The following data is part of a premarket notification filed by Totoku Electric Co., Ltd with the FDA for Monochrome Digital Mammography Lcd Monitor Ms33i2.
| Device ID | K112145 |
| 510k Number | K112145 |
| Device Name: | MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS33I2 |
| Classification | System, Image Processing, Radiological |
| Applicant | TOTOKU ELECTRIC CO., LTD 300 OYA Ueda, Nagano, JP 386-0192 |
| Contact | Tsukasa Tashiro |
| Correspondent | Tsukasa Tashiro TOTOKU ELECTRIC CO., LTD 300 OYA Ueda, Nagano, JP 386-0192 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-07-26 |
| Decision Date | 2011-11-07 |
| Summary: | summary |