Digital Radiography System (MobileApex 60E, MobileApex 60F, MobileApex 60G, MobileApex 60H)
FDA 510(k) K240284 · Shenzhen Browiner Tech Co., Ltd.
510(k) numberK240284
Submission
- Device name
- Digital Radiography System (MobileApex 60E, MobileApex 60F, MobileApex 60G, MobileApex 60H)
- Applicant
- Shenzhen Browiner Tech Co., Ltd.
Shenzhen, CN - Received
- February 1, 2024
- Decision date
- March 28, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K240841 | Digital Radiography System (ManntiX B, ManntiX K)IZL · Traditional | 12/09/2024SE |
Questions and answers
When was Digital Radiography System (MobileApex 60E, MobileApex 60F, MobileApex 60G, MobileApex 60H) cleared by the FDA?
Digital Radiography System (MobileApex 60E, MobileApex 60F, MobileApex 60G, MobileApex 60H) (K240284) received a 510(k) decision of Substantially Equivalent on March 28, 2024, 56 days after the submission was received.
What is the product code of K240284?
The FDA product code is IZL – System, X-Ray, Mobile, a Class II (moderate risk) device regulated under 21 CFR 892.1720.