FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Welch Allyn RetinaVue Network REF 901108 PACS Medical Image System
K Number: K181016
·
Decision Jul 16, 2018
Classifications
1
FEI Numbers
31
Registration Numbers
32
Same Product Code
51
Applicant Total
111
Review Days
90
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
- Welch Allyn RetinaVue Network REF 901108 PACS Medical Image System
- K Number
- K181016
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Welch Allyn, Inc.
- Date Received
- April 17, 2018
- Decision Date
- July 16, 2018
- Product Code
- NFJ
- Advisory Committee
- Radiology
- Review Advisory Committee
- OP
- 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 |
|---|---|---|---|
| NFJ | System, Image Management, Ophthalmic | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NFJ), ordered by most recent decision date.
Harmony Referral System with Harmony OCT Viewer (Octave)
FDA 510(k)
FDA Class 2
·Radiology
iCare ALTIUS CW
FDA 510(k)
FDA Class 2
·Radiology
IMAGEnet6 Ophthalmic Data System
FDA 510(k)
FDA Class 2
·Radiology
CALLISTO eye
FDA 510(k)
FDA Class 2
·Radiology
Harmony
FDA 510(k)
FDA Class 2
·Radiology
CALLISTO eye
FDA 510(k)
FDA Class 2
·Radiology
Other Clearances by Welch Allyn, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K243598 | Welch Allyn Connex® 360 (Multiple) | Jul 13, 2025 | Substantially Equivalent |
| K241411 | Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM) | Dec 20, 2024 | Substantially Equivalent |
| K223381 | iExaminer System with Panoptic Plus | Mar 15, 2023 | Substantially Equivalent |
| K212473 | Welch Allyn Connex Central Station | Oct 28, 2022 | Substantially Equivalent |
| K191013 | Welch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometry option | Sep 10, 2019 | Substantially Equivalent |
| K171621 | Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex Integrated Wall System, 901060 Vital Signs Monitor | Jun 30, 2017 | Substantially Equivalent |
| K142356 | Connex Spot Monitor,901058 Vital Signs Monitor Core | Dec 19, 2014 | Substantially Equivalent |
| K132807 | MONITORING STATION, CONNEX(R) CENTRAL STATION (CS) | Jan 31, 2014 | Substantially Equivalent |
| K132808 | VITAL SIGNS MONITOR, CONNEX VITAL SIGNS MONITOR | Nov 20, 2013 | Substantially Equivalent |
| K131573 | CP150 ELECTROCARDIOGRAPH | Jul 3, 2013 | Substantially Equivalent |