FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SENOGRAPH DS, SENOGRAPH ESSENSTIAL
K Number: K103485
·
Decision Oct 6, 2011
Classifications
1
FEI Numbers
40
Registration Numbers
40
Same Product Code
54
Applicant Total
2
Review Days
314
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Basic Information
- Device Name
- SENOGRAPH DS, SENOGRAPH ESSENSTIAL
- K Number
- K103485
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1715
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- General Electric Company
- Date Received
- November 26, 2010
- Decision Date
- October 6, 2011
- Product Code
- MUE
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MUE | Full Field Digital, System, X-Ray, Mammographic | FDA class 2 | Radiology |
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Other Clearances by General Electric Company
| K Number | Device Name | ||
|---|---|---|---|
| K110798 | SENOGRAPHE DS, SENOGRAPHE ESSENTIAL | Dec 22, 2011 | Substantially Equivalent |