Who else makes this device?

Name: Navik 3D
Brand: Navik 3D

Cardiovascular › DiagnosticComputer, Diagnostic, Programmable

Navik 3d

Navik 3D™ is a multi-component computer system that utilizes image processing methods to provide three-dimensional (3D) location of catheters in real-time from acquired two-dimensional (2D)…

Registry build 21.09.26

Navik 3D™ is a multi-component computer system that utilizes image processing methods to provide three-dimensional (3D) location of catheters in real-time from acquired two-dimensional (2D) fluoroscopic (fluoro) images. In addition, body surface electrocardiogram (ECG) and intracardiac electrogram (EGM) signals obtained from the patient recording and monitoring systems that already exist in the electrophysiology (EP) lab are digitized and displayed. Navik 3D utilizes data points from 3D catheter location and ECG-intracardiac EGM signals and uses this information to create and display 3D maps of the human heart. It does not require special catheters or patches, specially trained technicians, or fluoroscopy exposure beyond standard of care.

10manufacturers in China registered for this device type

1catalogue number

1510(k) clearance

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.

Chinese manufacturers registered for FDA product code DQK
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

Regulatory record for Navik 3D
Listed by	Apn Health, LLC, United States
FDA product code	DQK
Device type	Computer, Diagnostic, Programmable
Device class	Class 2
Regulation	21 CFR 870.1425
510(k)	K152160
Record published	2018-02-12
Record revised	2018-07-06 (version 3)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Label carries	manufacturing date, serial number
Storage	Handling environment temperature -4 to 140 °F; Handling environment humidity 8 to 90 % RH

Catalogue Numbers

Catalogue numbers for Navik 3D
Catalogue number	Size	Status
Navik 3D v2.0		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
EnSite™	St. Jude Medical	177
Computer, Diagnostic, Programmable	St. Jude Medical	57
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

Showing 12 of 228. All products under Computer, Diagnostic, Programmable

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K152160	2016-02-23

Recalls Naming This Product

1 recall names this product by its own identifier, the 510(k) it is cleared under.

Recalls naming the identifiers of Navik 3D
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity
Apn Health, LLC	510(k) number	2023-11-07	Class III	Process control	IFU update	1 unit

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.