21 CFR 892.1560 — System, Imaging, Pulsed Echo, Ultrasonic
Radiology (RA) · Subpart B—Diagnostic Devices · § 892.1560
Identification
An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
Classification Rationale
Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 2 | 892 | 3rd Party |
| LWI | Ultrasound, Sinus | 2 | 4 | |
| NQQ | System, Imaging, Optical Coherence Tomography (Oct) | 2 | 45 | 3rd Party |
| OIJ | Biopsy Needle Guide Kit | 2 | 0 | |
| QJG | Device System, Imaging, Tympanic Membrane And Middle Ear | 2 | 2 | SaMD |
| SGH | Ultrasound Imaging For Vascular Access For Hemodialysis | 2 | 1 | SaMD |
Special Controls
IYO — System, Imaging, Pulsed Echo, Ultrasonic
*Classification.* Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
eCFR
LWI — Ultrasound, Sinus
*Classification.* Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
eCFR
NQQ — System, Imaging, Optical Coherence Tomography (Oct)
*Classification.* Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
eCFR
OIJ — Biopsy Needle Guide Kit
*Classification.* Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
eCFR
QJG — Device System, Imaging, Tympanic Membrane And Middle Ear
*Classification.* Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
eCFR
SGH — Ultrasound Imaging For Vascular Access For Hemodialysis
*Classification.* Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
eCFR
