Computer, Diagnostic, Programmable
ADAS 3D LA License Temporary Software License
10manufacturers in China registered for this device type
57catalogue numbers in this listing
23510(k) clearances naming this product code
1recall
Who Else Makes It
Concentrated in Guangdong (7), Shanghai (2), Jiangsu (1). 4 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 |
| Jabil Circuit (Shanghai) Ltd. | Shanghai | Shanghai | Contract manufacturer | 31 |
| Amphenol Alden Products Company | Shenzhen | Guangdong | Contract manufacturer | 24 |
| Dongguan Ergotron Precision Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 2 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
| Shenzhen BelterHealthMeasurementAndAnalysisTechnologyCo.,Ltd | Shenzhen | Guangdong | Manufacturer | 7 |
| Philips (China) Investment Co., Ltd. Philips Healthcare – Shanghai CDC | Shanghai | Shanghai | Specification developer | 6 |
| Shenzhen Carewell Electronics Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 2 |
Record
| Listed by | St. Jude Medical, United States |
|---|---|
| FDA product code | DQK |
| Device type | Computer, Diagnostic, Programmable |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1425 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K242016 |
| Record published | 2015-04-16 |
| Record revised | 2026-07-21 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
| Storage | Special storage condition: Store at room temperature in a dry place. |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| C12962 | In distribution | |
| C12664 | In distribution | |
| 12607 | In distribution | |
| C12849 | In distribution | |
| 12918 | In distribution | |
| C12933 | In distribution | |
| C12649 | In distribution | |
| ENSITE-ADAS-01 | In distribution | |
| C12507 | In distribution | |
| H701805 | In distribution | |
| C12680 | In distribution | |
| C12961 | In distribution | |
| C12916 | In distribution | |
| C12685 | In distribution | |
| C12501 | In distribution | |
| C12932 | In distribution | |
| C12618 | In distribution | |
| C12502 | In distribution | |
| C12948 | In distribution | |
| C12964 | In distribution | |
| C12607 | In distribution | |
| 12610 | In distribution | |
| ENSITE-D-ADASLA-01 | In distribution | |
| C12924 | In distribution | |
| C12910 | In distribution | |
| 12964 | In distribution | |
| C12681 | In distribution | |
| ENSITE-ADASLV-01 | In distribution | |
| C12958 | In distribution | |
| 12748 | In distribution | |
| C12686 | In distribution | |
| C12616 | In distribution | |
| C12503 | In distribution | |
| C12971 | In distribution | |
| 12905 | In distribution | |
| H702499 | In distribution | |
| C12684 | In distribution | |
| 12661 | In distribution | |
| 12660 | In distribution | |
| C12901 | In distribution | |
| 12633 | In distribution | |
| 12637 | In distribution | |
| Adapter Cable | In distribution | |
| C12908 | In distribution | |
| 12658 | In distribution | |
| 12618 | In distribution | |
| ENSITE-ADASLA-01 | In distribution | |
| C12903 | In distribution | |
| ENSITE-D-ADASLV-01 | In distribution | |
| 12603 | In distribution | |
| 12601 | In distribution | |
| C12602 | In distribution | |
| C12505 | In distribution | |
| 12664 | In distribution | |
| C12632 | In distribution | |
| C12688 | In distribution | |
| H700182 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| EnSite™ | St. Jude Medical | 177 |
| MediGuide™ | St. Jude Medical | 41 |
| AcQMap | Acutus Medical, Inc. | 38 |
| WorkMate Claris™ | St. Jude Medical | 35 |
| iLab Ultrasound Imaging System | Boston Scientific Corporation | 32 |
| Rhythmia™ Mapping System | Boston Scientific Corporation | 31 |
| Sentinel | Spacelabs Healthcare (Washington), Inc | 28 |
| Rhythmia HDx™ | Boston Scientific Corporation | 26 |
| EnSite Precision™ | St. Jude Medical | 23 |
| PathfinderSL | Spacelabs Healthcare (Washington), Inc | 22 |
| Labsystem™ PRO | Boston Scientific Corporation | 19 |
| Pathfinder SL | Spacelabs Healthcare (Washington), Inc | 16 |
Showing 12 of 228. All products under Computer, Diagnostic, Programmable
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K172396 | 2018-04-23 |
| K160210 | 2016-12-13 |
| K162643 | 2016-12-13 |
| K160218 | 2016-12-13 |
| K160187 | 2016-10-21 |
| K160186 | 2016-10-07 |
| K151911 | 2015-10-22 |
| K141050 | 2014-06-06 |
| K132073 | 2013-09-09 |
| K130727 | 2013-08-29 |
| K130594 | 2013-05-03 |
| K112688 | 2011-11-09 |
| K110549 | 2011-05-05 |
| K101328 | 2010-07-14 |
| K101667 | 2010-07-02 |
| K101419 | 2010-06-11 |
| K093942 | 2010-02-25 |
| K093583 | 2009-12-15 |
| K092810 | 2009-10-09 |
| K083328 | 2009-05-22 |
| K082467 | 2008-09-11 |
| K071818 | 2007-12-20 |
| K070902 | 2007-05-01 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2009-02-13 | Not classified | Nonconforming Material/Component | Installation problem: there is a risk that the monitor may not be adequately secured to the stand, resulting in the monitor falling off which may cause injury. | 4 units | 2009-05-04 |
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.