Senograph DS, Senograph Essenstial
FDA 510(k) K103485 · General Electric Company
510(k) numberK103485
Submission
- Device name
- Senograph DS, Senograph Essenstial
- Applicant
- General Electric Company
Waukesha, WI, US - Received
- November 26, 2010
- Decision date
- October 6, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K072797 | GE Logiq I Comapact Ultrasound, GE Logiq E Compact Ultrasound, GE Vivid E Compact…IYO · Special | 10/17/2007SE |
| K072075 | Modification to GE Logiq A3IYN · Special | 08/29/2007SE |
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Questions and answers
When was Senograph DS, Senograph Essenstial cleared by the FDA?
Senograph DS, Senograph Essenstial (K103485) received a 510(k) decision of Substantially Equivalent on October 6, 2011, 314 days after the submission was received.
What is the product code of K103485?
The FDA product code is MUE – Full Field Digital, System, X-Ray, Mammographic, a Class II (moderate risk) device regulated under 21 CFR 892.1715.