(42 days)
The M7/M7T Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in gynecology, obstetric, abdominal, pediatric, small parts (breast, thyroid, etc.), neonatal cephalic, transcranial, cardiac, transvaginal, transrectal, peripheral vascular, urology, orthopedic, and musculoskeletal (conventional and superficial) exams.
M7/M7T Diagnostic Ultrasound System is a general purpose, portable/mobile, software controlled, ultrasound diagnostic system. Its function is to acquire and display ultrasound images in B-Mode, M-Mode, PW-Mode, CW mode, Color-Mode, Color M-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, convex array and phased array with a frequency range of approximately 2.5 MHz to 10.0 MHz.
The provided text is a 510(k) summary for the Shenzhen Mindray Bio-medical Electronics Co., LTD M7/M7T Diagnostic Ultrasound System. This document focuses on demonstrating substantial equivalence to predicate devices and does not contain detailed information about acceptance criteria or specific study results showing the device meets those criteria.
Therefore, many of the requested details related to acceptance criteria, study methodologies, sample sizes, ground truth establishment, expert qualifications, and comparative effectiveness studies are not available in the provided text.
Based on the available text, here's what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not provide a table of acceptance criteria or specific device performance metrics in numerical form. Instead, it makes a general statement about safety and effectiveness.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated (implied: "as safe and effective as the legally marketed predicate devices") | "The conclusions drawn from testing of the M7/M7T Diagnostic Ultrasound System demonstrate that the device is as safe and effective as the legally marketed predicate devices." |
| Conformance to medical device safety standards | "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." |
2. Sample size used for the test set and the data provenance:
- Sample size for test set: Not specified.
- Data provenance: Not specified (e.g., country of origin, retrospective or prospective). The document only states "drawing from testing" generally.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of experts: Not specified.
- Qualifications of experts: Not specified.
4. Adjudication method for the test set:
- Adjudication method: Not specified.
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:
- MRMC study: No indication of a MRMC study. This device is a diagnostic ultrasound system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone study: Not applicable. This device is a diagnostic ultrasound system, which requires a human operator for image acquisition and interpretation, not a standalone algorithm.
7. The type of ground truth used:
- Type of ground truth: Not specified. Given it's an ultrasound system, the "testing" likely refers to technical performance validation, image quality assessment, and safety testing rather than diagnostic ground truth in a clinical trial context as implied by "ground truth" for an AI device.
8. The sample size for the training set:
- Sample size for training set: Not applicable. This document describes a traditional diagnostic ultrasound system, not an AI/ML-based device that would typically have a "training set."
9. How the ground truth for the training set was established:
- How ground truth was established: Not applicable. As above, this document describes a traditional diagnostic ultrasound system.
{0}------------------------------------------------
510(K) SUMMARY
MAY - 5 2010
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: K 100830.
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 2658 2551 Fax: +86 755 2658 2680
Contact Person:
Zhai Pei 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: Feb 4, 2010
- Device Name: M7/M7T 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. Marketed Device:
The subject device is substantially equivalent in its technologies and functionality to the following devices: Mindray DC-7(K092691), Mindray M5(K083001),GE Logiq e(K072797).
4. Device Description:
{1}------------------------------------------------
M7/M7T Diagnostic Ultrasound System is a general purpose, portable/mobile, software controlled, ultrasound diagnostic system. Its function is to acquire and display ultrasound images in B-Mode, M-Mode, PW-Mode, CW mode, Color-Mode, Color M-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, convex array and phased array with a frequency range of approximately 2.5 MHz to 10.0 MHz.
5. Intended Use:
The M7/M7T Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in gynecology, obstetric, abdominal, pediatric, small parts (breast, thyroid, etc.), neonatal cephalic, transcranial, cardiac, transvaginal, transrectal, peripheral vascular, urology, orthopedic, and musculoskeletal (conventional and superficial) exams.
6. Safety Considerations:
The M7/M7T Diagnostic Ultrasound System has 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 Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment: 2004 and NEMA UD 3 Output Display Standard: 2004. 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 M7/M7T Diagnostic Ultrasound System demonstrate that the device is as safe and effective as the legally marketed predicate devices.
{2}------------------------------------------------
Image /page/2/Picture/0 description: The image is a circular seal or logo. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter of the circle. In the center of the seal is a stylized image of an eagle or bird-like figure with three distinct wing or feather shapes. The image is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Shenzhen Mindray Bio-Medical Electroinics Co., Ltd. % Mr. Robert Mosenkis President CITECH 5200 Butler Pike Plymouth Meeting, PA 19462-1298
MAY - 6 2010
Re: K100830
Trade/Device Name: M7/M7T 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: April 21, 2010 Received: April 22, 2010
Dear Mr. Mosenkis:
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 M7/M7T Diagnostic Ultrasound System, as described in your premarket notification:
Transducer Model Number
| C5-2s | P4-2s | |
|---|---|---|
| V10-4s, V10-4Bs | P7-3s | |
| 7L4s, L14-6s | 4CD4s |
{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 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/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 Ewa Czerska at (301) 796-6541.
Sincerely yours,
Robert M. Becker, Jr. (Ger.)
Donald St. Pierre Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure(s)
{4}------------------------------------------------
Indications for Use
510(k) Number (if known):
Device Name: M7/M7T Diagnostic Ultrasound System
Indications For Use:
The M7/M7T Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in gynecology, obstetric, abdominal,pediatric, small parts (breast, testes, thyroid, etc.), neonatal ceohalic, transcranial, cardiac,transvaginal, transrectal, peripheral vascular, urology, orthopedic, and musculoskeletal(conventional and superficial) exams.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Robert Becker
(Division Sign-Off) Division of Radiological Devices Office of In Vitro Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K K100830
Page 1 of
{5}------------------------------------------------
Transducer:
| Transducer: | N/A | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | ||||||||
| Clinical Application | Mode of Operation | ||||||||
| General(Track 1 Only) | Specific(Track 1 & 3) | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | Combined(specify) | Other (specify) |
| Ophthalmic | |||||||||
| Ophthalmic | Fetal | N | N | N | N | N | N | N | Note 1,2,3,4,6,7 |
| Abdominal | N | N | N | N | N | N | N | Note 1,2,3,4,5,6,7 | |
| Intraoperative (specify)* | |||||||||
| Intraoperative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| FetalImaging& Other | Pediatric | N | N | N | N | N | N | N | Note 1,2,3,4,5,6,7 |
| Small organ(specify)** | N | N | N | N | N | N | N | Note 1,2,4,6,7 | |
| Neonatal Cephalic | N | N | N | N | N | N | N | Note 1,2,4,5,6,7 | |
| Adult Cephalic | N | N | N | N | N | N | N | Note 1,2,5,6,7 | |
| Trans-rectal | N | N | N | N | N | N | N | Note 1,2,4,6,7 | |
| Trans-vaginal | N | N | N | N | N | N | N | Note 1, 2,4,6,7 | |
| Trans-urethral | |||||||||
| Trans-esoph.(non-Card.) | |||||||||
| Musculo-skeletalConventional | N | N | N | N | N | N | N | Note 1,2,4,5,6,7 | |
| Musculo-skeletalSuperficial | N | N | N | N | N | N | N | Note 1,2,4,6,7 | |
| Intravascular | |||||||||
| Cardiac | Cardiac Adult | N | N | N | N | N | N | N | Note 1,2,5,6,7 |
| Cardiac Pediatric | N | N | N | N | N | N | N | Note 1,2,5,6,7 | |
| Intravascular (Cardiac) | |||||||||
| Trans-esoph.(Cardiac) | |||||||||
| Intra-Cardiac | |||||||||
| PeripheralVascular | Peripheral Vascular | N | N | N | N | N | N | N | Note 1, 2, 4,6,7 |
| Other (specify)*** |
Diagnostic Ultrasound Indications for Use Form
M7/M7T Diagnostic Ultrasound System
N/A
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.
Note I: 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
Prescription USE (Per 21 CFR 801.109)
Robert Z. Beckel
(Division Sign-Off) Division of Radiological Devic ion and Safety Office of In Vitro Diagnostic Device Eva
1
510K K100830
{6}------------------------------------------------
Diagnostic Ultrasound Indications for Use Form
System:
M7/M7T Diagnostic Ultrasound System .
C5-2s
Transducer: Intended Use:
Diagnostic ultrasound imaging or tluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General(Track I Only) | Specific(Track 1 & 3) | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | Combined(specify) | Other (specify) |
| Ophthalmic | Ophthalmic | ||||||||
| FetalImaging& Other | Fetal | N | N | N | N | N | N | N | Note 1, 2, 4,6,7 |
| Abdominal | N | N | N | N | N | N | Note 1, 2, 4,6,7 | ||
| Intraoperative (specify)* | |||||||||
| Intraoperative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | N | N | N | N | N | N | N | Note 1, 2, 4,6,7 | |
| 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 | |||||||||
| Cardiac | Intravascular (Cardiac) | ||||||||
| Trans-esoph.(Cardiac) | |||||||||
| Intra-Cardiac | |||||||||
| PeripheralVascular | Peripheral Vascular | N | N | N | N | N | N | N | |
| 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.
510K
- Intraoperative includes abdominal, thoracic, and vascular etc.
** Small organ-breast, thyroid, testes, etc.
Note I: 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
Prescription USE (Per 21 CFR 801.109)
Robert M. Becker
(Division Sign-Off)
n of Radiological Devi Evaluation and Safety Office of In
0830
ੱ 2
{7}------------------------------------------------
Diagnostic Ultrasound Indications for Use Form M7/M7T Diagnostic Ultrasound System
V 10-4s
System: Transducer; Intended Use:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General(Track 1Only) | Specific(Track 1 & 3) | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | Combined(specify) | Other (specify) |
| Ophthalmic | Ophthalmic | ||||||||
| FetalImaging& Other | Fetal | N | N | N | N | N | N | Note 1, 2, 4,6,7 | |
| 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 | N | N | N | N | N | N | Note 1, 2, 4,6,7 | ||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal Conventional · | |||||||||
| Musculo-skeletal Superficial | |||||||||
| Intravascular | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Cardiac | Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-Cardiac | |||||||||
| PeripheralVascular | 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 Hannonic Imaging. The feature does not use contrast agents.
510
Note 2: Smart3D
Note 3:4D(Real-time 3D)
Note 4: iScape
Note5: TDI
Note6: Color M
Note7: Biopsy Guidance
Prescription USE (Per 21 CFR 801.109)
Robert M. Beckius
(Division Sign-Off)
Division of Radioloo Office of In ation and Safety
{8}------------------------------------------------
Intraoperative (Neuro) Laparoscopic Pediatric
Small organ(specify)**
Neonatal Cephalic
Adult Cephalic
Trans-rectai
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) ***
Fetal
lmaging
& Other
Cardiac
Peripheral Vascular
| System:Transducer: | M7/M7T Diagnostic Ultrasound SystemV10-4Bs | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | ||||||||
| Clinical Application | Mode of Operation | ||||||||
| General(Track 1Only) | Specific(Track 1 & 3) | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | Combined(specify) | Other (specify) |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | N | N | N | N | N | N | Note 1, 2, 4,6,7 | ||
| Abdominal | |||||||||
| Intraoperative (specify)* |
N
N
N
N
N
N
N
Diagnostic Ultrasound Indications for Use Form
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,
N N
N N N
*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: Color M
Note7: Biopsy Guidance
Prescription USE {Per 21 CFR 801.109}
51
Robert Becker
(Division Sign-Off)
Division of Radiological Office of adiological Devices
tic Device Evaluation and Safety
4
Note 1, 2, 4,6,7
Note 1, 2, 4,6,7
{9}------------------------------------------------
Diagnostic Ultrasound Indications for Use Form
M7/M7T Diagnostic Ultrasound System
System: Transducer:
7L4s
Intended Use:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| General(Track 1Only) | Specific(Track 1 & 3) | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | Combined(specify) | Other (specify) |
|---|---|---|---|---|---|---|---|---|---|
| Ophthalmic | 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 | ||
| FetalImaging& Other | 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 | |||||||||
| Cardiac | Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-Cardiac | |||||||||
| PeripheralVascular | 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.
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
Prescription USE (Per 21 CFR 801.109)
Robert H. Becker
(Division Sign-Off)
Office of In
510K R100830
{10}------------------------------------------------
| Transducer: | L14-6s | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | |||||||||
| Clinical Application | Mode of Operation | |||||||||
| General(Track 1Only) | Specific(Track 1 & 3) | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | Combined(specify) | Other (specify) | |
| Ophthalmic | Ophthalmic | |||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify)* | ||||||||||
| Intraoperative (Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| FetalImaging& Other | Pediatric | N | N | N | N | N | N | N | Note 1,2, 4,6,7 | |
| Small organ(specify) ** | N | N | N | N | N | N | N | Note 1,2, 4,6,7 | ||
| Neonatal Cephalic | N | N | N | N | N | N | N | Note 1,2, 4,6,7 | ||
| & Other | 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, 4,6,7 | ||
| Musculo-skeletal Superficial | N | N | N | N | N | N | N | Note 1,2, 4,6,7 | ||
| Intravascular | ||||||||||
| Cardiac | Cardiac Adult | |||||||||
| Cardiac Pediatric | ||||||||||
| Intravascular (Cardiac) | ||||||||||
| Trans-esoph.(Cardiac) | ||||||||||
| Intra-Cardiac | ||||||||||
| Peripheral | Peripheral Vascular | N | N | N | N | N | N | N | Note 1,2, 4,6,7 | |
| Vascular | Other (specify) *** |
Diagnostic Ultrasound Indications for Use Form
M7/M7T Diagnostic Ultrasound System
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.
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
Prescription USE (Per 21 CFR 801.109)
Robert L. Becker, Jr.
(Division Sign-Off Division of Radiological Devices Office of In Vitro Diagnostic De valuation and Safety
510K K100830
6
{11}------------------------------------------------
| Transducer: | P4-2s | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | ||||||||||
| Clinical Application | Mode of Operation | ||||||||||
| General(Track IOnly) | Specific(Track 1 & 3) | B | M | IWD | CWD | ColorDoppler | AmplitudeDoppler | Combined(specify) | Other (specify) | ||
| Ophthalmic Ophthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | N | N | N | N | N | N | N | Note 1, 2,5,6,7 | |||
| Intraoperative (specify)* | |||||||||||
| Intraoperative (Neuro) | |||||||||||
| Laparoscopic | |||||||||||
| Pediatric | N | N | N | N | N | N | N | Note 1, 2,5,6,7 | |||
| Small organ(specify)** | |||||||||||
| FetalImaging& Other | Neonatal Cephalic | N | N | N | N | N | N | N | Note 1, 2,5,6,7 | ||
| Adult Cephalic | N | N | N | N | N | N | N | Note 1, 2,5,6,7 | |||
| Trans-rectal | |||||||||||
| Trans-vaginal | |||||||||||
| Trans-urethral | |||||||||||
| Trans-esoph.(non-Card.) | |||||||||||
| Musculo-skeletal Conventional | |||||||||||
| Musculo-skeletal Superficial | |||||||||||
| Intravascular | |||||||||||
| Cardiac | Cardiac Adult | N | N | N | N | N | N | N | Note 1, 2,5,6,7 | ||
| Cardiac Pediatric | N | N | N | N | N | N | N | Note 1, 2,5,6,7 | |||
| Intravascular (Cardiac) | |||||||||||
| Trans-esoph. (Cardiac) | |||||||||||
| Intra-Cardiac | |||||||||||
| Peripheral | Peripheral Vascular | ||||||||||
| Vascular | Other (specify)*** | ||||||||||
Diagnostic Ultrasound Indications for Use Form M7/M7T Diagnostic Ultrasound System
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.
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
Prescription USE (Per 21 CFR 801.109
510K
Robert F. Rockenfeller
(Division Sign-Off)
Office of In and Safety 7
{12}------------------------------------------------
| System: | M7/M7T Diagnostic Ultrasound System | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Transducer: | P7-3s | |||||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | |||||||||
| Clinical Application | Mode of Operation | |||||||||
| General(Track IOnly) | Specific(Track 1 & 3) | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | Combined(specify) | Other (specify) | |
| Ophthalmic | Ophthalmic | |||||||||
| Fetal | ||||||||||
| Abdominal | N | N | N | N | N | N | N | Note 1, 2,5,6 | ||
| Intraoperative (specify)* | ||||||||||
| Intraoperative (Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | N | N | N | N | N | N | N | Note 1, 2,5,6 | ||
| Small organ(specify)** | ||||||||||
| FetalImaging& Other | Neonatal Cephalic | N | N | N | N | N | N | N | Note 1, 2,5,6 | |
| & Other | Adult Cephalic | N | N | N | N | N | N | N | Note 1, 2,5,6 | |
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph. (non-Card.) | ||||||||||
| Musculo-skeletal Conventional | N | N | N | N | N | N | N | Note 1, 2,5,6 | ||
| Musculo-skeletal Superficial | ||||||||||
| Intravascular | ||||||||||
| Cardiac Adult | N | N | N | N | N | N | N | Note 1, 2,5,6 | ||
| Cardiac Pediatric | N | N | N | N | N | N | N | Note 1, 2,5,6 | ||
| Cardiac | Intravascular (Cardiac) | |||||||||
| Trans-esoph.(Cardiac) | ||||||||||
| Intra-Cardiac | ||||||||||
| PeripheralVascular | Peripheral Vascular | |||||||||
| Vascular | Other (specify)*** |
Diagnostic Ultrasound Indications for Use Form
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.
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
Prescription USE (Per 21 CFR 801.109)
(Division Sign-Off)
Division of Radiological Devic Office of In Vitro Diagno ion and Safety .
510K K100830
8
{13}------------------------------------------------
| Transducer: | 4CD4s | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | |||||||||
| Clinical Application | Mode of Operation | |||||||||
| General(Track I Only) | Specific(Track 1 & 3) | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | Combined(specify) | Other (specify) | |
| Ophthalmic | Ophthalmic | |||||||||
| Fetal | N | N | N | N | N | N | Note1,2, 3, 4,6 | |||
| Abdominal | N | N | N | N | N | N | Note1, 2, 3, 4,6 | |||
| Intraoperative (specify)* | ||||||||||
| Intraoperative (Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | N | N | N | N | N | N | Note1,2, 3, 4,6 | |||
| Small organ(specify)** | ||||||||||
| FetalImaging& Other | Neonatal Cephalic | |||||||||
| Adult Cephalic | ||||||||||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph.(non-Card.) | ||||||||||
| Musculo-skeletalConventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Intravascular | ||||||||||
| Cardiac Adult | ||||||||||
| Cardiac Pediatric | ||||||||||
| Cardiac | Intravascular (Cardiac) | |||||||||
| Trans-esoph.(Cardiac) | ||||||||||
| Intra-Cardiac | ||||||||||
| PeripheralVascular | Peripheral Vascular | |||||||||
| Other (specify)*** |
Diagnostic Ultrasound Indications for Use Form M7/M7T Diagnostic Ultrasound System
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.
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
Prescription USE (Per 21 CFR 801.109)
(Division Sign-Off)
510K
Safety Office of In Vitro
9
§ 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.