Phantom, Anthropomorphic, Radiographic
An anthropomorphic radiographic phantom is a test device designed to simulate the physical and radiographic properties of the human body, used to evaluate imaging system performance, optimize exposure parameters, and train radiographic personnel. It is classified as FDA Class 1, the lowest risk category, subject only to general controls. The product code is IXG, regulated under 21 CFR 892.1950, within the Radiology medical specialty. This device is GMP exempt.
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Basic Information
- Product Code
- IXG
- Device Class
- FDA class 1
- Regulation Number
- 892.1950
- Medical Specialty
- Radiology
- Review Panel
- RA
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K913243 | BENNETT X-RAY HORIZ RADIO FLOAT/HI-LO ELEV TABLE | Sep 19, 1991 | Substantially Equivalent | Bennett X-Ray Corp. |
| K852528 | BONE DENSITY CT PHANTOM | Sep 26, 1985 | Substantially Equivalent | Computerized Imaging Reference Systems, Inc. |
| K840131 | COMPUTED TOMOGRAPHY CALIBRATION PHANT | Feb 21, 1984 | Substantially Equivalent | Imatron, Inc. |
| K834465 | SERIES OF DIAGNOSTIC PHANTOMS | Feb 21, 1984 | Substantially Equivalent | Cirs, Inc. |
FEI Numbers
This FDA classification entry is associated with 22 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 22 registration numbers. Click on an entry to view related FDA registrations.