(20 days)
The DC-7 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in abdominal, cardiac, small organ (breast, testes, thyroid, etc.), peripheral vascular, fetal, transvaginal, pediatric, transcranial (adult cephalic and neonatal cephalic), musculoskeletal (conventional and superficial), intraoperative, and urology exams.
The DC-7 Diagnostic Ultrasound System is a general purpose, portable, software controlled, ultrasound diagnostic system. Its function is to acquire and display ultrasound images in B-mode, M-mode, Color mode, Color M mode, CW mode, CW mode, Power/DirPower mode, TDI mode or the combined mode (i.e. B/M Mode). This system is a Track 3 device that employs an array of probes that include linear array probe, convex array probe, phased array probe and volume probe with a frequency range of approximately 1.8 MHz to 12.0 MHz. This modification will provide users with 3 additional transducers, some additional optional features called STIC, Stress Echo, iPage, and etc. These modifications all lead to overall quality and image enhancement.
The DC-7 Diagnostic Ultrasound System is a general purpose ultrasound system with various transducers and modes of operation. The provided text is a 510(k) summary for this device, seeking substantial equivalence to predicate devices, and outlines its intended use, non-clinical tests, and technological characteristics. The document does not contain specific acceptance criteria and a study proving the device meets those criteria in the way typically expected for an AI/CADe device.
Instead, the document details the Indications for Use (IFU) for the DC-7 Diagnostic Ultrasound System and its various transducers across different clinical applications and modes of operation. The "acceptance criteria" here are implicitly that the new system and its transducers can perform these functions ("P" for previously cleared, "N" for new indications) safely and effectively, demonstrating substantial equivalence to the listed predicate devices.
Here's a breakdown based on your request, interpreting "acceptance criteria" as the claimed capabilities and "study" as the information provided for regulatory clearance:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) clearance for a general-purpose ultrasound system and not a specific AI/CADe algorithm with performance metrics like sensitivity/specificity, the "acceptance criteria" are the claimed modes of operation and clinical applications for each transducer. The "reported device performance" is that the system and transducers are capable of these indicated uses, demonstrating substantial equivalence to predicate devices.
The tables for each transducer (e.g., 3C5A, C5-2, V10-4, L12-4, P7-3, etc.) list the following "acceptance criteria" (indicated by 'P' for previously cleared or 'N' for new) and their reported performance (the presence of 'P' or 'N' in the table signifies the device meets these criteria for the given transducer):
| Clinical Application | B Mode | M Mode | PWD | CWD | Color Doppler | Amplitude Doppler | Combined Mode | Other Features |
|---|---|---|---|---|---|---|---|---|
| Ophthalmic | ||||||||
| Fetal | P / N | P / N | P / N | P / N | P / N | P / N | P / N | Note 1,2,3,4,6,7 |
| Abdominal | P / N | P / N | P / N | P / N | P / N | P / N | P / N | Note 1,2,3,4,5,6,7 |
| Intraoperative (includes abdominal, thoracic, vascular) | P / N | P / N | P / N | P / N | P / N | P / N | P / N | Note 1,2,4,6,7 |
| Pediatric | P / N | P / N | P / N | P / N | P / N | P / N | P / N | Note 1,2,4,5,6,7 |
| Small Organ (breast, testes, thyroid) | P / N | P / N | P / N | P / N | P / N | P / N | P / N | Note 1,2,4,6,7 |
| Neonatal Cephalic | P / N | P / N | P / N | P / N | P / N | P / N | P / N | Note 1,2,4,5,6,7 |
| Adult Cephalic | P / N | P / N | P / N | P / N | P / N | P / N | P / N | Note 1,2,4,5,6,7 |
| Trans-rectal | P / N | P / N | P / N | P / N | P / N | P / N | P / N | Note 1,2,3,4,6,7 |
| Trans-vaginal | P / N | P / N | P / N | P / N | P / N | P / N | P / N | Note 1,2,3,4,6,7 |
| Musculoskeletal Conventional | P / N | P / N | P / N | P / N | P / N | P / N | P / N | Note 1,2,4,6,7 |
| Musculoskeletal Superficial | P / N | P / N | P / N | P / N | P / N | P / N | P / N | Note 1,2,4,6,7 |
| Cardiac Adult | P / N | P / N | P / N | P / N | P / N | P / N | P / N | Note 1,2,5,6,7 |
| Cardiac Pediatric | P / N | P / N | P / N | P / N | P / N | P / N | P / N | Note 1,2,5,6,7 |
| Peripheral Vascular | P / N | P / N | P / N | P / N | P / N | P / N | P / N | Note 1,2,4,6,7 |
| Other (Urology) | N | N | N | N | N | N | N | Note 1,2,4,6,7 |
Notes:
- Tissue Harmonic Imaging: The feature does not use contrast agents.
- Smart3D: (Likely a 3D imaging feature)
- 4D (Real-time 3D): (Real-time 3D imaging)
- iScape: (Likely an extended field of view imaging feature)
- TDI (Tissue Doppler Imaging): (Cardiac function assessment)
- Color M: (Color M-mode)
- Biopsy Guidance: (Assistance for biopsy procedures)
P = Previously cleared by FDA; N = New indication (for this specific K-number, it implies new to this device or transducer combination)
Entries are filled based on the collective information from all transducer tables where "P" or "N" is indicated for at least one transducer. Some specific cells might be blank for certain transducers, meaning that mode/application is not indicated for that specific transducer.
The "study" proving these criteria are met is the "Non-clinical Tests" and the demonstration of "Technological Characteristics" being substantially equivalent to predicate devices.
2. Sample Size Used for the Test Set and the Data Provenance
- The 510(k) summary does not describe a specific "test set" in terms of patient data for a clinical study comparing performance metrics.
- Instead, the submission relies on non-clinical tests (acoustic output, biocompatibility, cleaning/disinfection, thermal/electrical/mechanical safety) and comparison of technological characteristics to predicate devices to establish substantial equivalence.
- Data provenance: Not applicable in the context of a clinical test set from patient data. The provenance for the non-clinical tests would be internal laboratory testing by the manufacturer.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Not applicable. This is a clearance for a general diagnostic ultrasound system based on technological equivalence and safety standards, not an AI/CADe device requiring expert-established ground truth for a clinical performance study.
4. Adjudication Method for the Test Set
- Not applicable, as no clinical test set requiring expert adjudication is described in the provided summary.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
- Not applicable. This is not an AI/CADe device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This is not an AI/CADe device.
7. The Type of Ground Truth Used
- Not applicable. The clearance is based on adherence to medical safety standards (IEC, ISO), acoustic output, biocompatibility, and demonstrated technological equivalence to legally marketed predicate devices, rather than comparison to a clinical ground truth like pathology or outcomes data for a specific diagnostic task.
8. The Sample Size for the Training Set
- Not applicable. This is a hardware/software system, not an AI/CADe algorithm requiring a training set from patient data in the context of medical imaging.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As above, this is not an AI/CADe algorithm with a training set.
In summary: The provided 510(k) summary for the Mindray DC-7 Diagnostic Ultrasound System is for a general-purpose diagnostic imaging device, not an AI or CADe product. Therefore, the "acceptance criteria" and "study" described align with the requirements for establishing substantial equivalence for such a device, focusing on safety, performance, and technological similarity to already cleared predicate devices, rather than detailed performance metrics from clinical trials or AI algorithm validation.
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510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92(c).
The assigned 510(k) number is: ( 03583
1. Submitter:
Shenzhen Mindray Bio-medical Electronics Co., LTD Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan, Shenzhen, 518057, P. R. China
Contact Person:
Meng Xianjun Shenzhen Mindray Bio-medical Electronics Co., LTD Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan, Shenzhen, 518057, P. R. China Tel: +86 755 8188 5640 Fax: +86 755 2658 2680
Date Prepared: Sept. 25, 2010
2. Device Name: DC-7 Diagnostic Ultrasound System
Classification
Regulatory Class: II Review Category: Tier II 21 CFR 892.1550 Ultrasonic Pulsed Doppler Imaging System (90-IYN) 21 CFR 892.1560 Ultrasonic Pulsed Echo Imaging System (90-IYO) 21 CFR 892.1570 Diagnostic Ultrasound Transducer (90-ITX)
3. Predicate Device(s):
DC-7 Diagnostic Ultrasound System is substantially equivalent to the following devices. They have the same technological characteristics, are comparable in key safety and effectiveness features, and have the same intended uses and basic operating modes as the predicate device.
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| PredicateDevice | Manufacturer | Model | 510(k) Control Number |
|---|---|---|---|
| 1 | Mindray | DC-7 | K101041 |
| 2 | Mindray | DC-3 | K091941 |
| 3 | GE | Voluson E8 | K061682 |
| 4 | GE | VIVID 7 | K060542 |
| 5 | GE | LOGIQ5 Expert | K032974 |
| 6 | Siemens | Acuson CV70 | K050240 |
| 7 | Siemens | Acuson Sequoia 512 | K052410 |
| 8 | GE | LOGIQ P5 | K060993 |
4. Device Description:
The DC-7 Diagnostic Ultrasound System is a general purpose, portable, software controlled, ultrasound diagnostic system. Its function is to acquire and display ultrasound images in B-mode, M-mode, Color mode, Color M mode, CW mode, CW mode, Power/DirPower mode, TDI mode or the combined mode (i.e. B/M Mode). This system is a Track 3 device that employs an array of probes that include linear array probe, convex array probe, phased array probe and volume probe with a frequency range of approximately 1.8 MHz to 12.0 MHz.
This modification will provide users with 3 additional transducers, some additional optional features called STIC, Stress Echo, iPage, and etc. These modifications all lead to overall quality and image enhancement.
5. Intended Use:
The DC-7 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in abdominal, cardiac, small organ (breast, testes, thyroid, etc.), peripheral vascular, fetal, transvaginal, pediatric, transcranial (adult cephalic and neonatal cephalic), musculoskeletal (conventional and superficial), intraoperative, and urology exams.
6. Non-clinical Tests:
DC-7 Diagnostic Ultrasound System has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical and mechanical safety, and has been found to conform with applicable medical safety standards. This device has been designed to meet the following standards: UD 2, UD 3, IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-2-37 ,IEC 60601-1-4 and ISO 10993-1.
7. Technological Characteristics:
The DC-7 Diagnostic Ultrasound System has the same technological characteristics with the predicate devices. All systems transmit ultrasonic energy into patients, then perform
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post processing of received echoes to generate on-screen display of anatomic structures and fluid flow within the body. All system allow for specialized measurements of structures and flow, and calculations.
7.Conclusion:
The DC-7 Diagnostic Ultrasound System has the same technological characteristics, key safety and effectiveness features, and has the same intended uses and basic operating modes as the predicate devices.
Intended uses and other key features are consistent with traditional clinical practices, FDA guidelines and established methods of patient examination. The design, development and quality process of the manufacturer confirms with 21 CFR 820, ISO9001 and ISO13485 quality systems. The device conforms to applicable medical device safety standards. Therefore, the DC-7 Diagnostic Ultrasound System is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Shenzhen Mindray Bio-Medical Electronics Co., Ltd. % Mr. Jeff D. Rongero Senior Project Engineer Underwriters Laboratories, Inc. 12 Laboratory Drive Research Triangle Park, NC 27709
DFC 2 7 2010
Re: K103583
Trade/Device Name: DC-7 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: December 3, 2010 Received: December 7, 2010
Dear Mr. Rongero:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
This determination of substantial equivalence applies to the following transducers intended for use with the DC-7 Diagnostic Ultrasound System, as described in your premarket notification:
Transducer Model Number
| 3C5A | L12-4 | P7-3 |
|---|---|---|
| C5-2 | L7-3 | P12-4 |
| V10-4 | L11-4 | 7LT4 |
| V10-4B | L14-6 | DE10-3 |
| 6C2 | 2P2 | 6LB7 |
| 7L4A | 4CD4 | 6LE7 |
| 7L5 | P4-2 | CB10-4 |
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If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
If you have any questions regarding the content of this letter, please contact Paul Hardy at (301) 796-6542.
Sincerely yours.
David G. Brown, Ph.D. Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure(s)
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K(.03S8-3
Indications for Use
510(k) Number (if known):
DEC 2 7 2010
Device Name: DC-7 Diagnostic Ultrasound System
Indications For Use:
The DC-7 Diagnostic Ultrasound System is applicable for adults, pregnant women,pediatric patients and neonates. It is intended for use in abdominal, cardiac, small organ (breast, testes, thyroid, etc.), peripheral vascular, fetal, transrectal; transvaginal, pediatric, transcranial (adult cephalic and neonatal cephalic), musculoskeletal (conventional and superficial}, intraoperative, and urology exams.
Prescription Use __x
AND/OR
ﺎ Over-The-Counter ﺎ
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subp
Page 1 of _1
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Office of in Vitro Diagnostic Device Evaluation and Safety
510K K103583
008-1
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| System | X | Transducer | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Model: | DC-7 | ||||||||||
| 510(k) Number(s) | |||||||||||
| Mode of Operation | |||||||||||
| Clinical Application | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | Combined(specify) | Other (specify) | |||
| Ophthalmic | |||||||||||
| Fetal | P | P | P | P | P | P | P | Note 1,2, 3, 4,6,7 | |||
| Abdominal | P | P | P | P | P | P | P | Note 1, 2, 3, 4,5,6 | |||
| Intraoperative (specify)* | P | P | P | P | P | P | P | Note 1,2, 4,6,7 | |||
| Intraoperative (Neuro) | |||||||||||
| Laparoscopic | |||||||||||
| Pediatric | P | P | P | P | P | P | P | Note 1, 2, 4,5,6, | |||
| Small organ(specify)** | P | P | P | P | P | P | P | Notel, 2, 4,6,7 | |||
| Neonatal Cephalic | P | P | P | P | P | P | P | Notel, 2, 4,5,6,7 | |||
| Adult Cephalic | P | P | P | P | P | P | P | Notel, 2, 4,5,6,7 | |||
| Trans-rectal | P | P | P | P | P | P | P | Note 1,2,3,4,6,7 | |||
| Trans-vaginal | P | P | P | P | P | P | P | Note 1,2,3,4,6,7 | |||
| Trans-urethral | |||||||||||
| Trans-esoph. (non-Card.) | |||||||||||
| Musculo-skeletal Conventional | P | P | P | P | P | P | P | Note 1,2,4,6,7 | |||
| Musculo-skeletal Superficial | P | P | P | P | P | P | P | Note 1,2,4,6,7 | |||
| Intravascular | |||||||||||
| Cardiac Adult | P | P | P | P | P | P | P | Note 1,2,5,6,7 | |||
| Cardiac Pediatric | P | P | P | P | P | P | P | Note 1,2,5,6,7 | |||
| Intravascular (Cardiac) | |||||||||||
| Trans-esoph. (Cardiac) | |||||||||||
| Intra-Cardiac | |||||||||||
| Peripheral Vascular | P | P | P | P | P | P | P | Note 1,2,4,6,7 | |||
| Other (specify)*** | N | N | N | N | N | N | N | Note 1,2,4,6,7 | |||
| N=new indication; P=previously cleared by FDA; E=added under Appendix E | |||||||||||
| Additional comments: Combined modes: B+M, PW+B, Color + B, Power + B, PW +Color+ B, Power + PW +B. | |||||||||||
| * Intraoperative includes abdominal, thoracic, and vascular etc. | |||||||||||
| ** Small organ-breast, thyroid, testes, etc. | |||||||||||
| *** Other use includes Urology. | |||||||||||
| Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents. | |||||||||||
| Note 2: Smart3D | |||||||||||
| Note 3:4D(Real-time 3D) | |||||||||||
| Note 4: iScape | |||||||||||
| Note5: TDI | |||||||||||
| Note6: Color M |
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i
. .
Prescription USE (Per 21 CFR 801.109)
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510K K163583
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Image /page/7/Figure/0 description: The image shows the text "Mindray Co. Ltd.- DC-7 Diagnostic Ultrasound System". The text appears to be a product name or a company name and product description. The text is written in a simple, sans-serif font and is horizontally aligned. The text is likely part of a product label, advertisement, or informational material related to medical equipment.
| Model: | 3C5A | |||||||
|---|---|---|---|---|---|---|---|---|
| 510(k) Number(s) | ||||||||
| Clinical Application | Mode of Operation | |||||||
| B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | Combined(specify) | Other (specify) | |
| Ophthalmic | ||||||||
| Fetal | P | P | P | P | P | P | Note 1, 2, 4,6, | |
| Abdominal | P | P | P | P | P | P | Note 1, 2, 4,6, | |
| Intraoperative (specify)* | ||||||||
| Intraoperative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | P | P | P | Note 1, 2, 4,6, | |
| Small organ(specify)** | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph.(non-Card.) | ||||||||
| Musculo-skeletal Conventional | P | P | P | P | P | P | Note 1, 2, 4,6, | |
| Musculo-skeleta! Superficial | ||||||||
| Intravascular | ||||||||
| Cardiac Adult | ||||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-Cardiac | ||||||||
| Peripheral Vascular | P | P | P | P | P | P | Note 1, 2, 4,6, | |
| Other (specify) ** | ||||||||
| N=new indication; P=previously cleared by FDA; E=added under Appendix E | ||||||||
| Additional comments:Combined modes: B+M, PW+B, Color + B, PW +Color+ B, PW +Color+ B, Power + PW +B. | ||||||||
| * Intraoperative includes abdominal, thoracic, and vascular etc. | ||||||||
| * * Small organ-breast, thyroid, testes, etc. | ||||||||
| *** Other use includes Urology. | ||||||||
| Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents. | ||||||||
| Note 2: Smart3D | . | |||||||
| Note 3:4D(Real-time 3D) ´ | --- | |||||||
| Note 4: iScape | ||||||||
| Note5: TDI | ||||||||
| Note6: Color M |
Transducer
×
Model:
008-3
Prescription USE (Per 21 CFR 801.109)
።
(Division Sign-Off)
Division of Radiological D
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Office of In Vitro Diagnostic Device Evaluation and Safety
Concurrence of CDRH, Office of Device Evaluation(ODE)
510K
System
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. "
Prescription USE (Per 21 CFR 801.109)
| Model: | CS-2 | Transducer | X | |||||
|---|---|---|---|---|---|---|---|---|
| 510(k) Number(s) | ||||||||
| Mode of Operation | ||||||||
| Clinical Application | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | Combined(specify) | Other (specify) |
| Ophthalmic | ||||||||
| Fetal | P | P | P | P | P | P | Note 1, 2, 4,6 | |
| Abdominal | P | P | P | P | P | P | Note 1, 2, 4,6 | |
| Intraoperative (specify)* | ||||||||
| Intraoperative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | P | P | P | Note 1, 2, 4,6 | |
| Small organ(specify)** | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skeletal Conventional | P | P | P | P | P | P | Note 1, 2, 4,6 | |
| Musculo-skeletal Superficial | ||||||||
| Intravascular | ||||||||
| Cardiac Adult | ||||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-Cardiac | ||||||||
| Peripheral Vascular | P | P | P | P | P | P | Note 1, 2, 4,6 | |
| Other (specify)*** | ||||||||
| N=new indication; P=previously cleared by FDA; E=added under Appendix E | ||||||||
| Additional comments:Combined modes: B+M, PW+B, Color + B, Power + B, PW +Color+B, Power + PW +B. | ||||||||
| *Intraoperative includes abdominal, thoracic, and vascular etc. | ||||||||
| **Small organ-breast, thyroid, testes, etc. | ||||||||
| ***Other use includes Urology. | ||||||||
| Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents. | ||||||||
| Note 2: Smart3D | ||||||||
| Note 3:4D(Real-time 3D). | ||||||||
| Note 4: iScape | ||||||||
| Note 5: TDI | ||||||||
| Note6: Color M | ||||||||
| Note7: Biopsy Guidance | ||||||||
Diagnostic Ultrasound Indications for Use Form ﺍﻟﺨﺪﺍﻡ ﺍﻟ
'Transducer
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System
Concurrence of CDRH, Office of Device Evaluation(ODE)
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510K K103583
008-4
{9}------------------------------------------------
·
:
| Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Combined (specify) | Other (specify) |
| Ophthalmic | ||||||||
| Fetal | P | P | P | P | P | P | Note 1, 2, 4,6,7 | |
| Abdominal | ||||||||
| Intraoperative (specify)* | ||||||||
| Intraoperative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small organ(specify)** | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | P | P | P | P | P | P | Note 1, 2, 4,6,7 | |
| Trans-vaginal | P | P | P | P | P | P | Note 1, 2, 4,6,7 | |
| Trans-urethral | ||||||||
| Trans-esoph.(non-Card.) | ||||||||
| Musculo-skeletal Conventional | ||||||||
| Musculo-skeletal Superficial | ||||||||
| Intravascular | ||||||||
| Cardiac Adult | ||||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-Cardiac | ||||||||
| Peripheral Vascular | ||||||||
| Other (specify)*** | N | N | N | N | N | N | Note 1,2,4,6,7 |
N=new indication; P=previously cleared by FDA; E=added under Appendix E
Additional comments:Combined modes: B+M, PW+B, Color + B, Power + B, PW +Color+ B, Power + PW +B.
*Intraoperative includes abdominal, thoracic, and vascular etc.
**Small organ-breast, thyroid, testes, etc.
***Other use includes Urology.
Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
Note 2: Smart3D
Note 3:4D(Real-time 3D)
Note 4: iScape
Note5: TDI
Note6: Color M
Note7: Biopsy Guidance
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation(ODE)
Prescription USE (Per 21 CFR 801.109)
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K. K103583510K
Diagnostic Ultrasound Indications for Use Form
V 10-4
Transducer
×
System Model:
008-5
.
{10}------------------------------------------------
| : :- | ్రాల్యేక | ี | |
|---|---|---|---|
Mindray Co. Ltd.- DC-7 Diagnostic Ultrasound System
| System | Transducer | X | |
|---|---|---|---|
| Model: | V10-4B | ||
| 510(k) Number(s) |
| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Combined (specify) | Other (specify) |
|---|---|---|---|---|---|---|---|---|
| Ophthalmic | ||||||||
| Fetal | P | P | P | P | P | P | Note 1, 2, 4,6,7 | |
| Abdominal | ||||||||
| Intraoperative (specify)* | ||||||||
| Intraoperative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small organ(specify)** | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | P | P | P | P | P | P | Note 1, 2, 4,6,7 | |
| Trans-vaginal | P | P | P | P | P | P | Note 1, 2, 4,6,7 | |
| Trans-urethral | ||||||||
| Trans-esoph.(non-Card.) | ||||||||
| Musculo-skeletal Conventional | ||||||||
| Musculo-skeletal Superficial | ||||||||
| Intravascular | ||||||||
| Cardiac Adult | ||||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-Cardiac | ||||||||
| Peripheral Vascular | ||||||||
| Other (specify)*** | N | N | N | N | N | N | Note 1,2,4,6,7 |
N=new indication; P=previously cleared by FDA; E=added under Appendix E
Additional comments:Combined modes: B+M, PW+B, Color + B, Power + B, PW +Color+ B, Power + PW +B.
- Intraoperative includes abdominal, thoracic, and vascular etc.
**Small organ-breast, thyroid, testes, etc.
***Other use includes Urology.
Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
Note 2: Smart3D
Note 3:4D(Real-time 3D)
Note 4: iScape
Note5: TDI
Note6: Color M
Note7: Biopsy Guidance
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation(ODE)
| Prescription USE (Per 21 CFR 801.109) | (Division Sign-Off)Division of Radiological DevicesOffice of In Vitro Diagnostic Device Evaluation and Safety |
|---|---|
| --------------------------------------- | ----------------------------------------------------------------------------------------------------------------------- |
510K. K103583
Diagnostic Ultrasound Indications for Use Form
י
:
008-6
{11}------------------------------------------------
1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1
System Model:
. : Transducer × ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------6C2
510(k) Number(s)
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | Combined(specify) | Other (specify) | |
| Ophthalmic | ||||||||
| Fetal | ||||||||
| Abdominal | P | P | P | P | P | P | Note 1, 2, 4,6,7 | |
| Intraoperative (specify)* | ||||||||
| Intraoperative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | P | P | P | Note 1, 2, 4,6,7 | |
| Small organ(specify)** | ||||||||
| Neonatal Cephalic | P | P | P | P | P | P | Note 1, 2, 4,6,7 | |
| Adult Cephalic | P | P | P | P | P | P | Note 1, 2, 4,6,7 | |
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph.(non-Card.) | ||||||||
| Musculo-skeletal Conventional | E | P | P | P | P | P | Note 1, 2, 4,6,7 | |
| Musculo-skeletal Superficial | E | P | P | P | P | P | Note 1, 2, 4,6,7 | |
| Intravascular | ||||||||
| Cardiac Adult | ||||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-Cardiac | ||||||||
| Peripheral Vascular | P | P | P | P | P | P | Note 1, 2, 4,6,7 | |
| Other (specify)*** |
Prescription USE (Per 21 CFR 801.109)
510K
5582
008-7
{12}------------------------------------------------
: -
،
System Model:
Transducer ×
5 ! 0(k) Number(s)
7L4A
| Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | Combined(specify) | Other (specify) |
| Ophthalmic | ||||||||
| Fetal | ||||||||
| Abdominal | P | P | P | P | P | P | Note 1,2, 4,6,7 | |
| Intraoperative (specify)* | ||||||||
| Intraoperative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | P | P | P | Note 1,2, 4,6,7 | |
| Small organ(specify)** | P | P | P | P | P | P | Note 1,2, 4,6,7 | |
| Neonatal Cephalic | P | P | P | P | P | P | Note 1,2, 4,6,7 | |
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skeletal Conventional | P | P | P | P | P | P | Note 1,2, 4,6,7 | |
| Musculo-skeletal Superficial | P | P | P | P | P | P | Note 1,2, 4,6,7 | |
| Intravascular | ||||||||
| Cardiac Adult | ||||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-Cardiac | ||||||||
| Peripheral Vascular | P | P | P | P | P | P | Note 1,2, 4,6,7 | |
| Other (specify) *** | ||||||||
| N=new indication; P=previously cleared by FDA; E=added under Appendix E | ||||||||
| Additional comments: Combined modes: B+M, PW+B, Color + B, PW +Color+ B, PW +Color+ B, Power + PW +B, | ||||||||
| * Intraoperative includes abdominal, thoracic, and vascular etc. | ||||||||
| ** Small organ-breast, thyroid, testes, etc. | ||||||||
| *** Other use includes Urology: | ||||||||
| Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents. | ||||||||
| Note 2: Smart3D | ||||||||
| Note 3:4D(Real-time 3D) | ||||||||
| Note 4 iScape | ||||||||
| Note5 : TDI | ||||||||
| Note6: Color M | ||||||||
| Note7: Biopsy Guidance | ||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) | ||||||||
| Concurrence of CDRH, Office of Device Evaluation(ODE) |
Prescription USE (Per 21 CFR 801,109)
23 : 3 . !! .!! #f
・!・ミダ・ト・
... .. .
. -
..............................................................................................................................................................................
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K K103583
008-8
{13}------------------------------------------------
7L5
System Model:
Transducer ×
510(k) Number(s)
| Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | Combined(specify) | Other (specify) |
| Ophthalmic | ||||||||
| Felal | ||||||||
| Abdominal | p | P | P | P | P | p | Note 1,2, 4,6,7 | |
| ntraoperative (specify)* | ||||||||
| ntraoperative (Neuro) | ||||||||
| aparoscopic | ||||||||
| Pediatric | P | P | P | P | P | P | Note 1,2, 4,6,7 | |
| Small organ(specify)** | P | P | P | P | P | P | Note 1,2, 4,6,7 | |
| Neonatal Cephalic | b | P | P | P | P | P | Note 1,2, 4,6,7 | |
| 1 :Adult Cephalic | : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : | . - | ||||||
| rTrans-rectal | Texas P | |||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph (non-Card.) | ||||||||
| Musculo-skeletal Conventional | P | P | P | P | P | p | Note 1,2, 4,6,7 | |
| Musculo-skeletal Superficial | P | P | P | P | P | P | Note 1,2, 4,6,7 | |
| ntravascular | ||||||||
| Cardiac Adult | ||||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph.(Cardiac) | ||||||||
| Intra-Cardiac | ||||||||
| Peripheral Vascular | P | P | P | P | P | P | Note 1,2, 4,6,7 | |
| Other (specify)*** | ||||||||
| V=new indication; P=previously cleared by FDA; E=added under Appendix E | ||||||||
| Additional comments: Combined modes: B+M, PW+B, Color + B, PW +Color+ B, PW +Color+ B, Power + PW+B. | ||||||||
| * Intraoperative includes abdominal, thoracic, and vascular etc. | ||||||||
| ** Small organ-breast, thyroid, testes, etc. | ||||||||
| ** * Other use includes Urology. | ||||||||
| Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents. | ||||||||
| Note 2: Smart3D | ||||||||
| Note 3:4D(Real-time 3D) | ||||||||
| Note 4: iScape | ||||||||
| Notes: TDI | ||||||||
| Note6: Color M | : ' | |||||||
| Note7: Biopsy Guidance | ្រះ | |||||||
| PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) |
Concurrence of CDRH, Office of Device Evaluation(ODE)
. :
. . . . ..............................................................................................................................................................................
Prescription USE (Per 21 CFR 801.109)
(Division of Radiological Devioss
510K K103583
{14}------------------------------------------------
Transducer
×
:
: : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : :
L 12-4
.
. .
System Model:
510(k) Number(s)
| Clinical Application | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | Combined(specify) | Other (specify) |
|---|---|---|---|---|---|---|---|---|
| Ophthalmic | ||||||||
| Fetal | ||||||||
| Abdominal | P | P | P | P | P | P | Note 1,2, 4,6,7 | |
| Intraoperative (specify)* | ||||||||
| Intraoperative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | P | P | P | Note 1,2, 4,6,7 | |
| Small organ(specify)** | P | P | P | P | P | P | Note 1,2, 4,6,7 | |
| Neonatal Cephalic | P | P | P | P | P | P | Note 1,2, 4,6,7 | |
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph.(non-Card.) | ||||||||
| Musculo-skeletal Conventional | P | P | P | P | P | P | Note 1,2, 4,6,7 | |
| Musculo-skeletal Superficial | P | P | P | P | P | P | Note 1,2, 4,6,7 | |
| Intravascular | ||||||||
| Cardiac Adult | ||||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-Cardiac | ||||||||
| Peripheral Vascular | P | P | P | P | P | P | Note 1,2, 4,6,7 | |
| Other (specify)*** | ||||||||
| N=new indication; P=previously cleared by FDA; E=added under Appendix E | ||||||||
| Additional comments: Combined modes: B+M, PW+B, Color + B, Power + B, PW +Color+ B, Power + PW +B. | ||||||||
| *Intraoperative includes abdominal, thoracic, and vascular etc. | ||||||||
| **Small organ-breast, thyroid, testes, etc. | ||||||||
| ***Other use includes Urology. | ||||||||
| Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents. | ||||||||
| Note 2: Smart3D | ||||||||
| Note 3:4D(Real-time 3D) | ||||||||
| Note 4: iScape | ||||||||
| NoteS: TDI | ||||||||
| Note6: Color M | ||||||||
| Note7: Biopsy Guidance | ||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) | ||||||||
| Concurrence of CDRH, Office of Device Evaluation(ODE) |
Prescription USE (Per 21 CFR 801 109)
・・
(Division Sign-Off)
(Division Sign-Off)
Division of Radiological Devioss
Office of In Vito Diagnostic Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K K103583
{15}------------------------------------------------
L7-3
System Model:
Transducer
×
510(k) Number(s)
Mode of Operation Clinical Application Combined Color Amplitude PWD CWD Other (specify) B M Doppler Doppler (specify) Ophthalmic . . . . Fetal Note 1,2, 4,6,7 Abdominal P P P P P P Intraoperative (specify)* Intraoperative (Neuro) Laparoscopic p P P Note 1,2, 4,6,7 Pediatric P P P P P P P P P Note 1,2, 4,6,7 Small organ(specify)** P P Note 1,2, 4,6,7 Neonatal Cephalic P P P P Adult Cephalic Trans-rectal Trans-vaginal Trans-urethral Trans-esoph (non-Card.) P Musculo-skeletal Conventional p P P P Note 1,2, 4,6,7 P P Note 1,2, 4,6,7 P P P P Musculo-skeletal Superficial P Intravascular Cardiac Adult Cardiac Pediatric Intravascular (Cardiac) י Trans-esoph (Cardiac) Intra-Cardiac P P P Note 1,2, 4,6,7 Peripheral Vascular P P P Other (specify) ** * N=new indication; P=previously cleared by FDA; E=added under Appendix E Additional comments: Combined modes: B+M, PW+B, Color + B, PW+Color+ B, PW +Color+ B, Power + PW+B. * Intraoperative includes abdominal, thoracic, and vascular etc. * * Small organ-breast, thyroid, testes, etc. ... ***Other use includes Unology Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents. Note 2: Smart3D Note 3:4D(Real-time 3D) Note 4: iScape Note5: TDI Note6: Color M Note7: Biopsy Guidance (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation(ODE)
Prescription USE (Per 21 CFR 801.109)
(Division Sign-Off)
(Division Sign-Off) Division of Radiological Devices vice Evaluation and Safety office of In
510K. K103583
{16}------------------------------------------------
L | 1-4
System Model: Transducer ×
510(k) Number(s)
| Clinical Application | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | Combined(specify) | Other (specify) |
|---|---|---|---|---|---|---|---|---|
| Ophthalmic | ||||||||
| Fetal | ||||||||
| Abdominal | P | P | P | P | P | P | Note 1,2, 4,6,7 | |
| Intraoperative (specify)* | ||||||||
| Intraoperative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | P | P | P | Note 1,2, 4,6,7 | |
| Small organ(specify)** | P | P | P | P | P | P | Note 1,2, 4,6,7 | |
| Neonatal Cephalic | P | P | P | P | P | P | Note 1,2, 4,6,7 | |
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skeletal Conventional | P | P | P | P | P | P | Note 1,2, 4,6,7 | |
| Musculo-skeletal Superficial | P | P | P | P | P | P | Note 1,2, 4,6,7 | |
| Intravascular | ||||||||
| Cardiac Adult | ||||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-Cardiac | ||||||||
| Peripheral Vascular | P | P | P | P | P | P | Note 1,2, 4,6,7 | |
| Other (specify)*** | ||||||||
| N=new indication; P=previously cleared by FDA; E=added under Appendix E | ||||||||
| Additional comments: Combined modes: B+M, PW+B, Color + B, Power + B, PW +Color+ B, Power + PW +B. | ||||||||
| *Intraoperative includes abdominal, thoracic, and vascular etc. | ||||||||
| **Small organ-breast, thyroid, testes, etc. | ||||||||
| ***Other use includes Urology. | ||||||||
| Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents. | ||||||||
| Note 2: Smart3D | ||||||||
| Note 3:4D(Real-time 3D) | ||||||||
| Note 4: iScape | ||||||||
| Note5 : TDI | ||||||||
| Note6: Color M | ||||||||
| Note7 : Biopsy Guidante | ||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) | ||||||||
| Concurrence of CDRH, Office of Device Evaluation(ODE) |
Prescription USE (Per 21 CFR 801.109)
, ' ﻨ
. . : : 1
:
Signature
(Division of Rediological Devices
510K K103583
{17}------------------------------------------------
Image /page/17/Picture/0 description: The image shows a scattering of small, irregular black shapes against a white background. The shapes are concentrated in two distinct clusters, one on the left side of the image and another on the right. The shapes appear to be randomly distributed, with no discernible pattern or structure within each cluster.
L 14-6
System Model:
Transducer
×
SIO(k) Number(s)
| Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | Combined(specify) | Other (specify) |
| Ophthalmic | ||||||||
| Fetal | ||||||||
| Abdominal | P | P | P | P | P | P | Note 1,2, 4,6,7 | |
| Intraoperative (specify)* | ||||||||
| Intraoperative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | P | P | P | Note 1,2, 4,6,7 | |
| Small organ(specify)** | P | P | P | P | P | P | Note 1,2, 4,6,7 | |
| Neonatal Cephalic | P | P | P | P | P | P | Note 1,2, 4,6,7 | |
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph.(non-Card.) | ||||||||
| Musculo-skeletal Conventional | P | P | P | P | P | P | Note 1,2, 4,6,7 | |
| Musculo-skeletal Superficial | P | P | P | P | P | P | Note 1,2, 4,6,7 | |
| Intravascular | ||||||||
| Cardiac Adult | ||||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph.(Cardiac) | ||||||||
| Intra-Cardiac | ||||||||
| Peripheral Vascular | P | P | P | P | P | P | Note 1,2, 4,6,7 | |
| Other (specify)*** |
Concurrence of CDRH, Office of Device Evaluation(ODE)
·· ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・
Prescription USE (Per 21 CFR 801, 109)
: ............................................................................................................................................................................ . ; . -. :
(Division Sign-Off)
Division of Radiological Devioes Office of In Vitro Diagnostic Device Evaluation and Safety
510K K103583
{18}------------------------------------------------
:
Diagnostic Ultrasound Indications for Use Form
System Model:
Transducer × 2P2
510(k) Number(s)
.
| Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | Combined(specify) | Other (specify) |
| Ophthalmic | ||||||||
| Fetal | ||||||||
| Abdominal | P | P | P | P | P | P | P | Note 1, 2,5,6,7 |
| Intraoperative (specify)* | ||||||||
| Intraoperative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | P | P | P | P | Note 1, 2,5,6,7 |
| Small organ(specify)** | ||||||||
| Neonatal Cephalic | P | P | P | P | P | P | P | Note 1, 2,5,6,7 |
| Adult Cephalic | P | P | P | P | P | P | P | Note 1, 2,5,6,7 |
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph.(non-Card.) | ||||||||
| Musculo-skeletal Conventional | ||||||||
| Musculo-skeletal Superficial | ||||||||
| Intravascular | ||||||||
| Cardiac Adult | P | P | P | P | P | P | P | Note 1, 2,5,6,7 |
| Cardiac Pediatric | P | P | P | P | P | P | P | Note 1, 2,5,6,7 |
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-Cardiac | ||||||||
| Peripheral Vascular | ||||||||
| Other (specify)*** | ||||||||
| N=new indication; P=previously cleared by FDA; E=added under Appendix E | ||||||||
| Additional comments:Combined modes: B+M, PW+B, Color + B, Power + B, PW +Color+ B, Power + PW +B. | ||||||||
| *Intraoperative includes abdominal, thoracic, and vascular etc. | ||||||||
| **Small organ-breast, thyroid, testes, etc. | ||||||||
| ***Other use includes Urology. | ||||||||
| Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents. | ||||||||
| Note 2: Smart3D | ||||||||
| Note 3:4D(Real-time 3D) | ||||||||
| Note 4: iScape | ||||||||
| Note5: TDI | ||||||||
| Note6: Color M | ||||||||
| Note7: Biopsy Guidance | ||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) | ||||||||
| Concurrence of CDRH, Office of Device Evaluation(ODE) | ||||||||
| Prescription USE (Per 21 CFR 801.109) | ||||||||
| (Division Sign-Off)Division of Radiological DevicesOffice of In Vitro Diagnostic Device Evaluation and Safety |
·
{19}------------------------------------------------
| Model: | 4CD4 |
|---|---|
| 510(k) Number(s) |
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| B | M | PW D | CWD | Color Doppler | Amplitude Doppler | Combined (specify) | Other (specify) | ||
| Ophthalmic | |||||||||
| Fetal | P | P | P | P | P | P | Note 1,2, 3, 4,6 | ||
| Abdominal | P | P | P | P | P | P | Note 1,2, 3, 4,6 | ||
| Intraoperative (specify)* | |||||||||
| Intraoperative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | P | P | P | P | P | P | Note1,2, 4,6 | ||
| Small organ(specity)** | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph.(non-Card.) | |||||||||
| Musculo-skeletal Conventional | |||||||||
| Musculo-skeletal Superficial | |||||||||
| Intravascular | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph.(Cardiac) | |||||||||
| Intra-Cardiac | |||||||||
| Peripheral Vascular | |||||||||
| Other (specify)*** |
N=new indication; P=previously cleared by FDA; E=added under Appendix E
Additional comments: Combined modes: B+M, PW+B, Color + B, Power + B, PW +Color+ B, Power + PW +B.
*Intraoperative includes abdominal, thoracic, and vascular etc.
**Small organ-breast, thyroid, testes, etc.
***Other use includes Urology.
Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
Note 2: Smart3D
Note 3:4D(Real-time 3D)
Note 4: iScape
Note5: TDI
Note6: Color M
Note7: Biopsy Guidance
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation(ODE)
Prescription USE (Per 21 CFR 801.109)
(Division of Rediological Devices
Office of In Vitro Diagnostic Devices
Office of In Vitro Diagnostic Devices
Office of In Vitro Diagnostic Devices Evaluation and Safety
1 2 1 : 1 :
L
210K
:
Diagnostic Ultrasound Indications for Use Form
Transducer
X
System Model:
008-15
{20}------------------------------------------------
Image /page/20/Picture/0 description: The image shows a sparse distribution of black dots against a white background. The dots are concentrated more densely on the left side of the image, forming a cluster. As one moves to the right, the dots become more scattered and isolated, with larger gaps between them.
System Model:
Transducer P4-2
×
510(k) Number(s)
| Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | Combined(specify) | Other (specify) |
| Ophthalmic | ||||||||
| Fetal | ||||||||
| Abdominal | P | P | P | P | P | P | P | Note 1, 2,5,6,7 |
| Intraoperative (specify)* | ||||||||
| Intraoperative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | P | P | P | P | Note 1, 2,5,6,7 |
| Small organ(specify) ** | ||||||||
| Neonatal Cephalic | P | P | P | P | P | P | P | Note 1, 2,5,6,7 |
| Adult Cephalic | P | P | P | P | P | P | P | Note 1, 2,5,6,7 |
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph.(non-Card.) | ||||||||
| Musculo-skeletal Conventional | ||||||||
| Musculo-skeletal Superficial | ||||||||
| Intravascular | ||||||||
| Cardiac Adult | P | P | P | P | P | P | P | Note 1, 2,5,6,7 |
| Cardiac Pediatric | P | P | P | P | P | P | P | Note 1, 2,5,6,7 |
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-Cardiac | ||||||||
| Peripheral Vascular | ||||||||
| Other (specify) *** | ||||||||
| N=new indication; P=previously cleared by FDA; E=added under Appendix E | ||||||||
| Additional comments: Combined modes: B+M, PW+B, Color + B, Power + B, PW +Color+B, Power + PW +B. | ||||||||
| * Intraoperative includes abdominal, thoracic, and vascular etc. | ||||||||
| ** Small organ-breast, thyroid, testes, etc. | ||||||||
| *** Other use includes Urology. | ||||||||
| Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents. | ||||||||
| Note 2: Smart3D | ||||||||
| Note 3:4D(Real-time 3D) | ||||||||
| Note 4: iScape | ||||||||
| Note5: TDI | ||||||||
| Note6: Color M | ||||||||
| Note7: Biopsy Guidance | ||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) | ||||||||
| Concurrence of CDRH, Office of Device Evaluation(ODE) |
Prescription USE (Per 21 CFR 801 رام 1. 109)
-- :
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K K103583
008-16
{21}------------------------------------------------
Image /page/21/Picture/0 description: The image shows a scattering of small black dots and dashes against a white background. The dots are clustered in the upper left quadrant, with a few isolated dots elsewhere. The dashes are vertical and appear in the lower center of the image. The overall impression is one of sparse and random distribution of these simple graphic elements.
| System | Transducer | X | |
|---|---|---|---|
| Model: | P7-3 | ||
| 510(k) Number(s) |
| Clinical Application | B | M | PW D | CWD | Color Doppler | Amplitude Doppler | Combined (specify) | Other (specify) |
|---|---|---|---|---|---|---|---|---|
| Ophthalmic | ||||||||
| Fetal | ||||||||
| Abdominal | P | P | P | P | P | P | P | Note 1, 2,5,6 |
| Intraoperative (specify)* | ||||||||
| Intraoperative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | P | P | P | P | Note 1, 2,5,6 |
| Small organ(specify)** | ||||||||
| Neonatal Cephalic | P | P | P | P | P | P | P | Note 1, 2,5,6 |
| Adult Cephalic | P | P | P | P | P | P | P | Note 1, 2,5,6 |
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph.(non-Card.) | ||||||||
| Musculo-skeletal Conventional | P | P | P | P | P | P | Note 1, 2,6 | |
| Musculo-skeletal Superficial | ||||||||
| Intravascular | ||||||||
| Cardiac Adult | P | P | P | P | P | P | P | Note 1, 2,5,6 |
| Cardiac Pediatric | P | P | P | P | P | P | P | Note 1, 2,5,6 |
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-Cardiac | ||||||||
| Peripheral Vascular | ||||||||
| Other (specify)*** |
N=new indication; P=previously cleared by FDA; E=added under Appendix E
Additional comments: Combined modes: B+M, PW+B, Color + B, Power + B, PW +Color+ B, Power + PW +B.
*Intraoperative includes abdominal, thoracic, and vascular etc.
**Small organ-breast, thyroid, testes, etc.
***Other use includes Urology.
Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
Note 2: Smart3D
Note 3:4D(Real-time 3D)
Note 4: iScape
Note5: TDI
Note6: Color M
Note7: Biopsy Guidance
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation(ODE)
Prescription USE (Per 21 CFR 801.109)
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
4103583
ー
510K-
Diagnostic Ultrasound Indications for Use Form Transducer
008-17
.
{22}------------------------------------------------
| System | |
|---|---|
| Model: | P12-4 |
| 510(k) Number(s) |
| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Combined (specify) | Other (specify) |
|---|---|---|---|---|---|---|---|---|
| Ophthalmic | ||||||||
| Fetal | ||||||||
| Abdominal | P | P | P | P | P | P | P | Note 1, 2,5,6 |
| Intraoperative (specify)* | ||||||||
| Intraoperative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | P | P | P | P | Note 1, 2,5,6 |
| Small organ(specify)** | ||||||||
| Neonatal Cephalic | P | P | P | P | P | P | P | Note 1, 2,5,6 |
| Adult Cephalic | P | P | P | P | P | P | P | Note 1, 2,5,6 |
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph.(non-Card.) | ||||||||
| Musculo-skeletal Conventional | P | P | P | P | P | P | Note 1, 2,6 | |
| Musculo-skeletal Superficial | ||||||||
| Intravascular | ||||||||
| Cardiac Adult | P | P | P | P | P | P | P | Note 1, 2,5,6 |
| Cardiac Pediatric | P | P | P | P | P | P | P | Note 1, 2,5,6 |
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-Cardiac | ||||||||
| Peripheral Vascular | ||||||||
| Other (specify)*** |
N=new indication; P=previously cleared by FDA; E=added under Appendix E
Additional comments: Combined modes: B+M, PW+B, Color + B, Power + B, PW +Color+ B, Power + PW +B.
*Intraoperative includes abdominal, thoracic, and vascular etc.
**Small organ-breast, thyroid, testes, etc.
***Other use includes Urology.
Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
Note 2: Smart3D
Note 3:4D(Real-time 3D)
Note 4: iScape
Note5: TDI
Note6: Color M
Note7: Biopsy Guidance
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation(ODE)
Prescription USE (Per 21 CFR 801.109)
System
Transducer
(Division Sign-Off)
ಿ ದ
చిక్
: '
કાબ્રત
{23}------------------------------------------------
Image /page/23/Picture/0 description: The image shows a scattering of small, dark spots against a white background. The spots are concentrated in the left portion of the image, forming a cluster. As the view moves to the right, the spots become more sparse and isolated.
7LT4
Diagnostic Ultrasound Indications for Use Form
System Model: Transducer
×
510(k) Number(s)
| Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | PWD | CWD | Color | Amplitude | Combined | ||
| Doppler | Doppler | (specify) | Other (specify) | ||||||
| Ophthalmic | |||||||||
| Fetal | |||||||||
| Abdominal | P | P | P | P | P | P | P | Note 1,2, 4,6,7 | |
| Intraoperative (specify)* | P | P | P | P | P | P | P | Note 1,2, 4,6,7 | |
| Intraoperative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | P | P | P | P | P | P | P | Note 1,2, 4,6,7 | |
| Small organ(specify)** | P | P | P | P | P | P | P | Note 1,2, 4,6,7 | |
| Neonatal Cephalic | P | P | P | P | P | P | P | Note 1,2, 4,6,7 | |
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph.(non-Card.) | |||||||||
| Musculo-skeletal Conventional | P | P | P | P | P | P | P | Note 1.2, 4,6,7 | |
| Musculo-skeletal Superficial | P | P | P | P | P | P | P | Note 1,2, 4,6,7 | |
| Intravascular | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-Cardiac | |||||||||
| Peripheral Vascular | P | P | P | P | P | P | P | Note 1,2, 4,6,7 | |
| Other (specify)*** | |||||||||
| N=new indication; P=previously cleared by FDA; E=added under Appendix E | |||||||||
| Additional comments: Combined modes: B+M, PW+B, Color + B, Power + B, PW +Color+B, Power + PW +B, | |||||||||
| * Intraoperative includes abdominal, thoracic, and vascular etc. | |||||||||
| ** Small organ-breast, thyroid, testes, etc. | |||||||||
| *** Other use includes Urology. | |||||||||
| Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents. | |||||||||
| Note 2: Smart3D | |||||||||
| Note 3:4D(Real-time 3D) | |||||||||
| Note 4: iScape | |||||||||
| Note 5: TDI | |||||||||
| Note6: Color M | |||||||||
| Note 7 : Biopsy Guidance | |||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) | |||||||||
| Concurrence of CDRH, Office of Device Evaluation(ODE) | |||||||||
| Clinical Application | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | Combined(specify) | Other (specify) | |
| Ophthalmic | |||||||||
| Fetal | P | P | P | P | P | P | Note 1, 2,3, 4,6 | ||
| Abdominal | |||||||||
| Intraoperative (specify)* | |||||||||
| Intraoperative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small organ(specify)** | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | P | P | P | P | P | P | Note 1, 2, 3,4,6 | ||
| Trans-vaginal | P | P | P | P | P | P | Note 1, 2, 3,4,6 | ||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal Conventional | |||||||||
| Musculo-skeletal Superficial | |||||||||
| Intravascular | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-Cardiac | |||||||||
| Peripheral Vascular | |||||||||
| Other (specify)*** | |||||||||
| N=new indication; P=previously cleared by FDA; E=added under Appendix E | |||||||||
| Additional comments:Combined modes: B+M, PW+B, Color + B, Power + B, PW +Color+ B, Power + PW +B. | |||||||||
| *Intraoperative includes abdominal, thoracic, and vascular etc. | |||||||||
| **Small organ-breast, thyroid, testes, etc. | |||||||||
| ***Other use includes Urology. | |||||||||
| Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents. | |||||||||
| Note 2: Smart3D | |||||||||
| Note 3:4D(Real-time 3D) | |||||||||
| Note 4: iScape | |||||||||
| Note5: TDI | |||||||||
| Note6 Color M | |||||||||
| Note7 Biopsy Guidance | |||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) | |||||||||
| Concurrence of CDRH, Office of Device Evaluation(ODE) |
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ・・ Prescription USE (Per 21 CFR 801.109)
510K
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
{24}------------------------------------------------
| Diagnostic Ultrasound Indications for Use Form |
|---|
| ------------------------------------------------------- |
System Model:
Transducer × . . . . . ் - DE10-3 · :
... " : ; :"
510(k) Number(s)
!!!
Prescription USE (Per 21 CFR 801.109)
510K
(Division of Radiotogical Devices
Office of In Vitro Diagnostic Devices
Office of In Vitro Diagnostic Devices Evaluation and Safety
008-20
{25}------------------------------------------------
| System | Transducer | X | |
|---|---|---|---|
| Model: | 6LB7 | ||
| 510(k) Number(s) |
| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Combined (specify) | Other (specify) |
|---|---|---|---|---|---|---|---|---|
| Ophthalmic | ||||||||
| Fetal | ||||||||
| Abdominal | ||||||||
| Intraoperative (specify)* | ||||||||
| Intraoperative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small organ(specify)** | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | N | N | N | N | N | N | Note 1, 2, 4,6,7 | |
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph.(non-Card.) | ||||||||
| Musculo-skeletal Conventional | ||||||||
| Musculo-skeletal Superficial | ||||||||
| Intravascular | ||||||||
| Cardiac Adult | ||||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph.(Cardiac) | ||||||||
| Intra-Cardiac | ||||||||
| Peripheral Vascular | ||||||||
| Other (specify)*** | N | N | N | N | N | N | Note 1,2,4,6,7 |
N=new indication; P=previously cleared by FDA; E=added under Appendix E
Additional comments: Combined modes: B+M, PW+B, Color + B, Power + B, PW +Color+B, Power + PW +B,
- Intraoperative includes abdominal, thoracic, and vascular etc.
** Small organ-breast, thyroid, testes, etc.
*** Other use includes Urology.
Note 1 : Tissue Harmonic Imaging. The feature does not use contrast agents.
Note 2: Smart3D
Note 3:4D(Real-time 3D)
Note7: Biopsy Guidance (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Note 4: iScape Note5: TDI Note6: Color M
Concurrence of CDRH, Office of Device Evaluation(ODE)
Prescription USE (Per 21 CFR 801.109)
(Division Sign-Off) Division of Radiological Devices Diagnostic Device Evaluation and Safety Office of In
{26}------------------------------------------------
Diagnostic Ultrasound Indications for Use Form
| System | Transducer | X | |
|---|---|---|---|
| Model: | 6LE7 | ||
| 510(k) Number(s) |
्र के बाद में दिन में में में में में में में में में में में में में में में में में में में में में में में में में में में में में में में में में में में में में में में
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | Combined(specify) | Other (specify) | |
| Ophthalmic | ||||||||
| Fetal | ||||||||
| Abdominal | ||||||||
| Intraoperative (specify)* | ||||||||
| Intraoperative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small organ(specify)** | : | |||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | N | N | N | N | N | N | Note 1, 2, 4,6,7 | |
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skeletal Conventional | ||||||||
| Musculo-skeletal Superficial | ||||||||
| Intravascular | ||||||||
| Cardiac Adult | ||||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph (Cardiac) | ||||||||
| Intra-Cardiac | ||||||||
| Peripheral Vascular | ||||||||
| Other (specify) ** * | N | N | N | N | ત્વ | N | Note 1,2,4,6,7 | |
| N=new indication; P=previously cleared by FDA; E=added under Appendix E | ||||||||
| Additional comments:Combined modes: B+M, PW+B, Color + B, PW +Color+B, Power + PW+B, | ||||||||
| * Intraoperative includes abdominal, thoracic, and vascular etc. | ||||||||
| ** Small organ-breast, thyroid, testes, etc. | ||||||||
| ** * Other use includes Urology. | ||||||||
| Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents. | ||||||||
| Note 2: Smart3D | ||||||||
| Note 3:4D(Real-time 3D) | ||||||||
| Note 4: iScape | ||||||||
| Note5: TDI | ||||||||
| Note6: Color M | ||||||||
| Note7: Biopsy Guidance | ||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) | ||||||||
| Concurrence of CDRH, Office of Device Evaluation(ODE) |
Prescription USE (Per 21 CFR 801.109)
510K.
(Division Sign-Off)
Division of Radiological Devices
・・
008-22
(Division of Radiological Devioss
{27}------------------------------------------------
Transducer System × יי Model: CB10-4 . 510(k) Number(s)
Mode of Operation Clinical Application Amplitude Color Combined CWD B M PWD Other (specify) Doppler Doppler (specify) Ophthalmic Fetal Abdominal Intraoperative (specify)* Intraoperative (Neuro) Laparoscopic Pediatric Small organ(specify)** Neonatal Cephalic :・ Adult Cephalic Trans-rectal N N N N N N Note 1, 2, 4,6,7 Trans-vaginal Trans-urethrai Trans-esoph. (non-Card.) Musculo-skeletal Conventional Musculo-skeletal Superficial ... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Intravascular Cardiac Adult Cardiac Pediatric Intravascular (Cardiac) Trans-esoph (Cardiac) Intra-Cardiac Peripheral Vascular N Note 1,2,4,6,7 Other (specify) *** N N N N N N=new indication; P=previously cleared by FDA; E=added under Appendix E Additional comments:Combined modes: B+M, PW+B, Color + B, PW+Color+B, PW +Color+B, Power + PW+B. * Intraoperative includes abdominal, thoracic, and vascular etc. ** Small organ-breast, thyroid, testes, etc. *** Other use includes Urology. Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents. Note 2: Smart3D Note 3:4D(Real-time 3D) Note 4: iScape Note5: TDI Note6: Color M Note7: Biopsy Guidance (PLEASE DO NOT WRITE BELQW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation(ODE) Prescription USE (Per 21 CFR 801.109) -
(Division Sign Off)
(Division Sign-Off) Division of Radiological Devices Office of Ir The Color of Haulorogical Devices
Vitro Diagnostic Device Evaluation and Satel,
810
§ 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.