FDA 510(k)
FDA class 2
Unknown
🇨🇦 Canada
OTIS Optical Coherence Tomography System
K Number: K171560
·
Decision Aug 25, 2017
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
45
Applicant Total
3
Review Days
87
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
- OTIS Optical Coherence Tomography System
- K Number
- K171560
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1560
- Medical Specialty
- Radiology
- Decision
- Unknown
- Statement or Summary
- Summary
- Applicant
- Perimeter Medical Imaging, Inc.
- Date Received
- May 30, 2017
- Decision Date
- August 25, 2017
- Product Code
- NQQ
- Advisory Committee
- Radiology
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| NQQ | System, Imaging, Optical Coherence Tomography (Oct) | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NQQ), ordered by most recent decision date.
OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001)
FDA 510(k)
FDA Class 2
·Radiology
LIA Console (542-7)
FDA 510(k)
FDA Class 2
·Radiology
HyperVue Imaging System - Integrated
FDA 510(k)
FDA Class 2
·Radiology
deepLive (OSP12 + DMS)
FDA 510(k)
FDA Class 2
·Radiology
HyperVue Software
FDA 510(k)
FDA Class 2
·Radiology
OPUSWAVE Dual Sensor Imaging System
FDA 510(k)
FDA Class 2
·Radiology