DEVICE: IMAGE DIAGNOSTICS INC (00850977007331)
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Device Identifier (DI) Information
IMAGE DIAGNOSTICS INC
100RT
In Commercial Distribution
A100-2644
IMAGE DIAGNOSTICS, INC.
100RT
In Commercial Distribution
A100-2644
IMAGE DIAGNOSTICS, INC.
IDI,TABLE,VERT.-TILT-ROLL TABLETOP MOVEMENT,PAIN MANAGEMENT-GENERAL SURGERY-IMAGING,ASPECT 100RT,120V,TABLETOP WITH FACIAL CUTOUT,#A100-2644
Device Characteristics
| Labeling does not contain MRI Safety Information | |
| No | |
| No | |
| No | |
| No | |
| No | |
| No | |
| No | |
| No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
| GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
|---|---|---|---|---|
| 40655 | Basic diagnostic x-ray system table, powered |
A powered/programmable table that is a component of a basic diagnostic x-ray system designed to position and support a patient during a variety of routine/planar or speciality diagnostic procedures requiring the use of a diagnostic x-ray system; it is not a planar tomography nor computed tomography (CT) table. It can be a stationary or mobile unit and is made of radiolucent materials with low x-ray attenuation coefficients. It is not intended for use during interventional radiology/surgery.
|
Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| IXR | Table, Radiographic, Tilting |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| Premarket Submission Number Not Available/Not Released | |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| No storage/handling found |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
8a07e410-5201-47db-b898-00da94448450
June 15, 2023
1
June 07, 2023
June 15, 2023
1
June 07, 2023
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]| Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
|---|---|---|---|---|---|
| No Package DIs found | |||||
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| No Secondary DIs found | |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined