(46 days)
Not Found
No
The summary describes a standard ultrasonic imaging system and does not mention any AI or ML capabilities.
No
The device is described as a "Digital Ultrasonic Diagnostic Imaging System," which is designed to acquire and display ultrasound data for diagnostic purposes, not for treatment.
Yes
The device is explicitly referred to as a "Digital Ultrasonic Diagnostic Imaging System" in both the "Intended Use / Indications for Use" and "Device Description" sections, and its function is to acquire and display ultrasound data for various exams.
No
The device description explicitly states it is a "software controlled, ultrasonic diagnostic system" and mentions employing "an array of probes," which are hardware components essential for acquiring ultrasound data.
Based on the provided information, 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. They are used to examine these samples outside of the body.
- Device Function: The description clearly states that the DP-50 is an "ultrasonic diagnostic imaging system." It uses ultrasound waves to create images of internal structures within the body.
- Intended Use: The intended use lists various anatomical sites and patient populations for imaging, all of which involve examining structures inside the living patient.
- Lack of Sample Analysis: There is no mention of the device analyzing any samples taken from the body.
Therefore, the DP-50 is a medical imaging device used for diagnostic purposes in vivo (within the living body), not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The DP-50 Digital Ultrasonic Diagnostic Imaging System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatric, small organ(breast, thyroid, testes), neonatal and adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal(conventional, superficial), cardiac(pediatric) and peripheral vascular exams.
Product codes
IYO, ITX
Device Description
The DP-50 Digital Ultrasonic Diagnostic Imaging System is a general purpose, mobile, software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound data in B-Mode, or their combined mode B+M Mode. 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 3.5 MHz to 10.0 MHz.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasonic Pulsed Echo Imaging System
Anatomical Site
fetal, abdominal, pediatric, small organ(breast, thyroid, testes), neonatal and adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal(conventional, superficial), cardiac(pediatric) and peripheral vascular
Indicated Patient Age Range
adults, pregnant women, pediatric patients and neonates
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical Tests: DP-50 Digital Ultrasonic Diagnostic Imaging System has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical and mechanical safety, and has been found to conform with applicable medical safety standards.
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.
0
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: KII 1435
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 5635 Fax: +86 755 2658 2680
Contact Person:
Bai Yanhong Shenzhen Mindray Bio-medical Electronics Co., LTD Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan, Shenzhen, 518057, P. R. China
May 9, 2011 Date Prepared:
2. Device Name:
DP-50 Digital Ultrasonic Diagnostic Imaging System Classification Regulatory Class: II 21 CFR 892.1560 Ultrasonic Pulsed Echo Imaging System (90-1YO) 21 CFR 892.1570 Diagnostic Ultrasound Transducer (90-ITX)
3. Device Description:
The DP-50 Digital Ultrasonic Diagnostic Imaging System is a general purpose, mobile, software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound data in B-Mode, or their combined mode B+M Mode. 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 3.5 MHz to 10.0 MHz.
1
4. Intended Use:
The DP-50 Digital Ultrasonic Diagnostic Imaging System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatric, small organ(breast, thyroid, testes), neonatal and adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal(conventional, superficial), cardiac(pediatric) and peripheral vascular exams
5. Comparison with Predicate Device:
DP-50 Digital Ultrasonic Diagnostic Imaging System is comparable with and substantially equivalent to the Mindray DP-6900 Digital Ultrasonic Diagnostic Imaging System (K090912), M5 Diagnostic Ultrasound System(K102991) and M7 Diagnostic Ultrasound System(K103677). They have technological characteristics, are comparable in key safety and effectiveness features, and have the same intended uses and basic operating modes as the predicate device.
6. Non-clinical Tests:
DP-50 Digital Ultrasonic Diagnostic Imaging System has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical and mechanical safety, and has been found to conform with applicable medical safety standards. This device has been designed to meet the following standards: UD 2. UD 3,IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-2-37 ,IEC 60601-1-4 ,ISO 10993-1 and IEC 62304.
Conclusion:
Intended uses and other key features are consistent with traditional clinical practices, FDA guidelines and established methods of patient examination. The design, development and quality process of the manufacturer confirms with 21 CFR 820, ISO 9001 and ISO 13485 quality systems. The device conforms to applicable medical device safety standards. Therefore, the DP-50 Digital Ultrasonic Diagnostic Imaging System is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a caduceus, a symbol often associated with healthcare and medicine. The caduceus is depicted with a staff entwined by two snakes and topped with wings.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Shenzhen Mindray Bio-Medical Electronics Co., Ltd. % Ms. Susan D. Goldstein-Falk Official Correspondent mdi Consultants, Inc. 55 Northern Blvd., Suite 200 GREAT NECK NY 11021
JUL - 8 2011
Re: K111435
Trade/Device Name: DP-50 Digital Ultrasonic Diagnostic Imaging System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO and ITX Dated: June 15, 2011 Received: June 16, 2011
Dear Ms. Goldstein-Falk:
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 DP-50 Digital Ultrasonic Diagnostic Imaging System, as described in your premarket notification:
Transducer Model Number
| 35C50EA | 75L53EA |
|---|---|
| 65C15EA | 10L24EA |
| 65EC10EA | 65EB10EA |
| 75L38EA |
3
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 895. 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.
If you have any questions regarding the content of this letter, please contact Shahram Vaezy at (301) 796-6242.
Sincerely Yours,
Mary Statd
Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure(s)
4
Indications for Use
510(k) Number (if known):
Device Name: DP-50 Digital Ultrasonic Diagnostic Imaging System
Indications For Use:
The DP-50 Digital Ultrasonic Diagnostic Imaging System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatric, small organ(breast, thyroid, testes), neonatal and adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal(conventional, superficial), cardiac(pediatric) and peripheral vascular exams.
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Mary Statd
(Division Sign-Off)
510K
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
**5**
Diagnostic Ultrasound Indications for Use Form
System: Transducer: DP-50 Digital Ultrasonic Diagnostic Imaging System N/A
Intended Use:
ﺮ ﺩ
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|---|-----|-----|------------------|----------------------|-----------------------|-----------------|
| Clinical Application | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Combined
(specify) | Other (specify) |
| Ophthalmic | | | | | | | | |
| Fetal | N | N | | | | | N | Note 1,2 |
| Abdominal | N | N | | | | | N | Note 1,2 |
| Intraoperative (specify)* | | | | | | | | |
| Intraoperative (Neuro) | | | | | | | | |
| Laparoscopic | | | | | | | | |
| Pediatric | N | N | | | | | N | Note 1, 2 |
| Small organ(specify)** | N | N | | | | | N | Note 1,2 |
| Neonatal Cephalic | N | N | | | | | N | Note 1, 2 |
| Adult Cephalic | N | N | | | | | N | Note 1, 2 |
| Trans-rectal | N | N | | | | | N | Note 1, 2 |
| Trans-vaginal | N | N | | | | | N | Note 1, 2 |
| Trans-urethral | | | | | | | | |
| Trans-esoph.(non-Card.) | | | | | | | | |
| Musculo-skeletal | N | N | | | | | N | Note 1,2 |
| Conventional | | N | | | | | | |
| Musculo-skeletal | N | N | | | | | N | Note 1,2 |
| Superficial | | | | | | | | |
| Intravascular | | | | | | | | |
| Cardiac Adult | | | | | | | | |
| Cardiac Pediatric | N | N | | | | | N | Note 1,2 |
| Intravascular (Cardiac) | | | | | | | | |
| Trans-esoph.(Cardiac) | | | | | | | | |
| Intra-Cardiac | | | | | | | | |
| Peripheral Vascular | N | N | | | | | N | Note 1, 2 |
| Other (specify)*** | | | | | | | | |
| N=new indication; P=previously cleared by FDA; E=added under Appendix E
Additional comments: Combined modes: B+M.
*Intraoperative includes abdominal, thoracic, and vascular
**Small organ-breast, thyroid, testes
***Other use includes Urology.
Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
Note 2: Biopsy Guidance
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation(ODE) | | | | | | | | |
Prescription USE (Per 21 CFR 801.109)
Mary Slatel
(Division Sign-Off)
Division of Radiological Dev Office of In Vitro Diagnostic Dev tion and Safety
510K K11435
**6**
#### Diagnostic Ultrasound Indications for Use Form
System: Transducer:
Intended Use:
DP-50 Digital Ultrasonic Diagnostic Imaging System 35C50EA Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | |
|----------------------------------------------------------------------------|-------------------|---|-----|-----|------------------|----------------------|-----------------------|-----------------|
| Clinical Application | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Combined
(specify) | Other (specify) |
| Ophthalmic | | | | | | | | |
| Fetal | P | P | | | | | P | Note 1, 2 |
| Abdominal | P | P | | | | | P | Note 1, 2 |
| Intraoperative (specify)* | | | | | | | | |
| Intraoperative (Neuro) | | | | | | | | |
| Laparoscopic | | | | | | | | |
| Pediatric | P | P | | | | | P | Note 1, 2 |
| Small organ(specify)** | | | | | | | | |
| Neonatal Cephalic | | | | | | | | |
| Adult Cephalic | | | | | | | | |
| Trans-rectal | | | | | | | | |
| Trans-vaginal | | | | | | | | |
| Trans-urethral | | | | | | | | |
| Trans-esoph.(non-Card.) | | | | | | | | |
| Musculo-skeletal
Conventional | P | P | | | | | P | Note 1, 2 |
| Musculo-skeletal
Superficial | | | | | | | | |
| Intravascular | | | | | | | | |
| Cardiac Adult | | | | | | | | |
| Cardiac Pediatric | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | |
| Intra-Cardiac | | | | | | | | |
| Peripheral Vascular | P | P | | | | | P | Note 1, 2 |
| Other (specify) *** | | | | | | | | |
| N=new indication; P=previously cleared by FDA; E=added under Appendix E | | | | | | | | |
| Additional comments:Combined modes: B+M. | | | | | | | | |
| * Intraoperative includes abdominal, thoracic, and vascular | | | | | | | | |
| ** Small organ-breast, thyroid, testes | | | | | | | | |
| *** Other use includes Urology. | | | | | | | | |
| Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents. | | | | | | | | |
| Note 2: Biopsy Guidance | | | | | | | | |
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) | | | | | | | | |
| Concurrence of CDRH, Office of Device Evaluation(ODE) | | | | | | | | |
Prescription USE (Per 21 CFR 801.109)
Mary S. Patil
(Division Sign-Off)
Division of Radiological Dev Office of In Vitro D tion and Safety
510K K11435
**7**
System: Transducer:
DP-50 Digital Ultrasonic Diagnostic Imaging System 65C15EA
Diagnostic Ultrasound Indications for Use Form
Intended Use:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Combined (specify) | Other (specify) |
|---------------------------|---|---|-----|-----|---------------|-------------------|--------------------|-----------------|
| Ophthalmic | | | | | | | | |
| Fetal | | | | | | | | |
| Abdominal | P | P | | | | | P | Note 1, 2 |
| Intraoperative (specify)* | | | | | | | | |
| Intraoperative (Neuro) | | | | | | | | |
| Laparoscopic | | | | | | | | |
| Pediatric | P | P | | | | | P | Note 1, 2 |
| Small organ(specify)** | | | | | | | | |
| Neonatal Cephalic | P | P | | | | | P | Note 1, 2 |
| Adult Cephalic | P | P | | | | | P | Note 1, 2 |
| Trans-rectal | | | | | | | | |
| Trans-vaginal | | | | | | | | |
| Trans-urethral | | | | | | | | |
| Trans-esoph.(non-Card.) | | | | | | | | |
| Musculo-skeletal | | | | | | | | |
| Conventional | | | | | | | | |
| Musculo-skeletal | | | | | | | | |
| Superficial | | | | | | | | |
| Intravascular | | | | | | | | |
| Cardiac Adult | | | | | | | | |
| Cardiac Pediatric | P | P | | | | | P | Note 1, 2 |
| Intravascular (Cardiac) | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | |
| Intra-Cardiac | | | | | | | | |
| Peripheral Vascular | | | | | | | | |
| Other (specify)*** | | | | | | | | |
Prescription USE (Per 21 CFR 801.109)
Maie S. Pratt
(Division Sign-Off)
Division of Radiotogical Devices ice Evaluation and Safety Office of In Vitro Di
510K. K11435
**8**
**Diagnostic Ultrasound Indications for Use Form**
| System: | DP-50 Digital Ultrasonic Diagnostic Imaging System |
|---------------|------------------------------------------------------------------------------------|
| Transducer: | 65EC10EA |
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: |
| | Mode of Operation | | | | | | | |
|---------------------------|-------------------|---|-----|-----|---------------|-------------------|--------------------|-----------------|
| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Combined (specify) | Other (specify) |
| Ophthalmic | | | | | | | | |
| Fetal | P | P | | | | | P | Note 1, 2 |
| Abdominal | | | | | | | | |
| Intraoperative (specify)* | | | | | | | | |
| Intraoperative (Neuro) | | | | | | | | |
| Laparoscopic | | | | | | | | |
| Pediatric | | | | | | | | |
| Small organ(specify)** | | | | | | | | |
| Neonatal Cephalic | | | | | | | | |
| Adult Cephalic | | | | | | | | |
| Trans-rectal | P | P | | | | | P | Note 1, 2 |
| Trans-vaginal | P | P | | | | | P | Note 1, 2 |
| Trans-urethral | | | | | | | | |
| Trans-esoph.(non-Card.) | | | | | | | | |
| Musculo-skeletal | | | | | | | | |
| Conventional | | | | | | | | |
| Musculo-skeletal | | | | | | | | |
| Superficial | | | | | | | | |
| Intravascular | | | | | | | | |
| Cardiac Adult | | | | | | | | |
| Cardiac Pediatric | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | |
| Intra-Cardiac | | | | | | | | |
| Peripheral Vascular | | | | | | | | |
| Other (specify) *** | | | | | | | | |
Prescription USE (Per 21 CFR 801.109)
Mary Slastl
(Division Sign-Off)
(Division of Radiological Devices
Office of In Vitro Diagnostic Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
K11435
510K
**9**
System: Transducer:
Diagnostic Ultrasound Indications for Use Form DP-50 Digital Ultrasonic Diagnostic Imaging System 75L38EA Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Intended Use:
| | | | Mode of Operation | | | | | |
|----------------------------------------------------------------------------|---|---|-------------------|-----|------------------|----------------------|-----------------------|-----------------|
| Clinical Application | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Combined
(specify) | Other (specify) |
| Ophthalmic | | | | | | | | |
| Fetal | | | | | | | | |
| Abdominal | P | P | | | | | P | Note 1,2 |
| Intraoperative (specify)* | | | | | | | | |
| Intraoperative (Neuro) | | | | | | | | |
| Laparoscopic | | | | | | | | |
| Pediatric | P | P | | | | | P | Note 1,2 |
| Small organ(specify)** | P | P | | | | | P | Note 1,2 |
| Neonatal Cephalic | P | P | | | | | P | Note 1,2 |
| Adult Cephalic | | | | | | | | |
| Trans-rectal | | | | | | | | |
| Trans-vaginal | | | | | | | | |
| Trans-urethral | | | | | | | | |
| Trans-esoph.(non-Card.) | | | | | | | | |
| Musculo-skeletal
Conventional | P | P | | | | | P | Note 1,2 |
| Musculo-skeletal
Superficial | P | P | | | | | P | Note 1,2 |
| Intravascular | | | | | | | | |
| Cardiac Adult | | | | | | | | |
| Cardiac Pediatric | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | |
| Trans-esoph.(Cardiac) | | | | | | | | |
| Intra-Cardiac | | | | | | | | |
| Peripheral Vascular | P | P | | | | | P | Note 1,2 |
| Other (specify) *** | | | | | | | | |
| N=new indication; P=previously cleared by FDA; E=added under Appendix E | | | | | | | | |
| Additional comments:Combined modes: B+M. | | | | | | | | |
| * Intraoperative includes abdominal, thoracic, and vascular | | | | | | | | |
| ** Small organ-breast, thyroid, testes | | | | | | | | |
| *** Other use includes Urology. | | | | | | | | |
| Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents. | | | | | | | | |
| Note 2: Biopsy Guidance | | | | | | | | |
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) | | | | | | | | |
| Concurrence of CDRH, Office of Device Evaluation(ODE) | | | | | | | | |
Prescription USE (Per 21 CFR 801.109)
Mary Slatl
(Division Sign-Off)
Divi on of Radiological D Office of in Vitro agnostic Device Evaluation and Safety
510K K11435
**10**
Diagnostic Ultrasound Indications for Use Form DP-50 Digital Ultrasonic Diagnostic Imaging System 75L53EA
Transducer: Intended Use:
System:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | |
|----------------------------------|-------------------|---|-----|-----|------------------|----------------------|-----------------------|-----------------|
| Clinical Application | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Combined
(specify) | Other (specify) |
| Ophthalmic | | | | | | | | |
| Fetal | | | | | | | | |
| Abdominal | P | P | | | | | P | Note 1,2 |
| Intraoperative (specify)* | | | | | | | | |
| Intraoperative (Neuro) | | | | | | | | |
| Laparoscopic | | | | | | | | |
| Pediatric | P | P | | | | | P | Note 1,2 |
| Small organ(specify)** | P | P | | | | | P | Note 1,2 |
| Neonatal Cephalic | P | P | | | | | P | Note 1,2 |
| Adult Cephalic | | | | | | | | |
| Trans-rectal | | | | | | | | |
| Trans-vaginal | | | | | | | | |
| Trans-urethral | | | | | | | | |
| Trans-esoph.(non-Card.) | | | | | | | | |
| Musculo-skeletal
Conventional | P | P | | | | | P | Note 1,2 |
| Musculo-skeletal
Superficial | P | P | | | | | P | Note 1,2 |
| Intravascular | | | | | | | | |
| Cardiac Adult | | | | | | | | |
| Cardiac Pediatric | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | |
| Trans-esoph.(Cardiac) | | | | | | | | |
| Intra-Cardiac | | | | | | | | |
| Peripheral Vascular | P | P | | | | | P | Note 1,2 |
| Other (specify) *** | | | | | | | | |
Concurrence of CDRH, Office of Device Evaluation(ODE)
Prescription USE (Per 21 CFR 801.109)
Mary Slatel
(Division Sign-Off)
Division of Radiological Devices evice Evaluation and Safety Office of In Vitro I
[K111435](https://510k.innolitics.com/search/K111435)
510K
**11**
Diagnostic Ultrasound Indications for Use Form DP-50 Digital Ultrasonic Diagnostic Imaging System System: 10L24EA Transducer: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Intended Use:
| | Mode of Operation | | | | | | | |
|----------------------------------------------------------------------------|-------------------|---|-----|-----|---------------|-------------------|--------------------|-----------------|
| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Combined (specify) | Other (specify) |
| Ophthalmic | | | | | | | | |
| Fetal | | | | | | | | |
| Abdominal | N | N | | | | | N | Note 1,2 |
| Intraoperative (specify)* | | | | | | | | |
| Intraoperative (Neuro) | | | | | | | | |
| Laparoscopic | | | | | | | | |
| Pediatric | N | N | | | | | N | Note 1,2 |
| Small organ(specify)** | N | N | | | | | N | Note 1,2 |
| Neonatal Cephalic | N | N | | | | | N | Note 1,2 |
| Adult Cephalic | | | | | | | | |
| Trans-rectal | | | | | | | | |
| Trans-vaginal | | | | | | | | |
| Trans-urethral | | | | | | | | |
| Trans-esoph.(non-Card.) | | | | | | | | |
| Musculo-skeletal Conventional | N | N | | | | | N | Note 1,2 |
| Musculo-skeletal Superficial | N | N | | | | | N | Note 1,2 |
| Intravascular | | | | | | | | |
| Cardiac Adult | | | | | | | | |
| Cardiac Pediatric | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | |
| Trans-esoph.(Cardiac) | | | | | | | | |
| Intra-Cardiac | | | | | | | | |
| Peripheral Vascular | N | N | | | | | N | Note 1,2 |
| Other (specify)*** | | | | | | | | |
| N=new indication; P=previously cleared by FDA; E=added under Appendix E | | | | | | | | |
| Additional comments:Combined modes: B+M. | | | | | | | | |
| *Intraoperative includes abdominal, thoracic, and vascular | | | | | | | | |
| ** Small organ-breast, thyroid, testes | | | | | | | | |
| *** Other use includes Urology. | | | | | | | | |
| Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents. | | | | | | | | |
| Note 2: Biopsy Guidance | | | | | | | | |
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) | | | | | | | | |
| Concurrence of CDRH, Office of Device Evaluation(ODE) | | | | | | | | |
Prescription USE (Per 21 CFR 801.109)
Mary Patel
(Division Sign-Off)
Division and Safety Office of In Vitro Diagn
[K111435](https://510k.innolitics.com/search/K111435)
510K
**12**
| | | | | | | Diagnostic Ultrasound Indications for Use Form | | | | | |
|----------------------------------------------------------------------------|------------------------------------------------------------------------------------|-------------------|-----|-----|------------------|------------------------------------------------|-----------------------|-----------------|--|--|--|
| System | DP-50 Digital Ultrasonic Diagnostic Imaging System | | | | | | | | | | |
| Transducer: | 65EB10EA | | | | | | | | | | |
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | | | | |
| | | | | | | | | | | | |
| | | Mode of Operation | | | | | | | | | |
| Clinical Application | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Combined
(specify) | Other (specify) | | | |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intraoperative (specify)* | | | | | | | | | | | |
| Intraoperative (Neuro) | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small organ(specify)** | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Trans-rectal | N | N | | | | | N | Note 1,2 | | | |
| Trans-vaginal | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | |
| Trans-esoph.(non-Card.) | | | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | | | |
| Conventional | | | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | | | |
| Superficial | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | | | |
| Trans-esoph.(Cardiac) | | | | | | | | | | | |
| Intra-Cardiac | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Other (specify) *** | | | | | | | | | | | |
| N=new indication; P=previously cleared by FDA; E=added under Appendix E | | | | | | | | | | | |
| Additional comments:Combined modes: B+M. | | | | | | | | | | | |
| * 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. | | | | | | | | | | | |
| Note2: Biopsy Guidance | | | | | | | | | | | |
| (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)
Mary S Patel
(Division Sign-Off)
Division of R diological Device Device Evaluation and Safety Office of in Vitro D
ice of In Vitro Diagnostic Devices Evaluation and
510K [K111435](https://510k.innolitics.com/search/K111435)
0036