Description
This guidance document provides detailed recommendations for 510(k) submissions for diagnostic ultrasound systems and transducers. In addition to outlining regulatory approaches for certain diagnostic ultrasound devices, this guidance document describes the types of modifications to a diagnostic ultrasound device for which FDA does not intend to enforce the requirement for a new premarket notification (510(k)).
Scope & Applicability
Product Classes
10Guidance provides recommendations for 510(k) submissions for these systems.; Guidance for marketing clearance of these systems; Track 1 recommendations are for diagnostic ultrasound systems that do not follow the Output Display Standard
Track 3 Transducer/Mode Combination Summary Format
devices that must be sterilized
probes used in semi-critical applications requiring sterilization or high-level disinfection
ultrasound probes that should undergo low-level disinfection
Single-use devices intended by the OEM for one-time use
non-OEM replacement and remanufactured transducers are considered new medical devices
Specific device type with ISATA or ISAPA limits of 20 mW/cm².
Device track requiring documentation for each system/transducer/mode combination.
If you follow the Output Display Standard (IEC 60601-2-37), FDA considers your device a Track 3 device.; Track 3 Output Range Summary Format and Track 3 Summary
Stakeholders
5Entity responsible for submitting NDINs
entity responsible for tracking reprocessing cycles
entity required to submit a 510(k) for reprocessed SUDs
Original Equipment Manufacturer whose specifications are used as a baseline.; Original Equipment Manufacturer of the finished device; The flow rate accuracy fell outside the OEM's specified accuracy range; Original Equipment Manufacturer of the device or components.; Original Equipment Manufacturer providing parts and instructions.
Entity that established original safety and performance specifications
Regulatory Context
Attributes
10Parameter used for comparing new devices to predicate devices for safety.
Description of display accuracy as specified in IEC 60601-2-37
Description of uncertainties for acoustic quantities
Thermal Index for Cranial Bone
Thermal Index for Bone
Thermal Index for Soft Tissue
spatial-peak pulse-average intensity
spatial-peak temporal-average intensity
factor applied to acoustic output parameters to account for attenuation
Diagnostic range values related to cardiac rhythm disturbances
Identified Hazards
Hazards
4Potential risk at diagnostic acoustic output levels
protection against hazardous outputs in IEC 60601-2-37
Microorganisms or particulate matter that could adversely affect the device.
Potential risk at diagnostic acoustic output levels
Related CFR Sections (11)
- 21CFR807.81§ 807.81 When a premarket notification submission is required.
(a) Except as provided in paragraph (b) of this section, each person who is required to register his establishment pursuant to § 807.20 must submit a premarket notification submission to the Food and Drug Administration at least 90 days before he proposes to begin the introduction or delivery for inRead full regulation →
- 21CFR820.3§ 820.3 Definitions.
The definitions in ISO 13485 and in Clause 3 of ISO 9000 (incorporated by reference, see § 820.7 ) apply to this part, except as specified in paragraph (b) of this section, and do not affect the meaning of similar terms defined in this title.Read full regulation →
- 21CFR801.437§ 801.437 User labeling for devices that contain natural rubber.
(a) Data in the Medical Device Reporting System and the scientific literature indicate that some individuals are at risk of severe anaphylactic reactions to natural latex proteins. This labeling regulation is intended to minimize the risk to individuals sensitive to natural latex proteins and protecRead full regulation →
- 21CFR801.109§ 801.109 Prescription devices.
A device which, because of any potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use is not safe except under the supervision of a practitioner licensed by law to direct the use of such device, and hence for which “adequate directions for use” canRead full regulation →
- 21CFR807.87§ 807.87 Information required in a premarket notification submission.
Each premarket notification submission shall contain the following information:Read full regulation →
- 21CFR807.92§ 807.92 Content and format of a 510(k) summary.
(a) A 510(k) summary shall be in sufficient detail to provide an understanding of the basis for a determination of substantial equivalence. FDA will accept summaries as well as amendments thereto until such time as FDA issues a determination of substantial equivalence. All 510(k) summaries shall conRead full regulation →
- 21CFR1020.10§ 1020.10 Television receivers.
(a) Applicability. The provisions of this section are applicable to television receivers with cathode ray tubes manufactured subsequent to January 15, 1970.Read full regulation →
- 21CFR1002.20§ 1002.20 Reporting of accidental radiation occurrences.
(a) Manufacturers of electronic products shall, where reasonable grounds for suspecting that such an incident has occurred, report to the Director, Center for Devices and Radiological Health, all accidental radiation occurrences reported to or otherwise known to the manufacturer and arising from theRead full regulation →
- 21CFR892.1550§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a) Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces oRead full regulation →
- 21CFR892.1560§ 892.1560 Ultrasonic pulsed echo imaging system.
(a) 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 Read full regulation →
- 21CFR892.1570§ 892.1570 Diagnostic ultrasonic transducer.
(a) Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of dRead full regulation →
Related Warning Letters (10)
- 2025-12-09
CGMP/QSR/Medical Devices/Adulterated
Envoy Medical Inc.
- 2025-11-25
CGMP/QSR/Medical Devices/Adulterated
Hong Qiangxing Shenzhen Electronics Limited
- 2025-10-28
CGMP/QSR/Medical Devices/Adulterated
Contec Medical Systems Co., Ltd.
- 2025-10-28
CGMP/QSR/Medical Devices/Adulterated/Misbranded
Royal Philips
- 2025-10-28
CGMP/QSR/Medical Devices/Adulterated/Misbranded
Qianjiang Kingphar Medical Material Co Ltd.
- 2025-10-21
CGMP/QSR/Medical Devices/Adulterated
LEVO AG
- 2025-10-07
CGMP/QSR/Medical Devices/Adulterated
Technological Medical Advancements LLC
- 2025-09-23
Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k)
The Richline Group, Inc.
- 2025-09-16
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device
SeniorLife Technologies, Inc.
- 2025-08-26
CGMP/QSR/Medical Devices/Adulterated
Miach Orthopaedics
See Also (8)
- Menstrual Products - Performance Testing and Labeling Recommendations: Draft Guidance for Industry and Food and Drug Administration Staff (Status: Draft)
- CPG Sec. 300.600 Commercial Distribution with Regard to Premarket Notification (Section 510(k)) (Status: Final)
- Guidance for the Content of Premarket Notifications for Biopsy Devices Used in Gastroenterology and Urology (Status: Final)
- Guidance for the Content of Premarket Notifications for Ureteral Stents (Status: Final)
- Guidance on the Content of Premarket Notification [510(K)] Submissions for Piston Syringes (Status: Final)
- Guidance on the Content of Premarket Notification [510(K)] Submissions for Hypodermic Single Lumen Needles (Status: Final)
- Hysteroscopic and Laparoscopic Insufflators: Submission Guidance for a 510(k) (Status: Final)
- Inspection and Field Testing of Radiation-Emitting Electronic Products: Attachment C: Specific Instructions for Sunlamp Product Inspections and Tests (Status: Final)