(118 days)
Not Found
No
The document describes standard ultrasound imaging modes and processing techniques (autocorrelation, FFT) and does not mention AI, ML, or related concepts.
No
The device is described as a "Diagnostic Ultrasound System" for "clinical diagnostic imaging applications," indicating its purpose is for diagnosis, not treatment.
Yes
The "Device Description" explicitly states, "The QBit Series Diagnostic Ultrasound System is an integrated preprogrammed color doppler ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications." It also repeatedly uses the term "diagnostic ultrasound system."
No
The device description explicitly states it consists of a "mobile console with keyboard control panel, power supply module, color LCD monitor and optional probes," indicating it includes significant hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that this is a diagnostic ultrasound system. Ultrasound is an imaging modality that uses sound waves to create images of internal body structures. It does not involve the analysis of specimens taken from the body.
- Intended Use: The intended use lists various anatomical sites and clinical applications, all of which involve imaging the body directly.
Therefore, this device falls under the category of medical imaging devices, not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
IYN, IYO, ITX
Device Description
The QBit Series Diagnostic Ultrasound System is an integrated preprogrammed color doppler ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications.
This system is a Track 3 device that employs a wide array of probes that include linear array, convex array and phased array . This system consists of a mobile console with keyboard control panel, power supply module, color LCD monitor and optional probes.
This system is a mobile, general purpose, software controlled, color diagnostic ultrasound system. Its basic function is to acquire ultrasound echo data and to display the image B-Mode (including Fusion Harmonic Imaging), M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Power Doppler Mode, Directional Power Doppler Mode, TDI Mode or a combination of these modes, Elastography, 3D/4D.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Fetal, Abdominal, Pediatric, Small Organ (breast, thyroid, testes), Neonatal Cephalic, Adult Cephalic, Cardiac (adult, pediatric), Musculo-skeletal (Conventional, Superficial), Peripheral Vascular, Transesophageal, Transrectal, Transvaginal, Urology.
Indicated Patient Age Range
Fetal, Pediatric, Neonatal Cephalic, Adult Cephalic.
Intended User / Care Setting
qualified physician / Hospitals, clinics usage
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
No clinical testing was required.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces 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.(b)
Classification. Class II.
0
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.
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.
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
2
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.
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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."
3
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 | ||||||||||
| (Track 1 Only) | Specific | |||||||||
| (Tracks 1 & 3) | B | M | PW | |||||||
| Doppler | CW | |||||||||
| Doppler | Color | |||||||||
| Doppler | Power | |||||||||
| Doppler | Combined | |||||||||
| Modes | Other | |||||||||
| Ophthalmic | Ophthalmic | |||||||||
| Fetal Imaging & | ||||||||||
| 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 | ||||||||||
| (Conventional) | N | N | N | N | N | N | 4,5,6 | |||
| Musculo-skeletal | ||||||||||
| (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 |
- 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
- 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 | |||||||||
| (Track 1 Only) | Specific | ||||||||
| (Tracks 1 & 3) | B | M | PW | ||||||
| Doppler | CW | ||||||||
| Doppler | Color | ||||||||
| Doppler | Power | ||||||||
| Doppler | Combined | ||||||||
| Modes | |||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal Imaging & | |||||||||
| 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 | |||||||||
| (Conventional) | |||||||||
| Musculo-skeletal | |||||||||
| (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
- 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 | |||||||||
| (Track 1 Only) | Specific | ||||||||
| (Tracks 1 & 3) | B | M | PW | ||||||
| Doppler | CW | ||||||||
| Doppler | Color | ||||||||
| Doppler | Power | ||||||||
| Doppler | Combined | ||||||||
| Modes | Other | ||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal Imaging & | |||||||||
| 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 | |||||||||
| (Conventional) | |||||||||
| Musculo-skeletal | |||||||||
| (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
- 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 | |||||||||
| (Track 1 Only) | Specific | ||||||||
| (Tracks 1 & 3) | B | M | PW | ||||||
| Doppler | CW | ||||||||
| Doppler | Color | ||||||||
| Doppler | Power | ||||||||
| Doppler | Combined | ||||||||
| Modes | Other | ||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal Imaging & | |||||||||
| 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 | |||||||||
| (Conventional) | |||||||||
| Musculo-skeletal | |||||||||
| (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
- 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 | ||||||||||
| (Track 1 Only) | Specific | |||||||||
| (Tracks 1 & 3) | B | M | PW | |||||||
| Doppler | CW | |||||||||
| Doppler | Color | |||||||||
| Doppler | Power | |||||||||
| Doppler | Combined | |||||||||
| Modes | Other | |||||||||
| Ophthalmic | Ophthalmic | |||||||||
| Fetal Imaging & | ||||||||||
| 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 | ||||||||||
| (Conventional) | ||||||||||
| Musculo-skeletal | ||||||||||
| (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
- 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 | |||||||||
| (Track 1 Only) | Specific | ||||||||
| (Tracks 1 & 3) | B | M | PW | ||||||
| Doppler | CW | ||||||||
| Doppler | Color | ||||||||
| Doppler | Power | ||||||||
| Doppler | Combined | ||||||||
| Modes | |||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal Imaging & | |||||||||
| 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 | |||||||||
| (Conventional) | N | N | N | N | N | N | 4,5,6 | ||
| Musculo-skeletal | |||||||||
| (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
- 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 | |||||||||
| (Track 1 Only) | Specific | ||||||||
| (Tracks 1 & 3) | B | M | PW Doppler | CW Doppler | Color Doppler | Power Doppler | Combined Modes | ||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal Imaging & | |||||||||
| 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 | |||||||||
| (Conventional) | N | N | N | N | N | N | 4,5,6 | ||
| Musculo-skeletal | |||||||||
| (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
- 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 | |||||||||
| (Track 1 Only) | Specific | ||||||||
| (Tracks 1 & 3) | B | M | PW | ||||||
| Doppler | CW | ||||||||
| Doppler | Color | ||||||||
| Doppler | Power | ||||||||
| Doppler | Combined | ||||||||
| Modes | |||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal Imaging & | |||||||||
| 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 | |||||||||
| (Conventional) | N | N | N | N | N | N | 4,5,6 | ||
| Musculo-skeletal | |||||||||
| (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
- 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 | |||||||||
| (Track 1 Only) | Specific | ||||||||
| (Tracks 1 & 3) | B | M | PW | ||||||
| Doppler | CW | ||||||||
| Doppler | Color | ||||||||
| Doppler | Power | ||||||||
| Doppler | Combined | ||||||||
| Modes | |||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal Imaging & | |||||||||
| 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 | |||||||||
| (Conventional) | N | N | N | N | N | N | 4,5,6 | ||
| Musculo-skeletal | |||||||||
| (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
- 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 | |||||||||
| (Track 1 Only) | Specific | ||||||||
| (Tracks 1 & 3) | B | M | PW Doppler | CW Doppler | Color Doppler | Power Doppler | Combined | ||
| Modes | |||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal Imaging & | |||||||||
| 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 | |||||||||
| (Conventional) | N | N | N | N | N | N | 4,5,6 | ||
| Musculo-skeletal | |||||||||
| (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
- 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 | |||||||||
| (Track 1 Only) | Specific | ||||||||
| (Tracks 1 & 3) | B | M | PW | ||||||
| Doppler | CW | ||||||||
| Doppler | Color | ||||||||
| Doppler | Power | ||||||||
| Doppler | Combined | ||||||||
| Modes | Other | ||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal Imaging & | |||||||||
| 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 | |||||||||
| (Conventional) | N | N | N | N | N | N | 4,5,6 | ||
| Musculo-skeletal | |||||||||
| (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
- 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 | ||||||||||
| (Track 1 Only) | Specific | |||||||||
| (Tracks 1 & 3) | B | M | PW | |||||||
| Doppler | CW | |||||||||
| Doppler | Color | |||||||||
| Doppler | Power | |||||||||
| Doppler | Combined | |||||||||
| Modes | Other | |||||||||
| Ophthalmic | Ophthalmic | |||||||||
| Fetal Imaging & | ||||||||||
| 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 | ||||||||||
| (Conventional) | ||||||||||
| Musculo-skeletal | ||||||||||
| (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
- 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 | |||||||||
| (Track 1 Only) | Specific | ||||||||
| (Tracks 1 & 3) | B | M | PW | ||||||
| Doppler | CW | ||||||||
| Doppler | Color | ||||||||
| Doppler | Power | ||||||||
| Doppler | Combined | ||||||||
| Modes | |||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal Imaging & | |||||||||
| 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 | |||||||||
| (Conventional) | |||||||||
| Musculo-skeletal | |||||||||
| (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
- 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 | |||||||||
| (Track 1 Only) | Specific | ||||||||
| (Tracks 1 & 3) | B | M | PW | ||||||
| Doppler | CW | ||||||||
| Doppler | Color | ||||||||
| Doppler | Power | ||||||||
| Doppler | Combined | ||||||||
| Modes | |||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal Imaging & | |||||||||
| 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 | |||||||||
| (Conventional) | |||||||||
| Musculo-skeletal | |||||||||
| (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
- 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) | Doppler Doppler Doppler Doppler | Modes | |||||||
| Ophthalmic | Ophthalmic | |||||||||
| Fetal Imaging & | Fetal | |||||||||
| Other | Abdominal | |||||||||
| Intra-operative (Specify) | ||||||||||
| Intra-operative (Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | ||||||||||
| Small Organ111 (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 | ||||||||||
| (Conventional) | ||||||||||
| Musculo-skeletal | ||||||||||
| (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
- 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)
18
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General | |||||||||
| (Track 1 Only) | Specific | ||||||||
| (Tracks 1 & 3) | B | M | PW | ||||||
| Doppler | CW | ||||||||
| Doppler | Color | ||||||||
| Doppler | Power | ||||||||
| Doppler | Combined | ||||||||
| Modes | Other | ||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal Imaging & | |||||||||
| 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 | |||||||||
| (Conventional) | |||||||||
| Musculo-skeletal | |||||||||
| (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
- 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)
19
| Clinical Application | Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| General | ||||||||||
| (Track 1 Only) | Specific | |||||||||
| (Tracks 1 & 3) | B | M | PW Doppler | CW Doppler | Color Doppler | Power Doppler | Combined | |||
| Modes | Other | |||||||||
| Ophthalmic | Ophthalmic | |||||||||
| Fetal Imaging & | ||||||||||
| 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 | ||||||||||
| (Conventional) | ||||||||||
| Musculo-skeletal | ||||||||||
| (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
- 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)
20
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General | |||||||||
| (Track 1 Only) | Specific | ||||||||
| (Tracks 1 & 3) | B | M | PW | ||||||
| Doppler | CW | ||||||||
| Doppler | Color | ||||||||
| Doppler | Power | ||||||||
| Doppler | Combined | ||||||||
| Modes | Other | ||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal Imaging & | |||||||||
| 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 | N | 3,4,5,6 | |
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal | |||||||||
| (Conventional) | |||||||||
| Musculo-skeletal | |||||||||
| (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
- 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)
21
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General | |||||||||
| (Track 1 Only) | Specific | ||||||||
| (Tracks 1 & 3) | B | M | PW | ||||||
| Doppler | CW | ||||||||
| Doppler | Color | ||||||||
| Doppler | Power | ||||||||
| Doppler | Combined | ||||||||
| Modes | Other | ||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal Imaging & | |||||||||
| Other | Fetal | ||||||||
| Abdominal | N | N | N | N | N | N | N | 4,5,6 | |
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | N | N | N | N | N | N | N | 4,5,6 | |
| Small Organ1 (Specify) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal | |||||||||
| (Conventional) | |||||||||
| Musculo-skeletal | |||||||||
| (Superficial) | |||||||||
| Other (Urology) | |||||||||
| Cardiac | Cardiac Adult | N | N | N | N | N | N | N | 5,6 |
| Cardiac Pediatric | N | N | N | N | N | N | N | 5,6 | |
| 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
- 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)
22
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General | |||||||||
| (Track 1 Only) | Specific | ||||||||
| (Tracks 1 & 3) | B | M | PW | ||||||
| Doppler | CW | ||||||||
| Doppler | Color | ||||||||
| Doppler | Power | ||||||||
| Doppler | Combined | ||||||||
| Modes | Other | ||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal Imaging & | |||||||||
| Other | Fetal | ||||||||
| 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 | |||||||||
| (Conventional) | |||||||||
| Musculo-skeletal | |||||||||
| (Superficial) | |||||||||
| Other (Urology) | N | N | N | N | N | N | 5,6 | ||
| Cardiac | Cardiac Adult | N | N | N | N | N | N | 5,6 | |
| Cardiac Pediatric | N | N | N | N | N | N | 5,6 | ||
| 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
- 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)
23
| Clinical Application | Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| General | ||||||||||
| (Track 1 Only) | Specific | |||||||||
| (Tracks 1 & 3) | B | M | PW | CW | ||||||
| Doppler Doppler Doppler Doppler | Color | Power | Combined | |||||||
| Modes | Other | |||||||||
| Ophthalmic | Ophthalmic | |||||||||
| Fetal Imaging & | Fetal | N | N | Z | N | N | N | 5,6 | ||
| Other | Abdominal | N | N | N | N | N | N | 4,5,6 | ||
| 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) | ||||||||||
| 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
- 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)
24
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General | |||||||||
| (Track 1 Only) | Specific | ||||||||
| (Tracks 1 & 3) | B | M | PW | ||||||
| Doppler | CW | ||||||||
| Doppler | Color | ||||||||
| Doppler | Power | ||||||||
| Doppler | Combined | ||||||||
| Modes | Other | ||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal Imaging & | |||||||||
| Other | Fetal | ||||||||
| Abdominal | |||||||||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small OrganII (Specify) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | N | N | N | N | N | N | N | 6,7 | |
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal | |||||||||
| (Conventional) | |||||||||
| Musculo-skeletal | |||||||||
| (Superficial) | |||||||||
| Other (Urology) | |||||||||
| Cardiac | Cardiac Adult | N | N | N | N | N | N | N | 5,6,7 |
| 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
- 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)
25
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General | |||||||||
| (Track 1 Only) | Specific | ||||||||
| (Tracks 1 & 3) | B | M | PW | ||||||
| Doppler | CW | ||||||||
| Doppler | Color | ||||||||
| Doppler | Power | ||||||||
| Doppler | Combined | ||||||||
| Modes | Other | ||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal Imaging & | |||||||||
| Other | Fetal | ||||||||
| Abdominal | |||||||||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ[1] (Specify) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | N | N | N | N | N | N | N | 6,7 | |
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal | |||||||||
| (Conventional) | |||||||||
| Musculo-skeletal | |||||||||
| (Superficial) | |||||||||
| Other (Urology) | |||||||||
| Other (Ob/GYN) | |||||||||
| Cardiac | Cardiac Adult | N | N | N | N | N | N | N | 5,6,7 |
| 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
- 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)
26
| Clinical Application | Mode of Operation | Other | |||||||
|---|---|---|---|---|---|---|---|---|---|
| General | |||||||||
| (Track 1 Only) | Specific | ||||||||
| (Tracks 1 & 3) | B | M | PW | ||||||
| Doppler | CW | ||||||||
| Doppler | Color | ||||||||
| Doppler | Power | ||||||||
| Doppler | Combined | ||||||||
| Modes | |||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal Imaging & | |||||||||
| Other | Fetal | ||||||||
| Abdominal | |||||||||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small OrganII (Specify) | |||||||||
| Neonatal Cephalic | N | N | N | N | N | N | N | 6,7 | |
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal | |||||||||
| (Conventional) | |||||||||
| Musculo-skeletal | |||||||||
| (Superficial) | |||||||||
| Other (Urology) | |||||||||
| Cardiac | Cardiac Adult | ||||||||
| Cardiac Pediatric | N | N | N | N | N | N | N | 5,6,7 | |
| 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
- 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)
27
| Clinical Application | Mode of Operation | Other | |||||||
|---|---|---|---|---|---|---|---|---|---|
| General | Specific | B | M | PW | |||||
| Doppler | CW | ||||||||
| Doppler | Color | ||||||||
| Doppler | Power | ||||||||
| Doppler | Combined | ||||||||
| Modes | |||||||||
| (Track 1 Only) | (Tracks 1 & 3) | ||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal Imaging & | |||||||||
| Other | Fetal | ||||||||
| Abdominal | |||||||||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small OrganII (Specify) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | N | ||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal | |||||||||
| (Conventional) | |||||||||
| Musculo-skeletal | |||||||||
| (Superficial) | |||||||||
| Other (Urology) | |||||||||
| Cardiac Adult | N | ||||||||
| Cardiac Pediatric | N | ||||||||
| Transesophageal | |||||||||
| Peripheral Vessel | Peripheral vessel | N |
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
- 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)
28
| Clinical Application | Mode of Operation | Other | |||||||
|---|---|---|---|---|---|---|---|---|---|
| General | |||||||||
| (Track 1 Only) | Specific | ||||||||
| (Tracks 1 & 3) | B | M | PW | ||||||
| Doppler | CW | ||||||||
| Doppler | Color | ||||||||
| Doppler | Power | ||||||||
| Doppler | Combined | ||||||||
| Modes | |||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal Imaging & | |||||||||
| Other | Fetal | N | N | N | N | N | N | 3,6 | |
| Abdominal | N | N | N | N | N | N | 3,4,6 | ||
| 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 | |||||||||
| (Conventional) | |||||||||
| Musculo-skeletal | |||||||||
| (Superficial) | |||||||||
| Other (Urology) | N | N | N | N | N | N | 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
- 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)
29
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General | |||||||||
| (Track 1 Only) | Specific | ||||||||
| (Tracks 1 & 3) | B | M | PW | ||||||
| Doppler | CW | ||||||||
| Doppler | Color | ||||||||
| Doppler | Power | ||||||||
| Doppler | Combined | ||||||||
| Modes | Other | ||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal Imaging & | |||||||||
| Other | Fetal | ||||||||
| Abdominal | |||||||||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small OrganII (Specify) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal | |||||||||
| (Conventional) | |||||||||
| Musculo-skeletal | |||||||||
| (Superficial) | |||||||||
| Other (Urology) | |||||||||
| Cardiac | Cardiac Adult | ||||||||
| Cardiac Pediatric | |||||||||
| Transesophageal | N | N | N | N | N | N | N | 6,7 | |
| 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
- 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)
30
| Clinical Application | Mode of Operation | Other | |||||||
|---|---|---|---|---|---|---|---|---|---|
| General | |||||||||
| (Track 1 Only) | Specific | ||||||||
| (Tracks 1 & 3) | B | M | PW | ||||||
| Doppler | CW | ||||||||
| Doppler | Color | ||||||||
| Doppler | Power | ||||||||
| Doppler | Combined | ||||||||
| Modes | |||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal Imaging & | |||||||||
| Other | Fetal | ||||||||
| Abdominal | |||||||||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small OrganII (Specify) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal | |||||||||
| (Conventional) | |||||||||
| Musculo-skeletal | |||||||||
| (Superficial) | |||||||||
| Other (Urology) | |||||||||
| Cardiac | Cardiac Adult | ||||||||
| Cardiac Pediatric | |||||||||
| Transesophageal | N | N | N | N | N | N | N | 6,7 | |
| 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
- 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)
31
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
1. Submitter:
| Submitter: | Chison Medical Imaging Co., Ltd. |
|---|---|
| Address: | No.228, ChangJiang East Road,Block 51 and 53, |
| Phase 5 Industrial Park, ShuoFang, New District, | |
| Wuxi 214142, China | |
| No.9 Xin Hui Huan Road, New District ,WuXi P.R.China | |
| Contact: | Ms. Ruoli Mo |
| Tel: | +86-510-85311707, 85310593 |
| Fax: | +86-510-85310726 |
| Date Prepared: | February 16, 2015 |
2. Device :
QBit Series Diagnostic Ultrasound System Trade Name:
Common Name: Diagnostic Ultrasound System with Accessories
Classification: Regulatory Class: II Review Category: Tier II
| Classfication Name | 21 CFR Section | Product Code |
|---|---|---|
| Ultrasonic pulsed doppler imaging system | 892.1550 | 90-IYN |
| Ultrasonic pulsed echo imaging system | 892.1560 | 90-IYO |
| Diagnostic ultrasonic transducer | 892.1570 | 90-ITX |
3. Predicate Device(s):
DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System
510(k) Number: K132341
4. Device Description:
The QBit Series Diagnostic Ultrasound System is an integrated preprogrammed color doppler ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications.
This system is a Track 3 device that employs a wide array of probes that include linear array, convex array and phased array . This system consists of a mobile console with keyboard control panel, power supply module, color LCD monitor and optional probes.
This system is a mobile, general purpose, software controlled, color diagnostic ultrasound system. Its basic function is to acquire ultrasound echo data and to display the image B-Mode (including Fusion Harmonic Imaging), M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW)
32
Doppler Mode, Color Doppler Mode, Power Doppler Mode, Directional Power Doppler Mode, TDI Mode or a combination of these modes, Elastography, 3D/4D.
5. Indications for Use:
The device is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Fetal ,Abdominal,Pediatric,Small Organ (breast, thyroid,testes ), Neonatal Cephalic ,Adult Cephalic,Cardiac (adult , pediatric),Musculo-skeletal Superficial) (Conventional ,Peripheral Vascular,Transesophageal,Transrectal, Transvaginal, Urology.
6. Summary of Non-Clinical Tests:
The QBit Series Diagnostic Ultrasound System has been evaluated for electrical, mechanical, thermal and electromagnetic compatibility safety, biocompatibility and acoustic output.
The device has been found to conform to applicable medical device safety standards in regards to thermal, mechanical and electrical safety as well as biocompatibility.
IEC 60601-1: 2005 Medical Electrical Equipment - Part 1: General Requirements for Safety
IEC 60601-1-2: 2007 Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility -- Requirements and Tests.
IEC 60601-2-37: 2007 Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment.
NEMA UD 2-2004, Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment Version 3.
NEMA UD3: 2004 Standards for Real-time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment ISO 10993-1:2009 Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process
7. Clinical Test:
No clinical testing was required.
8. Comparison to Predicate Device:
| Predicate Device | Submission Device | ||
|---|---|---|---|
| Product | |||
| Name | |||
| (K number) | DC-8/DC-8 PRO/DC-8 CV/DC-8 | ||
| EXP/DC-8S | |||
| K132341 | QBit Series | ||
| TBD | Remark | ||
| Indications | |||
| for Use | Fetal | ||
| Abdominal | |||
| Pediatric | |||
| Small Organ (breast, thyroid, testes) | |||
| Neonatal Cephalic | Fetal | ||
| Abdominal | |||
| Pediatric | |||
| Small Organ (breast, thyroid, testes) | Same | ||
| Predicate Device | Submission Device | ||
| Product | |||
| Name | |||
| (K number) | DC-8/DC-8 PRO/DC-8 CV/DC-8 | ||
| EXP/DC-8S | |||
| K132341 | QBit Series | ||
| TBD | Remark | ||
| Adult Cephalic | Neonatal Cephalic ,Adult | ||
| Trans-rectal | Cephalic | ||
| Trans-vaginal | Transrectal | ||
| Musculo-skeletal( Conventional, | |||
| Superficial) | Transvaginal | ||
| adult Cardiac ,pediatric Cardiac) | Musculo-skeletal( | ||
| Conventional, Superficial) | |||
| Peripheral Vascular ; | Cardiac(adult ,pediatric) | ||
| Urology | Peripheral Vascular | ||
| Transesophageal(Cardiac) | Urology | ||
| Transesophageal | |||
| Design | Autocorrelation for color | ||
| processing and FFT for pulse | |||
| and CW Doppler processing. | |||
| Supporting Linear, Curve | |||
| Phase array and Volume probes | Autocorrelation for color | ||
| processing and FFT for pulse | |||
| and CW Doppler processing. | |||
| Supporting Linear, Curve , | |||
| Phase array and Volume probes . | Same | ||
| Cine play back capability | Cine play back capability | ||
| Image file archive | Image file archive | ||
| Operating | |||
| Controls | TGC 8 slider | TGC 8 slider | Same |
| Depth Range: 1.5 to 40 cm | Depth Range: 0 to 30 cm | SE | |
| Analysis | |||
| 1 | |||
| 256 shades of gray | 256 shades of gray | Same | |
| B Dynamic range control: | |||
| 180 dB, 5/step | 30-B Dynamic range control: 30- | ||
| 180 dB, 5/step | Same | ||
| Gain:0-100,1/step | Gain:0-255,1/step | SE | |
| Analysis | |||
| 1 | |||
| Focal Number:1-4 | Focal Number:1-4 | Same | |
| Focus position: adjustable | Focus position: adjustable | Same | |
| B steer: available on linear | |||
| transducers | B steer: available on linear | ||
| transducers | Same | ||
| B Persistence: 7 steps | B Persistence: 7 steps | Same | |
| ROI size/position: adjustable | ROI size/position: adjustable | Same | |
| Color Wall Filter settings:8 steps | Color Wall Filter settings:8 steps | Same | |
| Color Baseline: 16 steps | Color Baseline: 16 steps | Same | |
| Color Maps: 21 maps | Color Maps: 21 maps | Same | |
| Color Invert: on/off | Color Invert: on/off | Same | |
| PW sweeping speed: 6 steps | PW sweeping speed: 6 steps | Same | |
| PW Wall Filter: 7 steps | PW Wall Filter: 7 steps | Same | |
| PW sample volume: 0.5-30mm | |||
| (PW only), 13 steps | PW sample volume: 0.5- | ||
| 30mm (PW only), 13 steps | Same | ||
| PW angle correction:- | |||
| 89~89degrees, 1/step | PW angle correction:- | ||
| 89~89degrees, 1/step | Same | ||
| Baseline: 8steps | Baseline: 8steps | Same | |
| Predicate Device | Submission Device | ||
| Product | |||
| Name | |||
| (K number) | DC-8/DC-8 PRO/DC-8 CV/DC-8 | ||
| EXP/DC-8S | |||
| K132341 | QBit Series | ||
| TBD | |||
| Cine control: step, play | |||
| backward, play continuously | |||
| Doppler Auto Trace | Cine control: step, play | ||
| backward, play continuously | |||
| Doppler Auto Trace | Same | ||
| Freeze control:Toggling freeze | |||
| key | Freeze control:Toggling freeze | ||
| key | Same | ||
| Safety | |||
| Compliance | IEC60601-1 Medical electrical | ||
| equipment - Part 1: General | |||
| requirements for safety | |||
| IEC60601-1-2 Medical electrical | |||
| equipment - Part 1-2: General | |||
| requirements for safety | |||
| Collateral standard: | |||
| Electromagnetic compatibility - | |||
| Requirements and tests | |||
| IEC60601-2-37 Medical | |||
| electrical equipment - Part 2-37: | |||
| Particular requirements for the | |||
| safety of ultrasonic medical | |||
| diagnostic and monitoring | |||
| equipment | |||
| ISO 10993-1 Biological | |||
| evaluation of medical devices - | |||
| Part 1: Evaluation and testing- | |||
| within a risk management | |||
| process | IEC60601-1 Medical electrical | ||
| equipment - Part 1: General | |||
| requirements for safety | |||
| IEC60601-1-2 Medical | |||
| electrical equipment - Part 1- | |||
| 2: General requirements for | |||
| safety - Collateral standard: | |||
| Electromagnetic compatibility |
- Requirements and tests
IEC60601-2-37 Medical
electrical equipment - Part 2-
37: Particular requirements for
the safety of ultrasonic
medical diagnostic and
monitoring equipment
ISO 10993-1 Biological
evaluation of medical devices - Part 1: Evaluation and
testing within a risk
management process | Same |
| Patient
Contact
Materials | Bio-compatible | Bio-compatible | Same |
| Operation
Mode | B, THI, PSH (Phase Shift
Harmonic Imaging) , M,Color M,Steering
Free Xros MTM (Anatomical M-Doppler
mode), Free Xros CM (Curved Doppler
Anatomical M-mode), ColorPD, Pulsed Wave Doppler,
Doppler Imaging,Power Doppler
Imaging/Directional PD, Pulsed
Wave Doppler, Continuous
Wave Doppler , TDI, UWN+Panoramic ,Trapezoidal image
(Ultra Wideband Non-linear)
Contrast Imaging, 3D/ 4D
Elastography, iScape View
(Panoramic Imaging ) | B, FHI, M,Color M, Free
M mode , Color
Doppler Imaging,Power
Continuous Wave Doppler ,
TDI, Contrast Imaging, 3D/
4D ,Elastography, Curved | Same |
| Display
Modes | B,M,PW,CW,CFM,Power/Dirpower
,TDI,3D/4D;
B+M,B+PW,B+CFM,B+PD/DPD,
B+CFM+PW/CW,B+PW+PD/DP D | B,M,PW,CW,CFM,Power/Dirpower
,TDI,3D/4D;
B+M,B+PW,B+CFM,B+PD/DP
D,B+CFM+PW/CW,B+PW+P
D/DBD | Same |
| | Predicate Device | Submission Device | |
| Product
Name
(K number) | DC-8/DC-8 PRO/DC-8 CV/DC-8
EXP/DC-8S
K132341 | QBit Series
TBD | Remark |
| Display
Annotations | Logo; Hospital Name;Exam
date;Exam time; Acoustic
Power ;Mechanical index;Tissue
thermal indes;ID,Last name,First
Name,Middle
initial, Gender, Age; Probe
model;ECG ico;Operator;TGC
Corve;Focus
position;Thumbnail;Imaging
parameters;Dynamic Trackball
indices | Logo; Hospital Name;Exam
date;Exam time; Acoustic
Power ;Mechanical
thermal
indes;ID,Last
name,First
Name,Middle
initial, Gender, Age; Probe
model;ECG ico;Operator;TGC
Corve;Focus
position;Thumbnail;Imaging
parameters;Dynamic Trackball
indices | Same |
| Display
Monitor | 19" high-resolution color LCD
monitor | 15"/ 19" high-resolution color
LCD monitor | Same |
| Measurements | 2D mode: Depth , Distance
Area: Ellipse, Trace, Spline,
Cross,Trace Length , Double
Distance , Parallel ,Volume
:Distance, Ellipse, Ellipse +
Distance,Length Ratio ,Area
Ratio , IMT, B Histogram , B
Profile, Volume Flow, Color
Velocity;
M mode: Distance,Time, Slope,
Heart Rate, Velocity;
Doppler mode: D Velocity ,Time,
Heart Rate,Acceleration ,D
Trace,PS/ED , Volume Flow; | 2D mode: Depth , Distance
Area: Ellipse, Trace, Spline,
Trace Length , Double
Distance , Parallel ,Volume
:Distance, Ellipse, Ellipse +
Distance, Distance Ratio
,Area Ratio , IMT, Volume
Flow, Color Velocity;
M mode: Distance,Time,
Slope, Heart Rate,Velocity;
Doppler mode: D Velocity ,Time
,Heart
Rate,Acceleration ,D
Trace,PS/ED , Volume Flow; | Same |
| Transducer
Types &
Connectors | Convex Array, Phased Array,
Linear Array, Volume probe
4 ports | Convex Array, Phased Array,
Linear Array, Volume probe
4 ports | Same |
| Users
Sites | Hospitals, clinics usage | Hospitals, clinics usage | Same |
| Acoustic
Output | Track 3; MI, TIS, TIC, TIB
Derated Ispta: 720mW/cm²
maximum, TIS/TIB/TIC:0.1-4.0
Range, Mechanical Index: 1.94.0
Maximum, or Derated Isppa: 190
W/cm² max | Track 3; MI, TIS, TIC, TIB
Derated Ispta: 720mW/cm²
maximum, TIS/TIB/TIC:0.1-
4.0 Range, Mechanical Index:
1.9 Maximum, or Derated
Isppa: 190 W/cm² max | Same |
| | Predicate Device | Submission Device | |
| Product
Name
(K number) | DC-8/DC-8 PRO/DC-8 CV/DC-8
EXP/DC-8S
K132341 | QBit Series
TBD | Remark |
| Power
Requirements | Power requirements: | Power requirements: | SE |
| | AC: 100-127V, or 220-240v | AC :100V- 240V, | Analysis |
| | Frequenzy: 50/60 Hz | Frequenzy:50-60Hz | 2 |
| | Operating temperature: 0-40° C; relative humidity 30-85%;
Barometric pressure:700 to 1060 hPa | Operating temperature: 10-
40° C; relative humidity 30-
75%; Barometric pressure:700
to 1060 hPa | |
| | | | |
Table 1 Substantial Equivalence Comparison
33
34
35
36
Comparison Analysis
SE Analysis 1
The Operating Controls item of proposed device and the predicate device are with different Image Depth Range and Gain , but they can be considered Substantially Equivalent in safety and effectiveness. So the SE is not affected.
SE Analysis 2
The Power Supply of the proposed device and the predicate device are AC :100V- 240V and 100-127V,or 220-240V , but both them comply with the requirements of IEC60601-1 and include the voltage range in the United States. Therefore they can be considered Substantially Equivalent in safety and effectiveness, and no new risk is raised, so the SE is not affected. Therefore, power supply can be considered Substantially Equivalent in safety and effectiveness.
Conclusion:
In accordance with the Act. 21 CFR Part 807 and based on the information provided in this premarket notification, Chison Medical Imaging Co., Ltd. concludes that the QBit Series - Diagnostic Ultrasound System is substantially equivalent to the predicate devices with regard to safety and effectiveness.
9. Substantially Equivalent Conclusion:
In accordance with the Act. 21 CFR Part 807 and based on the information provided in this premarket notification, Chison Medical Imaging Co., Ltd. concludes that the QBit Series - Diagnostic Ultrasound System is substantially equivalent to the predicate devices with regard to safety and effectiveness.