E-Com DR-2000 DR
FDA 510(k) K193644 · Livermoretech, Inc.
510(k) numberK193644
Submission
- Device name
- E-Com DR-2000 DR
- Applicant
- Livermoretech, Inc.
Plano, TX, US - Received
- December 30, 2019
- Decision date
- February 14, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K243556 | Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43)MQB · Traditional | Iray Imaging Technology (Haining) Limited | 03/18/2025SE |
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Questions and answers
When was E-Com DR-2000 DR cleared by the FDA?
E-Com DR-2000 DR (K193644) received a 510(k) decision of Substantially Equivalent on February 14, 2020, 46 days after the submission was received.
What is the product code of K193644?
The FDA product code is MQB – Solid State X-Ray Imager (Flat Panel/Digital Imager), a Class II (moderate risk) device regulated under 21 CFR 892.1680.