CARESTREAM DRX-1 SYSTEM
FDA 510(k) clearance K090318 · decided 2009-04-06
Clearance details
- K-number
- K090318
- Device name
- CARESTREAM DRX-1 SYSTEM
- Applicant
- Carestream Health, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2009-02-09
- Decision date
- 2009-04-06
- Days to decision
- 56 days
- Clearance type
- Traditional
- Product code
- MQB
- Device class
- 2
- Regulation number
- 892.1680
- 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
| Record | Firm | Date |
|---|---|---|
| CARESTREAM DRX -Mobile Retrofit Kit, Catalog number: 1019397. Made in U.S.A. by Carestream recall (Z-0180-2014) | Carestream Health Inc. | 2013-11-07 |
| Carestream DRX-1 System Battery --- Made in U.S.A. for Carestream Health, Inc., Carestream recall (Z-2202-2012) | Carestream Health, Inc. | 2012-08-13 |
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 |