FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CERNER PROVISION WORKSTATION
K Number: K070394
·
Decision Mar 27, 2007
Classifications
1
FEI Numbers
609
Registration Numbers
609
Same Product Code
2221
Applicant Total
7
Review Days
46
Basic Information
- Device Name
- CERNER PROVISION WORKSTATION
- K Number
- K070394
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- CERNER CORP.
- Date Received
- February 9, 2007
- Decision Date
- March 27, 2007
- 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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|---|---|---|---|
| K121758 | CERNER FETALINK+(VERSION1.0) | Oct 9, 2012 | Substantially Equivalent |
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| K091251 | CERNER FETALINK (VERSION 1.0) | Aug 25, 2009 | Substantially Equivalent |
| K091032 | CERNER PROVISION WORKSTATION (VERSION 2.5) | Jun 22, 2009 | Substantially Equivalent |
| K000770 | PROVIEW MEDICAL IMAGE DISPLAY MODULE | May 16, 2000 | Substantially Equivalent |
| K955000 | REMOTE VIEWING SYSTEM MEDICAL IMAGE DISPLAY MODULE | Jan 26, 1996 | Substantially Equivalent |