IRIS INTELLIGENT RETINAL IMAGING SYSTEM
FDA 510(k) clearance K141922 · decided 2015-02-27
Clearance details
- K-number
- K141922
- Device name
- IRIS INTELLIGENT RETINAL IMAGING SYSTEM
- Applicant
- Intelligent Retinal Imaging Systems, LLC
- Decision
- Substantially Equivalent
- Date received
- 2014-07-16
- Decision date
- 2015-02-27
- Days to decision
- 226 days
- Clearance type
- Traditional
- Product code
- NFJ
- Device class
- 2
- Regulation number
- 892.2050
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Andover, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.