(157 days)
The SC1 Handheld Ultrasound Imaging System (Model: SC1) is intended for diagnostic ultrasound echo imaging, measurement, and analysis of the human body for general clinical applications including musculoskeletal (MSK), vascular, small parts (breast, thyroid) through B mode.
SC1 is a transportable ultrasound system intended for use in environments where healthcare is provided by appropriately trained healthcare professionals.
The SC1 Handheld ultrasound imaging system, Model: SC1, is a general purpose, software-controlled, diagnostic ultrasound system that uses pulsed-echo technology (B Mode (2D); Frequency: 5 - 13 MHz; module: linear; depth max: 10 cm) to transmit ultrasound images via wired communication to a mobile device that utilizes the Android operating system. Its function is to acquire ultrasound data and to display the data in operation.
The SC1 Handheld ultrasound imaging system is a portable, general-purpose, software-controlled, hand-held diagnostic ultrasound system that consists of (i) the battery-operated, SC1L (Linear type Ultrasound Probe) that communicates wired with Android mobile device, (ii) the software that runs as an app on the mobile device, (ii) batteries, charger (Cradle), cable, power cord, and magnetizers (option), (iv) the instructions for use manual.
The SC1 App software can be downloaded to an Android mobile device and utilizes an icon touch-based user interface. The software enables ultrasound image review, controls for depth, gain, linear measurement.
The SC1 App software allows the user to image in real time and review freeze-frame images on the screen in a B-Mode, 2-dimensional scan format.
SC1 Handheld ultrasound system is only intended for acquisition and real time diagnosis. SC1 Handheld ultrasound system (SC1 probe and SC1 app) is not intended to provide any function on patient data (entering new patient information, editing patient data saving, or transferring or exporting patient information). It does not have capability to connect to the PACS or equivalent DICOM network or export any patient data via USB cable.
Physician who is responsible for interpreting ultrasound images must be available in the room to provide diagnosis in real time.
The SC1 Handheld ultrasound imaging system utilizes pulsed-echo technology to determine the depth and location of tissue interfaces, and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. Ultrasound waves are emitted from the transducer, propagate through tissues, and return to the transducer as reflected echoes. The returned echoes are then converted into electrical impulses by transducer crystals and further processed in order to form the ultrasound image presented on the screen.
The device components are not supplied sterile and do not require sterilization prior to use.
The provided text describes the SC1 Handheld Ultrasound Imaging System (Model: SC1) and its comparison to predicate devices for a 510(k) premarket notification. However, it does not contain information about a study that establishes acceptance criteria for device performance or proves the device meets those criteria, especially in the context of an AI/algorithm-driven device.
The document primarily focuses on:
- Substantial Equivalence: Comparing the SC1's technological characteristics, indications for use, and safety features to legally marketed predicate devices (K170085 and K192226).
- Non-Clinical Testing: Detailing compliance with electrical safety, EMC, software validation, cybersecurity, biocompatibility, and general performance testing (axial/lateral resolution, distance, B-mode display, max depth).
- Lack of Clinical Studies: Explicitly stating that "No clinical studies were considered necessary and performed."
Therefore, I cannot fulfill the request for information regarding acceptance criteria and a study proving their fulfillment, as this information is not present in the provided text.
Based on the provided text, here's what can be extracted, assuming the request is for mechanical/electrical performance rather than AI performance (which isn't discussed):
1. Table of Acceptance Criteria and Reported Device Performance
The document lists performance tests but does not explicitly state quantitative acceptance criteria or detailed results beyond "compliance" and "supported."
| Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|
| Compliance with IEC 60601-1 (Electrical Safety) | Met |
| Compliance with IEC 60601-1-2 (EMC) | Met |
| Compliance with IEC 60601-1-6 (Usability) | Met |
| Software Validation | Verified and Validated |
| Cybersecurity Management | Compliant |
| Biocompatibility (ISO 10993-5, ISO 10993-10) | Verified and demonstrated safety |
| Axial Resolution | Performance defined |
| Lateral Resolution | Performance defined |
| Axial Distance Measurement | Performance defined |
| Lateral Distance Measurement | Performance defined |
| B-mode Display | Performance defined |
| Max Depth | Performance defined |
| Acoustic Output Levels | Below Track 3 FDA limits |
2. Sample size used for the test set and the data provenance
The document does not mention a test set, sample size, or data provenance related to AI/algorithm performance. The "performance testing" mentioned refers to engineering bench tests for resolution, distance, etc., not a clinical test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not mention experts or ground truth establishment for a test set.
4. Adjudication method for the test set
The document does not mention an adjudication method.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No, the document explicitly states, "No clinical studies were considered necessary and performed."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document does not describe an algorithm or AI functionality that would warrant standalone performance evaluation. The device is a "software-controlled, diagnostic ultrasound system" which implies software for image acquisition and display, not AI for interpretation or diagnosis.
7. The type of ground truth used
The document does not mention any ground truth for performance evaluation of an AI algorithm. The "performance testing" described (e.g., resolution, distance) would typically use phantoms or calibrated targets as "ground truth" for those specific measurements, but this is not an AI-driven system needing medical ground truth.
8. The sample size for the training set
The document does not mention a training set, as it does not describe an AI/algorithm-driven device requiring one.
9. How the ground truth for the training set was established
The document does not mention a training set or ground truth establishment for one.
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July 23, 2021
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
FCU Co., Ltd. % Lee Hee Yeon RA Manager B-620/621, Biz Center, 17, Techno 4-ro Yuseong-gu, Daejeon 34013 REPUBLIC OF KOREA
Re: K210468
Trade/Device Name: SC1 Handheld Ultrasound Imaging System (Model: SC1) Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: Class II Product Code: IYO, ITX Dated: May 18, 2021 Received: June 16, 2021
Dear Lee Hee Yeon:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name
SCI Handheld Ultrasound Imaging System (Model SC1)
Indications for Use (Describe)
The SC1 Handheld Ultrasound Imaging System (Model: SC1) is intended for diagnostic ultrasound echo imaging, measurement, and analysis of the human body for general clinical applications including musculoskeletal (MSK), vascular, small parts (breast, thyroid) through B mode,
SC1 is a transportable ultrasound system intended for use in environments where healthcare is provided by appropriately trained healthcare professionals.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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FCU Co., Ltd.
510(k) Summary
[As required by 21 CFR 807.92]
Date Prepared [21 CFR 807.92(a)(a)] 1.
Feb 8, 2021
2. Submitter's Information & Contact Person [21 CFR 807.92(a)(1)]
| - Name of Manufacturer: FCU Co., Ltd | |||
|---|---|---|---|
| -------------------------------------- | -- | -- | -- |
| - Address: | B-620/621, Biz Center, 17, Techno 4-ro, Yuseong-gu, Daejeon, 34013, Republic of Korea |
|---|---|
| - Contact Name: | Lee Hee Yeon/ RA manager |
| - Telephone No.: | +82-42-936-9078 |
| - Fax No.: | +82-42-936-9077 |
| - Email Address: | emma@fcultrasound.com |
3. Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)|
Common name: Handheld ultrasound imaging system Trade name: SC1 Handheld Ultrasound Imaging system (Model: SC1)
| Classification Description | 21 CFR Section | Product Code |
|---|---|---|
| Ultrasonic Pulsed Echo Imaging System | 21 CFR 892.1560 | IYO |
| Diagnostic Ultrasound Transducer | 21 CFR 892.1570 | ITX |
As stated in 21 CFR, parts 892.1560, and 892.1570, each of these generic types of devices has been classified as Class II.
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4. Identification of Predicate Device(s) [21 CFR 807.92(a)(3)|
The identified predicate devices within this submission are shown as follow:
Predicate device
| 510(k) Number: | K170085 |
|---|---|
| Applicant: | Healcerion Co., Ltd. |
| Classification Name: | Diagnostic Ultrasound System and Transducer |
| Trade Name: | SONON Ultrasound Imaging System, Model: 300D |
Reference device
| 510(k) Number: | K192226 | |
|---|---|---|
| Applicant: | Philips Healthcare | |
| Classification Name: | Diagnostic Ultrasound System and Transducer | |
| Trade Name: | Lumify Diagnostic Ultrasound System |
ર. Description of the Device [21 CFR 807.92(a)(4)]
The SC1 Handheld ultrasound imaging system, Model: SC1, is a general purpose, software-controlled, diagnostic ultrasound system that uses pulsed-echo technology (B Mode (2D); Frequency: 5 - 13 MHz; module: linear; depth max: 10 cm) to transmit ultrasound images via wired communication to a mobile device that utilizes the Android operating system. Its function is to acquire ultrasound data and to display the data in operation.
The minimum requirements for the mobile devices that utilize the Android operating system for use with the SC1 Handheld ultrasound imaging system, Model: SC1 are as follows:
| Item | Minimum Requirement |
|---|---|
| Recommended Tablet Device | Galaxy Tab S6 or later |
| Mobile OS Version | Android 9.0 or later |
The SC1 Handheld ultrasound imaging system is a portable, general-purpose, software-controlled, hand-held diagnostic ultrasound system that consists of (i) the battery-operated, SC1L (Linear type Ultrasound Probe) that communicates wired with Android mobile device, (ii) the software that runs as an app on the mobile device, (ii) batteries, charger (Cradle), cable, power cord, and magnetizers (option), (iv) the instructions for use manual.
The SC1 App software can be downloaded to an Android mobile device and utilizes an icon touch-based user interface. The software enables ultrasound image review, controls for depth, gain, linear measurement
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The SC1 App software allows the user to image in real time and review freeze-frame images on the screen in a B-Mode, 2-dimensional scan format.
SC1 Handheld ultrasound system is only intended for acquisition and real time diagnosis. SC1 Handheld ultrasound system (SC1 probe and SC1 app) is not intended to provide any function on patient data (entering new patient information, editing patient data saving, or transferring or exporting patient information). It does not have capability to connect to the PACS or equivalent DICOM network or export any patient data via USB cable.
Physician who is responsible for interpreting ultrasound images must be available in the room to provide diagnosis in real time.
The SC1 Handheld ultrasound imaging system utilizes pulsed-echo technology to determine the depth and location of tissue interfaces, and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. Ultrasound waves are emitted from the transducer, propagate through tissues, and return to the transducer as reflected echoes. The returned echoes are then converted into electrical impulses by transducer crystals and further processed in order to form the ultrasound image presented on the screen.
The device components are not supplied sterile and do not require sterilization prior to use.
Indications for Use [21 CFR 807.92(a)(5)] 6.
The SC1 Handheld Ultrasound Imaging System (Model: SC1) is intended for diagnostic ultrasound echo imaging, measurement, and analysis of the human body for general clinical applications including musculoskeletal (MSK), vascular, small parts (breast, thyroid) through B mode.
SC1 is a transportable ultrasound system intended for use in environments where healthcare is provided by appropriately trained healthcare professionals.
7. Determination of Substantial Equivalence [21 CFR 807.92(a)(6) and 21 CFR 807.92(b)]
There are no significant differences in the technological characteristics of this device compared to the predicate device which adversely affect safety or effectiveness. Provided below is a table summaring the technological characteristics of the SC1 and the predicate devices:
| Proposed Device | Predicate Device | Reference Device | SE decision | |
|---|---|---|---|---|
| K Number | To be assigned | K170085 | K192226 | - |
| Manufacturer | FCU Co., Ltd. | Healcerion Co., Ltd. | Philips Healthcare | - |
| Model | SC1 | 300L | Lumify DiagnosticUltrasound System | - |
| Indications forUse | The SC1 UltrasoundImaging System (Model:SC1) is intended for | Intended for ultrasoundecho imaging,measurement, and | Philips Lumify DiagnosticUltrasound System isintended for diagnostic | Equivalent* |
| Proposed Device | Predicate Device | Reference Device | SE decision | |
| diagnostic ultrasoundecho imaging,measurement, andanalysis of the humanbody for general clinicalapplications includingmusculoskeletal (MSK),vascular, small parts(breast, thyroid).SC1 is a transportableultrasound systemintended for use inenvironments wherehealthcare is provided byhealthcare professionals. | analysis of the humanbody for general clinicalapplications includingmusculoskeletal (MSK),vascular, small parts(breast, thyroid), andthoracic/pleural motionand fluid detectionimaging. | ultrasound imaging in B(2D), Color Doppler,Combined (B+Color), and Mmodes. It is indicated fordiagnostic ultrasoundimaging and fluid flowanalysis in the followingapplications:Fetal/Obstetric, Abdominal,Pediatric, Cephalic, Urology,Gynecological, CardiacFetal Echo, Small Organ,Musculoskeletal, PeripheralVessel, Carotid, Cardiac.Lumify is a transportableultrasound system intendedfor use in environmentswhere healthcare is providedby healthcareprofessionals. | ||
| Environment ofUse | Hospital, clinic, andmedical office settings | Hospital, clinic, andmedical office settings | Hospital, clinic, and medicaloffice settings | Same |
| Acoustic OutputLevels | - Compliance with IEC60601-2-37:2007+AMD1:2015- Below Track 3 FDAlimits in accordance withJune 2019 ultrasoundsystems guidancedocument | - Compliance with IEC60601-2-37:2007+AMD1:2015- Below Track 3 FDAlimits in accordance withSept. 2008 ultrasoundsystems guidancedocument | - Compliance with IEC60601-2-37:2007+AMD1:2015- Below Track 3 FDA limitsin accordance with Sept.2008 ultrasound systemsguidance document | Same |
| ImagingCapabilities | • Mode B (2D) | • pulsed-echo andDoppler ultrasound• Mode B (2D), Colorscan | Mode B (2D), ColorDoppler, Combined(B+Color), and M modes | Equivalent* |
| PatientPopulation | For use in all patients | For use in all patients | For use in all patients | Same |
| AnatomicStructures | • Musculoskeletal(MSK)• Vascular• Small parts (breast,thyroid) | • Musculoskeletal(MSK)• Vascular• Small parts (breast,thyroid)• Thoracic/pleuralmotion• Fluid detection | • Fetal/Obstetric• Abdominal• Pediatric• Cephalic• Urology• Gynecological• Cardiac Fetal Echo• Small Organ | Equivalent* |
| Proposed Device | Predicate Device | Reference Device | SE decision | |
| • Musculoskeletal• Peripheral Vessel• Carotid• Cardiac | ||||
| Users | Healthcare professionals | Healthcare professionals | Healthcare professionals | Same |
| Principle/Methodof Operation | Piezoelectric material inthe transducer is used asan ultrasound source totransmit sound wavesinto the body. Soundwaves are reflected backto the transducer andconverted to electricalsignals that areprocessed and displayedas images of anatomicstructures. | Piezoelectric material inthe transducer is used asan ultrasound source totransmit sound wavesinto the body. Soundwaves are reflected backto the transducer andconverted to electricalsignals that areprocessed and displayedas images of anatomicstructures. | Piezoelectric material in thetransducer is used as anultrasound source to transmitsound waves into the body.Sound waves are reflectedback to the transducer andconverted to electricalsignals that are processed anddisplayed as images ofanatomic structures. | Same |
| ProbeCharacteristics | Linear, 5 - 13MHz | Linear, 5MHz / 7.5MHz/ 10MHz frequency | Linear, 4 - 12 MHzCurved, 2 - 5 MHzPhased, 1 - 4 MHz | Equivalent** |
| ProbeConnection toDisplay | Wired | Wireless | Wired | Equivalent*** |
| Off-the-shelfoperating system | Android | iOS / Android | Android | Equivalent*** |
| Software | Runs as an app on off-the-shelf mobile device | Runs as an app on off-the-shelf mobile device | Runs as an app on off-the-shelf mobile device | Same |
| SystemComponents | • Ultrasound Probe• FCradle (Cradle)• AC/DC adapterincluding Power Cable• Communication Cable(USB Cable)• Batteries• Tablet (mobile device):Not provided.• User Manual• Magnetizer (Option)- long/short type- cap cover | • Ultrasound Probe• Battery Charger(Cradle)• AC/DC adapter• Power cable• Battery Pack• Tablet (mobile device):Not provided.• User Manual | • Ultrasound Probe• USB transducer cable• USB-C transducer cable• USB Micro-B transducercable• Android device (mobiledevice):• User Manual | Equivalent*** |
| Patient-Contacting | Tested by ISO 10993-5Tested by ISO 10993-10 | Tested by ISO 10993-5Tested by ISO 10993-10 | Tested by ISO 10993-5Tested by ISO 10993-10 | Same |
| Proposed Device | Predicate Device | Reference Device | SE decision | |
| Materials |
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ECJ FCU Co., Ltd.
B-620/621, Biz Center, 17, Techno 4-ro, Yuseong-gu, Daejeon, 34013, Republic of Korea Tel: +82 (42) 936 9078 Fax:+82 (42) 936 9077
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ECTFCU Co., Ltd.
B-620/621, Biz Center, 17, Techno 4-ro, Yuseong-gu, Daejeon, 34013, Republic of Korea Tel: +82 (42) 936 9078 Fax:+82 (42) 936 9077
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- The proposed device supports only Mode B (2D) to transport the convenience of moving the device. Therefore, the scope of clinical application is more limited than that of the predicate device. But the differences do not raise any new potential safety risks and therefore, we believe there is no impact on safety or the proposed device. This is described in the User's Manual, so the user will be aware of this.
** This device supports only linear type probe, and the frequency range of the probe is equivalent with the range of the predicate device. The differences indicated, do not raise any new potential safety risks and therefore, there is no impact on safety or efficacy for the proposed device.
*** The technical differences do not raise any new potential safety risks and therefore, there is no impact on safety or efficacy for the proposed device.
Non-Clinical Test Summary [21 CFR 807.92(b)(1)]
-
- Electrical Safety, Electromagnetic Compatibility Testing
Bench tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards:
- Electrical Safety, Electromagnetic Compatibility Testing
| Standard(Edition) | Standard Title | ConsensusStandard |
|---|---|---|
| IEC 60601-1:2005/A1:2012(3.1 edition) + NationalDifference | Medical electrical equipment ">– Part 1: Generalrequirements for basic safety and essential performance | Yes |
| IEC 60601-1-2:2014(4.0 edition) | Medical electrical equipment - Part 1-2: Generalrequirements for safety and essential performance –Collateral standard: Electromagnetic compatibility –Requirements and tests | Yes |
| IEC 60601-1-6:2010/AMD1:2013 | Medical electrical equipment - Part 1-6: Generalrequirements for basic safety and essential performance– Collateral standard: Usability | Yes |
2) Software Validation and Cybersecurity Management
The SC1 contains MODERATE level of concern software. The software was designed and developed according to a software development process and was verified and validated. The software information is provided in accordance with FDA guidance: The content of premarket submissions for software contained in medical devices, on May 11, 2005 and "Premarket Management of Cybersecurity in Medical Devices issued on December 28, 2016" and "ISO 14971:2007 Medical Devices – Application of Risk Management to Medical Devices".
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-
- Biocompatibility
The part of SCI in contact with the patient was verified and demonstrated for the safety of materials through the biocompatibility test in accordance with ISO 10993-1:2018.
- Biocompatibility
-
Cytotoxicity test according to ISO 10993-5:2009 -
-
-Intracutaneous (intradermal) reactivity test according to ISO 10993-10:2010
-
Skin sensitization test according to ISO 10993-10:2010 -
4) Performance Testing
Through compliance with the identified current standards, the safety and effectiveness of the device is supported. The additional performance test has been conducted to support the technological characteristics of the SC1. The performance of the SC1 has been defined as follows.
- Axial, Lateral Resolution
- Axial, Lateral distance
- B-mode display
- Max depth
Clinical Test Summary [21 CFR 807.92(b)(2)|
No clinical studies were considered necessary and performed.
8. Conclusion [21 CFR 807.92(b)(3)]
In conclusion, the tests conducted, as well as all verification activities, demonstrate that the design specifications and technological characteristics of the SC1 Handheld ultrasound imaging system (Model: SC1) meet applicable requirements and standards for the safety and effectiveness of the device for its intended use. There are some differences in technological characteristics between the predicates and proposed device, but those differences do not raise new or different questions of safety or effectiveness as compared to the predicate devices. Therefore, the SC1 Handheld ultrasound imaging system (Model: SC1) is substantially equivalent to the currently marketed predicate device.
§ 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 receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
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.