The following data is part of a premarket notification filed by Acist Medical Systems, Inc. with the FDA for Acist Rxi Mini System.
| Device ID | K172216 |
| 510k Number | K172216 |
| Device Name: | ACIST RXi Mini System |
| Classification | Amplifier And Signal Conditioner, Transducer Signal |
| Applicant | ACIST Medical Systems, Inc. 7905 Fuller Road Eden Prairie, MN 55344 |
| Contact | Amber Luker |
| Correspondent | Amber Luker ACIST Medical Systems, Inc. 7905 Fuller Road Eden Prairie, MN 55344 |
| Product Code | DRQ |
| CFR Regulation Number | 870.2060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-07-24 |
| Decision Date | 2017-08-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 40841716101753 | K172216 | 000 |
| 30841716101817 | K172216 | 000 |
| 30841716101800 | K172216 | 000 |
| 30841716101770 | K172216 | 000 |
| 40841716101586 | K172216 | 000 |