Acist RXi® Mini Processing Unit
RXi Mini Processing Unit p/n 701630-002
4manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
Who Else Makes It
All of them in Guangdong. 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Amphenol Alden Products Company | Shenzhen | Guangdong | Contract manufacturer | 24 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| Orantech Inc. | Shenzhen | Guangdong | Contract manufacturer | 40 |
Record
| Listed by | Acist Medical Systems, Inc., United States |
|---|---|
| FDA product code | DRQ |
| Device type | Amplifier And Signal Conditioner, Transducer Signal |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2060 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K172216 |
| Record published | 2017-09-27 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Packaging | Shipper box |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 018593 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Labsystem™ PRO | Boston Scientific Corporation | 53 |
| RXi® Mini Navvus Interface Cable | Acist Medical Systems, Inc. | 3 |
| Acist RXi® Mini System Overpack | Acist Medical Systems, Inc. | 2 |
| IBP Module | Philips Medizin Systeme Böblingen GmbH | 1 |
| Acist RXi® Mini Mount | Acist Medical Systems, Inc. | 1 |
| Acist RXi® Mini Navvus Interface | Acist Medical Systems, Inc. | 1 |
| Monitor Input Cable, Mikro-Cath to EP-Tracer System | Millar LLC. | 1 |
| IDS With Intergrated MIB | Draeger Medical Systems, Inc. | 1 |
| Pressure Control Unit PCU-2000 | Millar LLC. | 1 |
| MIB II Protocol Converter | Draeger Medical Systems, Inc. | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K172216 | 2017-08-18 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.