FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CARESTREAM VUE PACS VERSION 11.4 CARESTREAM VUE MOTION APPLICATION
K Number: K132824
·
Decision Feb 6, 2014
Classifications
1
FEI Numbers
609
Registration Numbers
609
Same Product Code
2221
Applicant Total
8
Review Days
150
Basic Information
- Device Name
- CARESTREAM VUE PACS VERSION 11.4 CARESTREAM VUE MOTION APPLICATION
- K Number
- K132824
- 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
- September 9, 2013
- Decision Date
- February 6, 2014
- 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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|---|---|---|---|
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| K120246 | KODAK DIRECTVIEW CR MAMMOGRAPHY SYSTEM (USING CARESTREAM CR MAMMOGRAPHY CASSETTE WITH SNP-M1 SCREEN) | Aug 28, 2012 | Substantially Equivalent |
| K111423 | CS 1600 INTRAORAL CAMERA | Mar 2, 2012 | Substantially Equivalent |
| K112321 | CS 1200 | Nov 10, 2011 | Substantially Equivalent |
| K111566 | DRYVIEW CHROMA IMAGING SYSTEM | Oct 6, 2011 | Substantially Equivalent |
| K081836 | CARESTREAM DR LONG LENGTH IMAGING SYSTEM FOR DR 7500 SYSTEM | Jul 30, 2008 | Substantially Equivalent |