X-Image Digital X-Ray System
FDA 510(k) K020588 · Escape Technology, Inc.
510(k) numberK020588
Submission
- Device name
- X-Image Digital X-Ray System
- Applicant
- Escape Technology, Inc.
Montebello, CA, US - Received
- February 22, 2002
- Decision date
- June 13, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was X-Image Digital X-Ray System cleared by the FDA?
X-Image Digital X-Ray System (K020588) received a 510(k) decision of Substantially Equivalent on June 13, 2002, 111 days after the submission was received.
What is the product code of K020588?
The FDA product code is MUH – System, X-Ray, Extraoral Source, Digital, a Class II (moderate risk) device regulated under 21 CFR 872.1800.