The following data is part of a premarket notification filed by Totoku Electric Co., Ltd. with the FDA for 21.3 (54 Cm) Monochrome Digital Mammography Lcd Monitor, Model Ms3112 (mdl2128a).
| Device ID | K090947 |
| 510k Number | K090947 |
| Device Name: | 21.3 (54 CM) MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR, MODEL MS3112 (MDL2128A) |
| 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 | 2009-04-03 |
| Decision Date | 2010-08-16 |
| Summary: | summary |