(16 days)
No
The document does not mention AI, ML, or related terms, nor does it describe any features or performance metrics typically associated with AI/ML in medical imaging.
No
The device is described as a "Diagnostic Ultrasound System" intended to "acquire and display ultrasound images," which indicates a diagnostic rather than therapeutic purpose.
Yes
The "Intended Use / Indications for Use" section explicitly states "The M7/M7T Diagnostic Ultrasound System is applicable..." and the "Device Description" section refers to it as an "ultrasound diagnostic system."
No
The device is described as a "Diagnostic Ultrasound System" and explicitly mentions employing "an array of probes" with a specific frequency range. This indicates the presence of hardware components (probes) essential for acquiring ultrasound data, making it a hardware-software integrated system, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. These tests are performed outside of the body.
- Device Description: The M7/M7T Diagnostic Ultrasound System is described as a system that acquires and displays ultrasound images. Ultrasound is a non-invasive imaging technique that uses sound waves to create images of internal body structures. This is performed on the body, not on samples taken from the body.
- Intended Use/Indications for Use: The intended uses listed are for various anatomical sites and patient populations, all of which involve imaging the body directly. There is no mention of testing samples.
Therefore, based on the provided information, the M7/M7T Diagnostic Ultrasound System is a diagnostic imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / 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), neonatal cephalic, transcranial, cardiac, transvaginal, transrectal, peripheral vascular, urology, orthopedic,and musculoskeletal(conventional and superficial); intraoperative and transesophagel (cardiac) exams.
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application:
- Fetal
- Abdominal
- Intraoperative (abdominal, thoracic, and vascular)
- Pediatric
- Small organ (breast, thyroid, testes)
- Neonatal Cephalic
- Adult Cephalic
- Trans-rectal
- Trans-vaginal
- Musculo-skeletal Conventional
- Musculo-skeletal Superficial
- Urology
- Cardiac Adult
- Cardiac Pediatric
- Trans-esoph. (Cardiac)
- Peripheral Vascular
Mode of Operation:
- B
- M
- PWD
- CWD
- Color Doppler
- Combined (B+M, PW+B, Color + B, PW +Color+B, PW +Color+B, Power + PW +B)
Other (specify):
- Tissue Harmonic Imaging. The feature does not use contrast agents.
- Smart3D
- 4D (Real-time 3D)
- iScape
- TDI
- Color M
- Biopsy Guidance
- Amplitude Doppler
Product codes
IYN, IYO, ITX
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
gynecology, obstetric, abdominal, pediatric, small parts (breast, testes, thyroid), neonatal cephalic, transcranial, cardiac, transvaginal, transrectal, peripheral vascular, urology, orthopedic, and musculoskeletal (conventional and superficial). Intraoperative (abdominal, thoracic, vascular) and transesophageal (cardiac) exams.
Indicated Patient Age Range
adults, pregnant women, pediatric patients and neonates.
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical Tests: M7/M7T 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 60601-1-4, IEC 60601-2-37,UL 60601-1, ISO14971, ISO 10993-1, IEC62304 and IEC60601-2-18.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K103677, K103583, K113647, K03218, K093563
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
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: KIQIOIQ
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 8188 5640 Fax: +86 755 2658 2680
Contact Person:
Yang Zhaohui
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: January 15, 2012
- 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. Device Description:
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
B-1
Image /page/0/Picture/21 description: The image shows the text '005-1' in a bold, sans-serif font. The numbers are aligned horizontally, with a hyphen separating '005' from '1'. The text is black against a white background, creating a high contrast.
1
and phased array with a frequency range of approximately 2.5 MHz to 10.0 MHz.
4. 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), neonatal cephalic, transcranial, cardiac, transvaginal, transrectal, peripheral vascular, urology, orthopedic, and musculoskeletal (conventional and superficial), intraoperative and transesophageal(cardiac) exams.
5. Comparison with Predicate Devices:
M7/M7T Diagnostic Ultrasound System is comparable with and substantially equivalent to these predicate devices:
| Predicate
Device | Manufacturer | Model | 510(k) Control
Number |
|---------------------|--------------|---------|--------------------------|
| 1 | Mindray | M7/M7T | K103677 |
| 2 | Mindray | DC-7 | K103583 |
| 3 | Mindray | DC-8 | K113647 |
| 4 | GE | Logiq 7 | K03218 |
| 5 | Philips | iU22 | K093563 |
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 devices.
6. Non-clinical Tests:
M7/M7T 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 60601-1-4, IEC 60601-2-37,UL 60601-1, ISO14971, ISO 10993-1, IEC62304 and IEC60601-2-18.
Conclusion:
2
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, ISO 9001 and ISO 13485 quality systems. The device conforms to applicable medical device safety standards. Therefore, the M7/M7T Diagnostic Ultrasound System is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.
005-3
B-3
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus consists of a staff with two snakes coiled around it and a pair of wings at the top.
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
Re: K121010
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: March 30, 2012 Received: April 3, 2012
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 M7/M7T Diagnostic Ultrasound System, as described in your premarket notification:
Transducer Model Number
| C5-2s | P7-3s | L14-6Ns |
|---|---|---|
| V10-4s | 4CD4s | P12-4s |
| V10-4Bs | 6C2s | CW2s |
| 7L4s | 7L5s | 7LT4s |
| L14-6s | L7-3s | P7-3Ts |
| P4-2s | L12-4s |
APR 1 9 2012
4
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 Lauren Hefner at (301) 796-6881.
Sincerely Yours,
Damme M. Morris
anine M. Morris Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
5
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), neonatal cephalic, transcranial, cardiac, transvaginal, transrectal, peripheral vascular, urology, orthopedic,and musculoskeletal(conventional and superficial); intraoperative and transesophagel (cardiac) exams.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ X (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)
Ranny Shouss
(Division Sign-
Division of Radiologica
Office of In Vitro Diagnostic Device Evalu
510K K121010
Page 1 of
008-1
6
Diagnostic Ultrasound Indications for Use Form M7/M7T Diagnostic Ultrasound System
System: 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 | Color | |||
| Doppler | Combined | |||||||
| (specify) | Other (specify) | |||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | P | P | P | P | P | P | Note 1,2,3,4,6,7,8 | |
| Abdominal | P | P | P | P | P | P | Note 1,2,3,4,5,6,7,8 | |
| Intraoperative (specify)* | N | N | N | N | N | N | Note1,2,4,6,7,8 | |
| Intraoperative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | P | P | P | Note 1,2,3,4,5,6,7,8 | |
| Small organ(specify)** | P | P | P | P | P | P | Note 1,2,4,6,7,8 | |
| Fetal | ||||||||
| Imaging | ||||||||
| & Other | Neonatal Cephalic | P | P | P | P | P | P | Note 1,2,4,5,6,7,8 |
| Adult Cephalic | P | P | P | P | P | P | Note 1,2,4,5,6,7,8 | |
| Trans-rectal | P | P | P | P | P | P | Note 1,2,4,6,7,8 | |
| Trans-vaginal | P | P | P | P | P | P | Note 1,2,4,6,7,8 | |
| Trans-urethral | ||||||||
| Trans-esoph.(non-Card.) | ||||||||
| Musculo-skeletal Conventional | P | P | P | P | P | P | Note 1,2,4,5,6,7,8 | |
| Musculo-skeletal Superficial | P | P | P | P | P | P | Note 1,2,4,6,7,8 | |
| Intravascular | ||||||||
| Other (specify)*** | P | P | P | P | P | P | Note 1, 2, 4,6,7,8 | |
| Cardiac Adult | P | P | P | P | P | P | Note 1,2,5,6,7,8 | |
| Cardiac Pediatric | P | P | P | P | P | P | Note 1,2,5,6,7,8 | |
| Cardiac | Intravascular (Cardiac) | |||||||
| Trans-esoph.(Cardiac) | N | N | N | N | N | N | Note 1,2,5,6,8 | |
| Intra-Cardiac | ||||||||
| Peripheral | ||||||||
| Vascular | Peripheral Vascular | P | P | P | P | P | P | Note 1, 2, 4,6,7,8 |
| 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, PW +Color+B, PW +Color+B, Power + PW +B.
*Intraoperative includes abdominal, thoracic, and vascular.
- **Small organ-breast, thyroid, testes.
***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
- Note8: Amplitude Doppler
(Division Sign-Off)
Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510K K121010
7
| System: | M7/M7T Diagnostic Ultrasound System | |||||||
|---|---|---|---|---|---|---|---|---|
| Transducer: | C5-2s | |||||||
| 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 | Color | |||
| Doppler (specify) | Combined | |||||||
| Doppler (specify) | Other (specify) | |||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | P | P | P | P | P | Note 1, 2, 4,6,7,8 | ||
| Abdominal | P | P | P | P | P | Note 1, 2, 4,6,7,8 | ||
| Intraoperative (specify)* | ||||||||
| Intraoperative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | P | P | Note 1, 2, 4,6,7,8 | ||
| Fetal | ||||||||
| Imaging | ||||||||
| & Other | Small organ(specify)** | |||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph.(non-Card.) | ||||||||
| Musculo-skeletal Conventional | ||||||||
| Musculo-skeletal Superficial | ||||||||
| Intravascular | ||||||||
| Other (specify)*** | ||||||||
| Cardiac Adult | ||||||||
| Cardiac Pediatric | ||||||||
| Cardiac | Intravascular (Cardiac) | |||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-Cardiac | ||||||||
| Peripheral | ||||||||
| Vascular | Peripheral Vascular | P | P | P | P | P | Note 1, 2, 4,6,7,8 | |
| Other (specify) |
N=new indication; P=previously cleared by FDA; E=added under Appendix E
1+1cw multed.com, 1 - provents: B+M, PW+B, Color + B, Power + B, PW +Color+B, Power + PW +B.
*Intraoperative includes abdominal, thoracic, and vascular.
- **Small organ-breast, thyroid, testes.
***Other use includes urology.
. 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
Note8: Amplitude Doppler
(Division Sign-Off)
Division of Radiological Devices
Show
Olyision of Sacrologic Evaluation and Safety Office of 10
8
Transducer:
Diagnostic Ultrasound Indications for Use Form
M7/M7T Diagnostic Ultrasound System System:
V 10-4s
. Diagnostic ultrasound imaging or fluid flow analysis öf the human body as follows: Intended Use:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track 1 Only) | Specific | |||||||
| (Track 1 & 3) | B | M | PWD | CWD | Color | |||
| Doppler | Combined | |||||||
| (specify) | Other (specify) | |||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Imaging | ||||||||
| & Other | Fetal | P | P | P | P | P | Note 1, 2, 4,6,7,8 | |
| Abdominal | ||||||||
| Intraoperative (specify)* | ||||||||
| Intraoperative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small organ(specify)** | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | P | P | P | P | P | Note 1, 2, 4,6,7,8 | ||
| Trans-vaginal | P | P | P | P | P | Note 1, 2, 4,6,7,8 | ||
| Trans-urethral | ||||||||
| Trans-esoph.(non-Card.) | ||||||||
| Musculo-skeletal Conventional | ||||||||
| Musculo-skeletal Superficial | ||||||||
| Intravascular | ||||||||
| Other (specify)*** | P | P | P | P | P | Note 1, 2, 4,6,7,8 | ||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph.(Cardiac) | ||||||||
| Intra-Cardiac | ||||||||
| Peripheral | ||||||||
| Vascular | 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, PW +Color+B, PW +Color+B, Power + PW +B.
*Intraoperative includes abdominal, thoracic, and vascular.
- **Small organ-breast, thyroid, testes.
- ***()ther 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
- Note8: Amplitude Doppler
(Division Sign-Off)
Division of Radiological Devices Vitro Diagnosuc Device Evaluation and Safety Office o n
008-4
9
M7/M7T Diagnostic Ultrasound System
i
Transducer: Intended Use:
System:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
V 10-4Bs
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track 1 Only) | Specific | |||||||
| (Track 1 & 3) | B | M | PWD | CWD | Color Doppler | |||
| (specify) | Combined | |||||||
| Doppler (specify) | Other (specify) | |||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | P | P | P | P | P | Note 1, 2, 4,6,7,8 | ||
| Abdominal | ||||||||
| Intraoperative (specify)* | ||||||||
| Intraoperative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small organ(specify)** | ||||||||
| Fetal | ||||||||
| Imaging | ||||||||
| & Other | Neonatal Cephalic | |||||||
| Adult Cephalic | ||||||||
| Trans-rectal | P | P | P | P | P | Note 1, 2, 4,6,7,8 | ||
| Trans-vaginal | P | P | P | P | P | Note 1, 2, 4,6,7,8 | ||
| Trans-urethral | ||||||||
| Trans-esoph.(non-Card.) | ||||||||
| Musculo-skeletal Conventional | ||||||||
| Musculo-skeletal Superficial | ||||||||
| Intravascular | ||||||||
| Other (specify)*** | P | P | P | P | P | Note 1, 2, 4,6,7,8 | ||
| Cardiac Adult | ||||||||
| Cardiac Pediatric | ||||||||
| Cardiac | Intravascular (Cardiac) | |||||||
| Trans-esoph.(Cardiac) | ||||||||
| Intra-Cardiac | ||||||||
| Peripheral | ||||||||
| Vascular | 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, PW +Color+B, PW +Color+B, Power + PW +B.
*Intraoperative includes abdominal, thoracic, and vascular.
- **Small organ-breast, thyroid, testes.
***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
- Note8: Amplitude Doppler
(Division Sign-Off)
Division of Radiological Devices
Office of la Vitro Dieynestic Device Evaluation and Safe
રાજ્યન
008-5
10
M7/M7T Diagnostic Ultrasound System
System: Transducer:
7L4s .
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 | Color | |||
| Doppler (specify) | Combined | |||||||
| Doppler (specify) | Other (specify) | |||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Abdominal | P | P | P | P | P | Note 1,2, 4,6,7,8 | ||
| Intraoperative (specify)* | ||||||||
| Intraoperative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | P | P | Note 1,2, 4,6,7,8 | ||
| Small organ(specify)** | P | P | P | P | P | Note 1,2, 4,6,7,8 | ||
| Fetal | ||||||||
| Imaging | ||||||||
| & Other | Neonatal Cephalic | P | P | P | P | P | Note 1,2, 4,6,7,8 | |
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph.(non-Card.) | ||||||||
| Musculo-skeletal Conventional | P | P | P | P | P | Note 1,2, 4,6,7,8 | ||
| Musculo-skeletal Superficial | P | P | P | P | P | Note 1,2, 4,6,7,8 | ||
| Intravascular | ||||||||
| Other (specify)*** | ||||||||
| Cardiac Adult | ||||||||
| Cardiac Pediatric | ||||||||
| Cardiac | Intravascular (Cardiac) | |||||||
| Trans-esoph.(Cardiac) | ||||||||
| Intra-Cardiac | ||||||||
| Peripheral | ||||||||
| Vascular | Peripheral Vascular | P | P | P | P | P | Note 1,2, 4,6,7,8 | |
| 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, PW +Color+B, PW +Color+B, Power + PW +B.
*Intraoperative includes abdominal, thoracic, and vascular.
- ** Small organ-breast, thyroid, testes.
***Other use includes urology.
Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
Note 2: Smart3D T
Note 3:4D(Real-time 3D)
Note 4: iScape
Note5: TDI
Note6: Color M
Note7: Biopsy Guidance
Note8: Amplitude Doppler
Evaluation and Salety
(Divisio Division of Radiological Devices Office വങ്ങ
રાભ
008-6
11
M7/M7T Diagnostic Ultrasound System
System: Transducer:
L 14-65
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 | Color | ||||
| Doppler | Combined | ||||||||
| (specify) | Other (specify) | ||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Abdominal | |||||||||
| Intraoperative (specify)* | |||||||||
| Intraoperative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | P | P | P | P | P | P | Note 1,2, 4,6,7,8 | ||
| Small organ(specify)** | P | P | P | P | P | P | Note 1,2, 4,6,7,8 | ||
| Fetal | |||||||||
| Imaging | |||||||||
| & Other | Neonatal Cephalic | P | P | P | P | P | P | Note 1,2, 4,6,7,8 | |
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph.(non-Card.) | |||||||||
| Musculo-skeletal Conventional | P | P | P | P | P | P | Note 1,2, 4,6,7,8 | ||
| Musculo-skeletal Superficial | P | P | P | P | P | P | Note 1,2, 4,6,7,8 | ||
| Intravascular | |||||||||
| Other (specify)*** | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Cardiac | Intravascular (Cardiac) | ||||||||
| Trans-esoph.(Cardiac) | |||||||||
| Intra-Cardiac | |||||||||
| Peripheral | |||||||||
| Vascular | Peripheral Vascular. | P | P | P | P | P | P | Note 1,2, 4,6,7,8 | |
| Other (specify) |
N=new indication; P=previously cleared by FDA; E=added under Appendix E
N=Hitw mureats:Combined modes: B+M, PW+B, Color + B, Power + B, PW +Color+B, Power + PW+B.
*Intraoperative includes abdominal, thoracic, and vascular.
- **Small organ-breast, thyroid, testes.
- ***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
Note8: Amplitude Doppler
Vhune Harts
(Division Sign-Off)
510K
Division ME adiolonical na Office 1910
12
| Diagnostic Ultrasound Indications for Use Form | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| System: | M7/M7T Diagnostic Ultrasound System | ||||||||
| 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 1 Only) | Specific | ||||||||
| (Track 1 & 3) | B | M | PWD | CWD | Color | ||||
| Doppler | Combined | ||||||||
| (specify) | Other (specify) | ||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Abdominal | P | P | P | P | P | P | Note 1, 2,5,6,7,8 | ||
| Intraoperative (specify)* | |||||||||
| Intraoperative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | P | P | P | P | P | P | Note 1, 2,5,6,7,8 | ||
| Small organ(specify)** | |||||||||
| Fetal | |||||||||
| Imaging | |||||||||
| & Other | Neonatal Cephalic | P | P | P | P | P | P | Note 1, 2,5,6,7,8 | |
| Adult Cephalic | P | P | P | P | P | P | Note 1, 2,5,6,7,8 | ||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph.(non-Card.) | |||||||||
| Musculo-skeletal Conventional | |||||||||
| Musculo-skeletal Superficial | |||||||||
| Intravascular | |||||||||
| Other (specify)*** | |||||||||
| Cardiac Adult | P | P | P | P | P | P | Note 1, 2,5,6,7,8 | ||
| Cardiac Pediatric | P | P | P | P | P | P | Note 1, 2,5,6,7,8 | ||
| Cardiac | Intravascular (Cardiac) | ||||||||
| Trans-esoph.(Cardiac) | |||||||||
| Intra-Cardiac | |||||||||
| Peripheral | |||||||||
| Vascular | 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, PW+Color+B, PW +Color+B, Power + PW +B.
*Intraoperative includes abdominal, thoracic, and vascular.
- **Small organ-breast, thyroid, testes.
*** 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
Note8: Amplitude Doppler
(Division Sign-Off)
Division of Radiological Devices
Office of in Vitro Diagnostic Device Evaluation and Safety
510K.
13
M7/M7T Diagnostic Ultrasound System
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 1 Only) | Specific | ||||||||
| (Track 1 & 3) | B | M | PWD | CWD | Color | ||||
| Doppler | Combined | ||||||||
| Doppler (specify) | Other (specify) | ||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Abdominal | P | P | P | P | P | P | Note 1, 2,5,6,8 | ||
| Intraoperative (specify)* | |||||||||
| Intraoperative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | P | P | P | P | P | P | Note 1, 2,5,6,8 | ||
| Small organ(specify)** | |||||||||
| Fetal | |||||||||
| Imaging | |||||||||
| & Other | Neonatal Cephalic | P | P | P | P | P | P | Note 1, 2,5,6,8 | |
| Adult Cephalic | P | P | P | P | P | P | Note 1, 2,5,6,8 | ||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal Conventional | P | P | P | P | P | P | Note 1, 2,5,6,8 | ||
| Musculo-skeletal Superficial | |||||||||
| Intravascular | |||||||||
| Other (specify)*** | |||||||||
| Cardiac Adult | P | P | P | P | P | P | Note 1, 2,5,6,8 | ||
| Cardiac Pediatric | P | P | P | P | P | P | Note 1, 2,5,6,8 | ||
| Cardiac | Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-Cardiac | |||||||||
| Peripheral | |||||||||
| Vascular | 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, PW+Color+B, PW +Color+B, Power + PW+B.
*Intraoperative includes abdominal, thoracic, and vascular.
**Small organ-breast, thyroid, testes.
***Other use includes urology.
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
Note8: Amplitude Doppler
Kausan thers
(Division Sign-Off)
Division of Radiological Devices
office office office office office office office office office office office office office office office office office office office office office office office office office valuation and Safety
રાભ
14
| 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 | Color | |||
| Doppler (specify) | Combined | |||||||
| Doppler (specify) | Other (specify) | |||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | P | P | P | P | P | Note1,2, 3, 4,6,8 | ||
| Abdominal | P | P | P | P | P | Note 1,2, 3, 4,6,8 | ||
| Intraoperative (specify)* | ||||||||
| Intraoperative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Fetal | ||||||||
| Imaging | ||||||||
| & Other | Pediatric | P | P | P | P | P | Note1,2, 3, 4,6,8 | |
| Small organ(specify)** | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph.(non-Card.) | ||||||||
| Musculo-skeletal Conventional | ||||||||
| Musculo-skeletal Superficial | ||||||||
| Intravascular | ||||||||
| Other (specify)*** | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph.(Cardiac) | ||||||||
| Intra-Cardiac | ||||||||
| Peripheral | Peripheral Vascular | |||||||
| Vascular | Other (specify) |
M7/M7T Diagnostic Ultrasound System
4CD4s
Transducer:
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.
** Small organ-breast, thyroid, testes.
***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
Evaluation and Safety
Note8 Amplitude Doppler
(Division Sign-Off)
Division A Radiological Devices
Office of in Vitro Versio
II
15
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track 1 Only) | Specific | |||||||
| (Track 1 & 3) | B | M | PWD | CWD | Color | |||
| Doppler | Combined | |||||||
| (specify) | Other (specify) | |||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Abdominal | P | P | P | P | P | Note 1, 2, 4,6,7,8 | ||
| Intraoperative (specify)* | ||||||||
| Intraoperative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | P | P | Note 1, 2, 4,6,7,8 | ||
| Small organ(specify)** | ||||||||
| Fetal | ||||||||
| Imaging | ||||||||
| & Other | Neonatal Cephalic | P | P | P | P | P | Note 1, 2, 4,6,7,8 | |
| Adult Cephalic | P | P | P | P | P | Note 1, 2, 4,6,7,8 | ||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph.(non-Card.) | ||||||||
| Musculo-skeletal Conventional | P | P | P | P | P | Note 1, 2, 4,6,7, | ||
| Musculo-skeletal Superficial | P | P | P | P | P | Note 1, 2, 4,6,7,- | ||
| Intravascular | ||||||||
| Other (specify)*** | ||||||||
| Cardiac Adult | ||||||||
| Cardiac Pediatric | ||||||||
| Cardiac | Intravascular (Cardiac) | |||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-Cardiac | ||||||||
| Peripheral | ||||||||
| Vascular | Peripheral Vascular | P | P | P | P | P | Note 1, 2, 4,6,7, | |
| Other (specify) |
.
M7/M7T Diagnostic Ultrasound System
6C2s
Transducer:
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.
- **Small organ-breast, thyroid, testes.
***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
Note8: Amplitude Doppler
(Division Bign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation
510K
aluzion and Salety
008-11
16
Diagnostic Ultrasound Indications for Use Form M7/M7T Diagnostic Ultrasound System
Transducer: Intended Use:
System:
7L5s 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 | Color | |||
| Doppler | Combined | |||||||
| (specify) | Other (specify) | |||||||
| Ophthalmic. | Ophthalmic | |||||||
| Fetal | ||||||||
| Abdominal | ||||||||
| Intraoperative (specify)* | ||||||||
| Intraoperative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | P | P | P | Note 1,2, 4,6,7,8 | |
| Small organ(specify)** | P | P | P | P | P | P | Note 1,2, 4,6,7,8 | |
| Fetal | ||||||||
| Imaging | ||||||||
| & Other | 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, 4,6,7,8 | |
| Musculo-skeletal Superficial | P | P | P | P | P | P | Note 1,2, 4,6,7,8 | |
| Intravascular | ||||||||
| Other (specify)*** | ||||||||
| Cardiac Adult | ||||||||
| Cardiac Pediatric | ||||||||
| Cardiac | Intravascular (Cardiac) | |||||||
| Trans-esoph.(Cardiac) | ||||||||
| Intra-Cardiac | ||||||||
| Peripheral | ||||||||
| Vascular | Peripheral Vascular | P | P | P | P | P | P | Note 1,2, 4,6,7,8 |
| 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, PW+Color+B, PW +Color+B, Power + PW+B.
*Intraoperative includes abdominal, thoracic, and vascular.
- **Small organ-breast, thyroid, testes.
***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
Amplitude Doppler
evice Evaluation and Safety
Raune Shaus
(Division Sign-Off)
Division of Radiological Devices
Vitto Diagnos
Office of In:
008-12
17
| System: | M7/M7T Diagnostic Ultrasound System | |||||||
|---|---|---|---|---|---|---|---|---|
| Transducer: | L7-3s | |||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | |||||||
| Clinical Application | ||||||||
| General | ||||||||
| (Track 1 Only) | Specific | |||||||
| (Track 1 & 3) | B | M | PWD | CWD | Color | |||
| Doppler (specify) | Combined | |||||||
| (specify) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Imaging | ||||||||
| & Other | Fetal | |||||||
| Abdominal | P | P | P | P | P | Note 1,2, 4,6,7,8 | ||
| Intraoperative (specify)* | ||||||||
| Intraoperative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | P | P | Note 1,2, 4,6,7,8 | ||
| Small organ(specify)** | P | P | P | P | P | Note 1,2, 4,6,7,8 | ||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph.(non-Card.) | ||||||||
| Musculo-skeletal Conventional | P | P | P | P | P | Note 1,2, 4,6,7,8 | ||
| Musculo-skeletal Superficial | P | P | P | P | P | Note 1,2, 4,6,7,8 | ||
| Intravascular | ||||||||
| Other (specify)*** | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-Cardiac | ||||||||
| Peripheral | ||||||||
| Vascular | Peripheral Vascular | P | P | P | P | P | Note 1,2, 4,6,7,8 | |
| 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, PW +Color+B, PW +Color+B, Power + PW +B.
*Intraoperative includes abdominal, thoracic, and vascular.
- **Small organ-breast, thyroid, testes.
***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
Note8: Amplitude Doppler
Uns
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K
008-13
Diagnostic Ultrasound Indications for Use Form
18
M7/M7T Diagnostic Ultrasound System
System: Transducer:
L12-4s
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 | Color | |||
| Doppler (specify) | Combined | |||||||
| Doppler (specify) | Other (specify) | |||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Abdominal | P | P | P | P | P | Note 1,2, 4,6,7,8 | ||
| Intraoperative (specify)* | ||||||||
| Intraoperative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | P | P | Note 1,2, 4,6,7,8 | ||
| Small organ(specify)** | P | P | P | P | P | Note 1,2, 4,6,7,8 | ||
| Fetal | ||||||||
| Imaging | ||||||||
| & Other | Neonatal Cephalic | |||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skeletal Conventional | P | P | P | P | P | Note 1,2, 4,6,7,8 | ||
| Musculo-skeletal Superficial | P | P | P | P | P | Note 1,2, 4,6,7,8 | ||
| Intravascular | ||||||||
| Other (specify) *** | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-Cardiac | ||||||||
| Peripheral | ||||||||
| Vascular | Peripheral Vascular | P | P | P | P | P | Note 1,2, 4,6,7,8 | |
| Other (specify) |
N=new indication; P=previously cleared by FDA; E=added under Appendix E
A - new merballen, a - posted - 3 - M, PW+B, Color + B, Power + B, PW +Color+ B, Power + PW +B.
*Intraoperative includes abdominal, thoracic, and vascular.
- ** Small organ-breast, thyroid, testes.
- ***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 Note8: Amplitude Doppler
- (Division
Division of Radiological Devices
Office of in Vitro, Diagnostic Device Evaluation and Safety
510K.
008-14
19
System:
Transducer:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track 1 Only) | Specific | |||||||
| (Track 1 & 3) | B | M | PWD | CWD | Color | |||
| Doppler (specify) | Combined | |||||||
| Doppler (specify) | Other (specify) | |||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Abdominal | ||||||||
| Intraoperative (specify)* | ||||||||
| Intraoperative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Fetal | ||||||||
| Imaging | ||||||||
| & Other | Pediatric | P | P | P | P | P | Note 1,2, 4,6,7, | |
| Small organ(specify)** | P | P | P | P | P | Note 1,2, 4,6,7, | ||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph.(non-Card.) | ||||||||
| Musculo-skeletal Conventional | P | P | P | P | P | Note 1,2, 4,6,7, | ||
| Musculo-skeletal Superficial | P | P | P | P | P | Note 1,2, 4,6,7, | ||
| Intravascular | ||||||||
| Other (specify)*** | ||||||||
| Cardiac Adult | ||||||||
| Cardiac Pediatric | ||||||||
| Cardiac | Intravascular (Cardiac) | |||||||
| Trans-esoph.(Cardiac) | ||||||||
| Intra-Cardiac | ||||||||
| Peripheral | Peripheral Vascular | P | P | P | P | P | Note 1,2, 4,6,7, | |
| Vascular | Other (specify) |
Diagnostic Ultrasound Indications for Use Form
M7/M7T Diagnostic Ultrasound System
L14-6Ns
N=new indication; P=previously cleared by FDA; E=added under Appendix E
14 tion matean.org + proveed modes: B+M, PW+B, Color + B, PW +Color+B, PW +Color+B, Power + PW+B.
*Intraoperative includes abdominal, thoracic, and vascular.
**Small organ-breast, thyroid, testes.
***Other use includes urology.
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
Note8: Amplitude Doppier.
SION S Division of Rociological Devicas ામને of In Dia Blustion and Salan
008-15
20
| System: | M7/M7T Diagnostic Ultrasound System | |||||||
|---|---|---|---|---|---|---|---|---|
| Transducer: | P12-4s | |||||||
| 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 | Color | |||
| Doppler (specify) | Combined | |||||||
| (specify) | Other (specify) | |||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Imaging | ||||||||
| & Other | Fetal | |||||||
| Abdominal | P | P | P | P | P | P | Note 1, 2,5,6,8 | |
| Intraoperative (specify)* | ||||||||
| Intraoperative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | P | P | P | Note 1, 2,5,6,8 | |
| Small organ(specify)** | ||||||||
| Neonatal Cephalic | P | P | P | P | P | P | Note 1,2,5,6,8 | |
| Adult Cephalic | P | P | P | P | P | P | Note 1, 2,5,6,8 | |
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph.(non-Card.) | ||||||||
| Musculo-skeletal Conventional | ||||||||
| Musculo-skeletal Superficial | ||||||||
| Intravascular | ||||||||
| Other (specify)*** | ||||||||
| Cardiac | Cardiac Adult | P | P | P | P | P | P | Note 1, 2,5,6,8 |
| Cardiac Pediatric | P | P | P | P | P | P | Note 1, 2,5,6,8 | |
| Intravascular (Cardiac) | ||||||||
| Trans-esoph.(Cardiac) | ||||||||
| Intra-Cardiac | ||||||||
| Peripheral | ||||||||
| Vascular | Peripheral Vascular | |||||||
| Other (specify) |
N=new indication; P=previously cleared by FDA; E=added under Appendix E
1+ hew marcator, 1 - provided yours: B+M, PW+B, Color + B, PW+Color+B, PW +Color+B, Power + PW +B.
-
- Intraoperative includes abdominal, thoracic, and vascular.
- **Small organ-breast, thyroid, testes.
- ***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
Note8: Amplitude Doppler
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
21
| Clinical Application | Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| General | Specific | |||||||||||
| (Track I Only) (Track I & 3) | B | M | PWD CWD | Color | Combined | |||||||
| Doppler (specify) | Other (specify) | |||||||||||
| Ophthalmic | Ophthalmic | |||||||||||
| Fetal | ||||||||||||
| Abdominal | ||||||||||||
| Intraoperative (specify)* | ||||||||||||
| Intraoperative (Neuro) | ||||||||||||
| Laparoscopic | ||||||||||||
| Pediatric | P | |||||||||||
| Fetal | ||||||||||||
| Imaging | ||||||||||||
| & Other | Small organ(specify) ** | |||||||||||
| Neonatal Cephalic | ||||||||||||
| Adult Cephalic | P | |||||||||||
| Trans-rectal | ||||||||||||
| Trans-vaginal | ||||||||||||
| Trans-urethral | ||||||||||||
| Trans-esoph.(non-Card.) | ||||||||||||
| Musculo-skeletal Conventional | ||||||||||||
| Musculo-skeletal Superficial | ||||||||||||
| Intravascular | ||||||||||||
| Other (specify) *** | ||||||||||||
| Cardiac Adult | P | |||||||||||
| Cardiac Pediatric | P | |||||||||||
| Cardiac | Intravascular (Cardiac) | |||||||||||
| Trans-esoph. (Cardiac) | ||||||||||||
| Intra-Cardiac | ||||||||||||
| Peripheral | Peripheral Vascular | |||||||||||
| Vascular | Other (specify) |
M7/M7T Diagnostic Ultrasound System
CW2s
Transducer:
System:
N=new indication; P=previously cleared by FDA; E=added under Appendix E
N +Color + Browents: Combined modes: B+M, PW+B, Color + B, PW +Color+B, PW +Color+B, Power + PW +B.
*Intraoperative includes abdominal, thoracic, and vascular.
- **Small organ-breast, thyroid, testes.
***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
Note8: Amplitude Doppler
svice Evaluation and Safety
Raume Thasur
(Division Sign-Off)
Division of Radiological Devices
Office office office office office office office office office office official official official official official official official official official official official offic
510K
.
.
108-17
22
M7/M7T Diagnostic Ultrasound System
System: Transducer: Intended Use:
7LT4s 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 | Color | |||
| Doppler (specify) | Combined | |||||||
| (specify) | Other (specify) | |||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Imaging | ||||||||
| & Other | Fetal | |||||||
| Abdominal | N | N | N | N | N | N | Note1,2,4,6,7,8 | |
| Intraoperative (specify)* | N | N | N | N | N | N | Note1,2,4,6,7,8 | |
| Intraoperative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | N | N | N | N | N | N | Note1,2,4,6,7,8 | |
| Small organ(specify)** | N | N | N | N | N | N | Note1,2,4,6,7,8 | |
| Neonatal Cephalic | N | N | N | N | N | N | Note1,2,4,6,7,8 | |
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skeletal Conventional | N | N | N | N | N | N | Note1,2,4,6,7,8 | |
| Musculo-skeletal Superficial | N | N | N | N | N | N | Note1,2,4,6,7,8 | |
| Intravascular | ||||||||
| Other (specify)*** | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph.(Cardiac) | ||||||||
| Intra-Cardiac | ||||||||
| Peripheral | ||||||||
| Vascular | Peripheral Vascular | N | N | N | N | N | N | Note1,2,4,6,7,8 |
| 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, PW+Color+B, PW +Color+B, Power+PW+B
*Intraoperative includes abdominal, thoracic, and vascular.
- ** Small organ-breast, thyroid, testes.
*** 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
Co Evaluation and Co
Note8: Amplitude Doppler
(Division Sign-Oll)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Selet
Vitro Dieg
008-18
23
M7/M7T Diagnostic Ultrasound System
System: . Transducer:
P7-3Ts
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 | Color | ||
| Doppler (specify) | Other (specify) | ||||||
| Ophthalmic | Ophthalmic | ||||||
| Fetal | |||||||
| Imaging | |||||||
| & Other | Fetal | ||||||
| Abdominal | |||||||
| Intraoperative (specify)* | |||||||
| Intraoperative (Neuro) | |||||||
| Laparoscopic | |||||||
| Pediatric | |||||||
| Small organ(specify)** | |||||||
| Neonatal Cephalic | |||||||
| Adult Cephalic | |||||||
| Trans-rectal | |||||||
| Trans-vaginal | |||||||
| Trans-urethral | |||||||
| Trans-esoph.(non-Card.) | |||||||
| Musculo-skeletal Conventional | |||||||
| Musculo-skeletal Superficial | |||||||
| Intravascular | |||||||
| Other (specify)*** | |||||||
| Cardiac | Cardiac Adult | ||||||
| Cardiac Pediatric | |||||||
| Intravascular (Cardiac) | |||||||
| Trans-esoph.(Cardiac) | N | N | N | N | N | Note 1,2,5,6,8 | |
| Intra-Cardiac | |||||||
| Peripheral | |||||||
| Vascular | 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, PW +Color+B, PW +Color+B, Power + PW +B.
.
- Intraoperative includes abdominal, thoracic, and vascular.
- **Small organ-breast, thyroid, testes.
***Other use includes urology.
Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
- Note 2: Smart3D
- Note 3:4D(Rea!-time 3D)
Note 4: iScape
Note5: TDI
Note6: Color M
Note7: Biopsy Guidance
ote8: Amplitude Doppler
Kame Massess
(Division Sign-Off)
gigel Devices Division of Radio o Evaluation and Safety Office Vitro Diagnostie of In
510K
108-19