CBit Series Digital Color Doppler Ultrasound System
Device Facts
| Record ID | K180974 |
|---|---|
| Device Name | CBit Series Digital Color Doppler Ultrasound System |
| Applicant | CHISON Medical Technologies Co., Ltd. |
| Product Code | IYN · Radiology |
| Decision Date | Aug 17, 2018 |
| 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, Adult Cephalic, Cardiac (adult, pediatric), Musculo-skeletal (Conventional, Superficial), Peripheral Vascular, Trans-esophageal, Trans-rectal, Trans-vaginal, OB/GYN and Urology.
Device Story
CBit Series is a mobile, software-controlled, digital color Doppler ultrasound system. It acquires ultrasound echo data via various probes (linear, convex, phased, volume) to produce diagnostic images. The system supports multiple modes: B-Mode (including Fusion Harmonic Imaging), M-Mode, PW/CW Doppler, Color/Power Doppler, Directional Power Doppler, TDI, Elastography, and 3D/4D. It is used in clinical settings by qualified clinicians for diagnostic imaging and fluid flow analysis. The system includes a mobile console, keyboard, power supply, and LCD monitor. Clinicians use the displayed images and measurements to evaluate anatomy and pathology, aiding in clinical decision-making. Benefits include non-invasive diagnostic visualization across a wide range of clinical applications.
Clinical Evidence
Bench testing only. The device was evaluated for electrical, mechanical, thermal, and electromagnetic compatibility safety, biocompatibility (ISO 10993-1), and acoustic output (NEMA UD 2, NEMA UD 3). No clinical testing was required.
Technological Characteristics
Mobile digital color Doppler ultrasound system. Supports linear, convex, phased, and volume array transducers. Modes: B, M, PW/CW Doppler, Color/Power Doppler, TDI, Elastography, 3D/4D. Connectivity: mobile console with LCD monitor. Software-controlled. Safety compliance: IEC 60601-1, IEC 60601-2-37, ISO 10993-1.
Indications for Use
Indicated for diagnostic ultrasound imaging or fluid flow analysis in fetal, abdominal, pediatric, small organ (breast, thyroid, testes), neonatal/adult cephalic, cardiac (adult/pediatric), musculoskeletal (conventional/superficial), peripheral vascular, trans-esophageal, trans-rectal, trans-vaginal, OB/GYN, and urology applications. For use by qualified clinicians.
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
Related Devices
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- K233697 — SonoMax Series Digital Color Doppler Ultrasound System · CHISON Medical Technologies Co., Ltd. · Aug 9, 2024
- K162172 — EBit Series Diagnostic Ultrasound System · Chison Medical Imaging Co., Ltd. · Sep 14, 2016
- K221117 — RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound System · Samsung Medison Co., Ltd. · Jun 17, 2022
- K202785 — Resona R9,Resona R9 Exp,Resona R9 Pro,Resona R9S, Nuewa R9,Nuewa R9 Exp,Nuewa R9 Pro,Nuewa R9S,Resona 7,Resona 7CV,Resona 7EXP,Resona 7S, Resona 7OB,Resona 7PRO,Imagyn 7,Resona Y Diagnostic Ultrasound System · Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. · Apr 8, 2021
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" above the word "ADMINISTRATION".
CHISON Medical Technologies Co., Ltd. August 17, 2018 % Mr. Liu Qifei Regulatory Affairs Manager No.228, Changjiang East Road, Block 51 and 53, Phase 5, Shuofang Industrial Park Xinwu District, Wuxi, Jiangsu 214142 CHINA
Re: K180974
Trade/Device Name: CBit Series Digital Color Doppler Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: July 5, 2018 Received: July 9, 2018
Dear Mr. Qifei:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice
(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jeff Bollyer
for Robert Ochs, Ph.D. 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
510(k) Number (if known)
K180974
Device Name
CBit Series Digital Color Doppler Ultrasound System
Indications for Use (Describe)
The device is a general-purpose ultrasonic imstrument intended for use by a qualified clinician for evaluation of Fetal , Abdominal, Pediatric, Small Organ (breast, thyroid,testes ), Neonatal Cephalic, Cardiac (adult , pediatric),Musculo-skeletal (Conventional , Superficial) ,Peripheral Vascular,Trans-esophageal,Trans-rectal, Trans-vaginal, OB/GYN and Urology.
| Type of Use (Select one or both, as applicable) | |
|---------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|
| <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |
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# Diagnostic Ultrasound Indications For Use
### System: CBit Series Digital Color Doppler 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 | 3,4,6,7 |
| | Abdominal | N | N | N | | N | N | N | 3,5,6,7 |
| | Intra-operative (Specify) | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | N | N | N | | N | N | N | 3,5,6,7 |
| | Small Organ[1] (Specify) | N | N | N | | N | N | N | 3,5,6,7 |
| | Neonatal Cephalic | N | N | N | N | N | N | N | 3,6,7,8 |
| | Adult Cephalic | N | N | N | N | N | N | N | 3,6,7,8 |
| | Trans-rectal | N | N | N | | N | N | N | 3,5,6,7 |
| | Trans-vaginal | N | N | N | | N | N | N | 3,4,5,6,7 |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | N | N | N | | N | N | N | 3,5,6,7 |
| | Musculo-skeletal<br>(Superficial) | N | N | N | | N | N | N | 3,5,6,7 |
| | Other (OB/GYN) | N | N | N | | N | N | N | 3,5,6,7 |
| | Other (Urology) | N | N | N | | N | N | N | 3,5,6,7 |
| Cardiac | Cardiac Adult | N | N | N | N | N | N | N | 3,6,7,8 |
| | Cardiac Pediatric | N | N | N | N | N | N | N | 3,6,7,8 |
| | Transesophageal | N | N | N | N | N | N | N | 3,7,8 |
| Peripheral Vessel | Peripheral vessel | N | N | N | | N | N | N | 3,5,6,7 |
P = previously cleared bv FDA: E = added under this appendix N = new indication:
Note : 1. Combined modes are B/M, B/CFM , B/PD, B/PW or CW, B/Color M, B/BC,B/CFM/PW or CW,B/PD or DPD/PW or CW
2. Small Organ: thyroid, testes, breast
3.3D
4.4D
5. Elastography
6. Includes guidance of biopsy (2D)
7. Fusion Harmonic Imaging
8.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)
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#### CBit Series Digital Color Doppler Ultrasound System System: Transducer: D3C60L
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 | N | 3,6,7 |
| | Abdominal | N | N | N | N | N | N | N | 3,5,6,7 |
| | 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) | N | N | N | N | N | N | N | 3,5,6,7 |
| | Musculo-skeletal<br>(Superficial) | | | | | | | | |
| | Other (OB/GYN) | N | N | N | N | N | N | N | 3,5,6,7 |
| | Other (Urology) | N | N | N | N | N | N | N | 3,5,6,7 |
| Cardiac | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| | Transesophageal | | | | | | | | |
| Peripheral Vessel | Peripheral vessel | N | N | N | N | N | N | N | 3,5,6,7 |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Note : 1. Combined modes are B/M, B/CFM , B/PD, B/PW or CW, B/Color M, B/BC,B/CFM/PW or CW,B/PD or DPD/PW or CW
2. Small Organ: thyroid, testes, breast
3.3D
4.4D
5. Elastography
6. Includes guidance of biopsy (2D)
7. Fusion Harmonic Imaging
8.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)
{5}------------------------------------------------
#### CBit Series Digital Color Doppler Ultrasound System System: Transducer: D5C40L
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 | 3,6,7 |
| | Abdominal | N | N | N | | N | N | N | 3,5,6,7 |
| | Intra-operative (Specify) | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | N | N | N | | N | N | N | 3,5,6,7 |
| | Small Organ[1] (Specify) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | N | N | N | | N | N | N | 3,5,6,7 |
| | Musculo-skeletal<br>(Superficial) | | | | | | | | |
| | Other (OB/GYN) | N | N | N | | N | N | N | 3,5,6,7 |
| | Other (Urology) | N | N | N | | N | N | N | 3,5,6,7 |
| Cardiac | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| | Transesophageal | | | | | | | | |
| Peripheral Vessel | Peripheral vessel | N | N | N | | N | N | N | 3,5,6,7 |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Note : 1. Combined modes are B/M, B/CFM , B/PD, B/PW or CW, B/Color M, B/BC,B/CFM/PW or CW,B/PD or DPD/PW or CW
2. Small Organ: thyroid, testes, breast
3.3D
4.4D
5. Elastography
6. Includes guidance of biopsy (2D)
7. Fusion Harmonic Imaging
8.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)
{6}------------------------------------------------
#### CBit Series Digital Color Doppler Ultrasound System System: Transducer: D3C50L
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 | N | 3,6,7 |
| | Abdominal | N | N | N | N | N | N | N | 3,5,6,7 |
| | 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) | N | N | N | N | N | N | N | 3,5,6,7 |
| | Musculo-skeletal<br>(Superficial) | | | | | | | | |
| | Other (OB/GYN) | N | N | N | N | N | N | N | 3,5,6,7 |
| | Other (Urology) | N | N | N | N | N | N | N | 3,5,6,7 |
| Cardiac | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| | Transesophageal | | | | | | | | |
| Peripheral Vessel | Peripheral vessel | N | N | N | N | N | N | N | 3,5,6,7 |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Note : 1. Combined modes are B/M, B/CFM , B/PD, B/PW or CW, B/Color M, B/BC,B/CFM/PW or CW,B/PD or DPD/PW or CW
2. Small Organ: thyroid, testes, breast
3.3D
4.4D
5. Elastography
6. Includes guidance of biopsy (2D)
7. Fusion Harmonic Imaging
8.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)
{7}------------------------------------------------
#### CBit Series Digital Color Doppler Ultrasound System System: Transducer: M3C60L
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 | N | 3,6,7 |
| | Abdominal | N | N | N | N | N | N | N | 3,5,6,7 |
| | 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) | N | N | N | N | N | N | N | 3,5,6,7 |
| | Musculo-skeletal<br>(Superficial) | | | | | | | | |
| | Other (OB/GYN) | N | N | N | N | N | N | N | 3,5,6,7 |
| | Other (Urology) | N | N | N | N | N | N | N | 3,5,6,7 |
| Cardiac | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| | Transesophageal | | | | | | | | |
| Peripheral Vessel | Peripheral vessel | N | N | N | N | N | N | N | 3,5,6,7 |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Note : 1. Combined modes are B/M, B/CFM , B/PD, B/PW or CW, B/Color M, B/BC,B/CFM/PW or CW,B/PD or DPD/PW or CW
2. Small Organ: thyroid, testes, breast
3.3D
4.4D
5. Elastography
6. Includes guidance of biopsy (2D)
7. Fusion Harmonic Imaging
8.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)
{8}------------------------------------------------
#### CBit Series Digital Color Doppler Ultrasound System System: Transducer: H3C60L
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| 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 | 3,6,7 |
| | Abdominal | N | N | N | | N | N | N | 3,5,6,7 |
| | 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) | N | N | N | | N | N | N | 3,5,6,7 |
| | Musculo-skeletal<br>(Superficial) | | | | | | | | |
| | Other (OB/GYN) | N | N | N | | N | N | N | 3,5,6,7 |
| | Other (Urology) | N | N | N | | N | N | N | 3,5,6,7 |
| Cardiac | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| | Transesophageal | | | | | | | | |
| Peripheral Vessel | Peripheral vessel | N | N | N | | N | N | N | 3,5,6,7 |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Note : 1. Combined modes are B/M, B/CFM , B/PD, B/PW or CW, B/Color M, B/BC,B/CFM/PW or CW,B/PD or DPD/PW or CW
2. Small Organ: thyroid, testes, breast
3.3D
4.4D
5. Elastography
6. Includes guidance of biopsy (2D)
7. Fusion Harmonic Imaging
8.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}------------------------------------------------
#### CBit Series Digital Color Doppler Ultrasound System System: Transducer: D7L40L
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 | | | | | | | | | | |
| | Abdominal | N | N | N | | N | N | N | 3,5,6,7 | | |
| | Intra-operative (Specify) | | | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | | | |
| | Laparoscopic | | | | | | | | | | |
| | Pediatric | N | N | N | | N | N | N | 3,5,6,7 | | |
| | Small Organ[1] (Specify) | N | N | N | | N | N | N | 3,5,6,7 | | |
| | Neonatal Cephalic | N | N | N | | N | N | N | 3,6,7 | | |
| | Adult Cephalic | | | | | | | | | | |
| | Trans-rectal | | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | | |
| | Trans-urethral | | | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | N | N | N | | N | N | N | 3,5,6,7 | | |
| | Musculo-skeletal<br>(Superficial) | N | N | N | | N | N | N | 3,5,6,7 | | |
| | Other (OB/GYN) | | | | | | | | | | |
| | Other (Urology) | | | | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | | | |
| | Transesophageal | | | | | | | | | | |
| Peripheral Vessel | Peripheral vessel | N | N | N | | N | N | N | 3,5,6,7 | | |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Note : 1. Combined modes are B/M, B/CFM , B/PD, B/PW or CW, B/Color M, B/BC,B/CFM/PW or CW,B/PD or DPD/PW or CW
2. Small Organ: thyroid, testes, breast
3.3D
4.4D
5. Elastography
6. Includes guidance of biopsy (2D)
7. Fusion Harmonic Imaging
8.TDI
Prescription Use × 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)
{10}------------------------------------------------
#### System: CBit Series Digital Color Doppler Ultrasound System Transducer: D12L40L
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| 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 | | Other | |
| Ophthalmic | Ophthalmic | | | | | | | | | | |
| Fetal Imaging &<br>Other | Fetal | | | | | | | | | | |
| | Abdominal | N | N | N | N | N | N | N | | 3,5,6,7 | |
| | Intra-operative (Specify) | | | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | | | |
| | Laparoscopic | | | | | | | | | | |
| | Pediatric | N | N | N | N | N | N | N | | 3,5,6,7 | |
| | Small Organ[1] (Specify) | N | N | N | N | N | N | N | | 3,5,6,7 | |
| | Neonatal Cephalic | N | N | N | N | N | N | N | | 3,6,7 | |
| | Adult Cephalic | | | | | | | | | | |
| | Trans-rectal | | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | | |
| | Trans-urethral | | | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | N | N | N | N | N | N | N | | 3,5,6,7 | |
| | Musculo-skeletal<br>(Superficial) | N | N | N | N | N | N | N | | 3,5,6,7 | |
| | Other (OB/GYN) | | | | | | | | | | |
| | Other (Urology) | | | | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | | | |
| | Transesophageal | | | | | | | | | | |
| Peripheral Vessel | Peripheral vessel | N | N | N | N | N | N | N | | 3, 5, 6, 7 | |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Note : 1. Combined modes are B/M, B/CFM , B/PD, B/PW or CW, B/Color M, B/BC,B/CFM/PW or CW,B/PD or DPD/PW or CW
2. Small Organ: thyroid, testes, breast
3.3D
4.4D
5. Elastography
6. Includes guidance of biopsy (2D)
7. Fusion Harmonic Imaging
8.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}------------------------------------------------
#### System: CBit Series Digital Color Doppler Ultrasound System Transducer: M8L40L
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 | | | | | | | | |
| | Abdominal | N | N | N | N | N | N | N | 3,5,6,7 |
| | Intra-operative (Specify) | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | N | N | N | N | N | N | N | 3,5,6,7 |
| | Small Organ[1] (Specify) | N | N | N | N | N | N | N | 3,5,6,7 |
| | Neonatal Cephalic | N | N | N | N | N | N | N | 3,6,7 |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | N | N | N | N | N | N | N | 3,5,6,7 |
| | Musculo-skeletal<br>(Superficial) | N | N | N | N | N | N | N | 3,5,6,7 |
| | Other (OB/GYN) | | | | | | | | |
| | Other (Urology) | | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| | Transesophageal | | | | | | | | |
| Peripheral Vessel | Peripheral vessel | N | N | N | N | N | N | N | 3,5,6,7 |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Note : 1. Combined modes are B/M, B/CFM , B/PD, B/PW or CW, B/Color M, B/BC,B/CFM/PW or CW,B/PD or DPD/PW or CW
2. Small Organ: thyroid, testes, breast
3.3D
4.4D
5. Elastography
6. Includes guidance of biopsy (2D)
7. Fusion Harmonic Imaging
8.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}------------------------------------------------
#### CBit Series Digital Color Doppler Ultrasound System System: Transducer: M8L60L
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 | | | | | | | | | | |
| | Abdominal | N | N | N | N | N | N | N | 3,5,6,7 | | |
| | Intra-operative (Specify) | | | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | | | |
| | Laparoscopic | | | | | | | | | | |
| | Pediatric | N | N | N | N | N | N | N | 3,5,6,7 | | |
| | Small Organ[1] (Specify) | N | N | N | N | N | N | N | 3,5,6,7 | | |
| | Neonatal Cephalic | N | N | N | N | N | N | N | 3,6,7 | | |
| | Adult Cephalic | | | | | | | | | | |
| | Trans-rectal | | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | | |
| | Trans-urethral | | | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | N | N | N | N | N | N | N | 3,5,6,7 | | |
| | Musculo-skeletal<br>(Superficial) | N | N | N | N | N | N | N | 3,5,6,7 | | |
| | Other (OB/GYN) | | | | | | | | | | |
| | Other (Urology) | | | | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | | | |
| | Transesophageal | | | | | | | | | | |
| Peripheral Vessel | Peripheral vessel | N | N | N | N | N | N | N | 3,5,6,7 | | |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Note : 1. Combined modes are B/M, B/CFM , B/PD, B/PW or CW, B/Color M, B/BC,B/CFM/PW or CW,B/PD or DPD/PW or CW
2. Small Organ: thyroid, testes, breast
3.3D
4.4D
5. Elastography
6. Includes guidance of biopsy (2D)
7. Fusion Harmonic Imaging
8.TDI
Prescription Use × 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)
{13}------------------------------------------------
#### CBit Series Digital Color Doppler Ultrasound System System: Transducer: D10L30L
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| 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 | N | 3,5,6,7 |
| | Small Organ[1] (Specify) | N | N | N | N | N | N | N | 3,5,6,7 |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | N | N | N | N | N | N | N | 3,5,6,7 |
| | Musculo-skeletal<br>(Superficial) | N | N | N | N | N | N | N | 3,5,6,7 |
| | Other (OB/GYN) | | | | | | | | |
| | Other (Urology) | | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| | Transesophageal | | | | | | | | |
| Peripheral Vessel | Peripheral vessel | N | N | N | N | N | N | N | 3,5,6,7 |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Note : 1. Combined modes are B/M, B/CFM , B/PD, B/PW or CW, B/Color M, B/BC,B/CFM/PW or CW,B/PD or DPD/PW or CW
2. Small Organ: thyroid, testes, breast
3.3D
4.4D
5. Elastography
6. Includes guidance of biopsy (2D)
7. Fusion Harmonic Imaging
8.TDI
Prescription Use × 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}------------------------------------------------
#### CBit Series Digital Color Doppler Ultrasound System System: Transducer: D8L50L
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 Doppler | CW Doppler | Color Doppler | Power Doppler | Combined<br>Modes | Other | |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| Fetal Imaging &<br>Other | Fetal | | | | | | | | | |
| | Abdominal | N | N | N | | N | N | N | 3,5,6,7 | |
| | Intra-operative (Specify) | | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | | |
| | Laparoscopic | | | | | | | | | |
| | Pediatric | N | N | N | | N | N | N | 3,5,6,7 | |
| | Small Organ1 (Specify) | N | N | N | | N | N | N | 3,5,6,7 | |
| | Neonatal Cephalic | N | N | N | | N | N | N | 3,6,7 | |
| | Adult Cephalic | | | | | | | | | |
| | Trans-rectal | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | |
| | Trans-urethral | | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | N | N | N | | N | N | N | 3,5,6,7 | |
| | Musculo-skeletal<br>(Superficial) | N | N | N | | N | N | N | 3,5,6,7 | |
| | Other (OB/GYN) | | | | | | | | | |
| | Other (Urology) | | | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | | |
| | Transesophageal | | | | | | | | | |
| Peripheral Vessel | Peripheral vessel | N | N | N | | N | N | N | 3,5,6,7 | |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Note : 1. Combined modes are B/M, B/CFM , B/PD, B/PW or CW, B/Color M, B/BC,B/CFM/PW or CW,B/PD or DPD/PW or CW
2. Small Organ: thyroid, testes, breast
3.3D
4.4D
5. Elastography
6. Includes guidance of biopsy (2D)
7. Fusion Harmonic Imaging
8.TDI
Prescription Use × 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)
{15}------------------------------------------------
#### CBit Series Digital Color Doppler Ultrasound System System: Transducer: D7L40L-REC
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 | | | | | | | | |
| | Abdominal | | | | | | | | |
| | Intra-operative (Specify) | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ[1] (Specify) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | N | N | N | | N | N | N | 3,5,6,7 |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | | |
| | Other (OB/GYN) | | | | | | | | |
| | Other (Urology) | N | N | N | | N | N | N | 3,5,6,7 |
| 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/CFM , B/PD, B/PW or CW, B/Color M, B/BC,B/CFM/PW or CW,B/PD or DPD/PW or CW
2. Small Organ: thyroid, testes, breast
3.3D
4.4D
5. Elastography
6. Includes guidance of biopsy (2D)
7. Fusion Harmonic Imaging
8.TDI
Prescription Use × 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)
{16}------------------------------------------------
#### System: CBit Series Digital Color Doppler Ultrasound System Transducer: V6C10L
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| 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 |…
