2020 Imaging
US Last updated 23 May 2026
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- Devices
- 1
- Registries
- FDA 510(k)
- FDA recalls
- 0
Catalogue
Opal Chiro, 20/20 P-Dr Ref K141435
What 2020 Imaging makes
2020 Imaging manufactures the OPAL CHIRO and 20/20 P-DR, which appear to be chiropractic adjustment devices designed for spinal manipulation and diagnostic imaging support.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Frequently asked questions
What types of medical devices does 2020 Imaging manufacture?
2020 Imaging specializes in chiropractic adjustment devices. Specifically, they produce the OPAL CHIRO and 20/20 P-DR, which appear to be designed for spinal manipulation and potentially support diagnostic imaging. These devices are intended for use in chiropractic care settings.
Where is 2020 Imaging based?
2020 Imaging is based in the United States. The company’s headquarters and operations are located within the country, though the exact region or city is not specified.
Which regulatory registries or databases list 2020 Imaging’s devices?
2020 Imaging’s devices, including the OPAL CHIRO and 20/20 P-DR, are listed in the FDA’s 510(k) registry. This pathway is used for Class II devices, which require premarket notification to demonstrate substantial equivalence to a legally marketed predicate device.
How are 2020 Imaging’s devices classified under FDA regulations?
2020 Imaging’s devices are classified as Class II under FDA regulations. This classification applies to devices that pose moderate risk and require special controls to ensure their safety and effectiveness, such as 510(k) clearance to demonstrate equivalence to an existing device.
Information
- Country
- US