(26 days)
Not Found
No
The document does not mention AI, ML, or related terms like deep learning or neural networks in the device description or performance studies. The focus is on standard ultrasound imaging modes and safety/performance standards.
No
The device is described as a "Diagnostic Ultrasound System," indicating its purpose is for diagnosis, not therapy. Its function is to "acquire and display ultrasound data" to "generate onscreen display of anatomic structures and fluid flow within the body."
Yes
The "Intended Use / Indications for Use" section explicitly states that it is a "Diagnostic Ultrasound System." Additionally, the "Device Description" identifies it as an "ultrasonic diagnostic system."
No
The device description explicitly states it is an "ultrasonic diagnostic system" and employs "an array of probes," which are hardware components. The non-clinical tests also include evaluations for acoustic output, biocompatibility, and thermal, electrical, and mechanical safety, all related to hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as an ultrasound system used for imaging various anatomical structures within the body. This is a form of in vivo (within the living body) diagnostic imaging.
- Device Description: The description details the system's function as acquiring and displaying ultrasound data, which is consistent with an in vivo imaging device.
- Mechanism: The description explicitly states the system "transmit ultrasonic energy into patients and perform post processing of received echoes to generate onscreen display of anatomic structures and fluid flow within the body." This is the fundamental principle of ultrasound imaging, which is performed on a living patient, not on samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or performing tests on these samples outside of the body, which are the defining characteristics of an IVD.
Therefore, the M9/M9CV/M9T Diagnostic Ultrasound System is an in vivo diagnostic imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The M9/M9CV/M9T Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatric, small organ(breast, thyroid, testes), neonatal and adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal(conventional, superficial), adult and pediatric cardiac, trans-esoph.(Cardiac), peripheral vessel , urology exams.
M9/M9T Diagnostic Ultrasound System:
Transducer: N/A
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): Fetal, Abdominal, Pediatric, Small Organ (breast, thyroid, testes), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Musculo-skeletal (Conventional), Musculo-skeletal (Superficial), Cardiac Adult, Cardiac Pediatric, Trans-esoph. (Cardiac), Peripheral vessel, Other (Urology).
Mode of Operation: B, M, PWD (for N=new indication), CWD (for N=new indication), Color Doppler (for N=new indication), Amplitude Doppler (for N=new indication), Combined (B+M, PW+B, Color + B, Power + B, PW+Color+B, Power + PW +B.).
Other (specify): Note 1 (Tissue Harmonic Imaging), Note 2 (iScape), Note 3 (TDI), Note 4 (Color M), Note 5 (Biopsy Guidance), Note 6 (Elastography), Note 7 (Contrast imaging (Contrast agent for LVO)).
M9/M9T Diagnostic Ultrasound System:
Transducer: C11-3s
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): Fetal, Abdominal, Pediatric, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Musculo-skeletal (Conventional), Musculo-skeletal (Superficial), Cardiac Adult, Cardiac Pediatric, Trans-esoph. (Cardiac), Peripheral vessel, Other (Urology).
Mode of Operation: B, M, PWD, CWD, Color Doppler, Amplitude Doppler, Combined (B+M, PW+B, Color + B, Power + B, PW+Color+B, Power + PW+B).
Other (specify): Note 1 (Tissue Harmonic Imaging), Note 2 (iScape), Note 3 (TDI), Note 4 (Color M), Note 5 (Biopsy Guidance), Note 6 (Elastography), Note 7 (Contrast imaging (Contrast agent for LVO)).
M9/M9T Diagnostic Ultrasound System:
Transducer: C5-1s
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application:
Fetal Imaging & Other - Specific (Track 1 & 3): Fetal, Abdominal, Pediatric, Small Organ (breast, thyroid, testes), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Musculo-skeletal (Conventional), Musculo-skeletal (Superficial), Cardiac Adult, Cardiac Pediatric, Trans-esoph. (Cardiac), Peripheral vessel, Other (Urology).
Mode of Operation: B, M, PWD, CWD, Color Doppler, Amplitude Doppler, Combined (B+M, PW+B, Color + B, Power + B, PW +Color+B, Power + PW +B).
Other (specify): Note 1 (Tissue Harmonic Imaging), Note 2 (iScape), Note 3 (TDI), Note 4 (Color M), Note 5 (Biopsy Guidance), Note 6 (Elastography), Note 7 (Contrast imaging (Contrast agent for LVO)).
M9/M9T Diagnostic Ultrasound System:
Transducer: L 12-4s
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application:
Fetal Imaging & Other - Specific (Track 1 & 3): Fetal, Abdominal, Pediatric, Small Organ (breast, thyroid, testes), Neonatal Cephalic, Trans-rectal, Trans-vaginal, Musculo-skeletal (Conventional), Musculo-skeletal (Superficial), Peripheral vessel, Other (Urology).
Mode of Operation: B, M, PWD, CWD, Color Doppler, Amplitude Doppler, Combined (B+M, PW+B, Color + B, Power + B, PW+Color+B, Power + PW+B).
Other (specify): Note 1 (Tissue Harmonic Imaging), Note 2 (iScape), Note 3 (TDI), Note 4 (Color M), Note 5 (Biopsy Guidance), Note 6 (Elastography), Note 7 (Contrast imaging (Contrast agent for LVO)).
M9/M9T Diagnostic Ultrasound System:
Transducer: P7-3Ts
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application:
Cardiac - Specific (Track 1 & 3): Cardiac Pediatric, Trans-esoph. (Cardiac).
Mode of Operation: B, M, PWD, CWD, Color Doppler, Amplitude Doppler, Combined (B+M, PW+B, Color + B, Power + B, PW +Color+B, Power + PW +B).
Other (specify): Note 1 (Tissue Harmonic Imaging), Note 3 (TDI), Note 4 (Color M), Note 5 (Biopsy Guidance), Note 7 (Contrast imaging (Contrast agent for LVO)).
M9/M9T Diagnostic Ultrasound System:
Transducer: SP5-1s
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): Fetal, Abdominal, Intra-operative (abdominal, thoracic, and vascular), Intra-operative (Neuro), Laparoscopic, Pediatric, Small Organ (breast, thyroid, testes), 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 vessel, Other (Urology).
Mode of Operation: B, M, PWD, CWD, Color Doppler, Amplitude Doppler, Combined (B+M, PW+B, Color + B, Power + B, PW+Color+B, Power + PW+B).
Other (specify): Note 1 (Tissue Harmonic Imaging), Note 2 (iScape), Note 3 (TDI), Note 4 (Color M), Note 5 (Biopsy Guidance), Note 6 (Elastography), Note 7 (Contrast imaging (Contrast agent for LVO)).
M9/M9T Diagnostic Ultrasound System:
Transducer: P 10-4s
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application:
Fetal Imaging & Other - Specific (Track 1 & 3): Fetal, Abdominal, Pediatric, Small Organ (breast, thyroid, testes), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Musculo-skeletal (Conventional), Musculo-skeletal (Superficial), Peripheral vessel, Other (Urology).
Mode of Operation: B, M, PWD, CWD, Color Doppler, Amplitude Doppler, Combined (B+M, PW+B, Color + B, Power + B, PW+Color+B, Power + PW+B).
Other (specify): Note 1 (Tissue Harmonic Imaging), Note 2 (iScape), Note 4 (Color M), Note 5 (Biopsy Guidance).
M9/M9T Diagnostic Ultrasound System:
Transducer: L 14-6Ns
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): Fetal, Abdominal, Pediatric, Small Organ (breast, thyroid, testes), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Musculo-skeletal (Conventional), Musculo-skeletal (Superficial), Peripheral vessel, Other (Urology).
Mode of Operation: B, M, PWD, CWD, Color Doppler, Amplitude Doppler, Combined (B+M, PW+B, Color+B, Power+B, PW+Color+B, Power + PW +B).
Other (specify): Note 1 (Tissue Harmonic Imaging), Note 2 (iScape), Note 3 (TDI), Note 4 (Color M), Note 5 (Biopsy Guidance), Note 6 (Elastography), Note 7 (Contrast imaging (Contrast agent for LVO)).
M9/M9T Diagnostic Ultrasound System:
Transducer: V11-3Ws
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application:
Fetal Imaging & Other - Specific (Track 1 & 3): Fetal, Abdominal, Pediatric, Small Organ (breast, thyroid, testes), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Musculo-skeletal (Conventional), Musculo-skeletal (Superficial), Cardiac Adult, Cardiac Pediatric, Trans-esoph. (Cardiac), Peripheral vessel, Other (Urology).
Mode of Operation: B, M, PWD, CWD, Color Doppler, Amplitude Doppler, Combined (B+M, PW+B, Color + B, Power + B, PW+Color+B, Power + PW+B).
Other (specify): Note 1 (Tissue Harmonic Imaging), Note 2 (iScape), Note 3 (TDI), Note 4 (Color M), Note 5 (Biopsy Guidance), Note 6 (Elastography), Note 7 (Contrast imaging (Contrast agent for LVO)).
M9/M9T Diagnostic Ultrasound System:
Transducer: CW2s
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application:
Cardiac - Specific (Track 1 & 3): Cardiac Pediatric.
Mode of Operation: CWD.
Other (specify): Note 1 (Tissue Harmonic Imaging), Note 3 (TDI), Note 4 (Color M).
M9/M9T Diagnostic Ultrasound System:
Transducer: CW5s
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application:
Cardiac - Specific (Track 1 & 3): Cardiac Pediatric.
Mode of Operation: CWD.
Other (specify): Note 1 (Tissue Harmonic Imaging), Note 3 (TDI), Note 4 (Color M).
Product codes
IYN, IYO, ITX
Device Description
M9/M9T/M9CV is a software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound data in B-Mode, PW-Mode, PW-Mode, Color-Mode, Power/Dirpower Mode, THI, iScape mode, Color M, Elastography, LVO or the combined mode (i.e. B/M-Mode, B/PW-mode, B/PW/Color). This system is a Track 3 device that employs an array of probes that include linear array and convex array with a frequency range of approximately 3.0 MHz to 10.0 MHz.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Fetal, abdominal, pediatric, small organ (breast, thyroid, testes), neonatal and adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal (conventional, superficial), adult and pediatric cardiac, trans-esoph. (Cardiac), peripheral vessel, urology.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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:
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 5658 Fax: +86 755 2658 2680
Contact Person:
Wu Zicui
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: February 19, 2014
- Device Name: M9/M9T/M9CV Diagnostic Ultrasound System
Classification
Regulatory Class: II
Review Category: Tier II
21 CFR 892.1550 Ultrasonic Pulsed Doppler Imaging System (IYN)
21 CFR 892.1560 Ultrasonic Pulsed Echo Imaging System (IYO)
21 CFR 892.1570 Diagnostic Ultrasound Transducer (ITX)
3. Device Description:
M9/M9T/M9CV is a software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound data in B-Mode, PW-Mode, PW-Mode, Color-Mode , Power/Dirpower Mode, THI, iScape mode, Color M, Elastography, LVO or the combined mode (i.e. B/M-Mode, B/PW-mode, B/PW/Color).
This system is a Track 3 device that employs an array of probes that include linear array and convex array with a frequency range of approximately 3.0 MHz to 10.0
1
MHz.
4. Intended Use:
The M9/M9CV/M9T Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatric, small organ(breast, thyroid, testes), neonatal and adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal(conventional, superficial), adult and pediatric cardiac, trans-esoph.(Cardiac), peripheral vessel , urology exams.
5. Comparison with Predicate Devices:
M9/M9T/M9CV Diagnostic Ultrasound System is comparable with and substantially equivalent to these predicate devices:
| Predicate Device | Manufacturer | Model | 510(k) Number |
|---|---|---|---|
| 1 | Mindray | DC-8 | K132341 |
| 2 | Mindray | M7 | K131690 |
| 3 | GE | Voluson E8 | K101236 |
M9/M9T/M9CV has the same technological characteristics, is comparable in key safety and effectiveness features, and has the same intended uses and basic operating modes as the predicate devices. All systems transmit ultrasonic energy into patients and perform post processing of received echoes to generate onscreen display of anatomic structures and fluid flow within the body. All systems allow for specialized measurements of structures and flow, and calculations.
- Subject device M9/M9T/M9CV has the same intended uses as the predicated device ● DC-8(K132341)
| Subject Device | Predicate device |
|---|---|
| M9/M9T/M9CV | DC-8 (K132341) |
| The M9/M9CV/M9T Diagnostic Ultrasound | |
| System is applicable for adults, pregnant | |
| women, pediatric patients and neonates. It is | |
| intended for use in fetal, abdominal, pediatric, | |
| small organ(breast, thyroid, testes), neonatal | |
| and adult cephalic, trans-rectal, trans-vaginal, | |
| musculo-skeletal(conventional, superficial), | |
| adult and pediatric cardiac, | |
| trans-esoph.(Cardiac), peripheral vessel , | |
| urology exams. | The DC-8/DC-8 PRO/DC-8 CV/DC-8 |
| EXP/DC-8S diagnostic ultrasound system is | |
| applicable for adults, pregnant women, pediatric | |
| patients and neonates. It is intended for use in | |
| fetal, abdominal, pediatric, small organ (breast, | |
| thyroid, testes), neonatal cephalic, adult | |
| cephalic, trans-rectal, trans-vaginal, | |
| musculo-skeletal (conventional, superficial), | |
| cardiac adult, cardiac pediatric, peripheral | |
| vessel, urology and transesophageal (Cardiac) | |
| exams |
2
- All of the patient contact material of the M9/M9T/M9CV are the same as that of the predicated device DC-8(K132341) and the predicated device M7(K131690) with the exception of the materials for probe SP5-1s. Materials for the SP5-1s are tested under ISO 10993-1 for its biocompatibility.
- The acoustic power levels of M9/M9T/M9CV are below the limits of FDA, which is the same as the predicated device DC-8(K132341).
- M9/M9T/M9CV is designed in compliance with the FDA recognized electrical and physical safety standard, which is the same as the predicated device DC-8(K132341).
- M9/M9T/M9CV has the same imaging modes as the predicated device DC-8(K132341): B, M, Color Doppler, PWD, CWD, Amplitude Doppler, Color M, Anatomical M Mode and combined mode).
- M9/M9T/M9CV has some special functions: iScape, TDI, TDI QA, LVO, Elastography, Stress Echo, Tissue Tracking QA, iWorks, iNeedle and IMT. All of them are identical as the predicated device DC-8(K132341).
- M9/M9T/M9CV has the same capacity in term of making comments and body marks on the images, reporting patient exam results as the predicated device DC-8(K132341).
- . M9/M9T/M9CV has similar probes as the predicated device DC-8(K132341) and M7(K131609):
| Subject device | Predicated device | Predicated device | NOTE |
|---|---|---|---|
| M9/M9T/M9CV | DC-8(K132341) | M7(K131690) | |
| C5-1s | C5-2E | / | They have same indications for use, mode of operation, array elements. Different design is intended to improve penetrability and spacial resolution. C5-1s probe has been tested under the IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37. Differences do not influence the safety and effectiveness of this probe. |
| L12-4s | / | L12-4s | Same. |
| P10-4s | P10-4E | / | Same (except for the shape of the socket which does not affect the performance of the probe). |
| P7-3Ts | / | P7-3Ts | Same. |
3
| L14-6Ns | L14-6Ns | Same. | |
|---|---|---|---|
| V11-3Ws | V11-3WE | / | Same (except for the shape- |
| of the socket which does | |||
| not affect the performance | |||
| of the probe). | |||
| C11-3s | C11-3E | / | Same (except for the shape |
| of the socket which does | |||
| not affect the performance | |||
| of the probe). | |||
| CW2s | CW2s | / | Same. |
| CW5s | CW5s | / | Same. |
| SP5-1s | P4-2NE | ||
| P4-2E | / | SP5-1s has the same | |
| indications for use and | |||
| performance specification | |||
| with P4-2NE, except that | |||
| indications for use Neonatal | |||
| Cephalic is substantially |
. M9/M9T/M9CV has the same measurement and calculation functions as the predicated device DC-8(K132341) except for the cardiac measurement and calculation MV ALL which is equivalent to predicated device Voluson E8(101236).
6. Non-clinical Tests:
M9/M9T/M9CV 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 designed to conform with applicable medical safety standards. This device has been tested and evaluated under the following standards:
- UD 2 Acoustic Output Measurement Standard for Diagnostic Ultrasound . Equipment.
- UD 3 Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
- 통 AAMI / ANS1 ES60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
- 를 IEC 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests (Edition 3)
- IEC 60601-2-37 Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
- ISO14971 Medical devices Application of risk management to medical devices B
- ISO 10993-1 Biological evaluation of medical devices -- Part 1: Evaluation and
0.5
4
K141010
Page 5 of 5
testing within a risk management process
- 에 IEC 62366 Medical devices - Application of usability engineering to medical devices
- l Medical device software - Software life cycle processes IEC 62304
These non-clinical tests relied on in this premarket notification submission can support the determination of substantial equivalence of the subject device.
7. Clinical Studies
Not applicable. The subject of this submission, M9/M9T/M9CV Diagnostic Ultrasound System, does not require clinical studies to support substantial equivalence.
Conclusion:
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 M9/M9T/M9CV Diagnostic Ultrasound System is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.
5
Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features three parallel lines that curve and converge, resembling a stylized human figure. The symbol is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement. The text is in uppercase letters and is evenly spaced around the symbol.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 14, 2014
Shenzhen Mindray Bio-Medical Electronics, Co. Ltd. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Scrvices LLC 1394 25" Street NW BUFFALO MN 55313
Re: K141010
Trade/Device Name: M9 Diagnostic Ultrasound System. M9T Diagnostic Ultrasound System, M9CV Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: 11 Product Code: IYN, IYO, ITX Dated: April 24, 2014 Received: April 25, 2014
Dear Mr. Job:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRFI does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
This determination of substantial equivalence applies to the following transducers intended for use with the M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9C V Diagnostic Ultrasound Systems, as described in your premarket notification:
Transducer Model Number
| C11-3s | C5-1s | L12-4s |
|---|---|---|
| P7-3Ts | SP5-1s | P10-4s |
| L14-6Ns | V11-3Ws | CW2s |
| CW5s |
6
Page 2-Mr. Job
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/McdicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
for
Janine Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
7
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
510(k) Number (if known)
Device Name M9/M9T/M9CV
Indications for Use (Describe)
The M91M9T Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatic, small organ(breast, thyroid, testes), neonatal and adult cephalic, transvaginal, musculo-skeletal(conventional, superficial), adult and pediatic cardiac, trans-soph.(Cardiac), peripheral vessel, urology exams.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Page 1 of 2
008-I
PSC Publishing Services (30); 441-4740 EF
FORM FDA 3881 (1/14)
8
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of Information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
008-2
9
Diagnostic Ultrasound Indications For Use Format
M9/M9T Diagnostic Ultrasound System System:
Transducer: N/A
Intended Use: Diagnostic ultrasound imaging or Nuid Now 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 | Amplitude | ||||||||||
| Doppler | Combined | ||||||||||
| (specify) | Other (specify) | ||||||||||
| Ophthalmic | Ophthalmic | ||||||||||
| Fetal Imaging | |||||||||||
| & Other | Fetal | N | N | N | N | N | N | N | Note 1, 2,4,5 | ||
| Abdominal | N | N | N | N | N | N | N | Note 1, 2,4,5 | |||
| Intra-operative (Specify*) | |||||||||||
| Intra-operative (Neuro) | |||||||||||
| Laparoscopic | |||||||||||
| Pediatric | N | N | N | N | N | N | N | Note 1, 2,4,5 | |||
| Small Organ (Specify**) | N | N | N | N | N | N | N | Note 1,2,5,6 | |||
| Neonatal Cephalic | N | N | N | N | N | N | N | Note 1,2,4,5 | |||
| Adult Cephalic | N | N | N | N | N | N | N | Note 1, 2,4,5 | |||
| Trans-rectal | N | N | N | N | N | N | N | Note 1,2,4,5 | |||
| Trans-vaginal | N | N | N | N | N | N | N | Note 1, 2,4,5 | |||
| Trans-urethral | |||||||||||
| Trans-esoph. (non-Card.) | |||||||||||
| Musculo-skeletal | |||||||||||
| (Conventional) | N | N | N | N | N | N | N | Note 1,2,4,5 | |||
| Musculo-skeletal (Superficial) | N | N | N | N | N | N | N | Note 1,2,5 | |||
| Intravascular | |||||||||||
| Cardiac Adult | N | N | N | N | N | N | N | Note 1,2,3,4,5,7 | |||
| Cardiac Pediatric | N | N | N | N | N | N | N | Note 1,2,3,4,5 | |||
| Cardiac | Intravascular (Cardiac) | ||||||||||
| Trans-esoph. (Cardiac) | N | N | N | N | N | N | N | Note 1, 3,4 | |||
| Intra-cardiac | |||||||||||
| Peripheral | |||||||||||
| vessel | Peripheral vessel | N | N | N | N | N | N | N | Note 1,2,4,5 | ||
| Other (Specify***) | N | N | N | N | N | N | N | Note 1,2,4,5 | |||
| 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. | |||||||||||
| ** Small organ-breast, thyroid, testes. | |||||||||||
| *** Other use includes Urology. | |||||||||||
| Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents. | |||||||||||
| Note 2: iScape | |||||||||||
| Note 3:TDI | |||||||||||
| Note 4: Color M | |||||||||||
| Notes: Biopsy Guidance | |||||||||||
| Note6: Elastography | |||||||||||
| Note7: Contrast imaging (Contrast agent for LVO) | |||||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | |||||||||||
| Concurrence of CDRH, Office of Device Evaluation(ODE) | |||||||||||
| Clinical Application | Mode of Operation | ||||||||||
| General | |||||||||||
| (Track 1 | |||||||||||
| Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color | |||||
| Doppler | Amplitude | ||||||||||
| Doppler | Combined | ||||||||||
| (specify) | Other (specify) | ||||||||||
| Ophthalmic | Ophthalmic | ||||||||||
| Fetal | |||||||||||
| Abdominal | N | N | N | N | N | N | Note 1,2,4,5 | ||||
| Intra-operative (Specify*) | |||||||||||
| Intra-operative (Neuro) | |||||||||||
| Laparoscopic | |||||||||||
| Pediatric | N | N | N | N | N | N | Note 1,2,4,5 | ||||
| Small Organ (Specify**) | |||||||||||
| Fetal Imaging | |||||||||||
| & Other | Neonatal Cephalic | N | N | N | N | N | N | Note 1,2,4,5 | |||
| Adult Cephalic | |||||||||||
| Trans-rectal | |||||||||||
| Trans-vaginal | |||||||||||
| Trans-urethral | |||||||||||
| Trans-esoph. (non-Card.) | |||||||||||
| Musculo-skeletal | |||||||||||
| (Conventional) | |||||||||||
| Musculo-skeletal (Superficial) | |||||||||||
| Intravascular | |||||||||||
| Cardiac Adult | |||||||||||
| Cardiac Pediatric | N | N | N | N | N | N | Note 1,2,4,5 | ||||
| Cardiac | Intravascular (Cardiac) | ||||||||||
| Trans-esoph. (Cardiac) | |||||||||||
| Intra-cardiac | |||||||||||
| Peripheral | |||||||||||
| vessel | Peripheral vessel | N | N | N | N | N | N | Note 1,2,4,5 | |||
| 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. | |||||||||||
| *** Other use includes Urology. | |||||||||||
| Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents. | |||||||||||
| Note 2: iScape | |||||||||||
| Note 3:TDI | |||||||||||
| Note 4: Color M | |||||||||||
| Note 5: Biopsy Guidance | |||||||||||
| Note6: Elastography | |||||||||||
| Note7: Contrast imaging (Contrast agent for LVO) | |||||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | |||||||||||
| Concurrence of CDRH, Office of Device Evaluation(ODE) | |||||||||||
| Clinical Application | Mode of Operation | ||||||||||
| General | |||||||||||
| (Track 1 | Specific (Track 1 & 3) | B | M | PWD | CWD | Color | |||||
| Doppler | Amplitude | ||||||||||
| Doppler | Combined | ||||||||||
| (specify) | Other (specify) | ||||||||||
| Only) | |||||||||||
| Ophthalmic | Ophthalmic | ||||||||||
| Fetal | N | N | N | N | N | N | Note 1.2.4.5 | ||||
| Abdominal | N | N | N | N | N | N | Note 1,2,4,5 | ||||
| Intra-operative (Specify®) | |||||||||||
| Intra-operative (Neuro) | |||||||||||
| Laparoscopic | |||||||||||
| Pediatric | N | N | N | N | N | N | Note 1,2,4,5 | ||||
| Small Organ (Specify**) | |||||||||||
| Fetal Imaging | Neonatal Cephalic | ||||||||||
| & Other | Adult Cephalic | ||||||||||
| Trans-rectal | |||||||||||
| Trans-vaginal | |||||||||||
| Trans-urethral | |||||||||||
| Trans-esoph. (non-Card.) | |||||||||||
| Musculo-skeletal | N | N | N | N | N | N | Note 1,2,4,5 | ||||
| (Conventional) | |||||||||||
| Musculo-skeletal (Superficial) | |||||||||||
| Intravascular | |||||||||||
| Cardiac Adult | |||||||||||
| Cardiac Pediatric | |||||||||||
| Cardiac | Intravascular (Cardiac) | ||||||||||
| Trans-esoph. (Cardiac) | |||||||||||
| Intra-cardiac | |||||||||||
| Peripheral | Peripheral vessel | N | N | ਮ | N | N | N | Note 1,2,4,5 | |||
| vesse. | 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、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: iScape | |||||||||||
| Note 3:TDI | |||||||||||
| Note 4: Color M | |||||||||||
| Note5: Biopsy Guidance | |||||||||||
| Note6: Elastography | |||||||||||
| Note7: Contrast imaging (Contrast agent for LVO) | |||||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | |||||||||||
| Concurrence of CDRH, Office of Device Evaluation(ODE) | |||||||||||
| Clinical Application | Mode of Operation | ||||||||||
| General | |||||||||||
| (Track 1 | |||||||||||
| Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color | |||||
| Doppler | Amplitude | ||||||||||
| Doppler | Combined | ||||||||||
| (specify) | Other (specify) | ||||||||||
| Ophthalmic | Ophthalmic | ||||||||||
| Fetal Imaging | |||||||||||
| & Other | Fetal | ||||||||||
| Abdominal | P | P | P | P | P | P | Note 1,2,5 | ||||
| Intra-operative (Specify*) | |||||||||||
| Intra-operative (Neuro) | |||||||||||
| Laparoscopic | |||||||||||
| Pediatric | P | P | P | P | P | P | Note 1.2,5 | ||||
| Small Organ (Specify**) | P | P | P | P | P | P | Note 1,2,5,6 | ||||
| Neonatal Cephalic | P | P | P | P | P | P | Note 1,2,5 | ||||
| Adult Cephalic | |||||||||||
| Trans-rectal | |||||||||||
| Trans-vaginal | |||||||||||
| Trans-urethral | |||||||||||
| Trans-esoph. (non-Card.) | |||||||||||
| Musculo-skeletal | |||||||||||
| (Conventional) | P | P | P | P | P | P | Note 1,2,5 | ||||
| Musculo-skeletal (Superficial) | P | P | P | P | P | P | Note 1.2,5 | ||||
| Intravascular | |||||||||||
| Cardiac Adult | |||||||||||
| Cardiac | Cardiac Pediatric | ||||||||||
| Intravascular (Cardiac) | |||||||||||
| Trans-esoph. (Cardiac) | |||||||||||
| Intra-cardiac | |||||||||||
| Peripheral | |||||||||||
| vessel | Peripheral vessel | P | P | P | P | P | P | Note 1,2,5 | |||
| 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. | |||||||||||
| ** Small organ-breast, thyroid, testes. | |||||||||||
| *** Other use includes Urology. | |||||||||||
| Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents. | |||||||||||
| Note 2: iScape | |||||||||||
| Note 3:TDI | |||||||||||
| Note 4: Color M | |||||||||||
| Note5: Biopsy Guidance | |||||||||||
| Note6: Elastography | |||||||||||
| Note7: Contrast imaging (Contrast agent for LVO) | |||||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | |||||||||||
| Concurrence of CDRH, Office of Device Evaluation(ODE) | |||||||||||
| Clinical Application | Mode of Operation | ||||||||||
| General | |||||||||||
| (Track I | |||||||||||
| Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color | |||||
| Doppler | Amplitude | ||||||||||
| Doppler | Combined | ||||||||||
| (specify) | Other (specify) | ||||||||||
| Ophthalmic | Ophthalmic | ||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intra-operative (Specify*) | |||||||||||
| Intra-operative (Neuro) | |||||||||||
| Laparoscopic | |||||||||||
| Pediatric | |||||||||||
| Small Organ (Specify**) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Fetal Imaging | |||||||||||
| & Other | 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) | P | P | P | P | P | P | P | Note 1, 3,4 | |||
| Intra-cardiac | |||||||||||
| Peripheral | |||||||||||
| vessel | Peripheral vessel | ||||||||||
| 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. | |||||||||||
| ** Small organ-breast, thyroid, testes. | |||||||||||
| *** Other use includes Urology. | |||||||||||
| Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents. | |||||||||||
| Note 2: iScape | |||||||||||
| Note 3:TDI | |||||||||||
| Note 4: Color M | |||||||||||
| Note5: Biopsy Guidance | |||||||||||
| Note6: Elastography | |||||||||||
| Note7: Contrast imaging (Contrast agent for LVO) | |||||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | |||||||||||
| Concurrence of CDRH, Office of Device Evaluation(ODE) | |||||||||||
| Clinical Application | Mode of Operation | ||||||||||
| General | |||||||||||
| (Track 1 | |||||||||||
| Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color | |||||
| Doppler | Amplitude | ||||||||||
| Doppler | Combined | ||||||||||
| (specify) | Other (specify) | ||||||||||
| Ophthalmic | Ophthalmic | ||||||||||
| Fetal | |||||||||||
| Abdominal | N | N | N | N | N | N | N | Note 1,2,4,5 | |||
| Intra-operative (Specify*) | |||||||||||
| Intra-operative (Neuro) | |||||||||||
| Laparoscopic | |||||||||||
| Pediatric | N | N | N | N | N | N | N | Note 1,2,4,5 | |||
| Small Organ (Specify **) | |||||||||||
| Neonatal Cephalic | N | N | N | N | N | N | N | Note 1,2,4,5 | |||
| Fetal Imaging | |||||||||||
| & Other | Adult Cephalic | N | N | N | N | N | N | N | Note 1,2,4,5 | ||
| 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 1,2,3,4,5,7 | |||
| Cardiac Pediatric | N | N | N | N | N | N | N | Note 1,2,3,4,5 | |||
| Cardiac | Intravascular (Cardiac) | ||||||||||
| Trans-esoph. (Cardiac) | |||||||||||
| Intra-cardiac | |||||||||||
| Peripheral | |||||||||||
| vessel | Peripheral vessel | ||||||||||
| 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. | |||||||||||
| ** Small organ-breast, thyroid, testes. | |||||||||||
| *** Other use includes Urology. | |||||||||||
| Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents. | |||||||||||
| Note 2: iScape | |||||||||||
| Note 3:TDI | |||||||||||
| Note 4: Color M | |||||||||||
| Note5: Biopsy Guidance | |||||||||||
| Note6: Elastography | |||||||||||
| Note7: Contrast imaging (Contrast agent for LVO) | |||||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | |||||||||||
| Concurrence of CDRH, Office of Device Evaluation(ODE) | |||||||||||
| Clinical Application | Mode of Operation | ||||||||||
| General | |||||||||||
| (Track 1 | |||||||||||
| Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color | |||||
| Doppler | Amplitude | ||||||||||
| Doppler | Combined | ||||||||||
| (specify) | Other (specify) | ||||||||||
| Ophthalmic | Ophthalmic | ||||||||||
| Fetal | |||||||||||
| Abdominal | N | N | N | N | N | N | N | Note 1,4 | |||
| Intra-operative (Specify*) | |||||||||||
| Intra-operative (Neuro) | |||||||||||
| Laparoscopic | |||||||||||
| Pediatric | N | N | N | N | N | N | N | Note 1,4 | |||
| Small Organ (Specify**) | |||||||||||
| Neonatal Cephalic | N | N | N | N | N | N | N | Note 1,4 | |||
| Fetal Imaging | |||||||||||
| & Other | Adult Cephalic | ||||||||||
| Trans-rectal | |||||||||||
| Trans-vaginal | |||||||||||
| Trans-urethral | |||||||||||
| Trans-esoph. (non-Card.) | |||||||||||
| Musculo-skeletal | |||||||||||
| (Conventional) | |||||||||||
| Musculo-skeletal (Superficial) | |||||||||||
| Intravascular | |||||||||||
| Cardiac Adult | |||||||||||
| Cardiac Pediatric | N | N | N | N | N | N | N | Note 1, 3,4 | |||
| Cardiac | Intravascular (Cardiac) | ||||||||||
| Trans-esoph. (Cardiac) | |||||||||||
| Intra-cardiac | |||||||||||
| Peripheral | |||||||||||
| vessel | Peripheral vessel | ||||||||||
| 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. | |||||||||||
| **Small organ-breast, thyroid, testes. | |||||||||||
| ***Other use includes Urology. | |||||||||||
| Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents. | |||||||||||
| Note 2: iScape | |||||||||||
| Note 3:TDI | |||||||||||
| Note 4:Color M | |||||||||||
| Note 5: Biopsy Guidance | |||||||||||
| Note 6: Elastography | |||||||||||
| Note 7: Contrast imaging (Contrast agent for LVO) | |||||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | |||||||||||
| Concurrence of CDRH, Office of Device Evaluation(ODE) |
10
M9/M9T Diagnostic Ultrasound System System: Transducer: C11-3s
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Prescription USE (Per 21 CFR 801.109)
.
ﻟ
11
System: M9/M9T Diagnostic Ultrasound System Transducer: CS-Is
.
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
12
M9/M9T Diagnostic Ultrasound System System:
Transducer: L 12-4s
Intended Use; Diagnostic ultrasound imaging or fluid Now analysis of the human body as follows:
Image /page/12/Picture/5 description: The image shows the text '008-6' in bold font at the top. Below that, the text 'Page 6 of 13' is printed in a smaller, regular font. The text indicates that this is page 6 of a document that is 13 pages long and the document number is 008-6.
13
M9/M9T Diagnostic Ultrasound System System:
Transducer: P7-3Ts
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
14
M9/M9T Diagnostic Ultrasound System System: Transducer: SPS-Is
Intended Use: Diagnostic ultrasound imaging or Nuid Now analysis of the human body as follows:
Prescription USE (Per 21 CFR 801.109)
・
Image /page/14/Picture/4 description: The image shows the text "OOS-8" in a bold, sans-serif font. Below this, the text "Page 8 of 13" is printed in a smaller, serif font. The text indicates that this is page 8 of a document that has 13 pages total.
15
M9/M9T Diagnostic Ultrasound System System: Transducer: P 10-4s
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
.
Image /page/15/Picture/4 description: The image shows the text "008-9" in bold font on the top line. Below that, the text "Page 9 of 13" is printed in a smaller, regular font. The text indicates a page number within a document.
16
M9/M9T Diagnostic Ultrasound System System: Transducer: L 14-6Ns
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 | Color | ||||
| Doppler | Amplitude Combined | |||||||||
| Doppler | (specify) | Other (specify) | ||||||||
| Ophthalmic | Ophthalmic | |||||||||
| Fetal | ||||||||||
| Abdominal | P | P | P | P | P | P | Note 1,2,5 | |||
| Intra-operative (Specify®) | ||||||||||
| Intra-operative (Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | P | P | P | P | P | P | Nole 1,2,5 | |||
| Small Organ (Specify* * ) | P | P | P | P | P | P | Note 1,2,5.6 | |||
| Neonatal Cephalic | p | P | P | P | P | P | Note 1,2,5 | |||
| Fetal Imaging | Adult Cephalic | |||||||||
| & Other | Trans-recial | |||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph. (non-Card.) | ||||||||||
| Musculo-skeletal | ক | P | P | P | P | P | Note 1.2.5 | |||
| (Conventional) | ||||||||||
| Musculo-skeletal (Superficial) | P | P | P | P | P | P | Note 1,2,5 | |||
| Intravascular | ||||||||||
| Cardiac Adult | ||||||||||
| Cardiac Pediatric | ||||||||||
| Cardiac | Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | ||||||||||
| Intra-cardiac | ||||||||||
| Peripheral | Peripheral vessel | P | P | P | P | P | P | Note 1,2,5 | ||
| vessel | 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、 | 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: iScape | ||||||||||
| Note 3:TDI | ||||||||||
| Note 4: Color M | ||||||||||
| Notes: Biopsy Guidance | ||||||||||
| Note6: Elastography | ||||||||||
| Note7: Contrast imaging (Contrast agent for LVO) | ||||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | ||||||||||
| Concurrence of CDRH, Office of Device Evaluation(ODE) | ||||||||||
| Clinical Application | Mode of Operation | |||||||||
| General | ||||||||||
| (Track I | ||||||||||
| Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Combined | |||||||||
| (specify) | Other (specify) | |||||||||
| Ophthalmic | Ophthalmic | |||||||||
| Fetal | N | N | N | N | N | N | Note 1,2,4,5 | |||
| Abdominal | ||||||||||
| Intra-operative (Specify*) | ||||||||||
| Intra-operative (Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | ||||||||||
| Small Organ (Specify**) | ||||||||||
| Fetal Imaging | ||||||||||
| & Other | Neonatal Cephalic | |||||||||
| Adult Cephalic | ||||||||||
| Trans-rectal | N | N | N | N | N | N | Note 1,2,4,5 | |||
| Trans-vaginal | N | N | N | N | N | N | Note 1, 2.4.5 | |||
| 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 | ||||||||||
| Peripheral | ||||||||||
| vessel | Peripheral vessel | |||||||||
| Other (Specify *** ) | N | N | N | N | N | N | Note 1,2,4,5 | |||
| 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. | ||||||||||
| **Small organ-breast, thyroid, testes. | ||||||||||
| ***Other use includes Urology. | ||||||||||
| Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents. | ||||||||||
| Note 2: iScape | ||||||||||
| Note 3: TDI | ||||||||||
| Note 4: Color M | ||||||||||
| Note5: Biopsy Guidance | ||||||||||
| Note6: Elastography | ||||||||||
| Note7: Contrast imaging (Contrast agent for LVO) | ||||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | ||||||||||
| Concurrence of CDRH, Office of Device Evaluation(ODE) | ||||||||||
| Clinical Application | Mode of Operation | |||||||||
| General | ||||||||||
| (Track 1 | ||||||||||
| Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Combined | |||||||||
| (specify) | Other (specify) | |||||||||
| Ophthalmic | Ophthalmic | |||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intra-operative (Specify*) | ||||||||||
| Intra-operative (Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | P | |||||||||
| Small Organ (Specify**) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Fetal Imaging | ||||||||||
| & Other | Adult Cephalic | P | ||||||||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph. (non-Card.) | ||||||||||
| Musculo-skeletal | ||||||||||
| (Conventional) | ||||||||||
| Musculo-skeletal (Superficial) | ||||||||||
| Intravascular | ||||||||||
| Cardiac Adult | P | |||||||||
| Cardiac Pediatric | P | |||||||||
| Cardiac | Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | ||||||||||
| Intra-cardiac | ||||||||||
| Peripheral | ||||||||||
| vessel | Peripheral vessel | P | ||||||||
| Other (Specify***) | ||||||||||
| N=new indication; P=previously cleared by FDA | E=added under Appendix E | |||||||||
| Additional comments: Combined modes--B+M、PW+B、Color + B、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: iScape | ||||||||||
| Note 3:TDI | ||||||||||
| Note 4: Color M | ||||||||||
| Note5: Biopsy Guidance | ||||||||||
| Note6: Elastography | ||||||||||
| Note7: Contrast imaging (Contrast agent for LVO) | ||||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | ||||||||||
| Concurrence of CDRH, Office of Device Evaluation(ODE) | ||||||||||
| Clinical Application | Mode of Operation | |||||||||
| General | ||||||||||
| (Track I | ||||||||||
| Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Combined | |||||||||
| (specify) | Other (specify) | |||||||||
| Ophthalmic | Ophthalmic | |||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intra-operative (Specify*) | ||||||||||
| Intra-operative (Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | P | |||||||||
| Small Organ (Specify**) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Fetal Imaging | ||||||||||
| & Other | Adult Cephalic | |||||||||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph. (non-Card.) | ||||||||||
| Musculo-skeletal | ||||||||||
| (Conventional) | ||||||||||
| Musculo-skeletal (Superficial) | ||||||||||
| Intravascular | ||||||||||
| Cardiac Adult | ||||||||||
| Cardiac Pediatric | P | |||||||||
| Cardiac | Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | ||||||||||
| Intra-cardiac | ||||||||||
| Peripheral | ||||||||||
| vessel | Peripheral vessel | |||||||||
| 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. | ||||||||||
| ** Small organ-breast, thyroid, testes. | ||||||||||
| *** Other use includes Urology. | ||||||||||
| Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents. | ||||||||||
| Note 2: iScape | ||||||||||
| Note 3:TDI | ||||||||||
| Note 4: Color M | ||||||||||
| Note5: Biopsy Guidance | ||||||||||
| Note6: Elastography | ||||||||||
| Note7: Contrast imaging (Contrast agent for I.VO) | ||||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | ||||||||||
| Concurrence of CDRH, Office of Device Evaluation(ODE) |
17
M9/M9T Diagnostic Ultrasound System System:
VII-3Ws Transducer:
Intended Use: Diagnostic ultrasound imaging or Nuid Now analysis of the human body as follows:
Image /page/17/Picture/5 description: The image shows the text "008-11" in bold font, followed by the text "Page 11 of 13" in a smaller, regular font. The text appears to be part of a document or report, indicating a page number and total number of pages. The numbers suggest that this is page 11 of a 13-page document.
18
System: M9/M9T Diagnostic Ultrasound System Transducer: CW2s
Intended Use: Diagnostic ultrasound imaging or fluid Now analysis of the human body as follows:
.
Prescription USE (Per 21 CFR 801.109)
.
19
System: M9/M9T Diagnostic Ultrasound System Transducer: CW5s
Intended Use; Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Prescription USE (Per 21 CFR 801.109)
008-13 Page 13 of 13
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