HP Echo Image Management System
FDA 510(k) K954668 · Hewlett-Packard Co.
510(k) numberK954668
Submission
- Device name
- HP Echo Image Management System
- Applicant
- Hewlett-Packard Co.
Andover, MA, US - Received
- October 10, 1995
- Decision date
- November 22, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was HP Echo Image Management System cleared by the FDA?
HP Echo Image Management System (K954668) received a 510(k) decision of Substantially Equivalent on November 22, 1995, 43 days after the submission was received.
What is the product code of K954668?
The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.