FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇼 Taiwan
MEDICAL DISPLAY, MDC1900-1LG (1LR)
K Number: K061305
·
Decision May 25, 2006
Classifications
1
FEI Numbers
599
Registration Numbers
599
Same Product Code
2271
Applicant Total
6
Review Days
15
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Basic Information
- Device Name
- MEDICAL DISPLAY, MDC1900-1LG (1LR)
- K Number
- K061305
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Chi Lin Technology Co., Ltd.
- Date Received
- May 10, 2006
- Decision Date
- May 25, 2006
- 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 Chi Lin Technology Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K063269 | 5MP MEDICAL MONOCHROME REFERENCE DISPLAY, MODEL MDM2010-5NC | May 23, 2007 | Substantially Equivalent |
| K063579 | 2MP MEDICAL COLOR REFERENCE DISPLAY, MODEL MDC2130-2HC | Dec 14, 2006 | Substantially Equivalent |
| K063289 | 2MP MEDICAL MONOCHROME REFERENCE DISPLAY, MODEL MDM2130-2NC | Nov 16, 2006 | Substantially Equivalent |
| K063266 | 3MP MEDICAL MONOCHROME REFERENCE DISPLAY, MODEL MDM2130-3NC | Nov 9, 2006 | Substantially Equivalent |
| K061303 | MEDICAL DISPLAY, MODELS MDM 1900-1NG AND MDM 1900-1NR | May 25, 2006 | Substantially Equivalent |