3D I-SCAN
System, Imaging, Pulsed Echo, Ultrasonic
OPHTHALMIC TECHNOLOGIES, INC.
The following data is part of a premarket notification filed by Ophthalmic Technologies, Inc. with the FDA for 3d I-scan.
Pre-market Notification Details
| Device ID | K974522 |
| 510k Number | K974522 |
| Device Name: | 3D I-SCAN |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | OPHTHALMIC TECHNOLOGIES, INC. 377 RT 17 S Hasbrouck Heights, NJ 07604 |
| Contact | George Myers |
| Correspondent | George Myers OPHTHALMIC TECHNOLOGIES, INC. 377 RT 17 S Hasbrouck Heights, NJ 07604 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-12-02 |
| Decision Date | 1998-02-25 |
| Summary: | summary |
Trademark Results [3D I-SCAN]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 3D I-SCAN 74640244 2204673 Dead/Cancelled |
OPHTHALMIC TECHNOLOGIES INC. 1995-03-01 |
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