FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
OmegaAI Image Viewer
K Number: K222476
·
Decision Nov 17, 2022
Classifications
1
FEI Numbers
599
Registration Numbers
599
Same Product Code
2271
Applicant Total
6
Review Days
93
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Basic Information
- Device Name
- OmegaAI Image Viewer
- K Number
- K222476
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ramsoft, Inc.
- Date Received
- August 16, 2022
- Decision Date
- November 17, 2022
- 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 Ramsoft, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K141881 | RAPIDRESULTS | Oct 31, 2014 | Substantially Equivalent |
| K052460 | POWERSERVER, POWERREADER, GATEWAY AND POWERCACHE | Sep 21, 2005 | Substantially Equivalent |
| K031562 | RAMSOFT PACS, MODEL 3.0 | Aug 11, 2003 | Substantially Equivalent |
| K982563 | ULTRAPRO MODEL 98 | Oct 6, 1998 | Substantially Equivalent |
| K942917 | ULTRAPRO WORKSTATION | Nov 14, 1994 | Substantially Equivalent |