Transonic
31 catalogue numbers from H6FX, listed by Transonic Systems, Inc., United States, under Computer, Diagnostic, Pre-Programmed, Single-Function. 5 manufacturers in China are registered for this product code.
5manufacturers in China registered for this device type
31catalogue numbers in this listing
5510(k) clearances naming this product code
1recall
Who Else Makes It
Concentrated in Guangdong (4), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
| Orantech Inc. | Shenzhen | Guangdong | Contract manufacturer | 40 |
| Shenzhen Comen Medical Instruments Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 24 |
Record
| Listed by | Transonic Systems, Inc., United States |
|---|---|
| FDA product code | DXG |
| Device type | Computer, Diagnostic, Pre-Programmed, Single-Function |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1435 |
| Establishment | Manufacturer |
| 510(k) | K080116 |
| Record published | 2016-04-28 |
| Record revised | 2021-11-05 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Distribution end date | 2021-10-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| H6FX | In distribution | |
| HC2T | In distribution | |
| HCE101 | In distribution | |
| HCS3011-5 | In distribution | |
| HCM101 | In distribution | |
| HCS3002-5 | In distribution | |
| HFW1000 | In distribution | |
| H7FX | In distribution | |
| H9FX | In distribution | |
| HCS3021-5 | In distribution | |
| HCP01 | In distribution | |
| HCS3012-5 | In distribution | |
| HCS3012-5 | Withdrawn | |
| HCS3012 | Withdrawn | |
| HC2T | Withdrawn | |
| HCS3021 | Withdrawn | |
| HCS3011 | Withdrawn | |
| HC2TP | Withdrawn | |
| HFW1000 | Withdrawn | |
| HCS3002 | Withdrawn | |
| HCM103 | Withdrawn | |
| HCS3021-5 | Withdrawn | |
| H7FX | Withdrawn | |
| H6FX | Withdrawn | |
| HCM102 | Withdrawn | |
| HCP01 | Withdrawn | |
| H9FX | Withdrawn | |
| HCE101 | Withdrawn | |
| HCM101 | Withdrawn | |
| HCS3002-5 | Withdrawn | |
| HCS3011-5 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| LiDCO Ltd | Lidco Ltd. | 133 |
| LiDCO | Lidco Ltd. | 32 |
| Computer, Diagnostic, Pre-Programmed, Single-Function | Edwards Lifesciences Technology Sarl | 23 |
| Retia Medical | Retia Medical, LLC | 17 |
| EV1000 | Edwards Lifesciences Technology Sarl | 11 |
| Computer, Diagnostic, Pre-Programmed, Single-Function | GE Healthcare Finland OY | 5 |
| Pediasat | Edwards Lifesciences Technology Sarl | 4 |
| LiDCO | Masimo Corporation | 4 |
| ICU Medical | ICU Medical, Inc | 4 |
| Cnap® Monitor 500 HD | Cnsystems Medizintechnik GmbH | 4 |
| Vigileo | Edwards Lifesciences Technology Sarl | 3 |
| Starling | Cheetah Medical (Israel) Ltd | 3 |
Showing 12 of 39. All products under Computer, Diagnostic, Pre-Programmed, Single-Function
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K134051 | 2015-01-29 |
| K134035 | 2014-09-17 |
| K140017 | 2014-09-16 |
| K113821 | 2012-09-07 |
| K080116 | 2008-09-08 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Transonic Systems, Inc. | 510(k) number | 2013-03-28 | Class II | Component design/selection | Transonic Systems Inc. have received complaints of blood leakage involving the AV Loop Kit. | 195 units total (140 units Domestic, 55 units Foreign) | 2014-03-05 |
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.