Device product
iVue 500 with iScan, D216606. Product non-contact, high resolution tomographic imaging device. It is intended for in vivo imaging, axial cross-sectional and three-dimensional imaging and measurement of anterior and posterior ocular structures, including retina, retinal nerve fiber layer, ganglion cell complex (GCC), optic disc, cornea, and anterior chamber of the eye. The iVue 500 with normative database is a quantitative tool for the comparison of retina, retinal nerve fiber layer, ganglion cell complex, and optic disc measurements to a database of known normal subjects. The iVue 500 with normative database is indicated for use as a device to aid in the diagnosis, documentation, and management of ocular health and diseases in the adult population.
Z-0010-2018
Product summary
- Firm
- Optovue, Inc.
- Event
- Event 77776
- Status
- Terminated
- Classification
- Class II
- Quantity
- 326 devices
- Official record key
device-enforcement:Z-0010-2018
Official wording
Reason: FDA determined that a 510(k) is needed for the Vault Mapping software (also known as Lens Fitting).
Code information: Cat No. 700-49428-001 (GTIN - N/A), 700-49428-002 (GTIN 00858848006315), 700-49428-003 (GTIN 00858848006018).
Distribution pattern: US Nationwide Distribution in the states of - AL, AR, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, WA, WI, & WV.
Derived failure modes
-
Unknown
FDA determined that a 510(k) is needed for the Vault Mapping software (also known as Lens Fitting).