(43 days)
The DC-7 diagnostic ultrasound system is designed for M, B, pulsed doppler, continuous Doppler, color Doppler, power Doppler modes, and combined modes (i.e. B/M Mode). The system is indicated for fetal, abdominal, pediatric, small organ (breast, thyroid, and testes), cephalic (neonatal and adult), transvaginal, peripheral vascular, musculo-skeletal (conventional and superficial), and cardiac (neonatal and adult). The system includes optional biopsy needle guides that attach to the transducers.
The DC-7 Diagnostic Ultrasound System is a general purpose, portable, software controlled, ultrasound diagnostic system. 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 2.0 MHz to 12.0 MHz.
This document refers to the Mindray DC-7 Diagnostic Ultrasound System (K092691).
Acceptance Criteria and Device Performance
The provided document primarily focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than establishing specific quantitative acceptance criteria for performance metrics. The core statement is that "The conclusions drawn from testing of the DC-7 Diagnostic Ultrasound System demonstrate that the device is as safe and effective as the legally marketed predicate devices."
The "Indications for Use" section (pages 4-11 of the original document) lists the clinical applications and operating modes for the device and its various transducers. These serve as the functional requirements the device needs to meet.
| Acceptance Criteria (Implicit) | Reported Device Performance (Implicit) |
|---|---|
| Safety: Device conforms to applicable medical device safety standards. | Conforms to IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-2-37, IEC 60601-1-4 and ISO 10993-1. Acoustic output measured and calculated per NEMA UD 2: 2004 and NEMA UD 3: 2004. |
| Effectiveness: Capable of performing specified clinical applications across various modes and transducers, similar to predicate devices. | The device is indicated for fetal, abdominal, pediatric, small organ (breast, thyroid, and testes), cephalic (neonatal and adult), transvaginal, peripheral vascular, musculo-skeletal (conventional and superficial), and cardiac (neonatal and adult) applications. Supports M, B, pulsed doppler, continuous Doppler, color Doppler, power Doppler modes, and combined modes (i.e., B/M Mode). Includes optional biopsy needle guides. |
| Substantial Equivalence: Features and performance are comparable to predicate devices. | Declared substantially equivalent to Mindray DC-3 (K#091491), Mindray DC-6 (K#072164), GE Vivid S6 (K#071985), Siemens X300 (K#090276), GE Logiq P5 (K#060993), GE Vivid 7 (K#060542). |
Study Information
The document describes the type of information typically provided for a 510(k) submission, which focuses more on substantial equivalence to existing devices rather than a standalone clinical trial with specific performance metrics. Therefore, detailed information about a dedicated study meeting the requested criteria is largely absent.
Here's an analysis based on the provided text:
-
Sample size used for the test set and the data provenance: Not explicitly stated in the provided document. The submission is based on engineering tests and comparison to predicate devices, not data from a specific patient test set in the way an AI/CADe device would typically require. The data provenance would be internal engineering verification and validation data, not patient data in the context of clinical performance evaluation.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable or not explicitly stated. For a diagnostic ultrasound system, "ground truth" typically refers to the physical and functional performance of the device against engineering specifications and industry standards, rather than expert interpretation of images for a specific disease. The "ground truth" for compliance with standards would be established by internal engineering and quality control teams.
-
Adjudication method for the test set: Not applicable or not explicitly stated. This concept (e.g., 2+1, 3+1) is typically relevant for studies involving human interpretation where discrepancies need to be resolved, usually for AI/CADe devices. This is not a performance study as would be conducted for an AI device.
-
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 or CADe device, but a general-purpose diagnostic ultrasound system. Hence, no MRMC study or AI-assistance effect size is mentioned.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is an ultrasound system, not an algorithm, and is designed for human-in-the-loop operation.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" in this context refers to compliance with safety and performance standards for an ultrasound system. This includes:
- Engineering specifications and test results: Measuring acoustic output (NEMA UD 2 & 3), electrical safety (IEC 60601 series), and biocompatibility (ISO 10993-1).
- Functional performance: Verifying the device's ability to operate in the stated modes (B, M, Doppler, etc.) and for the specified clinical applications, likely through phantom testing and internal verification.
- Comparison to predicate devices: Demonstration that its performance is "as safe and effective" as established, legally marketed predicate devices, implying similar image quality and diagnostic capabilities.
-
The sample size for the training set: Not applicable. This device is a traditional hardware and software diagnostic ultrasound system, not an AI/machine learning product that requires training data in the AI sense.
-
How the ground truth for the training set was established: Not applicable, as it's not an AI/machine learning device.
{0}------------------------------------------------
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: _______________________________________________________________________________________________________________________________________________
OCT 1 5 2009
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
Tel: +86 755 8611 9549 Fax: +86 755 2658 2680
Contact Person: Sheng Haobin Shenzhen Mindray Bio-medical Electronics Co., LTD Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan, Shenzhen, 518057, P. R. China
Date Prepared: July 31, 2009
- 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 (90-1YO)
- 21 CFR 892.1570 Diagnostic Ultrasound Transduccr (90-ITX)
3. Marketed Device:
DC-7 Diagnostic Ultrasound System is substantially equivalent to the following devices: Mindray DC-3 (K#091491), Mindray DC-6 (K#072164), GE Vivid S6 (K#071985), Siemens X300 (K#090276), GE Logiq P5 (K#060993), GE Vivid 7 (K#060542).
{1}------------------------------------------------
4. Device Description:
The DC-7 Diagnostic Ultrasound System is a general purpose, portable, software controlled, ultrasound diagnostic system. 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 2.0 MHz to 12.0 MHz.
5. Intended Use:
.
The DC-7 diagnostic ultrasound system is designed for M, B, pulsed doppler, continuous Doppler, color Doppler, power Doppler modes, and combined modes (i.e. B/M Mode). The system is indicated for fetal, abdominal, pediatric, small organ (breast, thyroid, and testes), cephalic (neonatal and adult), transvaginal, peripheral vascular, musculo-skeletal (conventional and superficial), and cardiac (neonatal and adult). The system includes optional biopsy needle guides that attach to the transducers.
6. Safety Considerations:
The DC-7 Diagnostic Ultrasound System had been tested as Track 3 Device per the FDA Guidance document "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" issued in September 2008. The acoustic output is measured and calculated per NEMA UD 2: 2004 Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment and NEMA UD 3: 2004 Standards for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment. The device conforms to applicable medical device safety standards, such as IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-2-37, IEC 60601-1-4 and ISO 10993-1.
Conclusion:
The conclusions drawn from testing of the DC-7 Diagnostic Ultrasound System demonstrate that the device is as safe and effective as the legally marketed predicate devices.
0032
{2}------------------------------------------------
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
JAN - 4 2010
Shenzhen Mindray Bio-Medical Electronics Co., Ltd. % Mr. Robert Mosenkis President CITECH 5200 Butler Pike PLYMOUTH MEETING PA 19462-1298
Re: K092691
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: September 29, 2009 Received: September 30, 2009
Dear Mr. Mosenkis:
This letter corrects our substantially equivalent letter of October 15, 2009.
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, C5-2V10-4, V10-4B6C27L4A, 7L5, L12-4, L7-3, L11-4 | L14-62P24CD4 |
|---|---|
| --------------------------------------------------------------------- | ---------------------- |
{3}------------------------------------------------
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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 Mr. Paul Hardy at (301) 796-6542.
Sincerely yours,
logu M. Whig
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
{4}------------------------------------------------
System Model:
Transducer × DC-7
510(k) Number(s)
| Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | Combined(specify) | Other (specify) |
| Ophthalmic | ||||||||
| Fetal | N | N | N | N | N | N | N | Note1,2, 3, 4,7,8 |
| Abdominal | N | N | N | N | N | N | N | Note1, 2, 3, 4,5,7,8 |
| Intraoperative (specify)* | ||||||||
| Intraoperative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | N | N | N | N | N | N | N | Note 1, 2, 4,5,7,8 |
| Small organ(specify)** | N | N | N | N | N | N | N | Note1, 2, 4,7,8 |
| Neonatal Cephalic | N | N | N | N | N | N | N | Note1, 2, 4,5,7,8 |
| Adult Cephalic | N | N | N | N | N | N | N | Note1, 2, 4,5,7,8 |
| Trans-rectal | N | N | N | N | N | N | N | Note 1,2,4,7,8 |
| Trans-vaginal | N | N | N | N | N | N | N | Note 1,2,4,7,8 |
| Trans-urethral | ||||||||
| Trans-esoph.(non-Card.) | ||||||||
| Musculo-skeletalConventional | N | N | N | N | N | N | N | Note 1,2,4,7,8 |
| Musculo-skeletalSuperficial | N | N | N | N | N | N | N | Note 1,2,4,7,8 |
| Intravascular | ||||||||
| Cardiac Adult | N | N | N | N | N | N | N | Note 1,2,5,7,8 |
| Cardiac Pediatric | N | N | N | N | N | N | N | Note 1,2,5,7,8 |
| Intravascular (Cardiac) | ||||||||
| Trans-esoph.(Cardiac) | ||||||||
| Intra-Cardiac | ||||||||
| Peripheral Vascular | N | N | N | N | N | N | N | Note 1,2,4,7,8 |
| 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. | ||||||||
| 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: Contrast Imaging | ||||||||
| Note7: Color M | ||||||||
| Note8: Biopsy Guidance | ||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) | ||||||||
| System | Transducer | X | ||||||
| Model: | 3C5A, C5-2 | |||||||
| 510(k) Number(s) | ||||||||
| Mode of Operation | ||||||||
| Clinical Application | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | Combined(specify) | Other (specify) |
| Ophthalmic | ||||||||
| Fetal | N | N | N | N | N | N | N | Note 1, 2, 4,7,8 |
| Abdominal | N | N | N | N | N | N | N | Note 1, 2, 4,7,8 |
| Intraoperative (specify)* | ||||||||
| Intraoperative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | N | N | N | N | N | N | N | Note 1, 2, 4,7,8 |
| Small organ(specify) ** | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph.(non-Card.) | ||||||||
| Musculo-skeletal Conventional | N | N | N | N | N | N | N | Note 1, 2, 4,7,8 |
| Musculo-skeletal Superficial | ||||||||
| Intravascular | ||||||||
| Cardiac Adult | ||||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-Cardiac | ||||||||
| Peripheral Vascular | N | N | N | N | N | N | N | Note 1, 2, 4,7,8 |
| 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. | ||||||||
| 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: Contrast Imaging | ||||||||
| Note7: Color M | ||||||||
| Note8: Biopsy Guidance | ||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) | ||||||||
| Concurrence of CDRH, Office of Device Evaluation(ODE) | ||||||||
| System | Transducer | X | ||||||
| Model: | V10-4, V10-4B | |||||||
| 510(k) Number(s) | ||||||||
| Mode of Operation | ||||||||
| Clinical Application | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | Combined(specify) | Other (specify) |
| Ophthalmic | ||||||||
| Fetal | N | N | N | N | N | N | Note 1, 2, 4,7,8 | |
| Abdominal | ||||||||
| Intraoperative (specify)* | ||||||||
| Intraoperative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small organ(specify) ** | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | N | N | N | N | N | N | N | Note 1, 2, 4,7,8 |
| Trans-vaginal | N | N | N | N | N | N | N | Note 1, 2, 4,7,8 |
| 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. | ||||||||
| **Small organ-breast, thyroid, testes, etc. | ||||||||
| 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: Contrast Imaging | ||||||||
| Note7: Color M | ||||||||
| Note8: Biopsy Guidance | ||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) | ||||||||
| Concurrence of CDRH, Office of Device Evaluation(ODE) | ||||||||
| System | Transducer | X | ||||||
| Model: | 6C2 | |||||||
| 510(k) Number(s) | ||||||||
| Mode of Operation | ||||||||
| Clinical Application | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | Combined(specify) | Other (specify) |
| Ophthalmic | ||||||||
| Fetal | ||||||||
| Abdominal | N | N | N | N | N | N | Note 1, 2, 4,7,8 | |
| Intraoperative (specify)* | ||||||||
| Intraoperative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | N | N | N | N | N | N | Note 1, 2, 4,7,8 | |
| Small organ(specify) ** | ||||||||
| Neonatal Cephalic | N | N | N | N | N | N | Note 1, 2, 4,7,8 | |
| Adult Cephalic | N | N | N | N | N | N | Note 1, 2, 4,7,8 | |
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph.(non-Card.) | ||||||||
| Musculo-skeletal Conventional | N | N | N | N | N | N | Note 1, 2, 4,7,8 | |
| Musculo-skeletal Superficial | N | N | N | N | N | N | Note 1, 2, 4,7,8 | |
| Intravascular | ||||||||
| Cardiac Adult | ||||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-Cardiac | ||||||||
| Peripheral Vascular | N | N | N | N | N | N | Note 1, 2, 4,7,8 | |
| 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. | ||||||||
| 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 : Contrast Imaging | ||||||||
| Note7 : Color M | ||||||||
| Note8 : 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 | Mode of Operation | |||||||
| B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | Combined(specify) | Other (specify) | |
| Ophthalmic | ||||||||
| Fetal | ||||||||
| Abdominal | N | N | N | N | N | N | Note 1,2, 4,7,8 | |
| Intraoperative (specify)* | ||||||||
| Intraoperative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | N | N | N | N | N | N | Note 1,2, 4,7,8 | |
| Small organ(specify) ** | N | N | N | N | N | N | Note 1,2, 4,7,8 | |
| Neonatal Cephalic | N | N | N | N | N | N | Note 1,2, 4,7,8 | |
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph.(non-Card.) | ||||||||
| Musculo-skeletal Conventional | N | N | N | N | N | N | Note 1,2, 4,7,8 | |
| Musculo-skeletal Superficial | N | N | N | N | N | N | Note 1,2, 4,7,8 | |
| Intravascular | ||||||||
| Cardiac Adult | ||||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph.(Cardiac) | ||||||||
| Intra-Cardiac | ||||||||
| Peripheral Vascular | N | N | N | N | N | N | Note 1,2, 4,7,8 | |
| 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. | ||||||||
| 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: Contrast Imaging | ||||||||
| Note7: Color M | ||||||||
| Note8: Biopsy Guidance | ||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) | ||||||||
| Concurrence of CDRH, Office of Device Evaluation(ODE) |
Concurrence of CDRH, Office of Device Evaluation(ODE)
Prescription USE (Per 21 CFR 801.109)
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
{5}------------------------------------------------
Prescription USE (Per 21 CFR 801.109)
K092691
(Division Sign-Off)
Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
{6}------------------------------------------------
ರಿದ್ದಾರೆ. ಇದರ್
(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number
{7}------------------------------------------------
Prescription USE (Pcr 21 CFR 801.109)
K092691
(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
Division of City of Cladiological Devices 510(k) Number -
{8}------------------------------------------------
| System | Transducer | X |
|---|---|---|
| Model: | 7L4A, 7L5, L12-4, L7-3, L11-4 | |
| 510(k) Number(s) |
c92691
(Division Sign-Off) (Division Sign-Off)
Division of Reproductive, Abdominal and Division of the Property of Radiological Devices
Radiological Number Radionograppen
510 (k) Number
{9}------------------------------------------------
System
| Model: | L14-6 | |||||||
|---|---|---|---|---|---|---|---|---|
| Transducer | X | |||||||
| 510(k) Number(s) | ||||||||
| Mode of Operation | ||||||||
| Clinical Application | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | Combined(specify) | Other (specify) |
| Ophthalmic | ||||||||
| Fetal | ||||||||
| Abdominal | N | N | N | N | N | N | Note 1,2, 4,7 | |
| Intraoperative (specify)* | ||||||||
| Intraoperative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | N | N | N | N | N | N | Note 1,2, 4,7 | |
| Small organ(specify)** | N | N | N | N | N | N | Note 1,2, 4,7 | |
| Neonatal Cephalic | N | N | N | N | N | N | Note 1,2, 4,7 | |
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph.(non-Card.) | ||||||||
| Musculo-skeletal Conventional | N | N | N | N | N | N | Note 1,2, 4,7 | |
| Musculo-skeletal Superficial | N | N | N | N | N | N | Note 1,2, 4,7 | |
| Intravascular | ||||||||
| Cardiac Adult | ||||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph.(Cardiac) | ||||||||
| Intra-Cardiac | ||||||||
| Peripheral Vascular | N | N | N | N | N | N | Note 1,2, 4,7 | |
| 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. | ||||||||
| 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: Contrast Imaging | ||||||||
| Note7: Color M | ||||||||
| Note8: Biopsy Guidance | ||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) | ||||||||
| Concurrence of CDRH, Office of Device Evaluation(ODE) |
Diagnostic Ultrasound Indications for Use Form Transducer
×
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
{10}------------------------------------------------
System
Modcl:
5 I 0(k) Number(s)
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | Combined(specify) | Other (specify) | |
| Ophthalmic | ||||||||
| Fetal | ||||||||
| Abdominal | N | N | N | N | N | N | N | Note 1, 2,5,7,8 |
| Intraoperative (specify)* | ||||||||
| Intraoperative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | N | N | N | N | N | N | N | Note 1, 2,5,7,8 |
| Small organ(specify)** | ||||||||
| Neonatal Cephalic | N | N | N | N | N | N | N | Note 1, 2,5,7,8 |
| Adult Cephalic | N | N | N | N | N | N | N | Note 1, 2,5,7,8 |
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph.(non-Card.) | ||||||||
| Musculo-skeletal Conventional | ||||||||
| Musculo-skeletal Superficial | ||||||||
| Intravascular | ||||||||
| Cardiac Adult | N | N | N | N | N | N | N | Note 1, 2,5,7,8 |
| Cardiac Pediatric | N | N | N | N | N | N | N | Note 1, 2,5,7,8 |
| Intravascular (Cardiac) | ||||||||
| Trans-esoph.(Cardiac) | ||||||||
| Intra-Cardiac | ||||||||
| Peripheral Vascular | ||||||||
| Other (specify)*** |
Diagnostic Ultrasound Indications for Use Form Transducer
2P2
×
Prescription USE (Per 21 CFR 801.109)
:
(Division Sign-Off) Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number
{11}------------------------------------------------
| System | Transducer | X | |||||||
|---|---|---|---|---|---|---|---|---|---|
| Model: | 4CD4 | ||||||||
| 510(k) Number(s) | |||||||||
| Mode of Operation | |||||||||
| Clinical Application | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | Combined(specify) | Other (specify) | |
| Ophthalmic | |||||||||
| Fetal | N | N | N | N | N | N | Note1,2, 3, 4,7 | ||
| Abdominal | N | N | N | N | N | N | Note1,2, 3, 4,7 | ||
| Intraoperative (specify)* | |||||||||
| Intraoperative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | N | N | N | N | N | N | Note1, 2, 3, 4,7 | ||
| Small organ(specify) ** | |||||||||
| 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. | |||||||||
| 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: Contrast Imaging | |||||||||
| Note7: Color M | |||||||||
| Note8: Biopsy Guidance | |||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) | |||||||||
| Concurrence of CDRH, Office of Device Evaluation(ODE) |
(Division Sign-Off) (Division Sign-Off)
Division of Reproductive, Abdominal and Division ogical Devices 510(k) Number
§ 892.1570 Diagnostic ultrasonic transducer.
(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.