(174 days)
The MobiUS Ultrasound Imaging System is indicated for ultrasound imaging, measurement and analysis of the human body for the following clinical applications: fetal/OB, abdominal, cardiac, pelvic, pediatric, musculoskeletal, and peripheral vessel imaging. Its compact size, portability and user interface enable it for use in primary care and special care areas.
The MobiUS Ultrasound Imaging System is a compact, portable ultrasound imaging system consisting of a handheld ultrasound probe, cable, host computer and user interface. The ultrasound probe and cable is one of the five models of the INTERSON USB Ultrasound Imaging Probe, ranging from 3.5 MHz to 12.0 MHz. The probes consist of a single-element mechanical sector scanner that contains the ultrasound generator and receiver, analog-todigital converter, microcontroller, control logic, USB 2.0 interface and control within the hand piece. It has a push button control to activate scanning. The probe is connected via a USB cable to a host computer. The host computer comes preloaded with the MobilUS software which utilizes an icon touch-based user interface. The software enables ultrasound image capture and review, image controls for near, mid, and far gain, as well as image intensity and contrast, linear measurement, storage and transmission of images and videos. The MobiUS Ultrasound Imaging System allows the user to image in real-time and review cine or freeze-frame images on the screen in B-Mode scan format.
The provided text does not contain information about acceptance criteria or a study proving that the "MobiUS Ultrasound Imaging System" device meets specific acceptance criteria. This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against defined acceptance criteria through a clinical or performance study.
The document lists the intended uses and technical characteristics of the MobiUS Ultrasound Imaging System and its various transducers, comparing them to previously cleared predicate devices (INTERSON USB Ultrasound Probe System, GE VScan Diagnostic Ultrasound System, Signos Personal Ultrasound).
Therefore, I cannot provide the requested information, including:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set or data provenance.
- Number of experts or their qualifications for ground truth establishment.
- Adjudication method.
- Information on a multi-reader multi-case (MRMC) comparative effectiveness study.
- Information on a standalone performance study.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
{0}------------------------------------------------
Section 5 - 510(k) Summary
K10253
| Submitter: | Mobisante, Inc.14035 NE 85th CTRedmond, WA 98052 | JAN 2 0 2011 |
|---|---|---|
| Contact Person: | Sailesh ChutaniPresident and CEO | |
| Telephone: | (650) 804-5421 | |
| Date Prepared: | July 30, 2010 | |
| Device Trade Name: | MobiUS Ultrasound Imaging System | |
| Device Common Name: | Diagnostic Ultrasound System and AccessoriesUltrasound Pulsed Echo Imaging SystemDiagnostic Ultrasound Transducer | |
| Classification Number andProduct Code: | §21CFR 892.1560 90-IYO§21CFR 892.1570 90-ITX | |
| Device Classification: | Class II | |
| Predicate Device(s): |
| DEVICE NAME | ACCESSION NUMBER(S) |
|---|---|
| INTERSON USB Ultrasound Probe System | K070907 |
| GE VScan Diagnostic Ultrasound System | K092756 |
| Signos Personal Ultrasound | K090505 |
Intended Use:
·
The MobiUS Ultrasound Imaging System is indicated for ultrasound imaging, measurement and analysis of the human body for the following clinical applications: fetal/OB, abdominal, cardiac, pelvic, pediatric, musculoskeletal, and peripheral vessel imaging. Its compact size, portability and user interface enable it for use in primary care and special care areas.
CONFIDENTIAL
{1}------------------------------------------------
Device Description:
The MobiUS Ultrasound Imaging System is a compact, portable ultrasound imaging system consisting of a handheld ultrasound probe, cable, host computer and user interface. The ultrasound probe and cable is one of the five models of the INTERSON USB Ultrasound Imaging Probe, ranging from 3.5 MHz to 12.0 MHz. The probes consist of a single-element mechanical sector scanner that contains the ultrasound generator and receiver, analog-todigital converter, microcontroller, control logic, USB 2.0 interface and control within the hand piece. It has a push button control to activate scanning. The probe is connected via a USB cable to a host computer. The host computer comes preloaded with the MobilUS software which utilizes an icon touch-based user interface. The software enables ultrasound image capture and review, image controls for near, mid, and far gain, as well as image intensity and contrast, linear measurement, storage and transmission of images and videos. The MobiUS Ultrasound Imaging System allows the user to image in real-time and review cine or freeze-frame images on the screen in B-Mode scan format.
Technological Characteristics:
The Mobisante MobiUS Ultrasound Imaging System operates in the same manner as the identified predicate devices in that piezoelectric material in the transducer is used as an ultrasound source to transmit sound waves into the body. Sound waves are reflected back to the transducer and converted to electrical signals that are processed and displayed as 2D images of anatomic structures within the body. All systems allow for the measurement of structures to aid in diagnosis.
Basis for Substantial Equivalence:
The MobiUS Ultrasound Imaging System is substantially equivalent to the identified predicate devices currently cleared for market with respect to intended use, principles of operation, technological characteristics and safety features. The system has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical and mechanical safety, and has been found to conform with applicable standards.
Confidential
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure with outstretched arms.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Mr. Sailesh Chutani President and CEO MOBISANTE, INC. 14035 NE 85th CT REDMOND WA 98052
JAN 2 0 2011
Re: K102153
Trade/Device Name: MobiUS Ultrasound Imaging System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO and ITX Dated: January 12, 2011 Received: January 12, 2011
Dear Mr. Chutani:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we 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). 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.
This determination of substantial equivalence applies to the following transducers intended for use with the MobiUS Ultrasound Imaging System, as described in your premarket notification:
Transducer Model Number
MV 12.0 MHz Mechanical Sector Probe EC 7.5 MHz Mechanical Sector Probe SR 7.5 MHz Mechanical Sector Probe GP 5.0 MHz Mechanical Sector Probe GP 3.5 MHz Mechanical Sector Probe
{3}------------------------------------------------
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. 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 vour 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); 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.
This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.
If you have any questions regarding the content of this letter. please contact Shahram Vaezy at (301) 796-6242.
·Sincerely Yours,
Mary Pastel
Mary Pastel, ScD. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure(s)
{4}------------------------------------------------
Section 4 - Indications for Use Statement
510(k) Number (if known): K102153
Device Name: MobiUS Ultrasound Imaging System
Indications for Use:
The MobiUS Ultrasound Imaging System is indicated for ultrasound imaging, measurement and analysis of the human body for the following clinical applications: fetal/OB, abdominal, cardiac, pelvic, pediatric, musculoskeletal, and peripheral vessel imaging. Its compact size, portability and user interface enable it for use in primary care and special care areas.
Please refer to the following diagnostic ultrasound indications for use forms for specific imaging modes and applications.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use _ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Mary S Potter
(Division Sign-Off)
510K K162153
{5}------------------------------------------------
510(k) Number:
MobiUS Ultrasound Imaging System with INTERSON USB Ultrasound Probe System System: Intended Use: Diagnostic ultrasound imaging of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General (Track1 only) | Specific(Tracks 1 & 3) | B | M | PWD | CWD | ColorDoppler | Combined | Other |
| Ophthalmic | Ophthalmic | |||||||
| Fetal | N | Note 3 | ||||||
| Abdominal | N | Note 1 | ||||||
| Note 3 | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | N | Note 3 | ||||||
| Small Organ (Specify) | N | Note 3Note 2 | ||||||
| Fetal Imaging &Other | Neonatal Cephalic | N | ||||||
| Adult Cephalic | ||||||||
| Trans-rectal | N | Note 3 | ||||||
| Trans-vaginal | N | Note 3 | ||||||
| Trans-urethral | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skeletal(Conventional) | N | |||||||
| Musculo-skeletal(Superficial) | N | |||||||
| Intravascular | ||||||||
| Other (Specify) | ||||||||
| Cardiac | Cardiac Adult | N | ||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| PeripheralVessel | Peripheral vessel | N | ||||||
| Other (Specify) |
N=New Indication
Note 1: Abdominal, Solid organs, aneurysms
Note 2: Small organ, breast, thyroid, testes
Note 3: Includes imaging for guidance of biopsy
| Prescription Use: YES | (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)consumers of cultify office of Ogyice EvaluationDivision of Radiological DevicesOffice of In Vitro Diagnostic Device Evaluation and Safety | |||||||
|---|---|---|---|---|---|---|---|---|
| Per 21 CFR 801. 109 | SIOK | 510(k) Number | ||||||
| Mobisante, Inc. | 510/k) Premarket Notification Submission | CONFIDENTIAL | PAGE 1. |
Mobisante, Inc 510(k) Premarket Notification Submission
CONFIDENTIAL
(Divislon Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K K102153
{6}------------------------------------------------
510(k) Number:
System: MobiUS Ultrasound Imaging System Transducer: INTERSON USB Ultrasound Probe System MV 12.0 MHz Mechanical Sector Probe
Diagnostic ultrasound imaging of the human body as follows: Intended Use:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General (Track1 only) | Specific(Tracks 1 & 3) | B | M | PWD | CWD | ColorDoppler | Combined | Other | |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal Imaging &Other | Fetal | ||||||||
| Abdominal | |||||||||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (Specify) | P | Note 2 | |||||||
| Note 3 | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| 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 | P | Note 3 | ||||||
| Other (Specify) |
P=Previously Cleared by INTERSON Corporation: K070907 Note 2: Small organ, breast, thyroid, testes
Note 3: Includes imaging for guidance of biopsy
(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED) concurrence of CDRH, Office of Device Evaluation
Prescription Use: YES Per 21 CFR 801. 109
510(k) Number_
Mobisante, Inc. 510(k) Premarket Notification Submission
CONFIDENTIAL
PAGE 13
Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510K K102153
{7}------------------------------------------------
510(k) Number:
MobiUS Ultrasound Imaging System System: Transducer: INTERSON USB Ultrasound Probe System
EC 7.5 MHz Mechanical Sector Probe
Diagnostic ultrasound imaging of the human body as follows: Intended Use:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General (Track1 only) | Specific(Tracks 1 & 3) | B | M | PWD | CWD | ColorDoppler | Combined | Other |
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Abdominal | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Specify) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Fetal Imaging &Other | Trans-rectal | P | Note 3 | |||||
| Trans-vaginal | P | Note 3 | ||||||
| Trans-urethral | ||||||||
| 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) |
P=Previously Cleared by INTERSON Corporation: K070907 Note 3: Includes imaging for guidance of biopsy
(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED) concurrence of CDRH, Office of Device Evaluation
Prescription Use: YES Per 21 CFR 801. 109
510{k} Number_________________________________________________________________________________________________________________________________________________________________
Mobisante, Inc. 510(k) Premarket Notification Submission
Confidential (Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510K K162153
PAGE 14
{8}------------------------------------------------
510(k) Number:
System: MobiUS Ultrasound Imaging System INTERSON USB Ultrasound Probe System Transducer: SR 7.5 MHz Mechanical Sector Probe
Diagnostic ultrasound imaging of the human body as follows: Intended Use:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General (Track | Specific | B | M | PWD | CWD | ColorDoppler | Combined | Other | |
| 1 only) | (Tracks 1 & 3) | ||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Abdominal | P | Note 3 | |||||||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (Specify) | P | ||||||||
| Neonatal Cephalic | P | ||||||||
| Adult Cephalic | |||||||||
| Fetal Imaging &Other | Trans-rectal | ||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| 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 | P | |||||||
| Other (Specify) |
P=Previously Cleared by INTERSON Corporation: K070907 Note 3: Includes imaging for guidance of biopsy
(Please do not WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED) concurrence of CDRH, Office of Device Evaluation
Prescription Use: YES Per 21 CFR 801. 109
510(k) Number
Mobisante, Inc. 510(k) Premarket Notification Submission
CONFIDENT Oivision Sic Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510K K102153
PAGE 15
{9}------------------------------------------------
510(k) Number:
System: MobiUS Ultrasound Imaging System INTERSON USB Ultrasound Probe System Transducer: GP 5.0 MHz Mechanical Sector Probe
GP 5.0 MHz Mechanical Sector Probe
Diagnostic ultrasound imaging of the human body as follows: Intended Use:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General (Track | Specific | B | M | PWD | CWD | ColorDoppler | Combined | Other |
| 1 only) | (Tracks 1 & 3) | |||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | P | |||||||
| Abdominal | P | Note 3 | ||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Specify) | P | Note 2 | ||||||
| Neonatal Cephalic | P | |||||||
| Adult Cephalic | ||||||||
| Fetal Imaging &Other | Trans-rectal | |||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skeletal(Conventional) | ||||||||
| Musculo-skeletal(Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Specify) | ||||||||
| Cardiac | Cardiac Adult | P | ||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| PeripheralVessel | Peripheral vessel | |||||||
| Other (Specify) |
P=Previously Cleared by INTERSON Corporation: K070907 Note 2: Small organ, breast, thyroid, testes Note 3: Includes imaging for guidance of biopsy
(Please do Not WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED) concurrence of CDRH, Office of Device Evaluation
510k
Prescription Use: YES Per 21 CFR 801. 109
510(k) Number_
Mobisante, Inc. 510(k) Premarket Notification Submission
Confidential vision Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
PAGE 16
{10}------------------------------------------------
510(k) Number:
MobiUS Ultrasound Imaging System System: Transducer: INTERSON USB Ultrasound Probe System GP 3.5 MHz Mechanical Sector Probe
Diagnostic ultrasound imaging of the human body as follows: Intended Use:
| Clinical Application | Mode of Operation | Other | |||||||
|---|---|---|---|---|---|---|---|---|---|
| General (Track1 only) | Specific(Tracks 1 & 3) | B | M | PWD | CWD | ColorDoppler | Combined | ||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | P | ||||||||
| Abdominal | P | Note 3 | |||||||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (Specify) | P | Note 2 | |||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Fetal Imaging &Other | Trans-rectal | ||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| 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) |
P= Previously Cleared by INTERSON Corporation: K070907 Note 2: Small organ, breast, thyroid, testes Note 3: Includes imaging for guidance of biopsy
(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED) concurrence of CDRH, Office of Device Evaluation
Prescription Use: YES Per 21 CFR 801. 109
510(k) Number _
Mobisante, Inc. 510(k) Premarket Notification Submission
Confidential Division Sign-Off) on of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510K K102153
Page 17
§ 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.