GXX · Block, Test, Ultrasonic Scanner Calibration
Neurology · 21 CFR 882.1925 · Class 1
Overview
| Product Code | GXX |
|---|---|
| Device Name | Block, Test, Ultrasonic Scanner Calibration |
| Regulation | 21 CFR 882.1925 |
| Device Class | Class 1 |
| Review Panel | Neurology |
Identification
An ultrasonic scanner calibration test block is a block of material with known properties used to calibrate ultrasonic scanning devices (e.g., the echoencephalograph).
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.
Cleared Devices (3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K893216 | RMI ULTRASOUND DOPPLER PHANTOM SYSTEM | Radiation Measurements, Inc. | Sep 5, 1989 | SESE |
| K844247 | ULTRASONIC SCANNER CALIBRATION & TEST PHANTOMS | Technicare Corp. | Jan 23, 1985 | SESE |
| K844120 | ULTRASONIC SCANNER CALIBRATION & TEST OBJECTS | Echo Ultrasound | Jan 23, 1985 | SESE |
Top Applicants
- Technicare Corp. — 1 clearance
- Radiation Measurements, Inc. — 1 clearance
- Echo Ultrasound — 1 clearance
