Optis™
11 catalogue numbers from Mobile System, listed by Lightlab Imaging, Inc., United States, under System, Imaging, Optical Coherence Tomography (Oct). 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
11catalogue numbers in this listing
8510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (1), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Micro-Tech (Nanjing) Co., Ltd. | Nan Jing | Jiangsu | Contract manufacturer | 49 |
| Shenzhen Vivolight Medical Device&Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 4 |
Record
| Listed by | Lightlab Imaging, Inc., United States |
|---|---|
| FDA product code | NQQ |
| Device type | System, Imaging, Optical Coherence Tomography (Oct) |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1560 |
| Record published | 2015-12-21 |
| Record revised | 2019-02-11 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
| Storage | Storage environment humidity 10 to 95 % RH; Special storage condition: Keep Dry; Handling environment humidity 10 to 95 % RH; Storage environment temperature -20 to 50 °C; Handling environment temperature -20 to 50 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Mobile System | In distribution | |
| Mobile System | In distribution | |
| Integrated System | In distribution | |
| Software Upgrade | In distribution | |
| Metallic Stent Optimization Software | In distribution | |
| Mobile System | In distribution | |
| Mobile System | In distribution | |
| C408653 | In distribution | |
| Integrated System E.2 Software | In distribution | |
| Integrated System | In distribution | |
| C408663 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Optis™ | St. Jude Medical | 13 |
| Luminscan(TM) Disposable Imaging Kit | Micro-Tech (Nanjing) Co., Ltd. | 9 |
| Ilumien™ | Lightlab Imaging, Inc. | 6 |
| Cornaris Intravascular Imaging System | Shenzhen Vivolight Medical Device&Technology Co., Ltd. | 2 |
| VivoSight | Michelson Diagnostics Ltd | 2 |
| AptiVue™ | Lightlab Imaging, Inc. | 2 |
| Pantheris | Avinger, Inc. | 2 |
| NvisionVLE Imaging Console | Ninepoint Medical, Inc. | 1 |
| NvisionVLE Imaging Console Refurbished | Ninepoint Medical, Inc. | 1 |
| NvisionVLE Marking Probe 17mm | Ninepoint Medical, Inc. | 1 |
| NvisionVLE Low Profile Imaging Probe, 20mm Working Distance | Ninepoint Medical, Inc. | 1 |
| S-Series OCT | Perimeter Medical Imaging AI, Inc. | 1 |
Showing 12 of 56. All products under System, Imaging, Optical Coherence Tomography (Oct)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K160878 | 2016-06-29 |
| K152120 | 2015-10-29 |
| K151286 | 2015-08-05 |
| K150878 | 2015-07-15 |
| K150237 | 2015-05-05 |
| K123369 | 2013-01-30 |
| K111201 | 2011-08-10 |
| K093857 | 2010-04-30 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.