Product Code: GXX
FDA class 1
21 CFR 882.1925
Block, Test, Ultrasonic Scanner Calibration
Neurology
The Ultrasonic Scanner Calibration Test Block is a quality assurance accessory used to verify and calibrate the performance of ultrasonic scanning equipment, ensuring consistent and accurate measurements in neurological diagnostic procedures. It is classified as a Class 1 device (lowest risk), subject to general controls only. The product code is GXX under regulation 21 CFR 882.1925 in the Neurology specialty. No implant, life-sustaining, GMP exempt, or third-party review flags apply.
510(k)s
3
FEI Numbers
0
Registration Numbers
0
Unique Applicants
3
Years Active
5
Basic Information
- Product Code
- GXX
- Device Class
- FDA class 1
- Regulation Number
- 882.1925
- Medical Specialty
- Neurology
- Review Panel
- NE
- Submission Type
- 4
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K893216 | RMI ULTRASOUND DOPPLER PHANTOM SYSTEM | Sep 05, 1989 | Substantially Equivalent | Radiation Measurements, Inc. |
| K844247 | ULTRASONIC SCANNER CALIBRATION & TEST PHANTOMS | Jan 23, 1985 | Substantially Equivalent | Technicare Corp. |
| K844120 | ULTRASONIC SCANNER CALIBRATION & TEST OBJECTS | Jan 23, 1985 | Substantially Equivalent | Echo Ultrasound |