Touch Ultrasound
FDA 510(k) clearance K152467 · decided 2015-12-09
Clearance details
- K-number
- K152467
- Device name
- Touch Ultrasound
- Applicant
- Carestream Health, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2015-08-31
- Decision date
- 2015-12-09
- Days to decision
- 100 days
- Clearance type
- Abbreviated
- Product code
- IYN
- Device class
- 2
- Regulation number
- 892.1550
- 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 Touch Prime, Catalog # 1738830, and Touch Prime XE, Catalog # 1738822, Ultrasou recall (Z-1052-2017) | Carestream Health Inc | 2017-01-19 |
| Carestream Touch Prime, Catalog Number 1738830, and Carestream Touch Prime XE, Catalog Num recall (Z-2217-2016) | Carestream Health Inc | 2016-07-18 |
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 |