FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Merge PACS
K Number: K173475
·
Decision Dec 8, 2017
Classifications
1
FEI Numbers
599
Registration Numbers
599
Same Product Code
2271
Applicant Total
8
Review Days
29
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Basic Information
- Device Name
- Merge PACS
- K Number
- K173475
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Merge Healthcare Incorporated
- Date Received
- November 9, 2017
- Decision Date
- December 8, 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 Merge Healthcare Incorporated
| K Number | Device Name | ||
|---|---|---|---|
| K250301 | Merge Universal Viewer (MUV) | Apr 14, 2025 | Substantially Equivalent |
| K233326 | Merge Hemo, Model RCSV2 | Jun 21, 2024 | Substantially Equivalent |
| K203104 | IBM iConnect Access | Jan 26, 2021 | Substantially Equivalent |
| K192455 | Merge PACS | Oct 17, 2019 | Substantially Equivalent |
| K192276 | Merge Cardio | Sep 20, 2019 | Substantially Equivalent |
| K182290 | IBM iConnect Access | Sep 25, 2018 | Substantially Equivalent |
| K152864 | Merge Hemo | Apr 7, 2016 | Substantially Equivalent |