| Primary Device ID | 00850053428500 |
| NIH Device Record Key | 6d993006-44e5-4cac-b08d-e468671d4416 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | VisiChart |
| Version Model Number | VisiChart II |
| Company DUNS | 053547238 |
| Company Name | TOPCON MEDICAL SYSTEMS, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850053428500 [Primary] |
| HOS | Projector, Ophthalmic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-06-28 |
| Device Publish Date | 2023-06-20 |
| 00850053428609 - OC-2200 | 2024-06-05 OC-2200 CHAIR-CHOCLT-GV 110/120V; Ophthalmic examination chair |
| 00850053428616 - IS-5500 | 2024-06-05 IS-5500 OPHTHALMIC STAND GRAND VISION 110V; AC-Powered Ophthalmic Instrument Stand |
| 00850053428517 - IS-6500 | 2024-05-27 IS-6500 OPHTHALMIC INSTRUMENT STAND 110V |
| 00850053428524 - IS-6500 | 2024-05-27 IS-6500 OPHTHALMIC INSTRUMENT STAND 220V |
| 00850053428548 - OC-2200 | 2024-03-20 OC-2200 CHAIR BLACK 120V LOW WIRELESS; Ophthalmic examination chair |
| 00850053428555 - OC-2200 | 2024-03-20 OC-2200 CHAIR CHARCOAL 120V LOW WIRELESS; Ophthalmic examination chair |
| 00850053428562 - OC-2300 | 2024-03-20 OC-2300 CHAIR BLACK 120V LOW WIRELESS; Ophthalmic examination chair |
| 00850053428579 - OC-2300 | 2024-03-20 OC-2300 CHAIR CHARCOAL 120V LOW WIRELESS; Ophthalmic examination chair |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() VISICHART 77063349 3310817 Live/Registered |
Topcon Medical Systems, Inc. 2006-12-13 |