FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ILUMIEN OPTIS System, OPTIS Integrated System, OPTIS Mobile System, with AptiVue Imaging Software version E.6
K Number: K232386
·
Decision Sep 8, 2023
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
45
Applicant Total
57
Review Days
30
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
- ILUMIEN OPTIS System, OPTIS Integrated System, OPTIS Mobile System, with AptiVue Imaging Software version E.6
- K Number
- K232386
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 892.1560
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- ABBOTT MEDICAL
- Date Received
- August 9, 2023
- Decision Date
- September 8, 2023
- Product Code
- NQQ
- Advisory Committee
- Radiology
- Review Advisory Committee
- CV
- 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
Other Clearances by ABBOTT MEDICAL
| K Number | Device Name | ||
|---|---|---|---|
| K253459 | OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001) | Apr 24, 2026 | Substantially Equivalent |
| K260212 | EnSite X EP System | Apr 20, 2026 | Substantially Equivalent |
| K253907 | Disposable Radiofrequency Cannula | Apr 16, 2026 | Substantially Equivalent |
| K260499 | Amplatzer Trevisio Intravascular Delivery System; 9-ATV06F45/609-ATV07F45/609-ATV07F45/809-ATV08F45/609-ATV08F45/809-ATV09F45/809-ATV10F45/809-ATV12F45/80 | Mar 13, 2026 | Substantially Equivalent |
| K252512 | Armada 14 NC PTA Catheter | Feb 13, 2026 | Substantially Equivalent |
| K253516 | Assert-IQ (DM5100) | Dec 18, 2025 | Substantially Equivalent |
| K252417 | Amplatzer Piccolo Delivery System (9-PDS-04F-045) | Dec 17, 2025 | Substantially Equivalent |
| K253232 | Seguin Annuloplasty Ring | Oct 29, 2025 | Substantially Equivalent |
| K250031 | Amplatzer Guidewire | Oct 3, 2025 | Substantially Equivalent |
| K252013 | EnSite X EP System | Sep 25, 2025 | Substantially Equivalent |