FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DOME CX DIGITAL FLAT-PANEL DISPLAY SYSTEM, MODELS C2 AND C5I
K Number: K032202
·
Decision Aug 1, 2003
Classifications
1
FEI Numbers
609
Registration Numbers
609
Same Product Code
2221
Applicant Total
4
Review Days
14
Basic Information
- Device Name
- DOME CX DIGITAL FLAT-PANEL DISPLAY SYSTEM, MODELS C2 AND C5I
- K Number
- K032202
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- PLANAR SYSTEMS, INC.
- Date Received
- July 18, 2003
- Decision Date
- August 1, 2003
- Product Code
- LLZ
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- Y
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 PLANAR SYSTEMS, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K061018 | PLANAR DOME EX LINE MODEL DOME E2C | Apr 28, 2006 | Substantially Equivalent |
| K060136 | PLANAR DOME EX SERIES DIGITAL FLAT-PANEL DISPLAY SYSTEM, MODEL E4C COLOR | Jan 31, 2006 | Substantially Equivalent |
| K032638 | DOME CX DIGITAL FLAT-PANEL DISPLAY SYSTEM MODEL, C3 COLOR AND C3 GRAY | Sep 11, 2003 | Substantially Equivalent |