ARTOSCAN
System, Nuclear Magnetic Resonance Imaging
BIOSOUND, INC.
The following data is part of a premarket notification filed by Biosound, Inc. with the FDA for Artoscan.
Pre-market Notification Details
| Device ID | K931022 |
| 510k Number | K931022 |
| Device Name: | ARTOSCAN |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | BIOSOUND, INC. 7990 CASTLEWAY DR. P.O. BOX 50867 Indianapolis, IN 46250 |
| Contact | Wayne Nethercutt |
| Correspondent | Wayne Nethercutt BIOSOUND, INC. 7990 CASTLEWAY DR. P.O. BOX 50867 Indianapolis, IN 46250 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-03-01 |
| Decision Date | 1993-10-07 |
Trademark Results [ARTOSCAN]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ARTOSCAN 74475127 1901647 Dead/Cancelled |
ESAOTE S.P.A. 1993-12-21 |
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