Duns Number:317138956
Device Description: The Pentacam Scheimpflug Camera is a non-invasive, diagnostic system created to takephotog The Pentacam Scheimpflug Camera is a non-invasive, diagnostic system created to takephotographs of the anterior segment of the eye, table mounted and AC powered. The systemis based on the Scheimpflug Principle for Slit Image photography. The device consists of ameasurement unit, power supply and a CPU. The measuring system uses blue light (UV-free)given to a slit to illuminate the eye, and a CCD-Camera for photography. The measuringsystem offers the possibility of automatically rotation to get photographs of every part of theeye. The system calculates from the photos a 3D-model1 of the eye
Catalog Number
-
Brand Name
Pentacam HR
Version/Model Number
70900
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
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
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K030719
Product Code
MXK
Product Code Name
Device,Analysis,Anterior Segment
Public Device Record Key
1a5dbe42-41c8-41ef-810f-eb604660b711
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 01, 2016
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7 |