Medium, Contrast, Radiologic
This device is a radiologic contrast medium, a substance administered to patients before or during imaging procedures to enhance the visibility of internal structures such as blood vessels, organs, or body cavities on x-ray, CT, or fluoroscopic images. Its classification status is currently unclassified (FDA unclassified), meaning it has not yet been assigned to Class 1, 2, or 3 through the standard classification process. The product code is KTA; no regulation number or medical specialty has been assigned. No special flags apply.
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Basic Information
- Product Code
- KTA
- Device Class
- FDA unclassified
- Medical Specialty
- Unknown
- Review Panel
- RA
- Submission Type
- 1
Device Characteristics
Unclassified Reason
1
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 8 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K800843 | MEDEFIZZ A & MEDEFIZZ B | Jun 17, 1980 | Substantially Equivalent | Medefield Pty. , Ltd. |
| K800840 | MEDEFOAM-2 | Jun 17, 1980 | Substantially Equivalent | Medefield Pty. , Ltd. |
| K800844 | MEDEBAR XL | May 30, 1980 | Substantially Equivalent | Medefield Pty. , Ltd. |
| K800842 | MEDEBAR XAC-90 | May 30, 1980 | Substantially Equivalent | Medefield Pty. , Ltd. |
| K800841 | MEDEBAR M | May 30, 1980 | Substantially Equivalent | Medefield Pty. , Ltd. |
| K800839 | MEDESCAN | May 30, 1980 | Substantially Equivalent | Medefield Pty. , Ltd. |
| K800459 | BARIUM SULFATE, USP IN SUSPENSION | May 30, 1980 | Substantially Equivalent | Central Pharmaceuticals, Inc. |
| K760736 | BARIMEX, BARIUM SULFATE COMPOUND | Nov 09, 1976 | Substantially Equivalent | C.R. Bard, Inc. |