(60 days)
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and does not mention any AI/ML-specific features or performance metrics.
No
The intended use states that the device is a "Diagnostic Ultrasound System." Diagnostic devices are used to identify a condition, not to treat it.
Yes
The "Intended Use / Indications for Use" and "Device Description" sections explicitly state the device is a "Diagnostic Ultrasound System".
No
The device description explicitly states it is a "general purpose, mobile, software controlled, ultrasound diagnostic system" and employs "an array of probes". This indicates it includes hardware components (the system itself and the probes) in addition to software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "general purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid". This describes a device used for imaging within the body, not for testing samples outside the body (which is the definition of in vitro).
- Device Description: The description reinforces that it's a "general purpose, mobile, software controlled, ultrasound diagnostic system".
- Anatomical Site: The listed anatomical sites are all parts of the human body.
- Modes of Operation: The modes listed are all related to ultrasound imaging and analysis techniques applied to the body.
IVD devices are used to examine specimens such as blood, urine, or tissue samples outside the body to provide information about a person's health. This ultrasound system operates by sending sound waves into the body and interpreting the echoes, which is a completely different diagnostic approach.
N/A
Intended Use / Indications for Use
DC-90/DC-90S/DC-90Q/DC-95/DC-95/DC-88/DC-888/DC-80A Exp/DC-80A Pro/DC-80A Pro/DC-8X/DC-8Q/DC-81/ DC-82 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, thoracic, and vascular), pediatric, small organ(breast, thyroid, testes), neonatal and adult cephalic, trans-vaginal, musculo-skeletal(conventional, superficial), superficial), superficial), adult and pediatric cardiac, Trans-esoph. (Cardiac), peripheral vessel and urology exams.
This device is a general purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid, which is intended to be used in a hospital or medical clinic.
Modes of operation include: B, M, PWD, CWD, Color Doppler, Tissue Harmonic Imaging, Smart 3D, 4D, iScape, TDI, Color M, Biopsy Guidance, Elastography, Contrast agent for Liver), Contrast imaging (Contrast agent for LVO), STE, STQ, Ultrasound Fusion Imaging, GYN/Pelvic and Combined mode:B+M, PW +B, Color+B, Power+B, PW+Color+B, Power+PW+B.
Product codes (comma separated list FDA assigned to the subject device)
IYN, IYO, ITX, LLZ
Device Description
DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80A Exp/ DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82 Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasound diagnostic system.
This system is a Track 3 device that employs an array of probes that include linear array, convex array, pencil phased and phased array.
The new added transducers C5-1E, SC5-1E, C6-2GE, C7-3E, L14-6WE, L16-4HE, P10-4E, 6LB7E, CB10-4E, V11-3E, V11-3BE, DE10-3WE, D7-2E, P7-3TE, CW5s were cleared in FDA (K192152) and the CW2s were cleared in FDA (K173471); L13-3WE is equivalent with transducer L14-5WE, which was cleared in FDA (K192152).
The needle-guided brackets in this submission were cleared in FDA (K192152) and (K200001).
The materials used in the new transducers (except for L13-3WE) and needle-guided brackets were the same as in the predicate device. And the L13-3WE transducer was testing for biocompatibility.
All the transducers and needle-guided brackets were provided non-sterile to the end user. And all the disinfection/sterilization methods for the new transducers and needle guide brackets were provided to the end user and the users are notified that disinfection /sterilizaiton are necessary in the Operation Manual.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
fetal, abdominal, thoracic, vascular, pediatric, small organ(breast, thyroid, testes), neonatal and adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal(conventional, superficial), adult and pediatric cardiac, Trans-esoph. (Cardiac), peripheral vessel and urology
Indicated Patient Age Range
adults, pregnant women, pediatric patients and neonates
Intended User / Care Setting
qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid, which is intended to be used in a hospital or medical clinic.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical tests were performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health and Human Services and the U.S. Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue.
Shenzhen Mindray Bio-medical Electronics Co., Ltd. August 21, 2020 % Zhang Wei Engineer of Technical Regulation Mindray Building, Keji 12th Road South Hi-tech Industrial Park Nanshan, Shenzhen 518057 P.R. CHINA Re: K201693 Trade/Device Name: DC-90/DC-90S/DC-900/DC-95/DC-95S/DC-88/DC-88S/DC-80A/ DC-80A Exp/DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX, LLZ Dated: May 20, 2020 Received: June 30, 2020
Dear Zhang Wei:
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
1
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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-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 T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
DC-90/DC-90S/DC-90Q/DC-95/DC-95/DC-88/DC-888/DC-80A/DC-80A Pro/DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-81/DC-82 Diagnostic Ultrasound System
Indications for Use (Describe)
DC-90/DC-90S/DC-90Q/DC-95/DC-95/DC-88/DC-888/DC-80A Exp/DC-80A Pro/DC-80A Pro/DC-8X/DC-8Q/DC-81/ DC-82 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, thoracic, and vascular), pediatric, small organ(breast, thyroid, testes), neonatal and adult cephalic, trans-vaginal, musculo-skeletal(conventional, superficial), superficial), superficial), adult and pediatric cardiac, Trans-esoph. (Cardiac), peripheral vessel and urology exams.
This device is a general purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid, which is intended to be used in a hospital or medical clinic.
Modes of operation include: B, M, PWD, CWD, Color Doppler, Tissue Harmonic Imaging, Smart 3D, 4D, iScape, TDI, Color M, Biopsy Guidance, Elastography, Contrast agent for Liver), Contrast imaging (Contrast agent for LVO), STE, STQ, Ultrasound Fusion Imaging, GYN/Pelvic and Combined mode:B+M, PW +B, Color+B, Power+B, PW+Color+B, Power+PW+B.
| Type of Use (Select one or both, as applicable) | X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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3
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.
The assigned 510(k) number: K201693
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 5655 Fax: +86 755 2658 2680
Contact Person:
Zhang Wei 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: May 20, 2020
2. Device Name:
DC-90/DC-90S/DC-90Q/DC-95/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80A Exp/DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82 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)
4
21 CFR 892.1570 Diagnostic Ultrasound Transducer (ITX)
21 CFR 892.2050 Picture Archiving and Communications System(LLZ)
| Predicate
Device | Manufacturer | Device Name | Devie
Class | Product
Code | 510(k)
Control
Number |
|--------------------------------------|--------------|--------------------------------------------------------------------------------------------------------------|----------------|-----------------------------|-----------------------------|
| 1.
Primary
predicate
device | Mindray | DC-80/DC-80 PRO/DC-80
EXP/DC-80S/DC-85/DC-86/DC-86S
/DC-89/DC-TV/DC-TQ Diagnostic
Ultrasound System | II | IYN,
IYO, ITX
and LLZ | K192152 |
| 2.
Reference
device | Mindray | DC-80/DC-80 PRO/DC-80
EXP/DC-80S/DC-85/DC-86/DC-86S
/DC-89/DC-TV/DC-TQ Diagnostic
Ultrasound System | II | IYN,
IYO, ITX | K173471 |
| 3.
Reference
device | Mindray | Resona 7/ Resona 7CV/ Resona
7EXP/ Resona 7S/ Resona 7OB
Diagnostic Ultrasound System | II | IYN, IYO,
ITX | K171233 |
3. Predicate Device
Regulation name and code
- 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)
4. Device Description:
DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80A Exp/
DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82 Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasound diagnostic system.
This system is a Track 3 device that employs an array of probes that include linear array, convex array, pencil phased and phased array.
The new added transducers C5-1E, SC5-1E, C6-2GE, C7-3E, L14-6WE, L16-4HE, P10-4E, 6LB7E, CB10-4E, V11-3E, V11-3BE, DE10-3WE, D7-2E, P7-3TE, CW5s were cleared in FDA (K192152) and the CW2s were cleared in FDA (K173471);
5
L13-3WE is equivalent with transducer L14-5WE, which was cleared in FDA (K192152).
The needle-guided brackets in this submission were cleared in FDA (K192152) and (K200001).
The materials used in the new transducers (except for L13-3WE) and needle-guided brackets were the same as in the predicate device. And the L13-3WE transducer was testing for biocompatibility.
All the transducers and needle-guided brackets were provided non-sterile to the end user. And all the disinfection/sterilization methods for the new transducers and needle guide brackets were provided to the end user and the users are notified that disinfection /sterilizaiton are necessary in the Operation Manual.
5. Intended Use:
The DC-80A /DC-80A Exp/DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82/DC-88/DC-90/ DC-95/DC-88S/DC-90S/DC-95S/DC-90Q Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, Intra-operative(abdominal, thoracic, and vascular), pediatric, small organ(breast, thyroid, testes), neonatal and adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal(conventional, superficial), adult and pediatric cardiac, Trans-esoph. (Cardiac), peripheral vessel and urology exams.
This device is a general purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid, which is intended to be used in a hospital or medical clinic.
Modes of operation include: B, M, PWD, CWD, Color Doppler, Amplitude Doppler, Tissue Harmonic Imaging, Smart 3D, 4D, iScape, TDI, Color M, Biopsy Guidance, Elastography, Contrast imaging (Contrast agent for Liver), Contrast imaging (Contrast agent for LVO), STE, STQ, Ultrasound Fusion Imaging, GYN/Pelvic and Combined mode:B+M, PW+B, Color+B, Power+B, PW+Color+B, Power+PW+B.
6. Summary of Modifications
6
New Added Transducers:
C5-1E, SC5-1E, C6-2GE, C7-3E, L14-6WE, L16-4HE, L13-3WE, P10-4E, 6LB7E, CB10-4E , V11-3E, V11-3BE, DE10-3WE, D7-2E, P7-3TE, CW5s, CW2s;
New Added Needle-Guided Bracket:
NGB-004、NGB-009、NGB-019、NGB-021、NGB-024、NGB-031、NGB-054;
Main Added Features:
-
- Ultrasound Fusion Imaging to C5-1E, SP5-1E, SC5-1E, L14-5WE, SC6-1E;
-
- Smart Pelvic to C5-1E, V11-3HE, D7-2E, DE11-3E, SC5-1E, C6-2GE, V11-3E, V11-3BE, SC6-1E, SD8-1E, DE10-3WE, C7-3E;
-
- STE/STQ to L13-3WE, SC5-1E, C5-1E
-
- Strain Elastography to L14-6WE、L13-3WE、V11-3E、V11-3BE
-
- Add the Fetal to the Clinical Application of L9-3E;
-
- Add the contrast imaging(Contrast imaging for Liver) function to SC5-1E . C5-1E, C6-2GE、C7-3E
-
- RIMT;
-
- Smart Planes FH;
-
- Glazing Flow;
-
- Fusion RESP;
The other New changes:
- Reference device
-
- STIC function to D7-2E;
-
- Add Transducer Element Check;
-
- OS Upgrade from win7 to win10;
-
- Add Macfee anti-virus software.
7. Comparison with Predicate Devices:
DC-90/DC-90S/DC-900/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80A Exp/
DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82 Diagnostic Ultrasound System is comparable
DC-80
| Predicate Device | Manufacturer | Model | 510(k) Control |
|---|---|---|---|
| 1. Primary predicate device | Mindray | DC-80 | K192152 |
Mindray
with and substantially equivalent to these predicate devices:
Number
7
| 3. Reference device | Mindray | Resona 7 | K171233 |
|---|---|---|---|
| --------------------- | --------- | ---------- | --------- |
DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80A Exp/
DC-80A Pro/DC-8X/DC-80/DC-81/DC-82 Diagnostic Ultrasound 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
DC-90/DC-90S/DC-900/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80A Exp/ DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82 has the same probes and indication for use and modes of operation with the predicated device DC-80 (K192152) , Reference device DC-80 (K173471)& Resona 7 ( K171233)
| Subject | DC-80(predicate | DC-80(Reference | Resona 7(Reference |
|---|---|---|---|
| Device | device) | device) | device) |
| DC-90 | (K192152) | (K173471) | (K171233) |
| C5-1E | C5-1E | / | / |
| SC5-1E | SC5-1E | / | / |
| C6-2GE | C6-2GE | / | / |
| C7-3E | C7-3E | / | / |
| L14-6WE | L14-6WE | / | / |
| L16-4HE | L16-4HE | / | / |
| L13-3WE | L14-5WE | / | / |
| P10-4E | P10-4E | / | / |
| 6LB7E | 6LB7E | / | / |
| CB10-4E | CB10-4E | / | / |
| V11-3E | V11-3E | / | / |
| V11-3BE | V11-3BE | / | / |
| DE10-3WE | DE10-3WE | / | / |
| D7-2E | D7-2E | / | / |
| P7-3TE | P7-3TE | / | / |
8
| CW5s | CW5s | / | / |
|---|---|---|---|
| CW2s | / | CW2s | / |
| L9-3E | / | / | L9-3E |
DC-90/DC-90S/DC-90Q/DC-95/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80A
Exp/DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82 has the same performance and functions with the predicated device DC-80 (K192152) .
| Subject Device DC-90 | Predicate device DC-80 (K192152) |
|---|---|
| Ultrasound Fusion Imaging | Ultrasound Fusion Imaging |
| Smart Pelvic | Smart Pelvic |
| STE/STQ | STE/STQ |
| Elastography | Elastography |
| Contrast imaging | Contrast imaging |
| Smart Planes FH | Smart Planes FH |
| Fusion RESP | Fusion RESP |
| Glazing Flow | Glazing Flow |
| Subject Device DC-90 | Reference device Resona 7( K171233) |
| RIMT | RIMT |
- . The materials of probes and Needle-guided brackets of DC-90/DC-90S/DC-90Q/DC-95/DC-95/DC-95S/DC-88/DC-88S/DC-80A Exp/DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82 are the same to the predicate device DC-80 (K192152).
- . The acoustic power levels of DC-90/DC-90S/DC-90Q/DC-95/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80A Exp/DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82 are below the limits of FDA, which is the same as the predicated device DC-80 (K192152).
- DC-90/DC-90S/DC-90Q/DC-95/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80A . Exp/DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82 is designed in compliance with the FDA recognized electrical and physical safety standards, which are the same as the predicated device DC-80 (K192152).
8. Non-clinical Tests:
DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80A Exp/
9
DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82 Diagnostic Ultrasound System has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical and mechanical safety, and has been found to conform with applicable medical safety standards.
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/(r)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 4.0 2014-02, medical electrical equipment - part 1-2: general requirements for basic safety and essential performance - collateral standard: electromagnetic compatibility - requirements and tests.
- . IEC 60601-2-37 Edition 2.1 2015, 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.
- . 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.
- . AAMI / ANSI / ISO 10993-1:2009/(R)2013, biological evaluation of medical devices - part 1: evaluation and testing within a risk management process.
- . 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
10
9. Clinical Tests:
Not Applicable.
10. Summary
Based on the performance data as documented in the study, the DC-90 Diagnostic Ultrasound system was found to have a safety and effectiveness profile that is similar to the predicate device.
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-90/DC-90S/DC-90S/DC-95/DC-95S/DC-88/ DC-88S/DC-80A/DC-80A Exp/DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82 Diagnostic Ultrasound System is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.