(46 days)
The Ultrasound System SONIMAGE HS1 and its transducers are products designed to collect ultrasonic image data of the human body for diagnostic purposes. The system employs the ultrasonic pulse-echo method to visualize the anatomic structures, characteristics, and dynamics of the human body, and using an image display, Doppler display or Doppler sound, offers a procedure applied to the human body for medical diagnosis or examination. The range of intended clinical applications is same as other conventional ultrasound imaging systems for general purpose, such as small parts, abdomen, musculoskeletal (soft tissue), peripheral vascular, and Cardiac.
The Ultrasound System SONIMAGE HS1 is a portable ultrasound system for general purposes. The system provides ultrasound imaging information such as used for the purpose of diagnosing the human body, which visually represents the internal geometry, characteristics and dynamics of the human body, and transmits / receives ultrasound waves to obtain image data of the visual representation. This system provides ultrasound images in all its modes of B-mode, Mmode, Color Doppler-mode, and PW/CW Doppler-mode. The optional items are available, such as a Pole Cart with storage basket, a power extension unit, and a foot switch with dual pedals. This system conforms to Real Time Display of Thermal and Mechanical Output Indices on Diagnostic Ultrasound Equipment (Track 3). Transducers have their own characteristic applications, and are brought into contact with the body surface.
The Konica Minolta Ultrasound System SONIMAGE HS1 and its transducers are medical devices intended for diagnostic ultrasound imaging and fluid flow analysis of the human body. The system is substantially equivalent to legally marketed predicate devices (K142197 and K061605).
Here's a breakdown of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance:
The document primarily focuses on demonstrating substantial equivalence to predicate devices rather than setting specific numerical performance acceptance criteria in the traditional sense of an original device evaluation. Instead, the "acceptance criteria" are implied by conformity to established standards and proven equivalence to predicate devices, particularly regarding safety and technological characteristics.
| Acceptance Criteria Category | Description | Reported Device Performance / Compliance |
|---|---|---|
| Intended Use | The device's intended clinical applications should be consistent with predicate devices and suitable for diagnostic ultrasound imaging (small parts, abdomen, musculoskeletal, peripheral vascular, cardiac). Contraindications: Eyeball examination, direct contact to central nerves and cardiac systems. | The range of intended clinical applications is the same as other conventional ultrasound imaging systems for general purpose, such as small parts, abdomen, musculoskeletal (soft tissue), peripheral vascular, and Cardiac. The additional intended use for Cardiac is the same as K061605. The system is contraindicated for eyeball examination or any other examination that may require the passage of an ultrasound beam through an eyeball. The system is NOT designed for use in direct contact to central nerves and cardiac systems. Only to be used by fully qualified and certified medical personnel. |
| Technological Characteristics | The device should employ fundamental scientific technologies, operating principles, and design features that are substantially similar to predicate devices. This includes imaging modes (B-mode, M-mode, Color Doppler-mode, PW/CW Doppler-mode) and display formats. | The proposed Ultrasound System SONIMAGE HS1 employs the same fundamental scientific technologies as the primary predicate device (K142197). The operating principle and designing (transmits ultrasonic energy, processes echoes for display, laptop shape, battery operation) are the same as the predicate devices. The proposed system and predicate devices support the same operating modes and display format, and same measurement functions. |
| Non-clinical Performance Testing | Verification of geometric accuracy in B-mode and accuracy of position/velocity for Color and PW/CW Doppler-mode, and time for PW/CW Doppler-mode. | Comprehensively tested as Bench-tests for geometric accuracy in B-mode, accuracy of position and velocity for Color and PW/CW Doppler-mode, and time for PW/CW Doppler-mode, except quantitative Doppler sensitivity. The systems do not have quantitative claims of sensitivity regarding Color Doppler-mode and PW/CW Doppler-mode. |
| Safety | Compliance with relevant electrical safety, electromagnetic compatibility, and medical device standards. Real-time display of thermal and mechanical output indices. | The system is in conformance with the standards described (AAMI / ANSI ES 60601-1, IEC 60601-1-6, IEC 60601-1-2, IEC 60601-2-37, IEC 62304, ISO 10993-1, ISO 10993-5, ISO 10993-10, NEMA UD 2-2004, NEMA UD 3-2004), which are same or equivalent standards to those of the predicate device. Both systems conform to real-time display of thermal and mechanical output indices under Track 3. |
| Biocompatibility | Patient contact materials should be evaluated for biocompatibility. | The patient contact materials of the human body surface are evaluated under ISO 10993 and determined as acceptable for these usage. Both systems achieve the same acceptance level for biocompatibility. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document states that non-clinical tests (Bench-tests) were performed. It does not specify a "test set" in terms of patient data or studies. The evaluation is based on comparing engineering and performance specifications to predicate devices and adherence to international standards. Therefore, information regarding sample size, data provenance, or retrospective/prospective nature of a clinical test set is not applicable as per the provided text for this determination of substantial equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable as there was no clinical test set described that required expert-established ground truth. The evaluation was based on engineering and performance comparisons.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as there was no clinical test set described requiring adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable. This submission is for an ultrasound system, not an AI-powered diagnostic device, and it does not mention any MRMC study or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This is an ultrasound imaging system, not an algorithm being evaluated in a standalone capacity.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable. The device's performance was demonstrated through non-clinical bench testing and comparison to legally marketed predicate devices, not through a clinical study that would require a ground truth for diagnostic accuracy.
8. The sample size for the training set
This information is not applicable. This submission is for an ultrasound system, not an AI/machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable. As no training set for an algorithm was used, no ground truth needed to be established for it.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of three stylized human profiles facing to the right, with a design that resembles an abstract bird or wing shape above them. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 5, 2015
KONICA MINOLTA, INC. % Mr. Russell D. Munves Official Correspondent Storch Amini & Munves PC 140 East 45th Street, 25th Floor NEW YORK NY 10017
Re: K151060
Trade/Device Name: Ultrasound System SONIMAGE HS1 Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO, IYN, ITX Dated: April 17, 2015 Received: April 20, 2015
Dear Mr. Munves:
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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
{1}------------------------------------------------
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Robert A Ochs
Robert Ochs. Ph.D. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
| 510(k) Number: | K151060 |
|---|---|
| Device Number: | Ultrasound System SONIMAGE HS1 |
| Indications for Use: | The Ultrasound System SONIMAGE HS1 and its transducers are products designed to collect ultrasonic image data of the human body for diagnostic purposes. The system employs the ultrasonic pulse-echo method to visualize the anatomic structures, characteristics, and dynamics of the human body, and using an image display, Doppler display or Doppler sound, offers a procedure applied to the human body for medical diagnosis or examination. The range of intended clinical applications is same as other conventional ultrasound imaging systems for general purpose, such as small parts, abdomen, musculoskeletal (soft tissue), peripheral vascular, and Cardiac. |
Type of Use (Select one or both, as applicable)
| Prescription Use | X | OR | Over-The-Counter Use |
|---|---|---|---|
| (Per 21 CFR 801 Subpart D) | (Per 21 CFR 801 Subpart C) |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
{3}------------------------------------------------
Ultrasound System SONIMAGE HS1 System:
Transducer:
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track 1 Only) | Specific(Tracks 1 & 3) | B | M | PWD | CWD | ColorDoppler | Combined(Specify) | Other*(Specify) |
| Ophthalmic | Ophthalmic | |||||||
| FetalImaging& Other | Fetal | |||||||
| Abdominal | P | P | P | N | P | Note1 | Note2 | |
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Note3) | P | P | P | P | Note1 | Note2 | ||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skeletal(Conventional) | P | P | P | P | Note1 | Note2 | ||
| Musculo-skeletal (Superficial) | P | P | P | P | Note1 | Note2 | ||
| Intravascular | ||||||||
| Other (Specify) | ||||||||
| Cardiac | Cardiac Adult | N | N | N | N | N | Note1 | Note2 |
| Cardiac Pediatric | N | N | N | N | N | Note1 | Note2 | |
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| PeripheralVessel | Peripheral vessel | P | P | P | P | Note1 | Note2 | |
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Note 1: Combined mode BM (B + M), BD (B + Pulse Doppler), BcMc (Color Doppler + M Color Doppler) and BcD (B Color Doppler + Pulse Doppler)
Note 2: Other mode Mc (M Color Mode)
Note 3: Small organ includes thyroid and breast
{4}------------------------------------------------
Ultrasound System SONIMAGE HS1 System: L18-4 Transducer:
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track 1 Only) | Specific(Tracks 1 & 3) | B | M | PWD | CWD | ColorDoppler | Combined(Specify) | Other*(Specify) |
| Ophthalmic | Ophthalmic | |||||||
| FetalImaging& Other | Fetal | |||||||
| Abdominal | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Note3) | P | P | P | P | Note1 | Note2 | ||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skeletal(Conventional) | P | P | P | P | Note1 | Note2 | ||
| Musculo-skeletal (Superficial) | P | P | P | P | Note1 | Note2 | ||
| Intravascular | ||||||||
| Other (Specify) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| PeripheralVessel | Peripheral vessel | P | P | P | P | Note1 | Note2 | |
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Note 1: Combined mode BM (B + M), BD (B + Pulse Doppler), BcMc (Color Doppler + M Color Doppler) and BcD (B Color Doppler + Pulse Doppler)
Note 2: Other mode Mc (M Color Mode)
Note 3: Small organ includes thyroid and breast
{5}------------------------------------------------
Ultrasound System SONIMAGE HS1 System: C5-2 Transducer:
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track 1 Only) | Specific(Tracks 1 & 3) | B | M | PWD | CWD | ColorDoppler | Combined(Specify) | Other*(Specify) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal | Fetal | |||||||
| Imaging& Other | Abdominal | P | P | P | P | Note1 | Note2 | |
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Specify) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skeletal(Conventional) | ||||||||
| Musculo-skeletal (Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Specify) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| PeripheralVessel | Peripheral vessel | |||||||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Note 1: Combined mode BM (B + M), BD (B + Pulse Doppler), BcMc (Color Doppler + M Color Doppler) and BcD (B Color Doppler + Pulse Doppler)
Note 2: Other mode Mc (M Color Mode)
{6}------------------------------------------------
Ultrasound System SONIMAGE HS1 System: S4-2 Transducer:
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track 1 Only) | Specific(Tracks 1 & 3) | B | M | PWD | CWD | ColorDoppler | Combined(Specify) | Other*(Specify) |
| Ophthalmic | Ophthalmic | |||||||
| FetalImaging& Other | Fetal | |||||||
| Abdominal | N | N | N | N | N | Note1 | Note2 | |
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Specify) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skeletal(Conventional) | ||||||||
| Musculo-skeletal (Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Specify) | ||||||||
| Cardiac | Cardiac Adult | N | N | N | N | N | Note1 | Note2 |
| Cardiac Pediatric | N | N | N | N | N | Note1 | Note2 | |
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| PeripheralVessel | Peripheral vessel | |||||||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Note 1: Combined mode BM (B + M), BD (B + Pulse Doppler), BcMc (Color Doppler + M Color Doppler) and BcD (B Color Doppler + Pulse Doppler)
Note 2: Other mode Mc (M Color Mode)
{7}------------------------------------------------
Chapter 4. 510(k) Summary
| Submitter's Name: | KONICA MINOLTA, INC. |
|---|---|
| Address: | 1 Sakura-machi,Hino-shi, 191-8511 Japan |
| Contact: | Shigeyuki Kojima |
| Telephone: | +81 42 589 8429 |
| Date: | April 17, 2015 |
| Trade Name: | Ultrasound System SONIMAGE HS1 |
| Model No: | SONIMAGE HS1 |
| Common Name: | Ultrasound Imaging System |
| Classification Name(s): | Ultrasonic Pulsed Doppler Imaging System (21 CFR 892.1550)Ultrasonic Pulsed Echo Imaging System (21 CFR 892.1560)Diagnostic Ultrasound Transducer (21 CFR 892.1570) |
| Classification Number(s): | 90-IYN; 90-IYO; 90-ITX |
| Regulatory Class: | Class II |
| Predicate Device(s): | K142197 - Ultrasound System SONIMAGE HS1,Konica Minolta, Inc.K061605 - Nemio XG, SSA-580A,Toshiba America Medical Systems, Inc. |
Device Description:
The Ultrasound System SONIMAGE HS1 is a portable ultrasound system for general purposes. The system provides ultrasound imaging information such as used for the purpose of diagnosing the human body, which visually represents the internal geometry, characteristics and
{8}------------------------------------------------
dynamics of the human body, and transmits / receives ultrasound waves to obtain image data of the visual representation.
This system provides ultrasound images in all its modes of B-mode, Mmode, Color Doppler-mode, and PW/CW Doppler-mode.
The optional items are available, such as a Pole Cart with storage basket, a power extension unit, and a foot switch with dual pedals.
This system conforms to Real Time Display of Thermal and Mechanical Output Indices on Diagnostic Ultrasound Equipment (Track 3). Transducers have their own characteristic applications, and are brought into contact with the body surface.
The Ultrasound System SONIMAGE HS1 and its transducers are designed to comply with the following standards:
AAMI / ANSI ES 60601-1: 2005 and C1:2009 and A2:2010; IEC 60601-1-6: 2013; IEC 60601-1-2: 2007; IEC 60601-2-37: 2007; IEC 62304: 2006; ISO 10993-1:2009; ISO 10993-5:2009; ISO 10993-10:2010; NEMA UD 2-2004; NEMA UD 3-2004;
Intended Use:
The Ultrasound System SONIMAGE HS1 and its transducers are products designed to collect ultrasonic image data of the human body for diagnostic purposes.
The system employs the ultrasonic pulse-echo method to visualize the anatomic structures, characteristics, and dynamics of the human body, and using an image display, Doppler display or Doppler sound, offers a procedure applied to the human body for medical diagnosis or examination.
The range of intended clinical applications is same as the predicate device, such as small parts, abdomen, musculoskeletal (soft tissue), peripheral vascular and cardiac.
{9}------------------------------------------------
This system is contraindicated for an eyeball examination or any other examination that may require the passage of an ultrasound beam through an eyeball. This system is NOT designed for use in direct contact to central nerves and cardiac systems.
The system should not be used by persons other than fully qualified and certified medical personnel.
Summary of Technological Characteristics
Compared to Predicate Device:
The proposed Ultrasound System SONIMAGE HS1 employs the same fundamental scientific technologies as the primary predicate device (K142197). The additional predicate device for the Cardiac usage including CW Doppler and Sector probe is Nemio XG SSA-580A system (K061605). The comparisons of technological characteristics for both systems are provided as follows;
Intended Use:
The additional intended use of the system and supporting clinical application is Cardiac that is the same as K061605.
The systems are intended to be used with a conventional extracorporeal transducers, which types are Linear, Convex and Sector as partially same as those of the predicate devices.
Operating Principle and designing:
The system transmits ultrasonic energy into patients, then perform post processing of received echoes to generate on-screen display of anatomic structures and dynamics of the human body. The system is designed in laptop shape to be transportable with battery operation. These operating principle and designing are the same as the predicate devices. The proposed system and the predicate devices support the same operating modes and display format, the same measurement functions for anatomic structures, internal geometry, characteristics and dynamics of the human body.
Non-clinical test:
The geometric accuracy verification in B-mode and the accuracy verification of the position and the velocity for Color Doppler-mode and PW/CW Doppler-mode, and the time for PW/CW Doppler-mode are
{10}------------------------------------------------
comprehensively tested as Bench-tests except quantitative Doppler sensitivity. The both systems do not have a quantitative claims of sensitivity regarding Color Doppler-mode and PW/CW Doppler-mode.
Safety:
The system is in conformance with the standards described above, which are same or equivalent standards to those of predicate device. The both systems conform to real time display of thermal and mechanical output indices under Track 3.
Biocompatibility:
The patient contact materials of human body surface are evaluated under ISO 10993 and determined as acceptable for these usage. The both systems achieve same acceptance level for biocompatibility.
Conclusion:
The clinical studies are not required to support substantial equivalence for these conventional ultrasound diagnostic equipment. In addition to that, as discussed in the above technological comparison, the technological characteristics of the Ultrasound System SONIMAGE HS1 are deemed to be substantially equivalent to the predicate devices that have already been cleared for USA distribution with 510(k) premarket notification numbers K142197 and K061605.
§ 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.