Image X-70 Plus Dental X-Ray Unit
FDA 510(k) K000551 · Medical Device Consultants, Inc.
510(k) numberK000551
Submission
- Device name
- Image X-70 Plus Dental X-Ray Unit
- Applicant
- Medical Device Consultants, Inc.
North Attleboro, MA, US - Received
- February 18, 2000
- Decision date
- March 16, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Image X-70 Plus Dental X-Ray Unit cleared by the FDA?
Image X-70 Plus Dental X-Ray Unit (K000551) received a 510(k) decision of Substantially Equivalent on March 16, 2000, 27 days after the submission was received.
What is the product code of K000551?
The FDA product code is EHD – Unit, X-Ray, Extraoral With Timer, a Class II (moderate risk) device regulated under 21 CFR 872.1800.