FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
INFINITT ULite
K Number: K163290
·
Decision Mar 24, 2017
Classifications
1
FEI Numbers
609
Registration Numbers
609
Same Product Code
2221
Applicant Total
12
Review Days
122
Basic Information
- Device Name
- INFINITT ULite
- K Number
- K163290
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- INFINITT CO., LTD.
- Date Received
- November 22, 2016
- Decision Date
- March 24, 2017
- 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 INFINITT CO., LTD.
| K Number | Device Name | ||
|---|---|---|---|
| K111660 | XELIS CARDIAC | Sep 13, 2011 | Substantially Equivalent |
| K111613 | XELIS FUSION | Sep 8, 2011 | Substantially Equivalent |
| K103130 | XELIS 3D | Jul 28, 2011 | Substantially Equivalent |
| K102684 | XELIS DENTAL | Oct 1, 2010 | Substantially Equivalent |
| K082990 | INFINITT XELIS | Nov 20, 2008 | Substantially Equivalent |
| K082706 | INFINITT CARDIOLOGY PACS | Nov 6, 2008 | Substantially Equivalent |
| K052545 | INFINITT G3 PACS | Nov 8, 2005 | Substantially Equivalent |
| K052284 | REFORMAT GATEWAY | Oct 17, 2005 | Substantially Equivalent |
| K051715 | STARPACS DENTAL | Aug 2, 2005 | Substantially Equivalent |
| K041761 | RAPIDIACOLON | Jul 13, 2004 | Substantially Equivalent |