FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SIS Software
K Number: K162830
·
Decision Feb 14, 2017
Classifications
1
FEI Numbers
599
Registration Numbers
599
Same Product Code
2271
Applicant Total
7
Review Days
130
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- SIS Software
- K Number
- K162830
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Surgical Information Sciences, Inc.
- Date Received
- October 7, 2016
- Decision Date
- February 14, 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LLZ), ordered by most recent decision date.
2D Hip Planning Software
FDA 510(k)
FDA Class 2
·Radiology
CustoMED Viewer
FDA 510(k)
FDA Class 2
·Radiology
Helion Viewer Suite
FDA 510(k)
FDA Class 2
·Radiology
CMN Capillary Function with Virtual Expert for MRI, CT and CBCT
FDA 510(k)
FDA Class 2
·Radiology
SubtleHD-PET (1.x)
FDA 510(k)
FDA Class 2
·Radiology
HipGuide (V 1.0.0.0)
FDA 510(k)
FDA Class 2
·Radiology
Other Clearances by Surgical Information Sciences, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K241083 | SIS System | Jun 14, 2024 | Substantially Equivalent |
| K230977 | SIS System | May 2, 2023 | Substantially Equivalent |
| K223032 | SIS System (Version 5.6.0) | Nov 21, 2022 | Substantially Equivalent |
| K210071 | SIS System (Version 5.1.0) | Mar 31, 2021 | Substantially Equivalent |
| K192304 | SIS Software Version 3.6.0 | Sep 13, 2019 | Substantially Equivalent |
| K183019 | SIS Software version 3.3.0 | Mar 19, 2019 | Substantially Equivalent |