CLISIS SYSTEMS - It is an R&F remote controlled table, that can be - GENERAL MEDICAL MERATE SPA

Duns Number:428658934

Device Description: It is an R&F remote controlled table, that can be used as a traditional R&F remote tilting It is an R&F remote controlled table, that can be used as a traditional R&F remote tilting table or it is possible to perform examination with detector directly in contact with the patient by using in combination the optional: Overhead Tube Suspension, Wall Stand and 2nd Wi-Fi detector.

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More Product Details

Catalog Number

-

Brand Name

CLISIS SYSTEMS

Version/Model Number

CLISIS EXEL DRF

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

K213081

Product Code Details

Product Code

KXJ

Product Code Name

Table, Radiologic

Device Record Status

Public Device Record Key

deffbe5a-1ed3-49f0-9676-45a5618d2faf

Public Version Date

December 23, 2021

Public Version Number

4

DI Record Publish Date

July 11, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"GENERAL MEDICAL MERATE SPA" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 6
2 A medical device with a moderate to high risk that requires special controls. 13