The following data is part of a premarket notification filed by Microtek International, Inc. with the FDA for Medi-6000 Medical Image Digitizer.
| Device ID | K091288 |
| 510k Number | K091288 |
| Device Name: | MEDI-6000 MEDICAL IMAGE DIGITIZER |
| Classification | Digitizer, Image, Radiological |
| Applicant | MICROTEK INTERNATIONAL, INC. NO. 8, LANE 29 WENMING ROAD Guisan, Taoyuan, TW 33383 |
| Contact | Hui-chen Kai |
| Correspondent | Hui-chen Kai MICROTEK INTERNATIONAL, INC. NO. 8, LANE 29 WENMING ROAD Guisan, Taoyuan, TW 33383 |
| Product Code | LMA |
| CFR Regulation Number | 892.2030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-05-01 |
| Decision Date | 2009-08-14 |
| Summary: | summary |