Duns Number:146920025
Device Description: Parts of the internal anatomy move relative to external or bony landmarks. The BATCAM 7.0 Parts of the internal anatomy move relative to external or bony landmarks. The BATCAM 7.0 MultiProbe Ultrasound Localization and Positioning System resolves this movement by permitting it’s users to locate and position the part of the internal anatomy that is being treated as accurately and correctly as possible for the delivery of conformal radiation without relying on external structures.
Catalog Number
-
Brand Name
BATCAM MultiProbe, 115V, Terason 3000
Version/Model Number
209678
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K070611
Product Code
IYE
Product Code Name
Accelerator, Linear, Medical
Public Device Record Key
f4019348-4ef5-4d16-841a-41dc3d1521aa
Public Version Date
August 16, 2018
Public Version Number
4
DI Record Publish Date
October 31, 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 | 35 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 15 |