The following data is part of a premarket notification filed by Aloka Co., Ltd. with the FDA for Ultrasound Data Analysis System, Model Das-rs1.
| Device ID | K081843 |
| 510k Number | K081843 |
| Device Name: | ULTRASOUND DATA ANALYSIS SYSTEM, MODEL DAS-RS1 |
| Classification | System, Image Processing, Radiological |
| Applicant | ALOKA CO., LTD. 10 FAIRFIELD BLVD. Wallingford, CT 06492 |
| Contact | Richard Cehovsky |
| Correspondent | Tamas Borsai TUV RHEINLAND OF NORTH AMERICA, INC. 12 COMMERCE RD. Newton, CT 06470 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2008-06-30 |
| Decision Date | 2008-07-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04562122958639 | K081843 | 000 |
| 04573596213759 | K081843 | 000 |