FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CARESTREAM PACS
K Number: K110919
·
Decision Oct 20, 2011
Classifications
1
FEI Numbers
609
Registration Numbers
609
Same Product Code
2221
Applicant Total
18
Review Days
202
Basic Information
- Device Name
- CARESTREAM PACS
- K Number
- K110919
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- CARESTREAM HEALTH, INC.
- Date Received
- April 1, 2011
- Decision Date
- October 20, 2011
- Product Code
- LLZ
- 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 |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | FDA class 2 | Radiology |
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Other Clearances by CARESTREAM HEALTH, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K160723 | OnSight 3D Extremity System | Aug 30, 2016 | Substantially Equivalent |
| K153103 | CARESTREAM Vue PACS | Feb 12, 2016 | Substantially Equivalent |
| K152467 | Touch Ultrasound | Dec 9, 2015 | Substantially Equivalent |
| K153142 | Carestream DRX-1 System with DRX Plus 4343 Detectors | Nov 25, 2015 | Substantially Equivalent |
| K151774 | CARESTREAM Vue Motion | Sep 21, 2015 | Substantially Equivalent |
| K150342 | Touch Ultrasound | May 8, 2015 | Substantially Equivalent |
| K140271 | TABLET VIEWER SOFTWARE FOR IMAGE SUITE | Apr 1, 2014 | Substantially Equivalent |
| K133442 | BONE SUPPRESSION SOFTWARE | Mar 11, 2014 | Substantially Equivalent |
| K130567 | DR LONG LENGTH IMAGING SOFTWARE | Jun 11, 2013 | Substantially Equivalent |
| K122523 | CARESTREAM VUE PACS | Oct 23, 2012 | Substantially Equivalent |