobile Digital Imaging System
FDA 510(k) K212523 · Imagexray, LLC
510(k) numberK212523
Submission
- Device name
- VFSS Pro Mobile Digital Imaging System
- Applicant
- Imagexray, LLC
Nutley, NJ, US - Received
- August 11, 2021
- Decision date
- November 5, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code OWB
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|---|---|---|---|
| K253726 | uAngio AVIVA CXOWB · Traditional | Shanghai United Imaging Healthcare Co., Ltd. | 08/21/2026SE |
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| K254205 | Zenition 30OWB · Traditional | Philips Medical Systems Nederland B.V. | 08/07/2026SE |
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| K252735 | C-beamOWB · Traditional | Pulmera, Inc. | 05/22/2026SE |
| K252503 | Intelligent NROWB · Traditional | Canon, Inc. | 04/30/2026SE |
| K254173 | ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS phenoOWB · Traditional | Siemens Medical Solutions USA, Inc. | 04/24/2026SE |
| K253752 | ARTIS genio floor; ARTIS icono.explore floorOWB · Traditional | Siemens Medical Solutions USA, Inc. | 04/23/2026SE |
| K252229 | Belliger AceOWB · Traditional | Genoray Co., Ltd. | 04/02/2026SE |
Questions and answers
When was VFSS Pro Mobile Digital Imaging System cleared by the FDA?
VFSS Pro Mobile Digital Imaging System (K212523) received a 510(k) decision of Substantially Equivalent on November 5, 2021, 86 days after the submission was received.
What is the product code of K212523?
The FDA product code is OWB – Interventional Fluoroscopic X-Ray System, a Class II (moderate risk) device regulated under 21 CFR 892.1650.