(103 days)
No
The summary describes a standard ultrasonic diagnostic imaging system and does not mention any AI or ML capabilities. The performance studies listed are standard electrical and safety compliance tests, not AI/ML performance evaluations.
No
The device is described as an "ultrasonic diagnostic imaging system" intended for "acquire and display ultrasound images," which points to a diagnostic rather than a therapeutic function.
Yes
The "Intended Use / Indications for Use" section explicitly states "Digital Ultrasonic Diagnostic Imaging 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, musculo-skeletal (conventional, superficial), cardiac (adult, pediatric), peripheral vascular and urology exams." and the "Device Description" section describes it as an "ultrasonic diagnostic system."
No
The device description explicitly states it is a "Digital Ultrasonic Diagnostic Imaging System" and mentions employing "an array of probes," which are hardware components essential for acquiring ultrasound images. While it is software-controlled and performs image processing, it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that this is an "Ultrasonic Diagnostic Imaging System." Its function is to "acquire and display ultrasound images" of structures within the body.
- Input Modality: The input modality is "Ultrasonic," which is an imaging technique, not a method for analyzing biological samples.
- Lack of Sample Analysis: There is no mention of analyzing biological samples or performing tests on them. The device processes received echoes to generate images.
Therefore, this device falls under the category of medical imaging equipment, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
DP-10/DP-30/DP-30 Digital Ultrasonic Diagnostic Imaging 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, musculo-skeletal (conventional, superficial), cardiac (adult, pediatric), peripheral vascular and urology exams.
In addition, “Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:” is provided in a table with a breakdown of clinical applications.
Product codes
IYN, IYO, ITX
Device Description
The The DP-10/DP-20/DP-30 Digital Ultrasonic Diagnostic Imaging System is a general purpose, portable/mobile (with mobile ultrasound trolley), software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound images in B-Mode, M-Mode, PW-Mode, Power Mode, THI or the combined mode (i.e. B/M-Mode, B/PW-mode, Power + B, Power + PW +B). This system is a Track 3 device that employs an array of probes that include linear array, convex array.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasonic
Anatomical Site
- Fetal
- Abdominal
- Pediatric
- Small organ (breast, thyroid, testes)
- Neonatal cephalic
- Adult cephalic
- Trans-rectal
- Trans-vaginal
- Musculo-skeletal (conventional, superficial)
- Cardiac (adult, pediatric)
- Peripheral vascular
- 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: acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical and mechanical safety. Compliance with AAMI / ANSI ES60601-1:2005/(R)2012 and A1:2012, c1:2009/(r)2012 and a2:2010/(t)2012; IEC 60601-1-2 Edition 3: 2007-03; IEC 60601-2-37 Edition 2.0 2007; IEC 62304 Edition 1.1 2015-06; IEC 62366-1 Edition 1.0 2015-02; IEC 60601-1-6 Edition 3.1 2013-10; ANSI AAMI ISO 10993-1:2009/(R)2013; ISO 14971 Second edition 2007-03-01; NEMA UD 2-2004 (R2009).
Clinical Studies: Not applicable. The subject of this submission, DP-10/DP-20/DP-30 Digital Ultrasonic Diagnostic Imaging System, does not require clinical studies to support substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
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April 9, 2019
Shenzhen Mindray Bio-Medical Electronics Co., LTD % Jiang Haosen Engineer of Technical Regulation Keji 12th Road South, Hi-tech Industrial Park Shenzhen. Guangdong 518057 P.R. CHINA
Re: K183660
Trade/Device Name: DP-10/DP-30 Digital Ultrasonic Diagnostic Imaging System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: March 22, 2019 Received: March 25, 2019
Dear Jiang Haosen:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 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,
For
Thalia Mills, 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)
K183660
Device Name DP-10/DP-20/DP-30 Digital Ultrasonic Diagnostic Imaging System
Indications for Use (Describe)
DP-10/DP-30/DP-30 Digital Ultrasonic Diagnostic Imaging 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, musculo-skeletal (conventional, superficial), cardiac (adult, pediatric), peripheral vascular and urology exams.
| 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
Diagnostic Ultrasound Indications For Use Format
DP-10/DP-20 Diagnostic Ultrasound System System:
Transducer: N/A
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: |
|---|---|
| --------------- | ------------------------------------------------------------------------------------ |
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General(Track 1 | |||||||||
| Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color | |||
| Doppler | Amplitude | ||||||||
| Doppler | Combined | ||||||||
| (specify) | Other (specify) | ||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | P | P | N | P | Note1, Note 2 | ||||
| Abdominal | P | P | N | P | Note1, Note 2 | ||||
| Intra-operative (Specify*) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | P | Note1, Note 2 | |||||||
| Pediatric | P | P | N | P | Note1, Note 2 | ||||
| Small Organ (Specify**) | P | P | N | P | Note 2 | ||||
| Neonatal Cephalic | P | P | N | P | Note 2 | ||||
| Fetal Imaging & | |||||||||
| Other | Adult Cephalic | P | P | N | P | Note 2 | |||
| Trans-rectal | P | P | N | P | Note 2 | ||||
| Trans-vaginal | P | P | N | P | Note 2 | ||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal | |||||||||
| (Conventional) | P | P | N | P | Note1, Note 2 | ||||
| Musculo-skeletal | |||||||||
| (Superficial) | P | P | N | P | Note 2 | ||||
| Intravascular | |||||||||
| Cardiac Adult | P | P | N | P | Note 2 | ||||
| Cardiac Pediatric | P | P | N | P | Note 2 | ||||
| Cardiac | Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Peripheral | |||||||||
| Vascular | Peripheral Vascular | P | P | N | P | Note 2 | |||
| Other (Specify***) | P | P | N | P | Note1, Note 2 | ||||
| N=new indication; P=previously cleared by FDA; E=added under Appendix E | |||||||||
| Additional comments: Combined modes--B+M, 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: Biopsy Guidance | |||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | |||||||||
| Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) |
4
35C20EA
System: DP-10/DP-20 Diagnostic Ultrasound System
Transducer: N/A
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows |
|---|---|
| --------------- | ----------------------------------------------------------------------------------- |
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General(Track 1 | |||||||||
| Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color | |||
| Doppler | Amplitude | ||||||||
| Doppler | Combined | ||||||||
| (specify) | Other (specify) | ||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Abdominal | P | P | N | P | Note 2 | ||||
| Intra-operative (Specify*) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | P | P | N | P | Note 2 | ||||
| Small Organ (Specify**) | |||||||||
| Neonatal Cephalic | |||||||||
| Fetal Imaging & | Adult Cephalic | ||||||||
| Other | Trans-rectal | ||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal | |||||||||
| (Conventional) | P | P | N | P | Note 2 | ||||
| Musculo-skeletal | |||||||||
| (Superficial) | |||||||||
| Intravascular | |||||||||
| Cardiac Adult | P | P | N | P | Note 2 | ||||
| Cardiac Pediatric | |||||||||
| Cardiac | Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Peripheral | Peripheral Vascular | P | P | N | P | Note 2 | |||
| Vascular | Other (Specify***) | ||||||||
| N=new indication; P=previously cleared by FDA; E=added under Appendix E | |||||||||
| Additional comments: Combined modes -- B+M, 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: Biopsy Guidance | |||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | |||||||||
| Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) |
5
35C50EB
System: DP-10/DP-20 Diagnostic Ultrasound System
Transducer: N/A
| Intended Use: | ||
|---|---|---|
| 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 | P | P | N | P | Note1, Note 2 | ||||
| Abdominal | P | P | N | P | Note1, Note 2 | ||||
| Intra-operative (Specify*) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | P | P | N | P | Note1, Note 2 | ||||
| Small Organ (Specify**) | |||||||||
| Neonatal Cephalic | |||||||||
| Fetal Imaging & | Adult Cephalic | ||||||||
| Other | Trans-rectal | ||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal | |||||||||
| (Conventional) | P | P | N | P | Note1, Note 2 | ||||
| Musculo-skeletal | |||||||||
| (Superficial) | |||||||||
| Intravascular | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Cardiac | Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Peripheral | Peripheral Vascular | ||||||||
| Vascular | Other (Specify***) | P | P | N | P | Note1, Note 2 | |||
| N=new indication; P=previously cleared by FDA; E=added under Appendix E | |||||||||
| Additional comments: Combined modes--B+M, 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: Biopsy Guidance | |||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) |
6
65C15EA
System: DP-10/DP-20 Diagnostic Ultrasound System
Transducer: N/A
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows- |
|---|---|
| --------------- | ------------------------------------------------------------------------------------ |
| Clinical Application | Specific (Track 1 & 3) | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Combined (specify) | Other (specify) | |
|---|---|---|---|---|---|---|---|---|---|---|
| General(Track 1 | ||||||||||
| Only) | Ophthalmic | |||||||||
| Ophthalmic | Fetal | |||||||||
| Abdominal | P | P | N | P | Note 2 | |||||
| Intra-operative (Specify*) | ||||||||||
| Intra-operative (Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | P | P | N | P | Note 2 | |||||
| Small Organ (Specify**) | ||||||||||
| Neonatal Cephalic | P | P | N | P | Note 2 | |||||
| Fetal Imaging & | ||||||||||
| Other | Adult Cephalic | P | P | N | P | Note 2 | ||||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph. (non-Card.) | ||||||||||
| Musculo-skeletal | ||||||||||
| (Conventional) | P | P | N | P | Note 2 | |||||
| Musculo-skeletal | ||||||||||
| (Superficial) | ||||||||||
| Intravascular | ||||||||||
| Cardiac Adult | ||||||||||
| Cardiac Pediatric | P | P | N | P | Note 2 | |||||
| Cardiac | Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | ||||||||||
| Intra-cardiac | ||||||||||
| Peripheral | ||||||||||
| Vascular | Peripheral Vascular | P | P | N | P | Note 2 | ||||
| Other (Specify***) | ||||||||||
| N=new indication; P=previously cleared by FDA; E=added under Appendix E | ||||||||||
| Additional comments: Combined modes--B+M, 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: Biopsy Guidance | ||||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | ||||||||||
| Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) |
7
65EC10EB
System: DP-10/DP-20 Diagnostic Ultrasound System
Transducer: N/A
| Intended Use: |
|---|
| 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 | P | P | N | P | Note 2 | |||||
| Abdominal | ||||||||||
| Intra-operative (Specify*) | ||||||||||
| Intra-operative (Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | ||||||||||
| Small Organ (Specify**) | ||||||||||
| Neonatal Cephalic | P | P | N | P | Note 2 | |||||
| Fetal Imaging & | ||||||||||
| Other | Adult Cephalic | |||||||||
| Trans-rectal | P | P | N | P | Note 2 | |||||
| Trans-vaginal | P | P | N | P | Note 2 | |||||
| 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 | ||||||||||
| Vascular | Peripheral Vascular | |||||||||
| Other (Specify***) | P | P | N | P | Note 2 | |||||
| N=new indication; P=previously cleared by FDA; E=added under Appendix E | ||||||||||
| Additional comments: Combined modes--B+M, 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: Biopsy Guidance | ||||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | ||||||||||
| Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) |
8
75L38EB
System: DP-10/DP-20 Diagnostic Ultrasound System
Transducer: N/A
| Intended Use: | |||||
|---|---|---|---|---|---|
| -- | -- | --------------- | -- | -- | -- |
| Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | Mode of Operation | ||||||||
| General(Track 1 | |||||||||
| Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color | |||
| Doppler | Amplitude | ||||||||
| Doppler | Combined | ||||||||
| (specify) | Other (specify) | ||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Abdominal | P | P | N | P | Note 2 | ||||
| Intra-operative (Specify*) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | P | P | N | P | Note 2 | ||||
| Small Organ (Specify**) | P | P | N | P | Note 2 | ||||
| Neonatal Cephalic | P | P | N | P | Note 2 | ||||
| Fetal Imaging & | |||||||||
| Other | Adult Cephalic | ||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal | |||||||||
| (Conventional) | P | P | N | P | Note 2 | ||||
| Musculo-skeletal | |||||||||
| (Superficial) | P | P | N | P | Note 2 | ||||
| Intravascular | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Cardiac | Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Peripheral | |||||||||
| Vascular | Peripheral Vascular | P | P | N | P | Note 2 | |||
| Other (Specify***) | |||||||||
| N=new indication; P=previously cleared by FDA; E=added under Appendix E | |||||||||
| Additional comments: Combined modes--B+M, 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: Biopsy Guidance | |||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | |||||||||
| Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) |
9
75L53EA
System: DP-10/DP-20 Diagnostic Ultrasound System
Transducer: N/A
| Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | |||
|---|---|---|---|
| Clinical Application | Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| General(Track 1 | ||||||||||
| Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Combined | |||||||||
| (specify) | Other (specify) | |||||||||
| Ophthalmic | Ophthalmic | |||||||||
| Fetal | ||||||||||
| Abdominal | P | P | N | P | Note 2 | |||||
| Intra-operative (Specify*) | ||||||||||
| Intra-operative (Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | P | P | N | P | Note 2 | |||||
| Small Organ (Specify**) | P | P | N | P | Note 2 | |||||
| Neonatal Cephalic | P | P | N | P | Note 2 | |||||
| Fetal Imaging & | Adult Cephalic | |||||||||
| Other | Trans-rectal | |||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph. (non-Card.) | ||||||||||
| Musculo-skeletal | ||||||||||
| (Conventional) | P | P | N | P | Note 2 | |||||
| Musculo-skeletal | ||||||||||
| (Superficial) | P | P | N | P | Note 2 | |||||
| Intravascular | ||||||||||
| Cardiac Adult | ||||||||||
| Cardiac Pediatric | ||||||||||
| Cardiac | Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | ||||||||||
| Intra-cardiac | ||||||||||
| Peripheral Vascular | P | P | N | P | Note 2 | |||||
| Other (Specify***) | ||||||||||
| N=new indication; P=previously cleared by FDA; E=added under Appendix E | ||||||||||
| Additional comments: Combined modes--B+M, 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: Biopsy Guidance | ||||||||||
| (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 | P | P | N | N | P | Note1, Note 2 | ||||
| Abdominal | P | P | N | N | P | Note1, Note 2 | ||||
| Intra-operative (Specify*) | ||||||||||
| Intra-operative (Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | P | P | N | N | P | Note1, Note 2 | ||||
| Small Organ (Specify**) | P | P | N | N | P | Note 2 | ||||
| Neonatal Cephalic | P | P | N | N | P | Note 2 | ||||
| Fetal Imaging & Other | Adult Cephalic | P | P | N | N | P | Note 2 | |||
| Trans-rectal | P | P | N | N | P | Note 2 | ||||
| Trans-vaginal | P | P | N | N | P | Note 2 | ||||
| Trans-urethral | ||||||||||
| Trans-esoph. (non-Card.) | ||||||||||
| Musculo-skeletal | ||||||||||
| (Conventional) | P | P | N | N | P | Note1, Note 2 | ||||
| Musculo-skeletal | ||||||||||
| (Superficial) | P | P | N | N | P | Note 2 | ||||
| Intravascular | ||||||||||
| Cardiac Adult | P | P | N | N | P | Note 2 | ||||
| Cardiac Pediatric | P | P | N | N | P | Note 2 | ||||
| Cardiac | Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | ||||||||||
| Intra-cardiac | ||||||||||
| Peripheral Vascular | Peripheral Vascular | P | P | N | N | P | Note 2 | |||
| Other (Specify***) | P | P | N | N | P | Note1, Note 2 | ||||
| N=new indication; P=previously cleared by FDA; E=added under Appendix E | ||||||||||
| Additional comments: Combined modes--B+M, PW+B, Power + 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: Biopsy Guidance | ||||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | ||||||||||
| Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) |
10
Diagnostic Ultrasound Indications For Use Format
System: DP-30 Diagnostic Ultrasound System
Transducer: N/A
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
11
35C20EA
System: DP-30 Diagnostic Ultrasound System
Transducer: N/A
| Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: |
|---|
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General(Track 1 | |||||||||
| Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color | |||
| Doppler | Amplitude | ||||||||
| Doppler | Combined | ||||||||
| (specify) | Other (specify) | ||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Abdominal | P | P | N | N | P | Note 2 | |||
| Intra-operative (Specify*) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | P | P | N | N | P | Note 2 | |||
| Small Organ (Specify**) | |||||||||
| Neonatal Cephalic | |||||||||
| Fetal Imaging & | Adult Cephalic | ||||||||
| Other | Trans-rectal | ||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal | |||||||||
| (Conventional) | P | P | N | N | P | Note 2 | |||
| Musculo-skeletal | |||||||||
| (Superficial) | |||||||||
| Intravascular | |||||||||
| Cardiac Adult | P | P | N | N | P | Note 2 | |||
| Cardiac Pediatric | |||||||||
| Cardiac | Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Peripheral | Peripheral Vascular | P | P | N | N | P | Note 2 | ||
| Vascular | Other (Specify***) | ||||||||
| N=new indication; P=previously cleared by FDA; E=added under Appendix E | |||||||||
| Additional comments: Combined modes--B+M, PW+B, Power + 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: Biopsy Guidance |
12
35C50EA
System: DP-30 Diagnostic Ultrasound System
Transducer: N/A
| Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | ||
|---|---|---|
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General(Track 1 | |||||||||
| Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color | |||
| Doppler | Amplitude | ||||||||
| Doppler | Combined | ||||||||
| (specify) | Other (specify) | ||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | P | P | N | N | P | Note1, Note 2 | |||
| Abdominal | P | P | N | N | P | Note1, Note 2 | |||
| Intra-operative (Specify*) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | P | P | N | N | P | Note1, Note 2 | |||
| Small Organ (Specify**) | |||||||||
| Neonatal Cephalic | |||||||||
| Fetal Imaging & | Adult Cephalic | ||||||||
| Other | Trans-rectal | ||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal | |||||||||
| (Conventional) | P | P | N | N | P | Note1, Note 2 | |||
| Musculo-skeletal | |||||||||
| (Superficial) | |||||||||
| Intravascular | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Cardiac | Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Peripheral | Peripheral Vascular | ||||||||
| Vascular | Other (Specify***) | P | P | N | N | P | Note1, Note 2 | ||
| N=new indication; P=previously cleared by FDA; E=added under Appendix E | |||||||||
| Additional comments: Combined modes--B+M, PW+B, Power + 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: Biopsy Guidance | |||||||||
| (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 | Other (specify) | |||||||
| General(Track 1 | |||||||||
| Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color | |||
| Doppler | Amplitude | ||||||||
| Doppler | Combined | ||||||||
| (specify) | |||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Abdominal | P | P | N | N | P | Note 2 | |||
| Intra-operative (Specify*) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | P | P | N | N | P | Note 2 | |||
| Small Organ (Specify**) | |||||||||
| Neonatal Cephalic | P | P | N | N | P | Note 2 | |||
| Fetal Imaging & | Adult Cephalic | P | P | N | N | P | Note 2 | ||
| Other | Trans-rectal | ||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal | |||||||||
| (Conventional) | P | P | N | N | P | Note 2 | |||
| Musculo-skeletal | |||||||||
| (Superficial) | |||||||||
| Intravascular | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | P | P | N | N | P | Note 2 | |||
| Cardiac | Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Peripheral | Peripheral Vascular | P | P | N | N | P | Note 2 | ||
| Vascular | 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 | P | P | N | N | P | Note 2 | |||
| Abdominal | |||||||||
| Intra-operative (Specify*) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (Specify**) | |||||||||
| Neonatal Cephalic | P | P | N | N | P | Note 2 | |||
| Fetal Imaging & | Adult Cephalic | ||||||||
| Other | Trans-rectal | P | P | N | N | P | Note 2 | ||
| Trans-vaginal | P | P | N | N | P | Note 2 | |||
| 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 | Peripheral Vascular | ||||||||
| Vascular | Other (Specify***) | P | P | N | N | P | Note 2 | ||
| N=new indication; P=previously cleared by FDA; E=added under Appendix E | |||||||||
| Additional comments: Combined modes--B+M, PW+B, Power + 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: Biopsy Guidance | |||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | |||||||||
| Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) |
13
65C15EA
System: DP-30 Diagnostic Ultrasound System
Transducer: N/A
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
14
65EC10EA
System: DP-30 Diagnostic Ultrasound System
Transducer: N/A
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
15
75L38EA
System: DP-30 Diagnostic Ultrasound System
Transducer: N/A
| Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | ||
|---|---|---|
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General (Track 1 | |||||||||
| Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color | |||
| Doppler | Amplitude | ||||||||
| Doppler | Combined | ||||||||
| (specify) | Other (specify) | ||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Abdominal | P | P | N | N | P | Note 2 | |||
| Intra-operative (Specify*) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | P | P | N | N | P | Note 2 | |||
| Small Organ (Specify**) | P | P | N | N | P | Note 2 | |||
| Neonatal Cephalic | P | P | N | N | P | Note 2 | |||
| Fetal Imaging & | Adult Cephalic | ||||||||
| Other | Trans-rectal | ||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal | |||||||||
| (Conventional) | P | P | N | N | P | Note 2 | |||
| Musculo-skeletal | |||||||||
| (Superficial) | P | P | N | N | P | Note 2 | |||
| Intravascular | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Cardiac | Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Peripheral | Peripheral Vascular | P | P | N | N | P | Note 2 | ||
| Vascular | Other (Specify***) | ||||||||
| N=new indication; P=previously cleared by FDA; E=added under Appendix E | |||||||||
| Additional comments: Combined modes--B+M, PW+B, Power + 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: Biopsy Guidance | |||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | |||||||||
| Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) |
16
75L53EA
System: DP-30 Diagnostic Ultrasound System
Transducer: N/A
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows |
|---|---|
| --------------- | ----------------------------------------------------------------------------------- |
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General (Track 1 | |||||||||
| Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color | |||
| Doppler | Amplitude | ||||||||
| Doppler | Combined | ||||||||
| (specify) | Other (specify) | ||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal Imaging & | |||||||||
| Other | Fetal | ||||||||
| Abdominal | P | P | N | N | P | Note 2 | |||
| Intra-operative (Specify*) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | P | P | N | N | P | Note 2 | |||
| Small Organ (Specify**) | P | P | N | N | P | Note 2 | |||
| Neonatal Cephalic | P | P | N | N | P | Note 2 | |||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal | |||||||||
| (Conventional) | P | P | N | N | P | Note 2 | |||
| Musculo-skeletal | |||||||||
| (Superficial) | P | P | N | N | P | Note 2 | |||
| Intravascular | |||||||||
| Cardiac | Cardiac Adult | ||||||||
| Cardiac Pediatric | |||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Peripheral | |||||||||
| Vascular | Peripheral Vascular | P | P | N | N | P | Note 2 | ||
| Other (Specify***) | |||||||||
| N=new indication; P=previously cleared by FDA; E=added under Appendix E | |||||||||
| Additional comments: Combined modes--B+M, PW+B, Power + 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: Biopsy Guidance | |||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) |
17
10L24EA
System: DP-30 Diagnostic Ultrasound System
Transducer: N/A
| Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | ||
|---|---|---|
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General(Track 1 | |||||||||
| Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color | |||
| Doppler | Amplitude | ||||||||
| Doppler | Combined | ||||||||
| (specify) | Other (specify) | ||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Abdominal | |||||||||
| Intra-operative (Specify*) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (Specify**) | P | P | N | N | P | Note 2 | |||
| Neonatal Cephalic | |||||||||
| Fetal Imaging & | |||||||||
| Other | Adult Cephalic | ||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal | |||||||||
| (Conventional) | P | P | N | N | P | Note 2 | |||
| Musculo-skeletal | |||||||||
| (Superficial) | P | P | N | N | P | Note 2 | |||
| Intravascular | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Cardiac | Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Peripheral | |||||||||
| Vascular | Peripheral Vascular | P | P | N | N | P | Note 2 | ||
| Other (Specify***) | |||||||||
| N=new indication; P=previously cleared by FDA; E=added under Appendix E | |||||||||
| Additional comments: Combined modes--B+M, PW+B, Power + 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: Biopsy Guidance | |||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | |||||||||
| Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) |
18
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 6183 Fax: +86 755 2658 2680
Contact Person:
Jiang Haosen 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: 2018-12-21
-
- Device Name: DP-10/DP-20/DP-30 Digital Ultrasonic Diagnostic Imaging 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)
- Device Name: DP-10/DP-20/DP-30 Digital Ultrasonic Diagnostic Imaging System Classification
3. Device Description:
The The DP-10/DP-20/DP-30 Digital Ultrasonic Diagnostic Imaging System is a
B-1
Resp-012-1
19
general purpose, portable/mobile (with mobile ultrasound trolley), software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound images in B-Mode, M-Mode, PW-Mode, Power Mode, THI or the combined mode (i.e. B/M-Mode, B/PW-mode, Power + B, Power + PW +B). This system is a Track 3 device that employs an array of probes that include linear array, convex array.
4. Indications for Use:
DP-10/DP-20/DP-30 Digital Ultrasonic Diagnostic Imaging 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, pediatric), peripheral vascular and urology exams.
5. Summary of Modifications
- . New added Models: DP-10 Digital Ultrasonic Diagnostic Imaging System
- Main added Features iScanHelper.
- . Indications For Use
Added PW image Mode to all of the transducers of DP-20 and DP-30 Digital Ultrasonic Diagnostic Imaging System.
Added Power image Mode to all of the transducers of DP-30 Digital Ultrasonic Diagnostic Imaging System.
6. Comparison with Predicate Devices:
DP-10/DP-20/DP-30 Digital Ultrasonic Diagnostic Imaging System is comparable with and substantially equivalent to these predicate devices:
| Predicate
Device | Manufacturer | Model | 510 (k)
Control
Number |
|-------------------------------|--------------|-------------|------------------------------|
| 1 Primary Predicate
device | Mindray | DP-20/DP-30 | K130833 |
| 2 Reference device | Mindray | Z5 | K130695 |
B-2
Resp-012-2
20
| 3 Reference device | Mindrav | M9 | K171034 | |
|---|---|---|---|---|
| t | 11 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 |
Compared to the predicate devices DP-20/DP-30 (K130833)
- DP-10/DP-30 Digital Ultrasonic Diagnostic Imaging System employs the same . technology as the predicate devices. All systems transmit ultrasonic energy into patients, then 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 DP-10/DP-20/DP-30 has the same intended uses as the predicated device DP-20/DP-30 (K130833);
- The acoustic power levels of DP-10/DP-20/DP-30 are below the limits of FDA, which is the same as the predicated device DP-20/DP-30 (K130833).
- DP-10/DP-20/DP-30 is designed in compliance with the FDA recognized electrical and physical safety standards, which are the same as the predicated device DP-20/DP-30 (K130833).
- . The new added features of DP-10/DP-20/DP-30 are the same as the predicated devices.
7. Non-clinical Tests:
DP-10/DP-30 Digital Ultrasonic Diagnostic Imaging System has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical and mechanical safety, and has been found to conform with applicable medical safety standards.
Non-clinical tests relied on in this premarket notification submission for a determination of substantial equivalence include testing showing compliance with the following standards:
- AAMI / ANSI ES60601-1:2005/(R)2012 and A1:2012, c1:2009/(r)2012 and a2:2010/(t)2012 (consolidated text) medical electrical equipment - part 1 : general requirements for basic safety and essential performance (iec 60601-1:2005, mod).
- . IEC 60601-1-2 Edition 3: 2007-03, medical electrical equipment - part 1-2: general requirements for basic safety and essential performance - collateral standard: electromagnetic compatibility - requirements and tests.
B-3
Resp-012-3
21
- . 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.
- . IEC 62304 Edition 1.1 2015-06, medical device software - software life cycle processes.
- I IEC 62366-1 Edition 1.0 2015-02, Medical devices - Part 1: Application of usability engineering to medical devices [Including CORRIGENDUM 1 (2016)]
- . 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.
- ANSI AAMI ISO 10993-1:2009/(R)2013, Biological evaluation of medical devices -. Part 1: Evaluation and testing within a risk management process.
- . ISO 14971 Second edition 2007-03-01, medical devices - application of risk management to medical devices.
- . NEMA UD 2-2004 (R2009), acoustic output measurement standard for diagnostic ultrasound equipment revision 3.
These non-clinical tests relied on in this premarket notification submission can support the determination of substantial equivalence of the subject device.
8. Clinical Studies
Not applicable. The subject of this submission, DP-10/DP-20/DP-30 Digital Ultrasonic Diagnostic Imaging 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 DP-10/DP-20/DP-30 Digital Ultrasonic Diagnostic Imaging System is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.
B–4