(14 days)
Not Found
No
The document describes a standard digital ultrasound system and does not mention any AI or ML capabilities, algorithms, or related performance metrics.
No.
The device is described as a "diagnostic system" and "diagnostic device" that produces ultrasound waves to "present the returned echo information on the monitor" and is used for "diagnostic examination." These functions are focused on imaging and diagnosis rather than treating a medical condition.
Yes
The document explicitly states in its "Intended Use / Indications for Use" and "Device Description" sections that it is an "Ultrasound Diagnostic System" and "Ultrasound Diagnostic Device," respectively. Furthermore, it details its use for various diagnostic applications across multiple anatomical sites and patient populations.
No
The device description explicitly states that the system consists of a main unit, a display, and four transducers, which are hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that the EMP-2100 is an "Ultrasound Diagnostic System." It works by producing ultrasound waves and analyzing the returned echoes to create images of internal body structures. This is an in vivo (within the living body) diagnostic method, not an in vitro method.
- Intended Use: The intended uses listed (abdomen, gynecology, obstetric, urology, small-parts, cardiology, etc.) are all applications of ultrasound imaging performed directly on the patient.
Therefore, the EMP-2100 is an in vivo diagnostic imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
EMP-2100 Full Digital Ultrasound Diagnostic System is a general-purpose, digital ultrasound diagnostic system for abdomen, gynecology, obstetric, urology, small-parts, and cardiology application.
The system is intended to use for the following type of studies: fetal organ, abdominal, pediatric, small organs, neonatal cephalic, cardiac, transvaginal, peripheral vascular, and musculo-skeletal(both conventional and superficial). The device is intended to adult, pregnant woman, pediatric and neonate.
The system is a prescription device intended to be used by or on the order of a physician or similar qualified health care professional. This device is not intended for home use.
Product codes
IYO, ITX
Device Description
EMP-2100 Full Digital Ultrasound Diagnostic Device is a portable digital ultrasonic diagnostic B/W system applied in ultrasound diagnostic examination of abdomen, gynecology, obstetric, urology, small-parts, and cardiology application.
It is designed to produce ultrasound waves into body tissue and to present the returned echo information on the monitor. The resulting information is displayed in five display modes as listed below. This system is a Track 1 device that employs an array of probes that include linear array, convex linear array and microconvex linear array with a frequency range of approximately 2.5MHz~7.5MHz.
The subject device is not for life-supporting or life-sustaining, not for implant. The device or transducers are not provided sterile and the transducer does not need sterilization and the transducer is reusable but does not need re-sterilization.
The system consists of a main unit, a display and four transducers.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Abdomen, gynecology, obstetric, urology, small-parts, cardiology, fetal organ, pediatric, neonatal cephalic, transvaginal, peripheral vascular, musculo-skeletal
Indicated Patient Age Range
Adult, pregnant woman, pediatric and neonate.
Intended User / Care Setting
Physician or similar qualified health care professional. Not intended for home use.
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)
Clinical Measurement Effectiveness Test was conducted on the subject device to evaluate its measurement accuracy.
The Electrical Safety Testing following IEC 60601-1 and Electromagnetic Compatibility Testing following IEC 60601-1-2 was conducted on the subject device.
Biocompatibility Testing includes: Cytotoxicity, Sensitization, Irritation.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
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Ko81873
JUL 1 6 2008
moer of Shenzhen Emperor Electronic Technology Co., Ltd
Appendix VI 510(k) Summary
As Required by CFR 807.92
- Submission Date: May 21, 2008
2. Sponsor Information
Shenzhen Emperor Electronic Technology Co., Ltd. 2/F, Building7, Tian'an Nanyou Industrial Area, Nanshan District, Shenzhen, 518054, China Contact Person: Ms. Cheng Guiyuan Tel: +86-755-26073381 Fax: +86-755- 26419886
3. Submission Correspondent:
Ms. Diana Hong Shanghai Mid-Link Business Consulting Co., Ltd Suite 8D, Zhongshan Zhongxin Mansion No.19, Lane 999, Zhongshan No.2 Road(S) Shanghai, 200030, China.
4. Subject Device Information
- Trade/Proprietary Name: EMP-2100 Full Digital Ultrasound A Device Diagnostic Device
- Device Classification Name: System, Imaging, Pulsed echo, Ultrasonic ア Transducer, Ultrasonic, Diagnostic
- A Device Common Name: Ultrasonic pulsed echo imaging system
- ア Review Panel: Radiology
- ア Product Code: 90-IYO & 90-ITX
- ア Regulation Number: 892.1560
-
Device Class: II
- A Review Category: Tier II
- A Intended Use:
EMP-2100 Full Digital Ultrasound Diagnostic System is a general-purpose, digital ultrasound diagnostic system for abdomen, gynecology, obstetric, urology, small-parts, and cardiology application.
The system is intended to use for the following type of studies: fetal organ, abdominal, pediatric, small organs, neonatal cephalic, cardiac, transvaginal,
1
Peror Shenzhen Emperor Electronic Technology Co., Ltd
peripheral vascular, and musculo-skeletal(both conventional and superficial). The device is intended to adult, pregnant woman, pediatric and neonate.
The system is a prescription device intended to be used by or on the order of a physician or similar qualified health care professional. This device is not intended for home use.
5. Predicate Device:
DP-6600 Digital Ultrasonic Diagnostic Imaging System with added transducers K-number: K060949
Product Code: IYO
Intended Use:
The system is a general-purpose, fully digital ultrasound system for abdominal, gynecologic and obstetric, small parts, and cardiac applications.
The system is intended to use for the following type of studies: fetal organ, abdominal, pediatric, small organs, neonatal cephalic, cardiac, transvaginal, and peripheral vascular and musculo-skeletal (both conventional and superficial).
This device is intended to adult, pregnant woman, pediatric and neonate. The system is a prescription device intended to be used by or on the order of a physician or similarly qualified health care professional. This Device is not intended for home use.
Manufactured by:
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 2658 2888 Fax: +86 755 2658 2680
6. Device Description
EMP-2100 Full Digital Ultrasound Diagnostic Device is a portable digital ultrasonic diagnostic B/W system applied in ultrasound diagnostic examination of abdomen, gynecology, obstetric, urology, small-parts, and cardiology application.
It is designed to produce ultrasound waves into body tissue and to present the returned echo information on the monitor. The resulting information is displayed in five display modes as listed below. This system is a Track 1 device that employs an array of probes that include linear array, convex linear array and microconvex linear array with a frequency range of approximately 2.5MHz~7.5MHz.
The subject device is not for life-supporting or life-sustaining, not for implant. The device or transducers are not provided sterile and the transducer does not need sterilization and the transducer is reusable but does not need re-sterilization.
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Shenzhen Emperor Electronic Technology Co., Ltd
| Transducer Model | Type | Nominal
Frequency | Application | Track |
|------------------|--------------|----------------------|-----------------------------------------------------------------------------|-------|
| C080-13G | Micro Convex | 6.5 MHz | gynecology, obstetric, urology and transvaginal | 1 |
| L096-42C | Liner Probe | 6.5 MHz | small-parts, neonatal cephalic, peripheral vascular and
musculo-skeletal | 1 |
| C096-20A | Micro Convex | 3.5 MHz | cardiology, pediatric, abdomen, gynecology and obstetric | 1 |
| C128-50 | Convex | 3.5 MHz | abdomen, pediatric, gynecology and obstetric | 1 |
The system consists of a main unit, a display and four transducers.
7. Technology Characteristics
Table VI-2 Technology Characteristics
| Display Mode | B,B/B,4B,B/M,M |
|---|---|
| Gray Scales | 256 |
| Frame rate | 60 frames/second max. |
| (various according different probes and the frequency) | |
| Display | 10"SVGA |
| Video output | PAL-D |
| Digital Scanning Converter | 576 ×460 ×8 bits |
| Zoom | 11 levels, partial zoom |
| Body mark | 38 types indicating probe positions |
| Power Supply | AC 100 |
| Input Power | 200 VA |
| Continuous Operation Period | >8 hours |
| Dimensions | 365 (height) ×292 (width) ×380 (depth) |
| Weight | Net weight 10 Kg |
| Working Condition | Temperature 5°C -40°C, relative humidity up to 90%RH |
| Storage Condition | Temperature -5-40°C, relative humidity up to 90%RH (no water |
| drop) air pressure 70-106Kpa |
8. Effectiveness and Safety Considerations
Effectiveness:
Clinical Measurement Effectiveness Test was conducted on the subject device to evaluate its measurement accuracy.
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Shenzhen Emperor Electronic Technology Co., Ltd
Safety Considerations:
The Electrical Safety Testing following IEC 60601-1 and Electromagnetic Compatibility Testing following IEC 60601-1-2 was conducted on the subject device
Guideline "INFORMATION FOR MANUFACTURERS Per FDA SEEKING MARKETING CLEARANCE OF DIAGNOSTIC ULTRASOUND SYSTEMS AND TRANSDUERS" dated May 1, 1997 and with regard to Table I Initial Evaluation Tests for Consideration and Table 2 Supplementary Evaluation Tests for Consideration in ISO 10993-1:2003(E), Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing, the necessary tests for Biocompatibility Testing includes: Cytotoxicity, Sensitization, Irritation.
9. Substantially Equivalent Analysis
The subject device has same classification information, same indication for use, similar product design, same performance effectiveness, performance safety as the predicate device.
The differences are included as followings:
Scanning angle
Linear probe width
Micro-convex probe scanning angle
Power supply: 110V±10%, 230V±10% vs 100~240VAC±10%
Volume and Weight: 306 mm (W)*426 mm (L)*357 mm (H), 12KG vs 86 mm(W)*385 mm(L)*306 mm(H), 11KG
Image Process: the subject device does not have Line Density as the predicate device Storage: 16 images in main unit vs 100 images in main unit
Operation Environment: Temperature 5°C -40°C relative humidity 30-80%RH vs Temperature 5°C-40°C ,relative humidity 30-85%RH
Storage Environment .: Temperature -5-40°C ,relative humidity 30-80%(no water drop) air pressure 86-106Kpa vs Temperature -22℃ -55℃ . relative humidity 30-85% (no condensation) air pressure 70-106Kpa
Display Mode
The differences above between the subject device and predicate device do not affect the basic design principle, usage, effectiveness and safety of the subject device. And no question is raised regarding to effectiveness and safety.
No new unique technology is applied in the subject device. Most of the main aspects on effectiveness and safety between the subject device and predicate device are same. The
4
PCI CI Shenzhen Emperor Electronic Technology Co., Ltd
differences are slight so that no substantial influence on the effectiveness and safety.
10. Substantially Equivalent Determination
.
The subject device, EMP-2100 Full Digital Ultrasound Diagnostic Device, is substantially equivalent to the predicate device, DP-6600 Digital Ultrasonic Diagnostic Imaging System with added transducers
:
5
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare, with three lines representing the branches of government. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 6 2008
Shenzhen Emperor Electronic Technology Co., Ltd % Mr. Morten Simon Christensen Staff Engineer & FDA Accredited Person Program Coordinator, Program Reviewer Underwriters Laboratories, Inc. UL Silicon Valley Office 455 E. Trimble Road SAN JOSE CA 95131-1230
Re: K081873
Trade/Device Name: EMP-2100 Full Digital Ultrasound Diagnostic System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO and ITX Dated: June 24, 2008 Received: July 2, 2008
Dear Mr. Christensen:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we 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). 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.
This determination of substantial equivalence applies to the following transducers intended for use with the EMP-2100 Full Digital Ultrasound Diagnostic System, as described in your premarket notification:
Transducer Model Number
| C128-50 |
|---|
| C080-13G |
| L096-42C |
| C096-20A |
6
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
If you have any questions regarding the content of this letter, please contact Robert A. Phillips, Ph.D. at (240) 276-3666.
Sincerely yours.
Arque M. Whan
A Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
7
Indication for Use
510(k) Number:
Device Name: EMP-2100 Full Digital Ultrasound Diagnostic System
Indications for Use:
EMP-2100 Full Digital Ultrasound Diagnostic System is a general-purpose, digital ultrasound diagnostic system for abdomen, gynecology, obstetric, urology, small-parts, and cardiology application.
The system is intended to use for the following type of studies: fetal organ, abdominal, pediatric, small organs, neonatal cephalic, cardiac, transvaginal, peripheral vascular, and musculo-skeletal(both conventional and superficial). The device is intended to adult, pregnant woman, pediatric and neonate.
The system is a prescription device intended to be used by or on the order of a physician or similar qualified health care professional. This device is not intended for home use.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-off)
Page 1 of __ 1
Division of Reproductive. Abdomina Radiological Devices 510(k) Number
8
Fill out one form for each ultrasound system and each transducer.
Device Name: EMP-2100 Full Digital Ultrasound Diagnostic System (C128-50 Transducer)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| A | B | M | PWD | CWD | Color | ||||||
| Doppler | Amplitude | ||||||||||
| Doppler | Color | ||||||||||
| Velocity | |||||||||||
| Imaging | Combined | ||||||||||
| (B/M) | Other | ||||||||||
| (specify) | |||||||||||
| Ophthalmic | |||||||||||
| Fetal | N | N | N | ||||||||
| Abdominal | N | N | N | ||||||||
| Intraoperative (specify) | |||||||||||
| Intraoperative Neurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ (specify) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletal Conventional | |||||||||||
| Musculo-skeletal Superficial | |||||||||||
| Other (specify) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E Comments:
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Aoguih Whag
ductive. Andominal 510(k) Nu
9
Fill out one form for each ultrasound system and each transducer.
Device Name: EMP-2100 Full Digital Ultrasound Diagnostic System (C080-13G Transducer) Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Clinical Application Mode of Operation A B M PWD CWD Color Amplitude Color Combined Other Doppler Doppler Velocity (B/M) (specify) Imaging Ophthalmic Fetal Abdominal Intraoperative (specify) Intraoperative Neurologica Pediatric Small Organ (specify) Neonatal Cephalic Adult Cephalic Transesophageal Transrectal Transvaginal N N N Transurethral N N N Intravascular Peripheral Vascular Laparoscopic Musculo-skeletalConventional Musculo-skeletal Superficial
N= new indication; P= previously cleared by FDA; E= added under Appendix E Comments:
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Other (specify)
forpaitm Whay
(Division Sian-Off) 510(k) Number
10
Fill out one form for each ultrasound system and each transducer.
Device Name: EMP-2100 Full Digital Ultrasound Diagnostic System (L096-42C Transducer)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| A | B | M | PWD | CWD | Color | |||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (B/M) | Other | |||||||||
| (specify) | ||||||||||
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurologica | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | N | N | N | |||||||
| Neonatal Cephalic | N | N | N | |||||||
| Adult Cephalic | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | N | N | N | |||||||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | N | N | N | |||||||
| Musculo-skeletal Superficial | N | N | N | |||||||
| Other (specify) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E Comments:
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(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
のお気になる。
Vornthethun
Prescription Use (Per 21 CFR 801.109)
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(Division Sign-Off)/
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K081873
11
Fill out one form for each ultrasound system and each transducer.
Device Name: EMP-2100 Full Digital Ultrasound Diagnostic System (C096-20A Transducer)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | Combined
(B/M) | Other
(specify) |
|------------------------------|---|---|---|-----|-----|------------------|----------------------|------------------------------|-------------------|--------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | N | N | N | | | | | | N | |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurologica | | | | | | | | | | |
| Pediatric | N | N | N | | | | | | N | |
| Small Organ (specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletalConventional | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
| Cardiac | N | N | N | | | | | | N | |
N= new indication; P= previously cleared by FDA; E= added under Appendix E Comments:
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Tomik Whing
(Division Sign-Off) Reproductive. Abdominal and