The following data is part of a premarket notification filed by Regulatory Management Services with the FDA for Mini Imager.
| Device ID | K950423 |
| 510k Number | K950423 |
| Device Name: | MINI IMAGER |
| Classification | Camera, Multi Format, Radiological |
| Applicant | REGULATORY MANAGEMENT SERVICES 16303 PANORAMIC WAY San Leandro, CA 94578 |
| Contact | Gary J Allsebrook |
| Correspondent | Gary J Allsebrook REGULATORY MANAGEMENT SERVICES 16303 PANORAMIC WAY San Leandro, CA 94578 |
| Product Code | LMC |
| CFR Regulation Number | 892.2040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-02-02 |
| Decision Date | 1995-05-12 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() MINI IMAGER 74362908 not registered Dead/Abandoned |
Aspect Electronics, Inc. 1993-03-01 |