The following data is part of a premarket notification filed by Totoku Electric Co., Ltd with the FDA for 5m Monochrome Digital Mammography Lcd Monitor Mdl2116a (me551i2).
| Device ID | K061447 |
| 510k Number | K061447 |
| Device Name: | 5M MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MDL2116A (ME551I2) |
| Classification | System, Image Processing, Radiological |
| Applicant | TOTOKU ELECTRIC CO., LTD 300 OYA, UEDA Nagano, JP 386-0192 |
| Contact | Mikio Hasegawa |
| Correspondent | Mikio Hasegawa 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 | 2006-05-25 |
| Decision Date | 2006-07-21 |
| Summary: | summary |