FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
KODAK DIRECTVIEW CR MAMMOGRAPHY SYSTEM (USING CARESTREAM CR MAMMOGRAPHY CASSETTE WITH SNP-M1 SCREEN)
K Number: K120246
·
Decision Aug 28, 2012
Classifications
1
FEI Numbers
40
Registration Numbers
40
Same Product Code
54
Applicant Total
48
Review Days
214
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Basic Information
- Device Name
- KODAK DIRECTVIEW CR MAMMOGRAPHY SYSTEM (USING CARESTREAM CR MAMMOGRAPHY CASSETTE WITH SNP-M1 SCREEN)
- K Number
- K120246
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1715
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Carestream Health, Inc.
- Date Received
- January 27, 2012
- Decision Date
- August 28, 2012
- 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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