C7-XR™
Catalogue number C.0.4 Software Upgrade, 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
1catalogue number
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 | 2016-03-18 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Storage | Handling environment atmospheric pressure 50 to 106 KiloPascal; Storage environment temperature -25 to 50 °C; Storage environment atmospheric pressure 50 to 106 KiloPascal; Handling environment temperature -25 to 50 °C; Handling environment humidity 10 to 95 % RH; Storage environment humidity 10 to 95 % RH |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| C.0.4 Software Upgrade | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Optis™ | St. Jude Medical | 13 |
| Optis™ | Lightlab Imaging, Inc. | 11 |
| 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 |
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.