Duns Number:713565195
Device Description: The FUJIFILM ultrasonic processor SP-900 is intended to be used in combination with FUJIFI The FUJIFILM ultrasonic processor SP-900 is intended to be used in combination with FUJIFILM Ultrasonic Probe, video processor, light source, monitor, recorder, and various peripheral devices.The product is intended to provide ultrasonic images of the gastrointestinal tract, biliary and pancreatic ducts and surrounding organs, airways and tracheobronchial tree for observation, recording and to aid in diagnosis during endoscopic evaluation.Modes of Operation: B-mode
Catalog Number
-
Brand Name
FUJIFILM
Version/Model Number
SP-900
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
-
Product Code
IYO
Product Code Name
System, Imaging, Pulsed Echo, Ultrasonic
Public Device Record Key
ab7f0569-5c8e-4efe-8e2d-7a3fe8740c11
Public Version Date
June 13, 2022
Public Version Number
4
DI Record Publish Date
February 23, 2018
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 | 43 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 324 |
| 3 | A medical device with high risk that requires premarket approval | 1 |