Test-Pattern, Radiographic
A radiographic test pattern is a phantom or resolution target used to evaluate and verify the spatial resolution, contrast, and other performance characteristics of radiographic imaging systems as part of quality assurance testing. It is classified as FDA Class 1, the lowest risk category, subject only to general controls. The product code is IXF, regulated under 21 CFR 892.1940, within the Radiology medical specialty. This device is GMP exempt.
Research product code IXF in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- IXF
- Device Class
- FDA class 1
- Regulation Number
- 892.1940
- 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 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K865100 | TISSUE-EQUIVALENT BREAST SIMULATOR | Jan 12, 1987 | Substantially Equivalent | Computerized Imaging Reference Systems, Inc. |
| K851812 | DIGITAL SUBTRACTION ANTIOGRAPHY PHANTOM 76-700/711 | Jun 05, 1985 | Substantially Equivalent | Victoreen, Inc. |
| K834482 | TISSUE MIMICKING ULTRASOUND PHANTOMS | Jan 25, 1984 | Substantially Equivalent | Radiation Measurements, Inc. |
| K834481 | DOPPLER PHANTOM FLOW CONTROL SYS | Jan 25, 1984 | Substantially Equivalent | Radiation Measurements, Inc. |
| K810254 | 1.5` FOCAL SPOT RESOLUTION PATTERN | Feb 19, 1981 | Substantially Equivalent | Machlett Laboratories, Inc. |
FEI Numbers
This FDA classification entry is associated with 12 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 12 registration numbers. Click on an entry to view related FDA registrations.