(71 days)
The DC-70/DC-70T /DC-70 PRO/DC-70 EXP Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatric, small organ(breast, thyroid, testes), neonatal and adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal(conventional, superficial), adult and pediatric cardiac, peripheral vessel and urology exams.
DC-70/DC-70T /DC-70 PRO/DC-70 EXP is a software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound data in B-Mode, M-Mode, PW-Mode, CW-Mode, Color-Mode, Power/Dirpower Mode, THI or the combined mode (i.e. B/M-Mode, B/PW-mode, B/PW/Color). This system is a Track 3 device that employs an array of probes that include linear array and convex array with a frequency range of approximately 3.0 MHz to 10.0 MHz.
This document is a 510(k) summary for the Shenzhen Mindray Bio-medical Electronics Co., LTD DC-70/DC-70T/DC-70 PRO/DC-70 EXP Diagnostic Ultrasound System. It details the device's substantial equivalence to previously cleared predicate devices.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present specific quantitative acceptance criteria (e.g., minimum accuracy rates for detecting certain conditions) or detailed device performance metrics in a typical table format like one would expect for a diagnostic AI algorithm. Instead, it relies on demonstrating substantial equivalence to predicate devices by asserting that the subject device has the same technological characteristics, comparable safety and effectiveness features, and the same intended uses and basic operating modes.
The performance is implicitly "met" by showing compliance with various medical device safety and performance standards. The key reported "performance" is the sameness of features and capabilities with the predicate device.
Here's an attempt to structure it based on the available information:
| Acceptance Criteria (Inferred from Substantial Equivalence) | Reported Device Performance |
|---|---|
| Intended Use Equivalence: Same indications for use as predicate. | The DC-70/DC-70T/DC-70 PRO/DC-70 EXP Diagnostic Ultrasound System has the same intended uses as the predicate device DC-8 (K132341). It is applicable for adults, pregnant women, pediatric patients and neonates,intended for use in fetal, abdominal, pediatric, small organ (breast, thyroid, testes), neonatal and adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal (conventional, superficial), adult and pediatric cardiac, peripheral vessel and urology exams. |
| Technological Characteristics Equivalence: Same basic technology and operating modes. | The device has the same technological characteristics as the predicate device. All systems transmit ultrasonic energy, perform post-processing of received echoes to generate on-screen displays of anatomic structures and fluid flow. It has the same imaging modes as the predicate DC-8: B, M, Color Doppler, PWD, CWD, Amplitude Doppler, Anatomical M Mode, and combined modes (B/M-Mode, B/PW-mode, B/PW/Color). |
| Safety and Effectiveness Equivalence: Comparable in features affecting safety and effectiveness, and compliant with relevant standards. | - Patient Contact Material: Same as predicate DC-8 (K132341). - Acoustic Power Levels: Below FDA limits and same as predicate DC-8 (K132341). - Electrical & Physical Safety: Compliant with FDA recognized standards (AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-37) and same as predicate DC-8 (K132341). - Special Functions: Identical to predicate devices DC-8 (K132341) and DC-N2 (K132779). - Image Annotation/Reporting: Same capacity as predicate DC-8 (K132341). - Probes: Has similar/same probes as predicate DC-8 (K132341), specifically listing C5-2E, C7-3E, C11-3E, P4-2E, P7-3E, V11-3E, V11-3BE, V11-3WE, L12-3E, L14-6NE, L14-6WE, D6-2E, DE10-3E, CW5s. - Measurement & Calculation Functions: Same as predicate DC-8 (K132341). |
| Quality System Compliance: Manufacturing processes adhere to recognized quality standards. | The design, development, and quality process of the manufacturer conforms with 21 CFR 820, ISO 9001 and ISO 13485 quality systems. |
| Biocompatibility: Demonstrated biocompatibility. | Evaluated for biocompatibility and designed to conform with applicable medical safety standards, including ISO 10993-1. |
| Cleaning and Disinfection Effectiveness: Effectiveness evaluated. | Evaluated for cleaning and disinfection effectiveness. |
| Risk Management: Application of risk management processes. | ISO14971 Medical devices - Application of risk management to medical devices was applied. |
| Software Life Cycle: Software development adheres to recognized standards. | IEC 62304 Medical device software - Software life cycle processes were followed. |
| Usability Engineering: Usability considered in design. | IEC 62366 Medical devices - Application of usability engineering to medical devices was applied. |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "7. Clinical Studies Not applicable. The subject of this submission, DC-70/DC-70T /DC-70 PRO/DC-70 EXP Diagnostic Ultrasound System, does not require clinical studies to support substantial equivalence."
Therefore, there is no test set of clinical images or patient data used for evaluating the device's performance in terms of diagnostic accuracy or clinical outcomes. The evaluation is based on non-clinical tests (acoustic output, electrical safety, biocompatibility, software standards, etc.) and comparison to predicate device specifications.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Since no clinical test set was used, there were no experts used to establish ground truth in the context of diagnostic accuracy for this submission.
4. Adjudication Method for the Test Set
Not applicable, as no clinical test set was used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs. without AI assistance
Not applicable. This device is a diagnostic ultrasound system (hardware and software for image acquisition and display), not an AI-assisted diagnostic tool that modifies human reader performance. No MRMC study was conducted or mentioned.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a complete diagnostic ultrasound system, not an AI algorithm for standalone interpretation. The system itself generates the images that a human interprets.
7. The Type of Ground Truth Used
Not applicable in the context of diagnostic performance (e.g., pathology, outcomes data). The "ground truth" for the non-clinical tests would be the established specifications and limits defined by the various engineering, safety, and performance standards listed (e.g., maximum acoustic output levels, electrical safety limits).
8. The Sample Size for the Training Set
Not applicable. As a diagnostic ultrasound system that relies on physical principles of sound wave generation and detection, and image processing, it does not use a "training set" in the context of machine learning. The system's design and software are developed based on engineering principles and validated through adherence to standards.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no machine learning "training set". The performance is established through adherence to recognized medical device standards and demonstrating equivalence to a legally marketed predicate device.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or feathers. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the emblem.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 10, 2015
Shenzhen Mindray Bio-Medical Electronics Co., LTD % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
Re: K150204 Trade/Device Name: DC-70/DC-70T/DC-70 PRO/DC-70 EXP Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX, LLZ Dated: March 15, 2015 Received: March 19, 2015
Dear Mr. Job:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
{1}------------------------------------------------
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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Robert A Ochs
Robert Ochs, Ph.D. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
| 510(k) Number (if known) | K150204 |
|---|---|
| Device Name | DC-70/DC-70T /DC-70 PRO/DC-70 EXP Diagnostic Ultrasound System |
| Indications for Use (Describe) | The DC-70/DC-70T /DC-70 PRO/DC-70 EXP Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatric, small organ(breast, thyroid, testes), neonatal and adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal(conventional, superficial), adult and pediatric cardiac, peripheral vessel 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (8/14)
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| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | ||||||||||
| Clinical Application | ||||||||||
| General | Specific (Track 1 & 3) | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | Combined(specify) | Other (specify) | |
| Ophthalmic | Ophthalmic | |||||||||
| Fetal | N | N | N | N | N | N | N | Note 1,2,3, 4,6,7 | ||
| Abdominal | N | N | N | N | N | N | N | Note 1,2,3, 4,6,7 | ||
| Intra-operative (Specify*) | ||||||||||
| Intra-operative (Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | N | N | N | N | N | N | N | Note 1,2, 4,6,7 | ||
| Small Organ (Specify**) | N | N | N | N | N | N | N | Note 1,2, 4,7,8 | ||
| Neonatal Cephalic | N | N | N | N | N | N | N | Note 1,2,4,6,7 | ||
| Fetal Imaging& Other | Adult Cephalic | N | N | N | N | N | N | N | Note 1,2,4,6,7 | |
| 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 | ||
| Musculo-skeletal(Superficial) | N | N | N | N | N | N | N | Note 1,2,4,7 | ||
| Intravascular | ||||||||||
| Cardiac | Cardiac Adult | N | N | N | N | N | N | N | Note 1,2,4,5,6,7 | |
| Cardiac Pediatric | N | N | N | N | N | N | N | Note 1,2,4,5,6,7 | ||
| Intravascular (Cardiac) | ||||||||||
| Trans-esoph. (Cardiac) | ||||||||||
| Intra-cardiac | ||||||||||
| Peripheralvessel | Peripheral vessel | N | N | N | N | N | N | N | Note 1,2,4,6,7 | |
| Other (Specify***) | N | N | N | N | N | N | N | Note 1,2,4,6,7 | ||
| N=new indication; P=previously cleared by FDA; E=added under Appendix E | ||||||||||
| Additional comments: Combined modes--B+M、PW+B、Color + B、Power+B、PW+Color+B、Power + PW + | ||||||||||
| *Intraoperative includes abdominal, thoracic, and vascular | ||||||||||
| **Small organ-breast, thyroid, testes. | ||||||||||
| ***Other use includes Urology. | ||||||||||
| Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents. | ||||||||||
| Note 2: Smart3D | ||||||||||
| Note 3:4D(Real-time 3D) | ||||||||||
| Note 4: iScape | ||||||||||
| Note5: TDI | ||||||||||
| Note6: Color M | ||||||||||
| Note7: Biopsy Guidance | ||||||||||
| Note8: Elastography | ||||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | ||||||||||
| Concurrence of CDRH, Office of Device Evaluation(ODE) |
ายทาง 1 จรุป 104 รู้ที่ 104 รินด้ายว่า 2017 คน
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| intra-operative (Neuro | ||||||||||
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| ສິນເຮືອນໄປໄປໄປໄປໄປປຸງໆ | Adult Cephalic | |||||||||
| & Other | Trans-rectal | |||||||||
| lanigav-suer | ||||||||||
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| Cardia | intravascular (Cardiac | |||||||||
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| ാല്പ്മാലവന | ||||||||||
| Periphers | Participing and the sex of | P | P | P | P | P | P | lote 1, 2, 4,6,7 | ||
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| Note 2: SamartISD | ||||||||||
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| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | |||||||||
| Clinical Application | Mode of Operation | |||||||||
| General(Track 1 Ophthalmic | Specific (Track 1 & 3) | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Combined (specify) | ||
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | P | P | P | P | P | Note 1, 2, 4,6,7 | ||||
| Intra-operative (Specify*) | ||||||||||
| Intra-operative (Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | P | P | P | P | P | Note 1, 2, 4,6,7 | ||||
| Small Organ (Specify**) | ||||||||||
| Neonatal Cephalic | P | P | P | P | P | Note 1, 2, 4,6,7 | ||||
| Fetal Imaging & Other | Adult Cephalic | |||||||||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph. (non-Card.) | ||||||||||
| Musculo-skeletal(Conventional) | ||||||||||
| Musculo-skeletal(Superficial) | ||||||||||
| Intravascular | ||||||||||
| Cardiac Adult | ||||||||||
| Cardiac | Cardiac Pediatric | P | P | P | P | P | Note 1, 2, 4,6,7 | |||
| Intravascular (Cardiac) | ||||||||||
| Trans-esoph. (Cardiac) | ||||||||||
| Intra-cardiac | ||||||||||
| Peripheral vessel | Peripheral vessel | P | P | P | P | P | Note 1, 2, 4,6,7 | |||
| Other (Specify***) | ||||||||||
| N=new indication; P=previously cleared by FDA(K132341); E=added under Appendix E | ||||||||||
| Additional comments: Combined modes--B+M、PW+B、Color + B、Power+B、PW+Color+B、Power + PW +1 | ||||||||||
| *Intraoperative includes abdominal, thoracic, and vascular etc. | ||||||||||
| **Small organ-breast, thyroid, testes. | ||||||||||
| ***Other use includes Urology. | ||||||||||
| Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents. | ||||||||||
| Note 2: Smart3D | ||||||||||
| Note 3:4D(Real-time 3D) | ||||||||||
| Note 4: iScape | ||||||||||
| Note5: TDI | ||||||||||
| Note6: Color M | ||||||||||
| Note7: Biopsy Guidance | ||||||||||
| Note8: Elastography | ||||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | ||||||||||
| Concurrence of CDRH, Office of Device Evaluation(ODE) | ||||||||||
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| Petal | P | P | P | P | P | P | lote 1, 2, 4,6,7 | |||
| Abbondoppy | P | P | P | P | P | P | lote 1, 2, 4,6,7 | |||
| (**11iつつd<) avits15d0-81111 | ||||||||||
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| ərində qalınmışdır. Bu mərkəzi və bir və qalınmışdır. Bu mərkəzi və bir mənist | P | P | P | P | P | lote 1, 2, 4,6,7 | ||||
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| ສິນເສັຍນາ ໄປເລືອກ | Adult Cephalic | |||||||||
| & Other | ransmassissim | |||||||||
| Isuigev-sus.rl | ||||||||||
| Frans-urethra | ||||||||||
| ans-sesoph. (non-Card | ||||||||||
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| หลังจากจรรมการทำใ | ||||||||||
| Superficial | ||||||||||
| travascuascular | ||||||||||
| ardisc Adult | ||||||||||
| Cardisc Pediatio | ||||||||||
| Cardiac | (วันโมรวิ) ายไมวรรษทาน | |||||||||
| (כפור (Cardison) .dqoranal | ||||||||||
| strations-side | ||||||||||
| Perphera | Perippers I vesses | |||||||||
| vəssəsl | (***(fissq{) radiO | |||||||||
| Ə xibuəqdə rəbun bəbbə=Ə (1482211)AQA və bəxsələ vəzən : noiisəibui wər=N | ||||||||||
| ו אינו אינו או ליין אין אין א א ויי א א יידי אין דער אין אין אין אין אין אין אין אין דער אין דער אין | ||||||||||
| to the sex bus issues sebulan issues and vessessorial * | ||||||||||
| מורים חוקמת מתחילות המועד ליצועים לו להתכונ | ||||||||||
| ສາກອງສ ປະຊາກາດວ ອຂນ 1011 ຂອງປີ ອາເປັນອາກີ ວິທີທີ ວິທີທີ່ສຸລິຍະຄັນ ວິທີອາຫານປີ ອາໄປປີ ຄvgolorU ຂອງມາວກi ຈຂນ ກອນໄO** | ||||||||||
| Note 2: SmartSD | ||||||||||
| Note 3:00(Real-time 3D | ||||||||||
| Alote 4: İSCcapc | ||||||||||
| İQT : Şəhən | ||||||||||
| Notes: Color M | ||||||||||
| teter : Biograpy Catalog | ||||||||||
| אין מקום במקום מקום מקום של המקום ה | ||||||||||
| A the same and the many of the wolled and submit on on estable | ||||||||||
| (ЯПО)пойтвитьмы эзілья 10 элійО 'НЯПО 10 эличиносо | ||||||||||
| Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:Clinical Application | Mode of Operation | |||||||||
| General(Track 1Ophthalmic | Specific (Track 1 & 3)Ophthalmic | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | Combined(specify) | Other (specify) | |
| 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 | |||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Cardiac | Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | ||||||||||
| Musculo-skeletal(Conventional) | P | P | P | P | P | P | Note 1, 2, 4,7 | |||
| Musculo-skeletal(Superficial) | P | P | P | P | P | P | Note 1, 2, 4,7 | |||
| Intravascular | ||||||||||
| Cardiac Adult | ||||||||||
| Cardiac Pediatric | ||||||||||
| Intravascular (Cardiac) | ||||||||||
| Trans-esoph. (Cardiac) | ||||||||||
| Intra-cardiac | ||||||||||
| Peripheralvessel | Peripheral vessel | P | P | P | P | P | P | |||
| Other (Specify***) | ||||||||||
| N=new indication; P=previously cleared by FDA(K132341); E=added under Appendix EAdditional comments: Combined modes--B+M、PW+B、Color+B、Power+B、PW+Color+B、Power + PW +B*Intraoperative includes abdominal, thoracic, and vascular etc.**Small organ-breast, thyroid, testes.***Other use includes Urology.Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.Note 2: Smart3DNote 3:4D(Real-time 3D)Note 4: iScapeNote5: TDINote6: Color MNote7: Biopsy GuidanceNote8: Elastography |
: material T นางเร็ง bunosenIU จุตรงตรีซี 4X3 07-201099 07-30107-20101-20101-201707-20101-20
{5}------------------------------------------------
ל-800
ารวมทรัพย์รัฐ
{6}------------------------------------------------
: ເມືອງຣ໌ຽ חיים מחיים
{7}------------------------------------------------
in cinsinə aid bitki növü. İstinadlar Türk Türk
{8}------------------------------------------------
| 1L |
|---|
| C |
| 8 |
| -1 |
| :193upsucer: | 日N9-セリフ | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| swollof se ypod namul att to sizylers woll biult 10 gaigsmi buuossatu 2017 bourotti | ||||||||||
| Clinical Application | obe of Operation | |||||||||
| (Trackareneral | യിച്ചു I റിാഗT) വ്യൂട്ടായ | B | M | מאכן מאכן מאר | aldogColor | əpmişdiri Aaldoo | Compinionspecify | (vijisədə) vəqil | ||
| imledged o | ാന്ത്രിക്കുന്നത്. അവലംബം | |||||||||
| Fetal | ||||||||||
| allettimopqy | P | P | P | P | P | P | Note 1,2, 4,7 | |||
| (*viised<) อviisisdo-snu | ||||||||||
| ortali) avitsisqo-situ | ||||||||||
| ാന്റോട്ടാമുണ്ടാം. | ||||||||||
| Pediatric | P | P | P | P | P | P | ote 1,2,4,47 | |||
| ***11:09q5) usg10 llems | P | P | P | P | P | P | ote I ,2, 4,7,7,8 | |||
| ərin fəsiləsinə aid bitki növü. İstinadlar | ||||||||||
| ສິນເສັ້ນໄປເຂົ້າສາ | Adult Cephalic | |||||||||
| ારાષ્ટ્રી જિલ્લામાં આવે છે. આ ગામના લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપા | ranans-rectal | |||||||||
| Isuigev-sus | ||||||||||
| lands-urstils | ||||||||||
| rans-sesorh. (non-card | ||||||||||
| Conventionalโยเอโอร์ระดุทวรที่) | P | P | P | P | P | P | lotes 1,2L´∀´ | |||
| ะนอโอริระดิเทวร์ทไฟ | P | P | P | P | P | P | L'+ 'Z'I atok | |||
| Superficial | ||||||||||
| traverseveitu | ||||||||||
| insibe PediatrictubA osipre | ||||||||||
| Cardia | วิธไป163) แปลวรรษราชมา | |||||||||
| rans-esoph. (Cardiac | ||||||||||
| threasonac | ||||||||||
| Perphera | əsinə aid bitki növü. İstinadlar Respublikasının Filmin Film Film Film Film Film Film Film Film Film Film Film Film Film Film Film Film Film Film Film | P | ਰ | P | P | P | T.P. 221 1910 1 | |||
| vesssel | (***(tissq{) radiC | |||||||||
| Ə xibaəqdA rəbuu bəbbə=Ə :(14ESE17)AQA va bərasın vəzirəngən : noqitsəibui wən=M | ||||||||||
| A + W + 1000 × 8 +1000 × W + 1000 × 8 + 1000 × 8 + 1000 × 8 + 1000 × 1000 × 1000 × 1000 × 1000 × 1000 × 1000 × 1000 × 10000 | ||||||||||
| * | ||||||||||
| 2018-11-01 01:511-01818, thursday, testes | ||||||||||
| ະ ສາ ສະ ການ ວາ ຈ. VBolorU sepuloni asu radiOr | ||||||||||
| lote 2: SmartI | ||||||||||
| otes 3:40)(Real-time 3D | ||||||||||
| ədə qalında qalan qalında qalan qalan qalan qalan qala qala qala qala qala qala qala qala qala qala qala qala qala qala qala qala qala qala qala qala qala qala qala qala qal | ||||||||||
| ldır. İstinadlar Respublikasının Filmin İstinadlar Türkinci İstinadlar Türkinci İstinadlar Türkinci İstinadlar Türkinci İstinadlar Türkinci İstinadlar T | ||||||||||
| lated: Color M | ||||||||||
| operations was considered on | ||||||||||
| a man a da gant one no quintino - and i sint wo and arman ton on extrain m | ||||||||||
| (ДПО)пойтвивать элічэп то ээйно ,НЯПО 10 ээцэттиэцоО | ||||||||||
| System: | DC-70/DC-70T/DC-70 PRO/DC-70 EXP Diagnostic Ultrasound System | |||||||||
| Transducer: | L14-6WE | |||||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | |||||||||
| Clinical Application | Mode of Operation | Other (specify) | ||||||||
| General(Track 1 | Specific (Track 1 & 3) | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler (specify) | |||
| Ophthalmic | Ophthalmic | |||||||||
| Fetal Imaging& Other | Fetal | P | P | P | P | P | P | P | ||
| Abdominal | P | P | P | P | P | P | P | |||
| Intra-operative (Specify*) | ||||||||||
| Intra-operative (Neuro) | ||||||||||
| Laparoscopic | P | P | P | P | P | P | P | |||
| Pediatric | P | P | P | P | P | P | P | Note 1,2, 4 | ||
| Small Organ (Specify**) | P | P | P | P | P | P | P | Note 1,2, 4 | ||
| Neonatal Cephalic | Note 1,2, 4, | |||||||||
| 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 | ||
| Musculo-skeletal(Superficial) | P | P | P | P | P | P | P | Note 1,2, 4 | ||
| Intravascular | Cardiac Adult | |||||||||
| Cardiac Pediatric | ||||||||||
| Intravascular (Cardiac) | ||||||||||
| Trans-esoph. (Cardiac) | ||||||||||
| Cardiac | Intra-cardiac | |||||||||
| Peripheral vessel | P | P | P | P | P | P | P | Note 1,2, 4 | ||
| Peripheral vessel | ||||||||||
| Other (Specify***) | ||||||||||
| N=new indication; P=previously cleared by FDA(K132341); E=added under Appendix E | ||||||||||
| Additional comments: Combined modes--B+M、PW+B、Color+B、Power+B、PW+Color+B、Power + PW | ||||||||||
| *Intraoperative includes abdominal, thoracic, and vascular etc. | ||||||||||
| **Small organ-breast, thyroid, testes. | ||||||||||
| ***Other use includes Urology. | ||||||||||
| Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents. | ||||||||||
| Note 2: Smart3D | ||||||||||
| Note 3:4D(Real-time 3D) | ||||||||||
| Note 4: iScape | ||||||||||
| Note5: TDI | ||||||||||
| Note6: Color M | ||||||||||
| Note7: Biopsy Guidance | ||||||||||
| Note8: Elastography | ||||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | ||||||||||
| Concurrence of CDRH, Office of Device Evaluation(ODE) | ||||||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | |||||||||
| Clinical Application | Mode of Operation | |||||||||
| General(Track 1 & 3) | Specific (Track 1 & 3) | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | Combined(specify) | Other (specify) | |
| Ophthalmic | Ophthalmic | |||||||||
| 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**) | ||||||||||
| Fetal Imaging& Other | 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 | N | 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 | ||||||||||
| Peripheralvessel | Peripheral vessel | |||||||||
| Other (Specify***) | P | P | P | P | Note 1, 2, 4,6,7 | |||||
| N=new indication; P=previously cleared by FDA(K132341); E=added under Appendix E | ||||||||||
| Additional comments: Combined modes--B+M、PW+B、Color+B、Power+B、PW+Color+B、Power + PW + | ||||||||||
| *Intraoperative includes abdominal, thoracic, and vascular etc. | ||||||||||
| **Small organ-breast, thyroid, testes. | ||||||||||
| ***Other use includes Urology. | ||||||||||
| Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents. | ||||||||||
| Note 2: Smart3D | ||||||||||
| Note 3:4D(Real-time 3D) | ||||||||||
| Note 4: iScape | ||||||||||
| Note5: TDI | ||||||||||
| Note6: Color M | ||||||||||
| Note7: Biopsy Guidance | ||||||||||
| Note8: Elastography | ||||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | ||||||||||
| Concurrence of CDRH, Office of Device Evaluation(ODE) | ||||||||||
| :193npsur1T | สมัยในปี พ.ศ. 1988 - 1 | |||||||||
| e only se your usmul att 10 sizelsus woll bird 10 gaigsmi bunossatu 2019 boutenCitical Application | noits1900 to эроМ | |||||||||
| General(Frack | particinc (last T) or the p | B | M | and one of the starter of the started on the starting of the starting of the starting of the starting of the starting of the starting of the state of the state of the state o | rəqqlərin qalınmışdır. Bu mənistColor | pəsiqatçılarının mənin fəsiləsinə cinsinə aid bitki növü. İstinadlar Respublikasının fəsiləsinə cinsinə aid bitki növü. İstinadlar Qaraqların Qaraqların Qaraqların Qaraqların Qaraql | (firsteds) | (Alisəds) təqv | ||
| ophthalmic | Ophthalmic | |||||||||
| Petal | P | P | P | P | P | P | ote 1, 2, 4,6,7 | |||
| booming | ||||||||||
| (*vfiisaqq) aviisisqo-siin | ||||||||||
| orusos) avitsissooo-sin | ||||||||||
| ാന്റ്റ് വാഹാര്മാ | ||||||||||
| ərin sinə aid bitki növü. İstinadlar Registric | ||||||||||
| ***1iつつqs) unsgr() [[sm] | ||||||||||
| ərin fəsiləsinə cinsinə aid bitki növü. İstinadlar | ||||||||||
| ຮົບເຮືອນໄປໄປເນື້ອປີ | ərin cinsinə aid bitki növü. İstinadlar Cəmin Mənbə Cəmin Cəmin Cəmin Cəmin Cəmin Cəmin Cəmin Cəmin Cəmin Cənubi Cəmin Cəmin Cənubi Cəmin Cənubi Cəmin C | |||||||||
| a Other | Trans-rects | P | P | P | P | P | P | lote I , 2, 4,6,7 | ||
| Isuigev-suerr | P | P | P | (010) 1, 2, 4,6,7 | ||||||
| rans-ursthal | ||||||||||
| sussessori. ((non-car | ||||||||||
| [ɐɪə[əːəːəːəːəːəːəːəːəːəːəːəːəːəːəːəːəːəːəːəːəːəːəːəːəːəːəːəːəːəːəːəːəːəːəːəːəːəːəːəːəːəːəːəːəːəːəːəːəːəːəːəːəːəːəːəːəːəːəːəːəːəːəːəːəːəːəːəːəːəːəːəːəːəːəːəːəːəːəːəːəːəːəːəːə | ||||||||||
| ຍາວໄລນ໌ລະວຽກຈາກປະເທດລາວConvertions | ||||||||||
| isippingung | ||||||||||
| utusvassasitu | ||||||||||
| lubA osipus | ||||||||||
| ordisc Pediatic | ||||||||||
| Cardia | sib163) 1181838252111 | |||||||||
| osib16つ) .dqose-sust | ||||||||||
| ാല്പോളായ | ||||||||||
| Persphera | espheral vessel | |||||||||
| vessel | (***(fissq{{) radiC | p | ote 1, 2, 4,6,7 | |||||||
| ə xibusqda rəbun bəbbə=Ə | ||||||||||
| to and user bar sinces on the mobile sebuloui avitrised on the2018-11-12 10:01/11/12 12:51 pm 11-11-2 | ||||||||||
| otOther use institutions | ||||||||||
| ສາຕອງສ ກະຊາດດວ ອຣນ 100 ຂອງ ອາເປນລາວ ອປີ .ສຸດເຮັອນໄ ວ່ານອກການປະກວດຄວາມ | ||||||||||
| ote 2: Smart3D | ||||||||||
| ote 3:40(Real-time 3D | ||||||||||
| lote 4: iScape | ||||||||||
| otes: TDI | ||||||||||
| loteg: Color M | ||||||||||
| onebino vasqoin considere | ||||||||||
| (ДПО)поїзвивать заічэа то езійо іняПО 10 езпеччизнос | ||||||||||
| Transducer: | VII-5WE | |||||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | |||||||||
| Clinical Application | Mode of Operation | |||||||||
| General(Track 1 | Specific (Track 1 & 3) | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | Combined(specify) | Other (specify) | |
| Ophthalmic | Ophthalmic | |||||||||
| Fetal | P | P | P | P | P | Note 1, 2, 4,6,7 | ||||
| Abdominal | ||||||||||
| Intra-operative (Specify*) | ||||||||||
| Intra-operative (Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | ||||||||||
| Small Organ (Specify**) | ||||||||||
| Fetal Imaging& Other | Neonatal Cephalic | P | P | P | P | P | P | Note 1, 2, 4,6,7 | ||
| Adult Cephalic | P | P | P | P | P | P | Note 1, 2, 4,6,7 | |||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph. (non-Card.) | ||||||||||
| Musculo-skeletal(Conventional) | ||||||||||
| Musculo-skeletal(Superficial) | ||||||||||
| Intravascular | ||||||||||
| Cardiac Adult | ||||||||||
| Cardiac Pediatric | ||||||||||
| Cardiac | Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | ||||||||||
| Intra-cardiac | ||||||||||
| Peripheralvessel | Peripheral vessel | P | P | P | P | P | P | Note 1, 2, 4,6,7 | ||
| Other (Specify***) | ||||||||||
| N=new indication; P=previously cleared by FDA(K132341); E=added under Appendix E | ||||||||||
| Additional comments: Combined modes--B+M、PW+B、Color+B、Power+B、PW+Color+B、Power + PW + | ||||||||||
| *Intraoperative includes abdominal, thoracic, and vascular etc. | ||||||||||
| **Small organ-breast, thyroid, testes. | ||||||||||
| ***Other use includes Urology. | ||||||||||
| Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents. | ||||||||||
| Note 2: Smart3D | ||||||||||
| Note 3:4D(Real-time 3D) | ||||||||||
| Note 4: iScape | ||||||||||
| Note5: TDI | ||||||||||
| Note6: Color M | ||||||||||
| Note7: Biopsy Guidance | ||||||||||
| Note8: Elastography | ||||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | ||||||||||
| Concurrence of CDRH, Office of Device Evaluation(ODE) | ||||||||||
| System: | DC-70/DC-70T/DC-70 PRO/DC-70 EXP Diagnostic Ultrasound System | |||||||||
| Transducer: | P4-2E | |||||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | |||||||||
| Clinical Application | Mode of Operation | |||||||||
| General(Track 1 | Specific (Track 1 & 3) | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler(specify) | Combined(specify) | ||
| Ophthalmic | Ophthalmic | |||||||||
| Fetal | Abdominal | P | P | P | P | P | P | Note 1, 2,4,6,7 | ||
| Intra-operative (Specify*) | ||||||||||
| Intra-operative (Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | P | P | P | P | P | P | Note 1, 2,4,6,7 | |||
| Small Organ (Specify**) | P | P | P | P | P | P | Note 1, 2,4,6,7 | |||
| Fetal Imaging& Other | Neonatal Cephalic | P | P | P | P | P | P | Note 1, 2,4,6,7 | ||
| Adult Cephalic | P | P | P | P | P | P | Note 1, 2,4,6,7 | |||
| 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 | Note 1, 2,4,5,6,7 | ||
| Cardiac Pediatric | P | P | P | P | P | P | Note 1, 2,4,5,6,7 | |||
| Intravascular (Cardiac) | ||||||||||
| Trans-esoph. (Cardiac) | ||||||||||
| Intra-cardiac | ||||||||||
| Peripheralvessel | Peripheral vessel | |||||||||
| Other (Specify***) | ||||||||||
| N=new indication; P=previously cleared by FDA(K132341); E=added under Appendix EAdditional comments: Combined modes--B+M、PW+B、Color+B、Power+B、PW+Color+B、Power + PW +1*Intraoperative includes abdominal, thoracic, and vascular etc.**Small organ-breast, thyroid, testes.***Other use includes Urology.Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.Note 2: Smart3DNote 3:4D(Real-time 3D)Note 4: iScapeNote5: TDINote6: Color MNote7: Biopsy GuidanceNote8: Elastography(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)Concurrence of CDRH, Office of Device Evaluation(ODE) | ||||||||||
| System: | DC-70/DC-70T/DC-70 PRO/DC-70 EXP Diagnostic Ultrasound System | |||||||||
| Transducer: | P7-3E | |||||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | |||||||||
| Clinical Application | Mode of Operation | Other (specify) | ||||||||
| General(Track 1 | Specific (Track 1 & 3) | B | M | PWD | CWD | Color Doppler | Amplitude Doppler (specify) | |||
| Ophthalmic | Ophthalmic | |||||||||
| Fetal Imaging& Other | Fetal | P | P | P | P | P | P | P | ||
| Abdominal | P | P | P | P | P | P | P | Note 1,2,4,6 | ||
| Intra-operative (Specify*) | ||||||||||
| Intra-operative (Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | P | P | P | P | P | P | P | Note 1,2,4,6 | ||
| Small Organ (Specify**) | P | P | P | P | P | P | P | Note 1,2,4,6 | ||
| Neonatal Cephalic | P | P | P | P | P | P | P | Note 1,2,4,6 | ||
| Adult Cephalic | P | P | P | P | P | P | P | Note 1,2,4,6 | ||
| 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 | |
| Cardiac Pediatric | P | P | P | P | P | P | P | Note 1, 2,4,5,6 | ||
| Intravascular (Cardiac) | ||||||||||
| Trans-esoph. (Cardiac) | ||||||||||
| Peripheralvessel | Intra-cardiac | |||||||||
| Peripheral vessel | ||||||||||
| Other (Specify***) | ||||||||||
| N=new indication; P=previously cleared by FDA(K132341); E=added under Appendix E | ||||||||||
| Additional comments: Combined modes--B+M、PW+B、Color+B、Power+B、PW+Color+B、Power + PW + | ||||||||||
| *Intraoperative includes abdominal, thoracic, and vascular etc. | ||||||||||
| **Small organ-breast, thyroid, testes. | ||||||||||
| ***Other use includes Urology. | ||||||||||
| Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents. | ||||||||||
| Note 2: Smart3D | ||||||||||
| Note 3:4D(Real-time 3D) | ||||||||||
| Note 4: iScape | ||||||||||
| Note5: TDI | ||||||||||
| Note6: Color M | ||||||||||
| Note7: Biopsy Guidance | ||||||||||
| Note8: Elastography | ||||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | ||||||||||
| Concurrence of CDRH, Office of Device Evaluation(ODE) | ||||||||||
| System: | DC-70/DC-70T/DC-70 PRO/DC-70 EXP Diagnostic Ultrasound System | |||||||||
| Transducer: | D6-2E | |||||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | |||||||||
| Clinical Application | Mode of Operation | Other (specify) | ||||||||
| General(Track 1 | Specific (Track 1 & 3) | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Combined (specify) | ||
| Ophthalmic | ||||||||||
| Fetal | P | P | P | P | P | Note 1, 3, 4, 6, 7 | ||||
| Abdominal | P | P | P | P | P | Note 1, 3, 4, 6, 7 | ||||
| Intra-operative (Specify*) | ||||||||||
| Intra-operative (Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | ||||||||||
| Small Organ (Specify**) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Fetal Imaging& Other | Adult Cephalic | |||||||||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph. (non-Card.) | ||||||||||
| Musculo-skeletal(Conventional) | ||||||||||
| Musculo-skeletal(Superficial) | ||||||||||
| Intravascular | ||||||||||
| Cardiac Adult | ||||||||||
| Cardiac | Cardiac Pediatric | |||||||||
| Intravascular (Cardiac) | ||||||||||
| Trans-esoph. (Cardiac) | ||||||||||
| Intra-cardiac | ||||||||||
| Peripheral vessel | ||||||||||
| Other (Specify***) | ||||||||||
| Peripheral vessel | N=new indication; P=previously cleared by FDA(K132341); E=added under Appendix E | |||||||||
| Additional comments: Combined modes--B+M、PW+B、Color+B、Power+B、PW+Color+B、Power + PW+ | ||||||||||
| *Intraoperative includes abdominal, thoracic, and vascular etc. | ||||||||||
| **Small organ-breast, thyroid, testes. | ||||||||||
| ***Other use includes Urology. | ||||||||||
| Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents. | ||||||||||
| Note 2: Smart3D | ||||||||||
| Note 3:4D(Real-time 3D) | ||||||||||
| Note 4: iScape | ||||||||||
| Note5: TDI | ||||||||||
| Note6: Color M | ||||||||||
| Note7: Biopsy Guidance | ||||||||||
| Note8: Elastography | ||||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | ||||||||||
| Concurrence of CDRH, Office of Device Evaluation(ODE) |
:ພາອຸຣະຣູ חב-20170281111 כלופסייני מספר מיליב-10 ב-10 ב-10 ב-10 ב-10 ב-10 ב-10 ב-10 ב-10 1
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:ພວາຣ໌ՀՀ นทรารขุร ทนทอรรมไป จุฬารงนักริงศ์ ศ.วัตกอรมัน ค.ศ. 201707-04-04T07-2010/
{11}------------------------------------------------
:ພວາຣ໌ՀՀ นทรารขุร ทุกบรรมป์ไป จุฬารงนักมี ศ.วัตกอรมัน ค.ศ. 2017/07/2017 ค.ศ. 11/1
{12}------------------------------------------------
:ພວາຣ໌ՀՀ นทรารขุร ทุกบรรมปี จุฬารงนักริวันที่ 4X3 07-201707-07-2010 ความระวัติ/107-2017
{13}------------------------------------------------
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{16}------------------------------------------------
| :1930psue1T | swollot se ybod namul att to sizylans woll biult 10 gaigsmi buuosstilu sitsongsid : 52U bonstillDE-01EDE | |||||||
|---|---|---|---|---|---|---|---|---|
| Circal Application | uoitsiadO to spoM | |||||||
| riereners(Track) | E & I റ്റാങT) വിലായ | B | M | and one | DopplerColor | əpmişdir. ADoppler | Commissspecify | (there (specify |
| opting the was and of the company of the comments of the comments of the country of the first of the first of the first of the first of the first of the first of the first of | omplitidO | |||||||
| Fetal | P | P | P | P | P | P | ote 1, 3, 4, 6, | |
| Abdomination | ||||||||
| (*viised<) องค์ที่มาอุดระที่มี | ||||||||
| ərinə və qalınmışdır. Bu mərkəzi və qalında qalında qalında qalında qalında qalında qalında qaların mərkəzi qalındığı qalında qalında qalında qalında qaların mərkəzi qalında | ||||||||
| oidosso.reds. | ||||||||
| ərin sinə aid bitki növü. İstinadlar Registric | ||||||||
| (**Viceds) ursgiO IIIums | ||||||||
| ərin cinsinə aid bitki növü. İstinadlar Respublikasının fəsiləsinə filmlərin fəsiləsinə cinsinə aid bitki növü. İstinadlar Cinsinə aid bitki növü. İstinadlar Cins | ||||||||
| ສິນເງິນເມຣິເນຊັນແນລໄທ | Adult Cephalic | |||||||
| & Other | Trans-rectal | P | P | P | P | P | P | lote 1, 3, 4, 6 |
| Isuigev-suarr | P | P | P | P | otes 1, 3, 4,6 | |||
| Frans-urethra | ||||||||
| plands-non) .uqose-susil | ||||||||
| Convertionsİstinadlar Şamarı Şamarı | ||||||||
| Musculo-skelets | ||||||||
| Sperficial | ||||||||
| approsesential | ||||||||
| artists Admin | ||||||||
| ordistric | ||||||||
| Cardiac | (วันที่มากว) แมวรรพยาน | |||||||
| submisesophi. (Cardiac | ||||||||
| ാല്പ്മാലവന | ||||||||
| Periphers | Peripheral vesse | |||||||
| ləssəsi | (***Viseq&) radiO | |||||||
| ə xibuəqdə rəbun bəbbə=Ə :(1482211)AQA ya bərasla visuoivərq=9 ;noitroibui wər=M | ||||||||
| 1 + W + 19wo9 >8 +10lo0+ W9 >8 + 10lo2 >8+W9 >M+8--25bom beridmo3 > 2119mmo 15modiəsinə aid bir növü. İstinadlar Şəhrin fəsiləsinə fəsiləsinə cinsinə aid bitk | ||||||||
| 2017/01/2017 11:58:51, thryuoid, testes | ||||||||
| orther use use includes Unologies | ||||||||
| ນກາງຮອບ ຂະໜາດ ອະນຸ ການປະຊາທິນ ອປປີ . ງານ່າງຄວາມໄວ້ເທດການປະກວດນາງງາມ | ||||||||
| lote 2: SmartID | ||||||||
| Vote 3:40(Real-time 3D | ||||||||
| Alote 4: İSCcape | ||||||||
| Notes: TDI | ||||||||
| Note6: Color M | ||||||||
| in and in British Curities | ||||||||
| ליין מערכת מקום מערכת המקום של המו | ||||||||
| (ЯПО)поізвивала взічэа 10 годно ,НЯПО 10 езпечтизцоС |
: ພວາຣ໌ นทางเร็ง ทนทอรมป์ปี จันรอนริหานี ศุทรายการ ครอบความการ จาก งานทางการจัดเขาวา
{17}------------------------------------------------
| System: | DC-70/DC-70T/DC-70 PRO/DC-70 EXP Diagnostic Ultrasound System | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Transducer: | CW5s | |||||||||
| 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) | ||
| General(Track 1) | Ophthalmic | |||||||||
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intra-operative (Specify*) | ||||||||||
| Intra-operative (Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | ||||||||||
| Small Organ (Specify**) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Fetal Imaging& Other | Adult Cephalic | |||||||||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph. (non-Card.) | ||||||||||
| Musculo-skeletal(Conventional) | ||||||||||
| Musculo-skeletal(Superficial) | ||||||||||
| Intravascular | ||||||||||
| Cardiac | Cardiac Adult | |||||||||
| Cardiac Pediatric | ||||||||||
| Intravascular (Cardiac) | ||||||||||
| Trans-esoph. (Cardiac) | ||||||||||
| Intra-cardiac | ||||||||||
| Peripheralvessel | Peripheral vessel | N | ||||||||
| Other (Specify***) | ||||||||||
| N=new indication; P=previously cleared by FDA; E=added under Appendix E | ||||||||||
| Additional comments: Combined modes--B+M、PW+B、Color + B、Power+B、PW+Color+ E | ||||||||||
| *Intraoperative includes abdominal, thoracic, and vascular etc. | ||||||||||
| **Small organ-breast, thyroid, testes. | ||||||||||
| ***Other use includes Urology. | ||||||||||
| Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents. | ||||||||||
| Note 2: Smart3D | ||||||||||
| Note 3:4D(Real-time 3D) | ||||||||||
| Note 4: iScape | ||||||||||
| Note5: TDI | ||||||||||
| Note6: Color M | ||||||||||
| Note7: Biopsy Guidance | ||||||||||
| Note8: Elastography | ||||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | ||||||||||
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
{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). The assigned 510(k) number is: __________________
1. Submitter:
Shenzhen Mindray Bio-medical Electronics Co., LTD Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan, Shenzhen, 518057, P. R. China
Tel: +86 755 8188 5640 Fax: +86 755 2658 2680
Contact Person:
Yang Zhaohui Shenzhen Mindray Bio-medical Electronics Co., LTD Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan, Shenzhen, 518057, P. R. China
Date Prepared: December 23, 2014
- Device Name: DC-70/DC-70T /DC-70 PRO/DC-70 EXP 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)
-
21 CFR 892.2050 Picture Archiving and Communications System(LLZ)
{19}------------------------------------------------
3. Device Description:
DC-70/DC-70T /DC-70 PRO/DC-70 EXP is a software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound data in B-Mode, M-Mode, PW-Mode, CW-Mode, Color-Mode, Power/Dirpower Mode, THI or the combined mode (i.e. B/M-Mode, B/PW-mode, B/PW/Color).
This system is a Track 3 device that employs an array of probes that include linear array and convex array with a frequency range of approximately 3.0 MHz to 10.0 MHz.
4. Intended Use:
DC-70/DC-70T /DC-70 PRO/DC-70 EXP Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatric, small organ(breast, thyroid, testes), neonatal and adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal(conventional, superficial), adult and pediatric cardiac, peripheral vessel and urology exams.
5. Comparison with Predicate Devices:
DC-70/DC-70T /DC-70 PRO/DC-70 EXP Diagnostic Ultrasound System is comparable with and substantially equivalent to these predicate devices:
| Predicate Device | Manufacturer | Model | 510(k) ControlNumber |
|---|---|---|---|
| 1 | Mindray | DC-8 | K132341 |
| 2 | Mindray | DC-N2 | K132779 |
DC-70/DC-70T /DC-70 PRO/DC-70 EXP has the same technological characteristics. is comparable in key safety and effectiveness features, and has the same intended uses and basic operating modes as the predicate devices. All systems transmit ultrasonic energy into patients and perform post processing of received echoes to generate onscreen display of anatomic structures and fluid flow within the body. All systems allow for specialized measurements of structures and flow, and calculations.
{20}------------------------------------------------
- Subject device DC-70/DC-70T /DC-70 PRO/DC-70 EXP has the same intended uses . as the predicated device DC-8(K132341)
| Subject Device | Predicate device |
|---|---|
| DC-70/DC-70T /DC-70 PRO/DC-70 EXP | DC-8(K132341) |
| The DC-70/DC-70T /DC-70 PRO/DC-70 EXP | The DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP |
| Diagnostic Ultrasound System is applicable | diagnostic ultrasound system is applicable for |
| for adults, pregnant women, pediatric patientsand neonates. It is intended for use in fetal, | adults, pregnant women, pediatric patients andneonates. It is intended for use in fetal, |
| abdominal, pediatric, small organ(breast,thyroid, testes), neonatal and adult cephalic, | abdominal, pediatric, small organ (breast,thyroid, testes), neonatal cephalic, adult |
| trans-rectal, trans-vaginal, musculo-skeletal(conventional, superficial), adult and pediatric | cephalic, trans-rectal, trans-vaginal,musculo-skeletal (conventional, superficial), |
| cardiac, peripheral vessel and urology exams. | cardiac adult, cardiac pediatric, peripheralvessel, urology exams. |
- All of the patient contact material of the DC-70/DC-70T /DC-70 PRO/DC-70 ● EXPare the same as that of the predicated device DC-8(K132341).
- The acoustic power levels of DC-70/DC-70T /DC-70 PRO/DC-70 EXP are below the limits of FDA, which is the same as the predicated device DC-8(K132341).
- DC-70/DC-70T /DC-70 PRO/DC-70 EXP is designed in compliance with the FDA recognized electrical and physical safety standard, which is the same as the predicated device DC-8(K132341).
- . DC-70/DC-70T /DC-70 PRO/DC-70 EXP has the same imaging modes as the predicated device DC-8(K132341): B, M, Color Doppler, PWD, CWD, Amplitude Doppler, Anatomical M Mode and combined mode).
- DC-70/DC-70T /DC-70 PRO/DC-70 EXP has some special functions. All of them are identical as the predicated device DC-8(K132341) and DC-N2(K132779).
- DC-70/DC-70T /DC-70 PRO/DC-70 EXP has the same capacity in term of making comments and body marks on the images, reporting patient exam results as the predicated device DC-8(K132341).
- . DC-70/DC-70T /DC-70 PRO/DC-70 EXP has similar probes as the predicated device DC-8(K132341):
{21}------------------------------------------------
| Subject device | Predicated device | NOTE |
|---|---|---|
| DC-70/DC-70T /DC-70PRO/DC-70 EXP | DC-8(K132341) | |
| C5-2E | C5-2E | Same |
| C7-3E | C7-3E | Same |
| C11-3E | C11-3E | Same |
| P4-2E | P4-2E | Same |
| P7-3E | P7-3E | Same |
| V11-3E | V11-3E | Same |
| V11-3BE | V11-3BE | Same |
| V11-3WE | V11-3WE | Same |
| L12-3E | L12-3E | Same |
| L14-6NE | L14-6NE | Same |
| L14-6WE | L14-6WE | Same |
| D6-2E | D6-2E | Same |
| DE10-3E | DE10-3E | Same |
| CW5s | CW5s/CW2s | Same |
- DC-70/DC-70T /DC-70 PRO/DC-70 EXP has the same measurement and calculation . functions as the predicated device DC-8(K132341).
6. Non-clinical Tests:
DC-70/DC-70T /DC-70 PRO/DC-70 EXP Diagnostic Ultrasound System has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical and mechanical safety, and has been designed to conform with applicable medical safety standards. This device has been tested and evaluated under the following standards:
- UD 2 Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment.
- AAMI / ANSI ES60601-1 Medical electrical equipment Part 1: General requirements for basic safety and essential performance.
- . IEC 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic
{22}------------------------------------------------
compatibility - Requirements and tests (Edition 3)
- . IEC 60601-2-37 Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
- ISO14971 Medical devices - Application of risk management to medical devices
- ISO 10993-1 Biological evaluation of medical devices -- Part 1: Evaluation and . testing within a risk management process
- . IEC 62366 Medical devices - Application of usability engineering to medical devices
- . IEC 62304 Medical device software - Software life cycle processes 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, DC-70/DC-70T /DC-70 PRO/DC-70 EXP Diagnostic Ultrasound System, does not require clinical studies to support substantial equivalence.
Conclusion:
Intended uses and other key features are consistent with traditional clinical practices, FDA guidelines and established methods of patient examination. The design, development and quality process of the manufacturer confirms with 21 CFR 820, ISO 9001 and ISO 13485 quality systems. The device conforms to applicable medical device safety standards. Therefore, the DC-70/DC-70T /DC-70 PRO/DC-70 EXP Diagnostic Ultrasound System is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.
B-5
§ 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.