KODAK DIRECTVIEW CR MAMMOGRAPHY SYSTEM (USING CARESTREAM CR MAMMOGRAPHY CASSETTE WITH SNP-M1 SCREEN)
FDA 510(k) clearance K120246 · decided 2012-08-28
Clearance details
- K-number
- K120246
- Device name
- KODAK DIRECTVIEW CR MAMMOGRAPHY SYSTEM (USING CARESTREAM CR MAMMOGRAPHY CASSETTE WITH SNP-M1 SCREEN)
- Applicant
- Carestream Health, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2012-01-27
- Decision date
- 2012-08-28
- Days to decision
- 214 days
- Clearance type
- Traditional
- Product code
- MUE
- Device class
- 2
- Regulation number
- 892.1715
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Rochester, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| KODAK DIRECTVIEW CR MAMMOGRAPHY FEATURE (P080018/S001) | Carestream Health, Inc. | 2010-12-01 |
| KODAK DIRECTVIEW COMPUTED RADIOGRAPHY (CR) MAMMOGRAPHY (P080018) | Carestream Health, Inc. | 2010-11-03 |
| KODAK MAMMOGRAPHY CAD ENGINE (P030007/S003) | Carestream Health, Inc. | 2007-03-23 |
| MAMMOGRAPHY CAD ENGINE (P030007/S001) | Carestream Health, Inc. | 2005-09-16 |
| KODAK MAMMOGRAPHY CAD ENGINE (P030007) | Carestream Health, Inc. | 2004-11-23 |