FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Artemis
K Number: K162474
·
Decision Oct 21, 2016
Classifications
1
FEI Numbers
609
Registration Numbers
609
Same Product Code
2221
Applicant Total
14
Review Days
45
Basic Information
- Device Name
- Artemis
- K Number
- K162474
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- EIGEN
- Date Received
- September 6, 2016
- Decision Date
- October 21, 2016
- 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 EIGEN
| K Number | Device Name | ||
|---|---|---|---|
| K063846 | EIGEN DSA 2000 | Jan 26, 2007 | Substantially Equivalent |
| K933115 | DIGITAL DISK RECORDER | Apr 7, 1994 | Substantially Equivalent |
| K924164 | DIGITAL DISK RECORDER W/DUALPATH ARCHIVE/30-60 OPT | Nov 23, 1992 | Substantially Equivalent |
| K923585 | DIGITAL FLUORO STORE | Oct 21, 1992 | Substantially Equivalent |
| K913012 | DIGITAL FLUORO STORE(DFS) W/NUMERICAL SUFFIXES | Sep 23, 1991 | Substantially Equivalent |
| K905111 | DIGITAL DISK RECORDER(DDR) W/NUMERICAL SUFFIXES | Jan 25, 1991 | Substantially Equivalent |
| K903821 | PSC-1 W/OTHER NUMERICAL | Nov 7, 1990 | Substantially Equivalent |
| K902927 | DIGITAL PHOTOSPOT | Aug 3, 1990 | Substantially Equivalent |
| K901956 | DIGITAL 8 W/OTHER NUMERICAL SUFFIXES (1-9, ETC.) | Jul 2, 1990 | Substantially Equivalent |
| K890745 | SC-1000 WITH SUFFIXES (SCAN CONVERTER) | Mar 14, 1989 | Substantially Equivalent |