Duns Number:024972857
Device Description: The NaviCam Capsule Endoscope System with NaviCam Stomach Capsule (“NaviCam Stomach System The NaviCam Capsule Endoscope System with NaviCam Stomach Capsule (“NaviCam Stomach System” in short), is a novel endoscopic capsule imaging system intended to obtain images of the stomach. It differs from passive capsule endoscopy systems in that it uses magnetic fields to allow the position of the capsule to be controlled by an operator.
Catalog Number
-
Brand Name
NaviCam Capsule Endoscope System
Version/Model Number
Stomach Capsule/AKEM-11SW
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
DEN190037
Product Code
QKZ
Product Code Name
Magnetically Maneuvered Capsule Endoscopy System
Public Device Record Key
c8f817da-533e-46b3-8b76-56f17612f750
Public Version Date
December 16, 2020
Public Version Number
1
DI Record Publish Date
December 08, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 10 |