The following data is part of a premarket notification filed by Array Corp. with the FDA for Film Digitzer, Model 2908 Mammo Pro.
| Device ID | K063424 |
| 510k Number | K063424 |
| Device Name: | FILM DIGITZER, MODEL 2908 MAMMO PRO |
| Classification | Digitizer, Image, Radiological |
| Applicant | ARRAY CORP. 3-42-10 YOYOGI, SHIBUYA-KU Tokyo, JP 151-0053 |
| Contact | Takashi Inami |
| Correspondent | Takashi Inami ARRAY CORP. 3-42-10 YOYOGI, SHIBUYA-KU Tokyo, JP 151-0053 |
| Product Code | LMA |
| CFR Regulation Number | 892.2030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-11-13 |
| Decision Date | 2006-12-21 |
| Summary: | summary |