ONDEMAND3D
System, Image Processing, Radiological
CYBERMED, INC.
The following data is part of a premarket notification filed by Cybermed, Inc. with the FDA for Ondemand3d.
Pre-market Notification Details
| Device ID | K070464 |
| 510k Number | K070464 |
| Device Name: | ONDEMAND3D |
| Classification | System, Image Processing, Radiological |
| Applicant | CYBERMED, INC. #504 SJ TECHNOVILLE, GASAN-DONG 60-19, GEUMCHEON-GU Seoul, KR 153-710 |
| Contact | Song N Choi |
| Correspondent | Marc M Mouser UNDERWRITERS LABORATORIES, INC. 2600 NW LAKE RD. Camas, WA 98607 -9526 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2007-02-16 |
| Decision Date | 2007-03-16 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 88000231000068 | K070464 | 000 |
| 08800023100068 | K070464 | 000 |
| 08800023100006 | K070464 | 000 |
Trademark Results [ONDEMAND3D]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ONDEMAND3D 78913546 not registered Dead/Abandoned |
CYBERMED, INC. 2006-06-21 |
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