QBit Series Diagnostic Ultrasound System
Device Facts
| Record ID | K150861 |
|---|---|
| Device Name | QBit Series Diagnostic Ultrasound System |
| Applicant | Chison Medical Imaging Co., Ltd. |
| Product Code | IYN · Radiology |
| Decision Date | Jul 28, 2015 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Intended Use
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal, Abdominal, Pediatric, Small Organ (breast, thyroid, testes), Neonatal Cephalic, Cardiac (adult, pediatric), Musculo-skeletal (Conventional, Superficial), Peripheral Vascular, Transrectal, Transvaginal, Urology.
Device Story
The QBit Series is a mobile, software-controlled, color Doppler ultrasound system used in hospitals and clinics by qualified physicians. It acquires ultrasound echo data via various probes (linear, convex, phased array) and processes signals to display images in multiple modes: B-Mode (including Fusion Harmonic Imaging), M-Mode, Pulsed (PW) Doppler, Continuous (CW) Doppler, Color Doppler, Power Doppler, Directional Power Doppler, and Tissue Doppler Imaging (TDI). It also supports 3D/4D imaging and elastography. The system includes a mobile console, keyboard, power supply, and color LCD monitor. Clinicians use the system to visualize internal structures and blood flow, aiding in diagnostic evaluations. The output is displayed on the monitor for real-time clinical decision-making, potentially benefiting patients through non-invasive diagnostic assessment.
Clinical Evidence
No clinical testing was required. Substantial equivalence is supported by bench testing, including electrical, mechanical, thermal, and electromagnetic compatibility safety, as well as acoustic output measurements per NEMA UD 2-2004 and NEMA UD3: 2004.
Technological Characteristics
Mobile ultrasound system with color LCD monitor. Supports linear, convex, phased, and volume probes. Modes: B, M, PW/CW Doppler, Color/Power Doppler, TDI, 3D/4D, Elastography. Connectivity: 4 probe ports. Power: 100-240V AC. Safety standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-1. Software-controlled image processing.
Indications for Use
Indicated for use by a qualified physician for diagnostic ultrasound imaging or fluid flow analysis of the human body, including fetal, abdominal, pediatric, small organ (breast, thyroid, testes), neonatal cephalic, adult cephalic, cardiac (adult, pediatric), musculoskeletal (conventional, superficial), peripheral vascular, transrectal, transvaginal, and urological applications.
Regulatory Classification
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 or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
Predicate Devices
- DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System (K132341)
Related Devices
- K153085 — Q Series Diagnostic Ultrasound System · Chison Medical Imaging Co., Ltd. · Dec 21, 2015
- K180974 — CBit Series Digital Color Doppler Ultrasound System · CHISON Medical Technologies Co., Ltd. · Aug 17, 2018
- K162172 — EBit Series Diagnostic Ultrasound System · Chison Medical Imaging Co., Ltd. · Sep 14, 2016
- K123185 — DC-8/DC-8 PRO/DC-8, CV/DC-8, EXP/DC-8S DIAGNOSTIC ULTRASOUND SYSTEM · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Nov 2, 2012
- K233697 — SonoMax Series Digital Color Doppler Ultrasound System · CHISON Medical Technologies Co., Ltd. · Aug 9, 2024
Submission Summary (Full Text)
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Image /page/0/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles three human profiles facing to the right, with flowing lines beneath them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 28, 2015
CHISON Medical Imaging Co., Ltd. % Mr. Bob Leiker Regulatory Consultant Leiker Regulatory & Quality Consulting 4157 North Del Rey Avenue CLOVIS CA 93619
Re: K150861
Trade/Device Name: OBit Series Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: June 11, 2015 Received: June 30, 2015
Dear Mr. Leiker:
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.
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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.
Michael D'Hara
For
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
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# Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
#### 510(k) Number (if known)
# K150861
Device Name QBit Series Diagnostic Ultrasound System
Indications for Use (Describe)
The device is a general-purpose ultrasonic instrument intended for use by a qualified physician for evaluation of Fetal , Abdominal, Pediatric, Small Organ (breast, thyroid,testes ), Neonatal Cephalic, Cardiac (adult , pediatric),Musculo-skeletal (Conventional , Superficial) ,Peripheral Vascular,Transectal, Transvaginal, Urology.
**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)
#### CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.qov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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# Diagnostic Ultrasound Indications For Use
# System: QBit Series Diagnostic Ultrasound System
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Clinical Application | Mode of Operation | | | | | | | | |
|---------------------------|------------------------------------------------------------------------------------|-------------------|---|---------------|-------------------------------|------------------|------------------|-------------------|---------|--|
| General<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Power<br>Doppler | Combined<br>Modes | Other | |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| Fetal Imaging &<br>Other | Fetal | N | N | N | | N | N | N | 3,5,6 | |
| | Abdominal | N | N | N | | N | N | N | 3,4,5,6 | |
| | Intra-operative (Specify) | | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | | |
| | Laparoscopic | | | | | | | | | |
| | Pediatric | N | N | N | | N | N | N | 4,5,6 | |
| | Small Organ1 (Specify) | N | N | N | | N | N | N | 4,5,6 | |
| | Neonatal Cephalic | N | N | N | N | N | N | N | 6,7 | |
| | Adult Cephalic | N | N | N | N | N | N | N | 6,7 | |
| | Trans-rectal | N | N | N | | N | N | N | 4,5,6 | |
| | Trans-vaginal | N | N | N | | N | N | N | 3,4,5,6 | |
| | Trans-urethral | | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | N | N | N | | N | N | N | 4,5,6 | |
| | Musculo-skeletal<br>(Superficial) | N | N | N | | N | N | N | 4,5,6 | |
| | Other (Urology) | N | N | N | | N | N | N | 5,6 | |
| Cardiac | Cardiac Adult | N | N | N | N | N | N | N | 5,6,7 | |
| | Cardiac Pediatric | N | N | N | N | N | N | N | 5,6,7 | |
| | Transesophageal | N | N | N | N | N | N | N | 6,7 | |
| Peripheral Vessel | Peripheral vessel | N | N | N | | N | N | N | 5,6 | |
| N = new indication; | P = previously cleared by FDA; | | | | E = added under this appendix | | | | | |
| | Note : 1 Combined modes are B/M R+PWD or CWD or CWD B/Color PWD or CWD B/Power/PWD | | | | | | | | | |
1. Combined modes are B/M, B+PWD, B/Color M, B/PWD or CWD, B/Color/PWD or CWD,B/Power/ 2.Small Organ: thyroid, testes, breast
3.3D/4D
4.Elastography
5. Includes guidance of biopsy(2D)
6.Fusion Harmonic Imaging
7.TDI
Prescription Use × AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
{4}------------------------------------------------
| Clinical Application | | Mode of Operation | | | | | | | Other |
|---------------------------|------------------------------------|-------------------|---|---------------|---------------|------------------|------------------|-------------------|-------|
| General<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Power<br>Doppler | Combined<br>Modes | |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal Imaging &<br>Other | Fetal | N | N | N | | N | N | N | 5,6 |
| | Abdominal | N | N | N | | N | N | N | 4,5,6 |
| | Intra-operative (Specify) | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ1 (Specify) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | | |
| | Other (Urology) | N | N | N | | N | N | N | 5,6 |
| Cardiac | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| | Transesophageal | | | | | | | | |
| Peripheral Vessel | Peripheral vessel | | | | | | | | |
P = previously cleared by FDA; E = added under this appendix N = new indication;
Note : 1. Combined modes are B/M, B+PWD, B/Color M, B/PWD or CWD, B/Color/PWD or CWD,B/Power/PWD 2.Small Organ: thyroid, testes, breast
3.3D/4D
4.Elastography
5. Includes guidance of biopsy(2D)
6.Fusion Harmonic Imaging
7.TDI
Prescription Use × AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
{5}------------------------------------------------
| Clinical Application | Mode of Operation | | | | | | | | |
|---------------------------|------------------------------------|---|---|---------------|---------------|------------------|------------------|-------------------|-------|
| General<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Power<br>Doppler | Combined<br>Modes | Other |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal Imaging &<br>Other | Fetal | N | N | N | | N | N | N | 5,6 |
| | Abdominal | N | N | N | | N | N | N | 4,5,6 |
| | Intra-operative (Specify) | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ1 (Specify) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | | |
| | Other (Urology) | N | N | N | | N | N | N | 5,6 |
| Cardiac | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| | Transesophageal | | | | | | | | |
| Peripheral Vessel | Peripheral vessel | | | | | | | | |
P = previously cleared by FDA; E = added under this appendix N = new indication;
Note : 1. Combined modes are B/M, B+PWD, B/Color M, B/PWD or CWD, B/Color/PWD or CWD,B/Power/PWD 2.Small Organ: thyroid, testes, breast
3.3D/4D
4.Elastography
5. Includes guidance of biopsy(2D)
6.Fusion Harmonic Imaging
7.TDI
Prescription Use × AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
{6}------------------------------------------------
| Clinical Application | Mode of Operation | | | | | | | | |
|---------------------------|------------------------------------|---|---|---------------|---------------|------------------|------------------|-------------------|-------|
| General<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Power<br>Doppler | Combined<br>Modes | Other |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal Imaging &<br>Other | Fetal | N | N | N | N | N | N | N | 5,6 |
| | Abdominal | N | N | N | N | N | N | N | 4,5,6 |
| | Intra-operative (Specify) | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ1 (Specify) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | | |
| | Other (Urology) | N | N | N | N | N | N | N | 5,6 |
| Cardiac | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| | Transesophageal | | | | | | | | |
| Peripheral Vessel | Peripheral vessel | | | | | | | | |
P = previously cleared by FDA; E = added under this appendix N = new indication;
Note : 1. Combined modes are B/M, B+PWD, B/Color M, B/PWD or CWD, B/Color/PWD or CWD,B/Power/PWD 2.Small Organ: thyroid, testes, breast
3.3D/4D
4.Elastography
5. Includes guidance of biopsy(2D)
6.Fusion Harmonic Imaging
7.TDI
Prescription Use × AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
{7}------------------------------------------------
| Clinical Application | | | Mode of Operation | | | | | | | |
|---------------------------|------------------------------------|---|-------------------|---------------|---------------|------------------|------------------|-------------------|-------|--|
| General<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Power<br>Doppler | Combined<br>Modes | Other | |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| Fetal Imaging &<br>Other | Fetal | N | N | N | N | N | N | N | 5,6 | |
| | Abdominal | N | N | N | N | N | N | N | 4,5,6 | |
| | Intra-operative (Specify) | | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | | |
| | Laparoscopic | | | | | | | | | |
| | Pediatric | | | | | | | | | |
| | Small Organ[1] (Specify) | | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | | |
| | Adult Cephalic | | | | | | | | | |
| | Trans-rectal | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | |
| | Trans-urethral | | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | | | |
| | Other (Urology) | N | N | N | N | N | N | N | 5,6 | |
| Cardiac | Cardiac Adult | | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | | |
| | Transesophageal | | | | | | | | | |
| Peripheral Vessel | Peripheral vessel | | | | | | | | | |
N = new indication;
P = previously cleared by FDA;
E = added under this appendix
Note : 1. Combined modes are B/M, B+PWD, B/Color M, B/PWD or CWD, B/Color/PWD or CWD,B/Power/PWD 2.Small Organ: thyroid, testes, breast
3.3D/4D
4.Elastography
5. Includes guidance of biopsy(2D)
6.Fusion Harmonic Imaging
7.TDI
Prescription Use × AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
{8}------------------------------------------------
| Clinical Application | | Mode of Operation | | | | | | | Other |
|---------------------------|------------------------------------|-------------------|---|---------------|---------------|------------------|------------------|-------------------|-------|
| General<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Power<br>Doppler | Combined<br>Modes | |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal Imaging &<br>Other | Fetal | | | | | | | | |
| | Abdominal | | | | | | | | |
| | Intra-operative (Specify) | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | N | N | N | | N | N | N | 4,5,6 |
| | Small Organ1 (Specify) | N | N | N | | N | N | N | 4,5,6 |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | N | N | N | | N | N | N | 4,5,6 |
| | Musculo-skeletal<br>(Superficial) | N | N | N | | N | N | N | 4,5,6 |
| | Other (Urology) | | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| | Transesophageal | | | | | | | | |
| Peripheral Vessel | Peripheral vessel | N | N | N | | N | N | N | 5,6 |
N = new indication; P = previously cleared by FDA;
E = added under this appendix
Note : 1. Combined modes are B/M, B+PWD, B/Color M, B/PWD or CWD, B/Color/PWD or CWD,B/Power/PWD 2.Small Organ: thyroid, testes, breast
3.3D/4D
4.Elastography
5. Includes guidance of biopsy(2D)
6.Fusion Harmonic Imaging
7.TDI
Prescription Use_ メ AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
{9}------------------------------------------------
| Clinical Application | | Mode of Operation | | | | | | | Other |
|---------------------------|------------------------------------|-------------------|---|------------|------------|---------------|---------------|----------------|-------|
| General<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PW Doppler | CW Doppler | Color Doppler | Power Doppler | Combined Modes | |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal Imaging &<br>Other | Fetal | | | | | | | | |
| | Abdominal | | | | | | | | |
| | Intra-operative (Specify) | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | N | N | N | | N | N | N | 4,5,6 |
| | Small Organ1 (Specify) | N | N | N | | N | N | N | 4,5,6 |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | N | N | N | | N | N | N | 4,5,6 |
| | Musculo-skeletal<br>(Superficial) | N | N | N | | N | N | N | 4,5,6 |
| | Other (Urology) | | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| | Transesophageal | | | | | | | | |
| Peripheral Vessel | Peripheral vessel | N | N | N | | N | N | N | 5,6 |
N = new indication; P = previously cleared by FDA;
E = added under this appendix
Note : 1. Combined modes are B/M, B+PWD, B/Color M, B/PWD or CWD, B/Color/PWD or CWD,B/Power/PWD 2.Small Organ: thyroid, testes, breast
3.3D/4D
4.Elastography
5. Includes guidance of biopsy(2D)
6.Fusion Harmonic Imaging
7.TDI
Prescription Use_ メ AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
{10}------------------------------------------------
| Clinical Application | | Mode of Operation | | | | | | | Other |
|---------------------------|------------------------------------|-------------------|---|---------------|---------------|------------------|------------------|-------------------|-------|
| General<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Power<br>Doppler | Combined<br>Modes | |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal Imaging &<br>Other | Fetal | | | | | | | | |
| | Abdominal | | | | | | | | |
| | Intra-operative (Specify) | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | N | N | N | | N | N | N | 4,5,6 |
| | Small OrganII (Specify) | N | N | N | | N | N | N | 4,5,6 |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | N | N | N | | N | N | N | 4,5,6 |
| | Musculo-skeletal<br>(Superficial) | N | N | N | | N | N | N | 4,5,6 |
| | Other (Urology) | | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| | Transesophageal | | | | | | | | |
| Peripheral Vessel | Peripheral vessel | N | N | N | | N | N | N | 5,6 |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Note : 1. Combined modes are B/M, B+PWD, B/Color M, B/PWD or CWD, B/Color/PWD or CWD,B/Power/PWD 2.Small Organ: thyroid, testes, breast
3.3D/4D
4.Elastography
5. Includes guidance of biopsy(2D)
6.Fusion Harmonic Imaging
7.TDI
Prescription Use × AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
{11}------------------------------------------------
| Clinical Application | | Mode of Operation | | | | | | | Other |
|---------------------------|------------------------------------|-------------------|---|---------------|---------------|------------------|------------------|-------------------|-------|
| General<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Power<br>Doppler | Combined<br>Modes | |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal Imaging &<br>Other | Fetal | | | | | | | | |
| | Abdominal | | | | | | | | |
| | Intra-operative (Specify) | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | N | N | N | | N | N | N | 4,5,6 |
| | Small Organ1 (Specify) | N | N | N | | N | N | N | 4,5,6 |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | N | N | N | | N | N | N | 4,5,6 |
| | Musculo-skeletal<br>(Superficial) | N | N | N | | N | N | N | 4,5,6 |
| | Other (Urology) | | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| | Transesophageal | | | | | | | | |
| Peripheral Vessel | Peripheral vessel | N | N | N | | N | N | N | 5,6 |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Note : 1. Combined modes are B/M, B+PWD, B/Color M, B/PWD or CWD, B/Color/PWD or CWD,B/Power/PWD 2.Small Organ: thyroid, testes, breast
3.3D/4D
4.Elastography
5. Includes guidance of biopsy(2D)
6.Fusion Harmonic Imaging
7.TDI
Prescription Use × AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
{12}------------------------------------------------
| Clinical Application | | Mode of Operation | | | | | | | Other |
|---------------------------|------------------------------------|-------------------|---|------------|------------|---------------|---------------|-------------------|-------|
| General<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PW Doppler | CW Doppler | Color Doppler | Power Doppler | Combined<br>Modes | |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal Imaging &<br>Other | Fetal | | | | | | | | |
| | Abdominal | | | | | | | | |
| | Intra-operative (Specify) | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | N | N | N | | N | N | N | 4,5,6 |
| | Small Organ1 (Specify) | N | N | N | | N | N | N | 4,5,6 |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | N | N | N | | N | N | N | 4,5,6 |
| | Musculo-skeletal<br>(Superficial) | N | N | N | | N | N | N | 4,5,6 |
| | Other (Urology) | | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| | Transesophageal | | | | | | | | |
| Peripheral Vessel | Peripheral vessel | N | N | N | | N | N | N | 5,6 |
N = new indication; P = previously cleared by FDA;
E = added under this appendix
Note : 1. Combined modes are B/M, B+PWD, B/Color M, B/PWD or CWD, B/Color/PWD or CWD,B/Power/PWD 2.Small Organ: thyroid, testes, breast
- 3.3D/4D
4.Elastography
5. Includes guidance of biopsy(2D)
6.Fusion Harmonic Imaging
7.TDI
Prescription Use × AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
{13}------------------------------------------------
| Clinical Application | | Mode of Operation | | | | | | | |
|---------------------------|------------------------------------|-------------------|---|---------------|---------------|------------------|------------------|-------------------|-------|
| General<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Power<br>Doppler | Combined<br>Modes | Other |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal Imaging &<br>Other | Fetal | | | | | | | | |
| | Abdominal | | | | | | | | |
| | Intra-operative (Specify) | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ[1] (Specify) | N | N | N | | N | N | N | 4,5,6 |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | N | N | N | | N | N | N | 4,5,6 |
| | Musculo-skeletal<br>(Superficial) | N | N | N | | N | N | N | 4,5,6 |
| | Other (Urology) | | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| | Transesophageal | | | | | | | | |
| Peripheral Vessel | Peripheral vessel | N | N | N | | N | N | N | 5,6 |
N = new indication;
P = previously cleared by FDA;
E = added under this appendix
Note : 1. Combined modes are B/M, B+PWD, B/Color M, B/PWD or CWD, B/Color/PWD or CWD,B/Power/PWD 2.Small Organ: thyroid, testes, breast
3.3D/4D
4.Elastography
5. Includes guidance of biopsy(2D)
6.Fusion Harmonic Imaging
7.TDI
Prescription Use メ Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
{14}------------------------------------------------
| Clinical Application | | Mode of Operation | | | | | | | | |
|---------------------------|------------------------------------|-------------------|---|---------------|---------------|------------------|------------------|-------------------|-------|--|
| General<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Power<br>Doppler | Combined<br>Modes | Other | |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| Fetal Imaging &<br>Other | Fetal | | | | | | | | | |
| | Abdominal | | | | | | | | | |
| | Intra-operative (Specify) | | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | | |
| | Laparoscopic | | | | | | | | | |
| | Pediatric | | | | | | | | | |
| | Small Organ1 (Specify) | | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | | |
| | Adult Cephalic | | | | | | | | | |
| | Trans-rectal | N | N | N | | N | N | N | 4,5,6 | |
| | Trans-vaginal | | | | | | | | | |
| | Trans-urethral | | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | | | |
| | Other (Urology) | N | N | N | | N | N | N | 5,6 | |
| Cardiac | Cardiac Adult | | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | | |
| | Transesophageal | | | | | | | | | |
| Peripheral Vessel | Peripheral vessel | | | | | | | | | |
P = previously cleared by FDA; E = added under this appendix N = new indication;
Note : 1. Combined modes are B/M, B+PWD, B/Color M, B/PWD or CWD, B/Color/PWD or CWD,B/Power/PWD 2.Small Organ: thyroid, testes, breast
3.3D/4D
4.Elastography
5. Includes guidance of biopsy(2D)
6.Fusion Harmonic Imaging
7.TDI
Prescription Use メ AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
{15}------------------------------------------------
| Clinical Application | | Mode of Operation | | | | | | | Other |
|---------------------------|------------------------------------|-------------------|---|---------------|---------------|------------------|------------------|-------------------|-------|
| General<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Power<br>Doppler | Combined<br>Modes | |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal Imaging &<br>Other | Fetal | | | | | | | | |
| | Abdominal | | | | | | | | |
| | Intra-operative (Specify) | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ1 (Specify) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | N | N | N | | N | N | N | 4,5,6 |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | | |
| | Other (Urology) | N | N | N | | N | N | N | 5,6 |
| Cardiac | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| | Transesophageal | | | | | | | | |
| Peripheral Vessel | Peripheral vessel | | | | | | | | |
P = previously cleared by FDA; E = added under this appendix N = new indication;
Note : 1. Combined modes are B/M, B+PWD, B/Color M, B/PWD or CWD, B/Color/PWD or CWD,B/Power/PWD 2.Small Organ: thyroid, testes, breast
3.3D/4D
4.Elastography
5. Includes guidance of biopsy(2D)
6.Fusion Harmonic Imaging
7.TDI
Prescription Use × AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
{16}------------------------------------------------
| Clinical Application | | Mode of Operation | | | | | | | Other |
|---------------------------|------------------------------------|-------------------|---|---------------|---------------|------------------|------------------|-------------------|-------|
| General<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Power<br>Doppler | Combined<br>Modes | |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal Imaging &<br>Other | Fetal | | | | | | | | |
| | Abdominal | | | | | | | | |
| | Intra-operative (Specify) | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ[1] (Specify) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | N | N | N | N | N | N | N | 4,5,6 |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | | |
| | Other (Urology) | N | N | N | N | N | N | N | 5,6 |
| Cardiac | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| | Transesophageal | | | | | | | | |
| Peripheral Vessel | Peripheral vessel | | | | | | | | |
P = previously cleared by FDA; E = added under this appendix N = new indication;
Note : 1. Combined modes are B/M, B+PWD, B/Color M, B/PWD or CWD, B/Color/PWD or CWD,B/Power/PWD 2.Small Organ: thyroid, testes, breast
3.3D/4D
4.Elastography
5. Includes guidance of biopsy(2D)
6.Fusion Harmonic Imaging
7.TDI
Prescription Use メ AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
{17}------------------------------------------------
| Clinical Application | | Mode of Operation | | | | | | | | |
|----------------------|------------------------------------|-------------------|---|----|----|-------|---------------------------------|----------|-------|--|
| General | Specific | B | M | PW | CW | Color | Power | Combined | Other | |
| (Track 1 Only) | (Tracks 1 & 3) | | | | |…
