(104 days)
No
The document does not mention AI, ML, deep learning, or any related terms in the device description or intended use. The description focuses on standard ultrasound imaging modes and post-processing techniques.
No
The device is described as a "Diagnostic Ultrasound System" and its intended use is to "acquire and display ultrasound images," which indicates a diagnostic rather than therapeutic function.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is a "Diagnostic Ultrasound System" and is "intended for use in fetal, abdominal, pediatric, small organ (breast, thyroid, testes), adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal (conventional, superficial), adult and pediatric cardiac, peripheral vessel, urology exam," which are diagnostic procedures. Additionally, the "Device Description" section reiterates that it is a "Diagnostic Ultrasound System."
No
The device description explicitly states it is a "Diagnostic Ultrasound System" and mentions employing "an array of probes that include linear array. Phased array and convex array." These are hardware components essential to the device's function, indicating it is not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that the Resona system is a "Diagnostic Ultrasound System." Its function is to "acquire and display ultrasound images" of anatomical structures and fluid flow within the body.
- Imaging Modality: The input imaging modality is Ultrasound, which is an in-vivo (within the living body) imaging technique, not an in-vitro technique.
- Intended Use: The intended use describes imaging various anatomical sites within patients (fetal, abdominal, cardiac, etc.).
The device is a diagnostic imaging system that uses ultrasound waves to visualize internal structures, which is fundamentally different from an in-vitro diagnostic test that analyzes samples outside the body.
N/A
Intended Use / Indications for Use
The Resona 6/Resona 6T/Resona 6Elite/Resona 6S/Resona 6PRO/Resona 6OB/Resona 6/Resona 5/Resona 57/ Resona 5EXP/Resona 5Elite 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), adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal (conventional, superficial), adult and pediatric cardiac, peripheral vessel, urology exam.
Product codes (comma separated list FDA assigned to the subject device)
IYN, IYO, ITX
Device Description
The Resona 6/Resona 6T/Resona 6EXP/Resona 6Elite/Resona 6S/Resona 6PRO/Resona 6OB/Resona 5/Resona 5T/Resona 5EXP/Resona 5Elite Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound images in B-Mode, M-Mode, PW-Mode, CW-Mode, Color-Mode, Power/Dirpower Mode, THI, iScape mode, TDI mode, Color M, Strain Elastography, 3D/4D mode, Contrast imaging (Contrast agent for Liver), Contrast imaging (Contrast agent for LVO), Ultrasound Fusion Imaging, V Flow, STE, STQ 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. Phased array and convex array.
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), Adult Cephalic, Trans-rectal, Trans-vaginal, Musculo-skeletal (conventional, superficial), Adult Cardiac, Pediatric 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)
Non-clinical tests were conducted for acoustic output, biocompatibility, cleaning and disinfection effectiveness, and thermal, electrical, and mechanical safety. The device conforms to applicable medical safety standards. Clinical studies were not applicable and not required to support substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
January 2, 2018
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Shenzhen Mindray Bio-Medical Electronics Co., Ltd. % Ma Chao Engineer of Technical Regulation Department Mindray Building, Keji 12th Road South High-tech Industrial Park. Nanshan Shenzhen, Guangdong 518057 P. R. CHINA
Re: K172860
Trade/Device Name: Resona 6/Resona 6T/Resona 6Elite/Resona 6Elite/Resona 6S/Resona 6PRO/Resona 6OB/Resona 5/Resona 5T/Resona 5EXP/Resona 5Elite Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: December 1, 2017 Received: December 4, 2017
Dear Ma Chao:
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: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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 of medical device-related adverse events) (21 CFR 803); good
1
manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Michael D. O'Hara For
Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K172860
Device Name
Resona 6/Resona 6T/Resona 6Elite/Resona 6S/Resona 6PRO/Resona 6OB/Resona 5/Resona 57/Resona 5EXP/Resona 5Elite Diagnostic Ultrasound System
Indications for Use (Describe)
The Resona 6/Resona 6T/Resona 6Elite/Resona 6S/Resona 6PRO/Resona 6OB/Resona 6/Resona 5/Resona 57/ Resona 5EXP/Resona 5Elite 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), adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal (conventional, superficial), adult and pediatric cardiac, peripheral vessel, urology exam.
Type of Use (Select one or both, as applicable)
| ✔ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
System:
Resona 6/Resona 6T/Resona 6Elite/Resona 6S/Resona 6S/Resona 6OB/Resona 5/Resona 5/Resona 5T/Resona 5EXP/Resona 5Elite Diagnostic Ultrasound System
N/A Transducer:
| 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, 3, 4, 5, 6, 7 |
| Abdominal | N | N | N | N | N | N | N | Note 1, 2, 3, 4, 5, 6, 7, | |
| 10, 14 | |||||||||
| Intra-operative (Specify*) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | N | N | N | N | N | N | N | Note 1, 2, 4, 7 | |
| Small Organ (Specify**) | N | N | N | N | N | N | N | Note 1, 2, 4, 7, 8, 12, 13 | |
| Neonatal Cephalic | |||||||||
| Adult Cephalic | N | N | N | N | N | N | N | Note 1, 2, 4, 5, 6, 7, 10 | |
| Trans-rectal | N | N | N | N | N | N | N | Note 1, 2, 3, 4, 6, 7 | |
| Trans-vaginal | N | N | N | N | N | N | N | Note 1, 2, 3, 4, 6, 7 | |
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal | |||||||||
| (Conventional) | N | N | N | N | N | N | N | Note 1, 2, 4, 6, 7, 8, 10, | |
| 12, 13 | |||||||||
| Musculo-skeletal | |||||||||
| (Superficial) | N | N | N | N | N | N | N | Note 1, 2, 4, 7, 8, 12, 13 | |
| Intravascular | |||||||||
| Cardiac | Cardiac Adult | N | N | N | N | N | N | N | Note 1, 2, 4, 5, 6, 7,9,10 |
| Cardiac Pediatric | N | N | N | N | N | N | N | Note 1, 2, 4, 5, 6, 7,10 | |
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Peripheral | |||||||||
| vessel | Peripheral vessel | N | N | N | N | N | N | N | Note 1, 2, 4, 6, 7, 8, 10, |
| 11, 12, 13 | |||||||||
| Other (Specify***) | N | N | N | N | N | N | N | Note 1, 2, 4, 6, 7 |
4
System:
Resona 6/Resona 6T/Resona 6Elite/Resona 6S/Resona 6S/Resona 6OB/Resona 5/Resona 5/Resona 5T/Resona 5EXP/Resona 5Elite Diagnostic Ultrasound System
| C5-1U |
|---|
| 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 | P | P | P | P | P | P | Note 1, 2, 4, 6, 7,10 | ||
| Abdominal | P | P | P | P | P | P | Note 1, 2, 4, 6, 7,10,14 | |||
| Intra-operative (Specify*) | ||||||||||
| Intra-operative (Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | ||||||||||
| Small Organ (Specify**) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph. (non-Card.) | ||||||||||
| Musculo-skeletal | ||||||||||
| (Conventional) | P | P | P | P | P | P | Note 1, 2, 4, 6, 7,10 | |||
| Musculo-skeletal | ||||||||||
| (Superficial) | ||||||||||
| Intravascular | ||||||||||
| Cardiac | Cardiac Adult | |||||||||
| Cardiac Pediatric | ||||||||||
| Intravascular (Cardiac) | ||||||||||
| Trans-esoph. (Cardiac) | ||||||||||
| Intra-cardiac | ||||||||||
| Peripheral | ||||||||||
| vessel | Peripheral vessel | P | P | P | P | P | P | Note 1, 2, 4, 6, 7,10 | ||
| Other (Specify***) | ||||||||||
| N=new indication; P=previously cleared by FDA (K171233); 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. | ||||||||||
| Note 2: Smart3D | ||||||||||
| Note 3:4D(Real-time 3D) | ||||||||||
| Note 4: iScape | ||||||||||
| Note 5: TDI | ||||||||||
| Note 6: Color M | ||||||||||
| Note 7: Biopsy Guidance | ||||||||||
| Note8: Strain Elastography | ||||||||||
| Note 9: Contrast imaging (Contrast agent for LVO) | ||||||||||
| Note 10: Ultrasound Fusion Imaging | ||||||||||
| Note 11: V Flow | ||||||||||
| Note12: STE | ||||||||||
| Note13: STQ | ||||||||||
| Note14: Contrast imaging (Contrast agent for Liver) | ||||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | ||||||||||
| Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) | ||||||||||
| Prescription USE (Per 21 CFR 801.109) | ||||||||||
| 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 | P | P | P | P | P | P | Note 1, 2, 4, 5, 6, 10 | ||
| Abdominal | P | P | P | P | P | P | Note 1, 2, 4, 6, 10 | |||
| Intra-operative (Specify*) | ||||||||||
| Intra-operative (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 | ||||||||||
| Cardiac | Cardiac Adult | |||||||||
| Cardiac Pediatric | ||||||||||
| Intravascular (Cardiac) | ||||||||||
| Trans-esoph. (Cardiac) | ||||||||||
| Intra-cardiac | ||||||||||
| Peripheral | ||||||||||
| vessel | Peripheral vessel | |||||||||
| Other (Specify***) | ||||||||||
| N=new indication; P=previously cleared by FDA (K171233); 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. | ||||||||||
| Note 2: Smart3D | ||||||||||
| Note 3:4D(Real-time 3D) | ||||||||||
| Note 4: iScape | ||||||||||
| Note 5: TDI | ||||||||||
| Note 6: Color M | ||||||||||
| Note 7: Biopsy Guidance | ||||||||||
| Note8: Strain Elastography | ||||||||||
| Note 9: Contrast imaging (Contrast agent for LVO) | ||||||||||
| Note 10: Ultrasound Fusion Imaging | ||||||||||
| Note 11: V Flow | ||||||||||
| Note12: STE | ||||||||||
| Note13: STQ | ||||||||||
| Note14: Contrast imaging (Contrast agent for Liver) | ||||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | ||||||||||
| Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) | ||||||||||
| Prescription USE (Per 21 CFR 801.109) | ||||||||||
| Clinical Application | Mode of Operation | |||||||||
| General | Specific | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Combined (specify) | Other (Specify) | |
| (Track 1 Only) | (Track 1 & 3) | |||||||||
| Ophthalmic | Ophthalmic | |||||||||
| Fetal Imaging | ||||||||||
| & Other | Fetal | P | P | P | P | P | P | Note 1, 2, 4, 6, 7 | ||
| Abdominal | ||||||||||
| Intra-operative (Specify*) | ||||||||||
| Intra-operative (Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | ||||||||||
| Small Organ (Specify**) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Trans-rectal | P | P | P | P | P | P | Note 1, 2, 4, 6, 7 | |||
| Trans-vaginal | P | P | P | P | P | P | Note 1, 2, 4, 6, 7 | |||
| Trans-urethral | ||||||||||
| Trans-esoph. (non-Card.) | ||||||||||
| Musculo-skeletal | ||||||||||
| (Conventional) | ||||||||||
| Musculo-skeletal | ||||||||||
| (Superficial) | ||||||||||
| Intravascular | ||||||||||
| Cardiac | Cardiac Adult | |||||||||
| Cardiac Pediatric | ||||||||||
| Intravascular (Cardiac) | ||||||||||
| Trans-esoph. (Cardiac) | ||||||||||
| Intra-cardiac | ||||||||||
| Peripheral | ||||||||||
| vessel | Peripheral vessel | |||||||||
| Other (Specify***) | P | P | P | P | P | P | Note 1, 2, 4, 6, 7 | |||
| N=new indication; P=previously cleared by FDA (K171233); | 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. | ||||||||||
| Note 2: Smart3D | ||||||||||
| Note 3:4D(Real-time 3D) | ||||||||||
| Note 4: iScape | ||||||||||
| Note 5: TDI | ||||||||||
| Note 6: Color M | ||||||||||
| Note 7: Biopsy Guidance | ||||||||||
| Note8: Strain Elastography | ||||||||||
| Note 9: Contrast imaging (Contrast agent for LVO) | ||||||||||
| Note 10: Ultrasound Fusion Imaging | ||||||||||
| Note 11: V Flow | ||||||||||
| Note12: STE | ||||||||||
| Note13: STQ | ||||||||||
| Note14: Contrast imaging (Contrast agent for Liver) | ||||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | ||||||||||
| Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) | ||||||||||
| Clinical Application | Mode of Operation | |||||||||
| General | Specific | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Combined | |||||||||
| (specify) | Other | |||||||||
| (Specify) | ||||||||||
| (Track 1 Only) | (Track 1 & 3) | |||||||||
| Ophthalmic | Ophthalmic | |||||||||
| Fetal Imaging | ||||||||||
| & Other | Fetal | P | P | P | P | P | P | Note 1, 3, 4, 5, 6 | ||
| & Other | Abdominal | P | P | P | P | P | P | Note 1, 3, 4, 6 | ||
| Intra-operative (Specify*) | ||||||||||
| Intra-operative (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 | ||||||||||
| Cardiac | Cardiac Adult | |||||||||
| Cardiac Pediatric | ||||||||||
| Intravascular (Cardiac) | ||||||||||
| Trans-esoph. (Cardiac) | ||||||||||
| Intra-cardiac | ||||||||||
| Peripheral | ||||||||||
| vessel | Peripheral vessel | |||||||||
| Other (Specify***) | ||||||||||
| N=new indication; P=previously cleared by FDA (K171233); | 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. | ||||||||||
| Note 2: Smart3D | ||||||||||
| Note 3:4D(Real-time 3D) | ||||||||||
| Note 4: iScape | ||||||||||
| Note 5: TDI | ||||||||||
| Note 6: Color M | ||||||||||
| Note 7: Biopsy Guidance | ||||||||||
| Note8: Strain Elastography | ||||||||||
| Note 9: Contrast imaging (Contrast agent for LVO) | ||||||||||
| Note 10: Ultrasound Fusion Imaging | ||||||||||
| Note 11: V Flow | ||||||||||
| Note12: STE | ||||||||||
| Note13: STQ | ||||||||||
| Note14: Contrast imaging (Contrast agent for Liver) | ||||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | ||||||||||
| Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) | ||||||||||
| Clinical Application | Mode of Operation | |||||||||
| General | Specific | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Combined | |||||||||
| (specify) | Other | |||||||||
| (Specify) | ||||||||||
| (Track 1 Only) | (Track 1 & 3) | |||||||||
| Ophthalmic | Ophthalmic | |||||||||
| Fetal Imaging | ||||||||||
| & Other | Fetal | P | P | P | P | P | P | P | Note 1, 3, 4, 6, 7 | |
| Abdominal | ||||||||||
| Intra-operative (Specify*) | ||||||||||
| Intra-operative (Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | ||||||||||
| Small Organ (Specify**) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Trans-rectal | P | P | P | P | P | P | P | Note 1, 3, 4, 6, 7 | ||
| Trans-vaginal | P | P | P | P | P | P | P | Note 1, 3, 4, 6, 7 | ||
| Trans-urethral | ||||||||||
| Trans-esoph. (non-Card.) | ||||||||||
| Musculo-skeletal | ||||||||||
| (Conventional) | ||||||||||
| Musculo-skeletal | ||||||||||
| (Superficial) | ||||||||||
| Intravascular | ||||||||||
| Cardiac | Cardiac Adult | |||||||||
| Cardiac Pediatric | ||||||||||
| Intravascular (Cardiac) | ||||||||||
| Trans-esoph. (Cardiac) | ||||||||||
| Intra-cardiac | ||||||||||
| Peripheral | ||||||||||
| vessel | Peripheral vessel | |||||||||
| Other (Specify***) | ||||||||||
| N=new indication; P=previously cleared by FDA (K171233); | 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. | ||||||||||
| Note 2: Smart3D | ||||||||||
| Note 3:4D(Real-time 3D) | ||||||||||
| Note 4: iScape | ||||||||||
| Note 5: TDI | ||||||||||
| Note 6: Color M | ||||||||||
| Note 7: Biopsy Guidance | ||||||||||
| Note8: Strain Elastography | ||||||||||
| Note 9: Contrast imaging (Contrast agent for LVO) | ||||||||||
| Note 10: Ultrasound Fusion Imaging | ||||||||||
| Note 11: V Flow | ||||||||||
| Note12: STE | ||||||||||
| Note13: STQ | ||||||||||
| Note14: Contrast imaging (Contrast agent for Liver) | ||||||||||
| 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 | ||||||||||
| Fetal Imaging | ||||||||||
| & Other | Fetal | |||||||||
| Abdominal | P | P | P | P | P | P | Note 1, 2, 4, 7 | |||
| Intra-operative (Specify*) | ||||||||||
| Intra-operative (Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | P | P | P | P | P | P | Note 1, 2, 4, 7 | |||
| Small Organ (Specify**) | P | P | P | P | P | P | Note 1, 2, 4, 7,8,12,13 | |||
| 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, 7, 8,12,13 | |||
| Musculo-skeletal | ||||||||||
| (Superficial) | P | P | P | P | P | P | Note 1, 2, 4, 7, 8,12,13 | |||
| Intravascular | ||||||||||
| Cardiac | Cardiac Adult | |||||||||
| Cardiac Pediatric | ||||||||||
| Intravascular (Cardiac) | ||||||||||
| Trans-esoph. (Cardiac) | ||||||||||
| Intra-cardiac | ||||||||||
| Peripheral | ||||||||||
| vessel | Peripheral vessel | P | P | P | P | P | P | Note 1, 2, 4, 7 | ||
| Other (Specify***) | ||||||||||
| N=new indication; P=previously cleared by FDA (K171233); 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. | ||||||||||
| Note 2: Smart3D | ||||||||||
| Note 3:4D(Real-time 3D) | ||||||||||
| Note 4: iScape | ||||||||||
| Note 5: TDI | ||||||||||
| Note 6: Color M | ||||||||||
| Note 7: Biopsy Guidance | ||||||||||
| Note8: Strain Elastography | ||||||||||
| Note 9: Contrast imaging (Contrast agent for LVO) | ||||||||||
| Note 10: Ultrasound Fusion Imaging | ||||||||||
| Note 11: V Flow | ||||||||||
| Note12: STE | ||||||||||
| Note13: STQ | ||||||||||
| Note14: Contrast imaging (Contrast agent for Liver) | ||||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | ||||||||||
| Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) | ||||||||||
| Clinical Application | Mode of Operation | |||||||||
| General | Specific | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Combined | |||||||||
| (specify) | Other | |||||||||
| (Specify) | ||||||||||
| (Track 1 Only) | (Track 1 & 3) | |||||||||
| Ophthalmic | Ophthalmic | |||||||||
| Fetal Imaging | ||||||||||
| & Other | Fetal | |||||||||
| Abdominal | P | P | P | P | P | P | P | Note 1, 2, 4, 7 | ||
| Intra-operative (Specify*) | ||||||||||
| Intra-operative (Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | P | P | P | P | P | P | P | Note 1, 2, 4, 7 | ||
| Small Organ (Specify**) | P | P | P | P | P | P | P | Note 1,2,4,7,8,12,13 | ||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph. (non-Card.) | ||||||||||
| Musculo-skeletal | ||||||||||
| (Conventional) | P | P | P | P | P | P | P | Note 1, 2, 4, 7, 8,12,13 | ||
| Musculo-skeletal | ||||||||||
| (Superficial) | P | P | P | P | P | P | P | Note 1, 2, 4, 7, 8,12,13 | ||
| Intravascular | ||||||||||
| Cardiac | Cardiac Adult | |||||||||
| Cardiac Pediatric | ||||||||||
| Intravascular (Cardiac) | ||||||||||
| Trans-esoph. (Cardiac) | ||||||||||
| Intra-cardiac | ||||||||||
| Peripheral | ||||||||||
| vessel | Peripheral vessel | P | P | P | P | P | P | P | Note 1, 2, 4, 7, 11 | |
| Other (Specify***) | ||||||||||
| 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 | P | Note 1, 2, 4, 5, 6, 7,10 | ||
| Intra-operative (Specify*) | ||||||||||
| Intra-operative (Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | ||||||||||
| Small Organ (Specify**) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | P | P | P | P | P | P | P | Note 1, 2, 4, 5, 6, 7,10 | ||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph. (non-Card.) | ||||||||||
| Musculo-skeletal | ||||||||||
| (Conventional) | ||||||||||
| Musculo-skeletal | ||||||||||
| (Superficial) | ||||||||||
| Intravascular | ||||||||||
| Cardiac | Cardiac Adult | P | P | P | P | P | P | P | Note 1, 2, 4, 5, 6, 7,9,10 | |
| Cardiac Pediatric | P | P | P | P | P | P | P | Note 1, 2, 4, 5, 6, 7,10 | ||
| Intravascular (Cardiac) | ||||||||||
| Trans-esoph. (Cardiac) | ||||||||||
| Intra-cardiac | ||||||||||
| Peripheral | ||||||||||
| vessel | Peripheral vessel | |||||||||
| Other (Specify***) | ||||||||||
| N=new indication; P=previously cleared by FDA (K171233); 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. | ||||||||||
| Note 2: Smart3D | ||||||||||
| Note 3:4D(Real-time 3D) | ||||||||||
| Note 4: iScape | ||||||||||
| Note 5: TDI | ||||||||||
| Note 6: Color M | ||||||||||
| Note 7: Biopsy Guidance | ||||||||||
| Note8: Strain Elastography | ||||||||||
| Note 9: Contrast imaging (Contrast agent for LVO) | ||||||||||
| Note 10: Ultrasound Fusion Imaging | ||||||||||
| Note 11: V Flow | ||||||||||
| Note12: STE | ||||||||||
| Note13: STQ | ||||||||||
| Note14: Contrast imaging (Contrast agent for Liver) | ||||||||||
| 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 | P | P | P | P | P | P | P | Note 1, 3, 4, 6, 7 | |
| Abdominal | ||||||||||
| Intra-operative (Specify*) | ||||||||||
| Intra-operative (Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | ||||||||||
| Small Organ (Specify**) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Trans-rectal | P | P | P | P | P | P | P | Note 1, 3, 4, 6, 7 | ||
| Trans-vaginal | P | P | P | P | P | P | P | Note 1, 3, 4, 6, 7 | ||
| Trans-urethral | ||||||||||
| Trans-esoph. (non-Card.) | ||||||||||
| Musculo-skeletal | ||||||||||
| (Conventional) | ||||||||||
| Musculo-skeletal | ||||||||||
| (Superficial) | ||||||||||
| Intravascular | ||||||||||
| Cardiac | Cardiac Adult | |||||||||
| Cardiac Pediatric | ||||||||||
| Intravascular (Cardiac) | ||||||||||
| Trans-esoph. (Cardiac) | ||||||||||
| Intra-cardiac | ||||||||||
| Peripheral | ||||||||||
| vessel | Peripheral vessel | |||||||||
| Other (Specify***) | ||||||||||
| N=new indication; P=previously cleared by FDA (K171233); E=added under Appendix E | ||||||||||
| Additional comments: Combined modes--B+M\u3001PW+B\u3001Color + B\u3001Power + B\u3001PW+Color+B\u3001Power + PW +B. | ||||||||||
| *Intraoperative includes abdominal, thoracic, and vascular. | ||||||||||
| **Small organ-breast, thyroid, testes. | ||||||||||
| ***Other use includes Urology. | ||||||||||
| Note 1: Tissue Harmonic Imaging. | ||||||||||
| Note 2: Smart3D | ||||||||||
| Note 3:4D(Real-time 3D) | ||||||||||
| Note 4: iScape | ||||||||||
| Note 5: TDI | ||||||||||
| Note 6: Color M | ||||||||||
| Note 7: Biopsy Guidance | ||||||||||
| Note8: Strain Elastography | ||||||||||
| Note 9: Contrast imaging (Contrast agent for LVO) | ||||||||||
| Note 10: Ultrasound Fusion Imaging | ||||||||||
| Note 11: V Flow | ||||||||||
| Note12: STE | ||||||||||
| Note13: STQ | ||||||||||
| Note14: Contrast imaging (Contrast agent for Liver) | ||||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | ||||||||||
| Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) | ||||||||||
| Prescription USE (Per 21 CFR 801.109) | ||||||||||
| 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 | P | P | P | P | P | P | Note 1, 2, 4, 5, 6,7,10 | ||
| Abdominal | P | P | P | P | P | P | Note 1, 2, 4,6,7,10,14 | |||
| Intra-operative (Specify*) | ||||||||||
| Intra-operative (Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | ||||||||||
| Small Organ (Specify**) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph. (non-Card.) | ||||||||||
| Musculo-skeletal | ||||||||||
| (Conventional) | P | P | P | P | P | P | Note 1, 2, 4,6,7,10 | |||
| Musculo-skeletal | ||||||||||
| (Superficial) | ||||||||||
| Intravascular | ||||||||||
| Cardiac | Cardiac Adult | |||||||||
| Cardiac Pediatric | ||||||||||
| Intravascular (Cardiac) | ||||||||||
| Trans-esoph. (Cardiac) | ||||||||||
| Intra-cardiac | ||||||||||
| Peripheral | ||||||||||
| vessel | Peripheral vessel | P | P | P | P | P | P | Note 1, 2, 4,6,7,10 | ||
| Other (Specify***) | ||||||||||
| N=new indication; P=previously cleared by FDA (K171233); 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. | ||||||||||
| Note 2: Smart3D | ||||||||||
| Note 3:4D(Real-time 3D) | ||||||||||
| Note 4: iScape | ||||||||||
| Note 5: TDI | ||||||||||
| Note 6: Color M | ||||||||||
| Note 7: Biopsy Guidance | ||||||||||
| Note8: Strain Elastography | ||||||||||
| Note 9: Contrast imaging (Contrast agent for LVO) | ||||||||||
| Note 10: Ultrasound Fusion Imaging | ||||||||||
| Note 11: V Flow | ||||||||||
| Note12: STE | ||||||||||
| Note13: STQ | ||||||||||
| Note14: Contrast imaging (Contrast agent for Liver) | ||||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | ||||||||||
| Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) | ||||||||||
| Prescription USE (Per 21 CFR 801.109) | ||||||||||
| 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 | ||||||||||
| Intra-operative (Specify*) | ||||||||||
| Intra-operative (Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | ||||||||||
| Small Organ (Specify**) | P | P | P | P | P | P | Note 1, 2, 4 | |||
| 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 | |||
| Musculo-skeletal | ||||||||||
| (Superficial) | P | P | P | P | P | P | Note 1, 2, 4 | |||
| Intravascular | ||||||||||
| Cardiac | Cardiac Adult | |||||||||
| Cardiac Pediatric | ||||||||||
| Intravascular (Cardiac) | ||||||||||
| Trans-esoph. (Cardiac) | ||||||||||
| Intra-cardiac | ||||||||||
| Peripheral | ||||||||||
| vessel | Peripheral vessel | P | P | P | P | P | P | Note 1, 2, 4 | ||
| Other (Specify***) | ||||||||||
| N=new indication; P=previously cleared by FDA (K171233); 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. | ||||||||||
| Note 2: Smart3D | ||||||||||
| Note 3:4D(Real-time 3D) | ||||||||||
| Note 4: iScape | ||||||||||
| Note 5: TDI | ||||||||||
| Note 6: Color M | ||||||||||
| Note 7: Biopsy Guidance | ||||||||||
| Note8: Strain Elastography | ||||||||||
| Note 9: Contrast imaging (Contrast agent for LVO) | ||||||||||
| Note 10: Ultrasound Fusion Imaging | ||||||||||
| Note 11: V Flow | ||||||||||
| Note12: STE | ||||||||||
| Note13: STQ | ||||||||||
| Note14: Contrast imaging (Contrast agent for Liver) | ||||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | ||||||||||
| Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) | ||||||||||
| 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, 4,7 | |||
| Intra-operative (Specify*) | ||||||||||
| Intra-operative (Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | P | P | P | P | P | P | Note 1,2, 4,7 | |||
| Small Organ (Specify**) | P | P | P | P | P | P | Note 1,2, 4,7,8,12,13 | |||
| 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, 4,7,8,12,13 | |||
| Musculo-skeletal | ||||||||||
| (Superficial) | P | P | P | P | P | P | Note 1,2, 4,7,8,12,13 | |||
| Intravascular | ||||||||||
| Cardiac | Cardiac Adult | |||||||||
| Cardiac Pediatric | ||||||||||
| Intravascular (Cardiac) | ||||||||||
| Trans-esoph. (Cardiac) | ||||||||||
| Intra-cardiac | ||||||||||
| Peripheral | ||||||||||
| vessel | Peripheral vessel | P | P | P | P | P | P | Note 1,2, 4,7,8,11,12,13 | ||
| Other (Specify***) | ||||||||||
| 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, 4 | |||
| Intra-operative (Specify*) | ||||||||||
| Intra-operative (Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | P | P | P | P | P | P | Note 1, 2, 4 | |||
| Small Organ (Specify**) | P | P | P | P | P | P | Note 1, 2, 4, 8,12,13 | |||
| 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, 8,12,13 | |||
| Musculo-skeletal | ||||||||||
| (Superficial) | P | P | P | P | P | P | Note 1, 2, 4, 8,12,13 | |||
| Intravascular | ||||||||||
| Cardiac | Cardiac Adult | |||||||||
| Cardiac Pediatric | ||||||||||
| Intravascular (Cardiac) | ||||||||||
| Trans-esoph. (Cardiac) | ||||||||||
| Intra-cardiac | ||||||||||
| Peripheral | ||||||||||
| vessel | Peripheral vessel | P | P | P | P | P | P | Note 1, 2, 4 | ||
| Other (Specify***) |
5
System:
Resona 6/Resona 6T/Resona 6Elite/Resona 6S/Resona 6S/Resona 6OB/Resona 5/Resona 5/Resona 5T/Resona 5EXP/Resona 5Elite Diagnostic Ultrasound System
Transducer: SC8-2U
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
6
System:
Resona 6/Resona 6T/Resona 6Elite/Resona 6S/Resona 6S/Resona 6OB/Resona 5/Resona 5/Resona 5T/Resona 5EXP/Resona 5Elite Diagnostic Ultrasound System
Transducer: V11-3HU
7
System:
Resona 6/Resona 6T/Resona 6Elite/Resona 6S/Resona 6S/Resona 6OB/Resona 5/Resona 5/Resona 5T/Resona 5EXP/Resona 5Elite Diagnostic Ultrasound System
Transducer: D8-4U
8
System:
Resona 6/Resona 6T/Resona 6Elite/Resona 6S/Resona 6S/Resona 6OB/Resona 5/Resona 5/Resona 5T/Resona 5EXP/Resona 5Elite Diagnostic Ultrasound System
DE10-3U Transducer:
9
System:
Resona 6/Resona 6T/Resona 6EXP/Resona 6Elite/Resona 6S/Resona 6OB/Resona 5/Resona 5/Resona 5T/Resona
5EXP/Resona 5Elite Diagnostic Ultrasound System
Transducer: L14-6WU
10
System:
Resona 6/Resona 6T/Resona 6EXP/Resona 6Elite/Resona 6S/Resona 6OB/Resona 5/Resona 5/Resona 5T/Resona
5EXP/Resona 5Elite Diagnostic Ultrasound System
Transducer: L11-3U
11
System:
Resona 6/Resona 6T/Resona 6Elite/Resona 6S/Resona 6S/Resona 6OB/Resona 5/Resona 5/Resona 5T/Resona 5EXP/Resona 5Elite Diagnostic Ultrasound System
Transducer: SP5-1U
12
System:
Resona 6/Resona 6T/Resona 6Elite/Resona 6S/Resona 6S/Resona 6OB/Resona 5/Resona 5/Resona 5T/Resona 5EXP/Resona 5Elite Diagnostic Ultrasound System
Transducer: DE11-3U
13
System:
Resona 6/Resona 6T/Resona 6Elite/Resona 6S/Resona 6S/Resona 6OB/Resona 5/Resona 5/Resona 5T/Resona 5EXP/Resona 5Elite Diagnostic Ultrasound System
Transducer: SC5-1U
14
System:
Resona 6/Resona 6T/Resona 6Elite/Resona 6S/Resona 6S/Resona 6OB/Resona 5/Resona 5/Resona 5T/Resona 5EXP/Resona 5Elite Diagnostic Ultrasound System
Transducer: L20-5U
15
System:
Resona 6/Resona 6T/Resona 6EXP/Resona 6Elite/Resona 6S/Resona 6OB/Resona 5/Resona 5/Resona 5T/Resona
5EXP/Resona 5Elite Diagnostic Ultrasound System
L9-3U Transducer:
16
System:
Resona 6/Resona 6T/Resona 6Elite/Resona 6S/Resona 6S/Resona 6OB/Resona 5/Resona 5/Resona 5T/Resona 5EXP/Resona 5Elite Diagnostic Ultrasound System
Transducer: L14-5WU
17
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).
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 6573 Fax: +86 755 2658 2680
Contact Person:
Ma Chao 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: September 15, 2017
2. Device Name:
Resona 6/Resona 6T/Resona 6EXP/Resona 6Elite/Resona 6S/Resona 6PRO/Resona 60B/Resona 5/Resona 5T/Resona 5EXP/Resona 5Elite 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:
The Resona 6/Resona 6T/Resona 6EXP/Resona 6Elite/Resona 6S/Resona 6PRO/Resona 6OB/Resona 5/Resona 5T/Resona 5EXP/Resona 5Elite Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound images in
Image /page/17/Picture/13 description: The image shows the number 007-1 in a bold, sans-serif font. The numbers are black and the background is white. The numbers are evenly spaced and the hyphen is centered between the 7 and the 1.
18
B-Mode, M-Mode, PW-Mode, CW-Mode, Color-Mode, Power/Dirpower Mode, THI, iScape mode, TDI mode, Color M, Strain Elastography, 3D/4D mode, Contrast imaging (Contrast agent for Liver), Contrast imaging (Contrast agent for LVO), Ultrasound Fusion Imaging, V Flow, STE, STQ 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. Phased array and convex array.
4. Intended Use:
The Resona 6/Resona 6T/Resona 6EXP/Resona 6Elite/Resona 6S/Resona 6PRO/Resona 6OB/Resona 5/Resona 5T/Resona 5EXP/Resona 5Elite 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), adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal (conventional, superficial), adult and pediatric cardiac, peripheral vessel, urology exam.
5. Comparison with Predicate Devices:
The Resona 6/Resona 6T/Resona 6EXP/Resona 6Elite/Resona 6S/Resona 6PRO/Resona 6OB/Resona 5/Resona 5T/Resona 5EXP/Resona 5Elite Diagnostic Ultrasound System is comparable with and substantially equivalent to these predicate devices:
| Device | Manufacturer | Model | 510(k) Number |
|---|---|---|---|
| 1. Main predicate device | Mindray | Resona 7 | K171233 |
| 2. Reference device | Mindray | M9 | K171034 |
- Resona 6/Resona 6T/Resona 6EXP/Resona 6Elite/Resona 6S/Resona 6PRO/Resona 6OB/Resona 5/Resona 5T/Resona 5EXP/Resona 5Elite has the same technological characteristics, are comparable in key safety and effectiveness features, and have the same intended uses and basic operating modes. All systems transmit ultrasonic energy into patients, 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. The subject device also has the same intended uses and basic operating modes as the predicate devices
- Subject device Resona 6/Resona 6T/Resona 6EXP/Resona 6Elite/Resona 6S/Resona 6PRO/Resona 6OB/Resona 5/Resona 5T/Resona 5EXP/Resona 5Elite has the same intended uses as the predicated device Resona 7 (K171233).
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| Items | Subject Device
Resona 6/Resona 6T/Resona
6EXP/Resona 6Elite/Resona
6S/Resona 6PRO/Resona
6OB/Resona 5/Resona
5T/Resona 5EXP/Resona
5Elite | Predicate device
Resona 7
(K171233) |
|-----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended
Use | The Resona 6/Resona 6T/Resona
6EXP/Resona 6Elite/Resona
6S/Resona 6PRO/Resona
6OB/Resona 5/Resona 5T/Resona
5EXP/Resona 5Elite 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), adult
cephalic, trans-rectal,
trans-vaginal, musculo-skeletal
(conventional, superficial), adult
and pediatric cardiac, peripheral
vessel, urology exam. | Resona 7 Diagnostic Ultrasound
System is applicable for adults,
pregnant women, pediatric
patients and neonates. It is
intended for use in fetal,
abdominal, intra-operative
(abdominal, thoracic, and
vascular), pediatric, small organ
(breast, thyroid, testes), neonatal
cephalic, adult
cephalic, trans-rectal,
trans-vaginal, musculo-skeletal
(conventional, superficial),
cardiac adult,cardiac pediatric,
trans-esoph. (cardiac) ,peripheral
vessel, and urology exams. |
● The patient contact materials of the transducers are tested under ISO 10993-1.
● The acoustic power levels of Resona 6/Resona 6T/Resona 6EXP/Resona 6Elite/Resona 6S/Resona 6PRO/Resona 6OB/Resona 5/Resona 5T/Resona 5EXP/Resona 5Elite are below the limits of FDA, which are the same as the predicated device Resona 7 (K171233).
- Resona 6/Resona 6T/Resona 6EXP/Resona 6Elite/Resona 6S/Resona 6PRO/Resona 6OB/Resona 5/Resona 5T/Resona 5EXP/Resona 5Elite is designed in compliance with the FDA recognized electrical and physical safety standards, which are the same as the predicated device Resona 7 (K171233).
- The Resona 6/Resona 6T/Resona 6EXP/Resona 6Elite/Resona 6S/Resona 6PRO/Resona 6OB/Resona 5/Resona 5T/Resona 5EXP/Resona 5Elite has the same imaging modes as the predicated devices.
- All of the functions of Resona 6/Resona 6T/Resona 6EXP/Resona 6Elite/Resona 6S/Resona 6PRO/Resona 6OB/Resona 5/Resona 5T/Resona 5EXP/Resona 5Elite are the same as the predicated devices.
- The Resona 6/Resona 6T/Resona 6EXP/Resona 6Elite/Resona 6S/Resona 6PRO/Resona 6OB/Resona 5/Resona 5T/Resona 5EXP/Resona 5Elite has similar tranducers with the predicated devices.
Image /page/19/Picture/7 description: The image shows the number 007-3 in a bold, sans-serif font. The numbers are black and the background is white. The numbers are evenly spaced and the hyphen is centered between the 7 and the 3.
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6. Non-clinical Tests:
Resona 6/Resona 6T/Resona 6EXP/Resona 6Elite/Resona 6S/Resona 6PRO/Resona 60B/Resona 5/Resona 5T/Resona 5EXP/Resona 5Elite 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:
- NEMA UD 2-2004 (R2009), acoustic output measurement standard for diagnostic ultrasound equipment revision 3.
- AAMI / ANSI ES60601-1:2005/(R)2012 and A1:2012, c1:2009/(r)2012 and a2:2010/(r)2012 (consolidated text) medical electrical equipment - part 1: general requirements for basic safety and essential performance (iec 60601-1:2005, mod).
- AAMI / ANSI / IEC 60601-1-2:2007/(R)2012, medical electrical equipment part 1-2: general requirements for basic safety and essential performance collateral standard: electromagnetic compatibility - requirements and tests (edition 3).
- IEC 60601-1-6 Edition 3.1 2013-10, medical electrical equipment - part 1-6: general requirements for basic safety and essential performance - collateral standard: usability.
- IEC 60601-2-37 Edition 2.0 2007. medical electrical equipment - part 2-37: particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment.
- ISO 14971 Second edition 2007-03-01, medical devices - application of risk management to medical devices.
- AAMI / ANSI / ISO 10993-1:2009/(R)2013, biological evaluation of medical devices - part 1: evaluation and testing within a risk management process.
- AAMI / ANSI / IEC 62304:2006, medical device software - software life cycle processes.
- AAMI / ANSI / IEC 62366:2007/(R)2013, medical devices - application of usability engineering to medical devices.
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, Resona 6/Resona 6T/Resona 6EXP/Resona 6Elite/Resona 6S/Resona 6PRO/Resona 6OB/Resona 5/Resona 5T/Resona 5EXP/Resona 5Elite Diagnostic Ultrasound System, does not require
Image /page/20/Picture/14 description: The image shows the number 007-4 in a bold, sans-serif font. The numbers are black and the background is white. The numbers are evenly spaced and the hyphen is centered between the 7 and the 4.
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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 Resona 6T/Resona 6EXP/Resona 6Elite/Resona 6S/Resona 6PRO/Resona 6OB/Resona 5/Resona 5T/Resona 5EXP/Resona 5Elite Diagnostic Ultrasound System is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.