DELTAMANAGER
System, Tomography, Computed, Emission
MEDIMAGE, INC.
The following data is part of a premarket notification filed by Medimage, Inc. with the FDA for Deltamanager.
Pre-market Notification Details
| Device ID | K933321 |
| 510k Number | K933321 |
| Device Name: | DELTAMANAGER |
| Classification | System, Tomography, Computed, Emission |
| Applicant | MEDIMAGE, INC. 6276 JACKSON RD. STE. G Ann Arbor, MI 48103 -9579 |
| Contact | William C Forgacs |
| Correspondent | William C Forgacs MEDIMAGE, INC. 6276 JACKSON RD. STE. G Ann Arbor, MI 48103 -9579 |
| Product Code | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-07-16 |
| Decision Date | 1993-11-03 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00861333000309 | K933321 | 000 |
Trademark Results [DELTAMANAGER]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DELTAMANAGER 74159189 1687700 Live/Registered |
MedImage, Inc. 1991-04-22 |
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