Duns Number:687797852
Device Description: New retractable feed tray provides space savings for small dark rooms.Exceptionally quiet New retractable feed tray provides space savings for small dark rooms.Exceptionally quiet operation.1. Microprocessor controlled.2. High-quality film image3. The control panel digitally displays.4. Water level sensor prevents overflowing of tank.5. Stand-by mode for energy saving.
Catalog Number
-
Brand Name
Automatic Radiographic Film Processor
Version/Model Number
JP-33
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
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
-
Product Code
IXW
Product Code Name
Processor, Radiographic-Film, Automatic
Public Device Record Key
9e76f1fe-5e76-4e46-8556-67f4d97adeb9
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
August 01, 2017
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 | 36 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 11 |