DRX-REVOLUTION MOBILE X-RAY SYSTEM
FDA 510(k) clearance K120062 · decided 2012-04-13
Clearance details
- K-number
- K120062
- Device name
- DRX-REVOLUTION MOBILE X-RAY SYSTEM
- Applicant
- Carestream Health, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2012-01-09
- Decision date
- 2012-04-13
- Days to decision
- 95 days
- Clearance type
- Traditional
- Product code
- IZL
- Device class
- 2
- Regulation number
- 892.1720
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Los Angeles, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| DRX-Revolution Mobile X-Ray System; MODEL DRXR-1; Catalog # 1019397 (all other countries) recall (Z-2651-2017) | Carestream Health Inc | 2017-06-19 |
| DRX-Revolution Mobile X-Ray System, MODEL DRXR-1, Service Code 1243, Catalog Number 106017 recall (Z-0800-2015) | Carestream Health Inc | 2014-12-16 |
| DRX- Revolution, Catalog number: 101937, 1023415 & 1023423. Made in U.S.A. by Carestream H recall (Z-0179-2014) | Carestream Health Inc. | 2013-11-07 |
| DRX Revolution, Catalog #'s 1)1019397, 2) 1023415 (w/ installation warranty, US-only) and recall (Z-0132-2014) | Carestream Health Inc. | 2013-11-01 |
| DRX Revolution Mobile X-Ray System, Model DRXR-1, Verona Street Rochester, NY 14608 Catalo recall (Z-0090-2014) | Carestream Health, Inc. | 2013-10-31 |
| Carestream DRX-Revolution Mobile X-ray System. Produces radiographic images. recall (Z-0126-2014) | Carestream Health, Inc. | 2013-10-31 |
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 |