(87 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on standard ultrasound imaging modes and hardware.
No.
The device is described as a "Digital Ultrasonic Diagnostic Imaging System," and its function is to "acquire and display ultrasound data." It is intended for use in various "exams" for diagnostic purposes, not for providing therapy or treatment.
Yes
The "Intended Use / Indications for Use" section states: "The Digital Ultrasonic Diagnostic Imaging System is applicable for adults... It is intended for use in fetal, abdominal... exams."
The "Device Description" section states: "The DP-20 and DP-30 Digital Ultrasonic Diagnostic Imaging System are general purpose... ultrasonic diagnostic systems."
These phrases directly indicate that the device performs diagnostic functions.
No
The device description explicitly states it is a "Digital Ultrasonic Diagnostic Imaging System" and mentions employing "an array of transducers," which are hardware components essential for acquiring ultrasound data. While it is software-controlled, it is not solely software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the body (in vitro).
- Device Description: The provided text describes a "Digital Ultrasonic Diagnostic Imaging System." This system uses ultrasound technology to create images of internal body structures. This is an in vivo diagnostic method, meaning it is performed inside the body.
- Intended Use: The intended use lists various anatomical sites and patient populations for imaging exams. This aligns with the function of an ultrasound machine, not an IVD.
Therefore, based on the provided information, the Digital Ultrasonic Diagnostic Imaging System is a diagnostic imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Digital Ultrasonic Diagnostic Imaging System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatric, small organ(breast, thyroid, testes), neonatal cephalic, adult cephalic, trans-rectal, trans-vaginal, trans-vaginal, (conventional, superficial), musculo-skeletal cardiac(adult, pediatric), peripheral vascular and urology exams.
Product codes
IYN, IYO, ITX
Device Description
The DP-20 and DP-30 Digital Ultrasonic Diagnostic Imaging System are general purpose, portable/mobile (with mobile ultrasound trolley), software controlled, ultrasonic diagnostic systems. Its function is to acquire and display ultrasound data in B-Mode, M-Mode, or their combined mode B+M Mode. The systems are Track 3 device that employs an array of transducers including linear array and convex array. The frequency range of DP-20 is approximately 2.0 MHz to 10.0 MHz and that of DP-30 is approximately 2.0 MHz to 12.0 MHz.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasonic
Anatomical Site
fetal, abdominal, pediatric, small organ(breast, thyroid, testes), neonatal cephalic, adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal(conventional, superficial), cardiac(adult, pediatric), peripheral vascular and urology
Indicated Patient Age Range
adults, pregnant women, pediatric patients and neonates.
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not applicable. The subject of this submission, DP-20 and DP-30 Digital Ultrasonic Diagnostic Imaging System, does not require clinical studies to support substantial equivelance.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
K130833
Page 1 of 3
510(K) SUMMARY
JUN 2 1 2013
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 5658 Fax: +86 755 2658 2680
Contact Person:
Wu Zicui 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: February 01, 2013
2. Device Name:
DP-20 Digital Ultrasonic Diagnostic Imaging System DP-30 Digital Ultrasonic Diagnostic Imaging System Classification Regulatory Class: II Review Category: Tier II 21 CFR 892.1550 Ultrasonic Pulsed Doppler Imaging System (1YN) 21 CFR 892.1560 Ultrasonic Pulsed Echo Imaging System (IYO) 21 CFR 892.1570 Diagnostic Ultrasound Transducer (ITX)
3. Device Description:
The DP-20 and DP-30 Digital Ultrasonic Diagnostic Imaging System are general purpose, portable/mobile (with mobile ultrasound trolley), software controlled, ultrasonic diagnostic systems. Its function is to acquire and display ultrasound data in B-Mode,
Image /page/0/Picture/16 description: The image shows the text "006-1" in a bold, sans-serif font. The numbers are large and easily readable. The text appears to be a label or identifier, possibly indicating a page number or a reference code.
1
M-Mode, or their combined mode B+M Mode. The systems are Track 3 device that employs an array of transducers including linear array and convex array. The frequency range of DP-20 is approximately 2.0 MHz to 10.0 MHz and that of DP-30 is approximately 2.0 MHz to 12.0 MHz.
4. Intended Use:
The Digital Ultrasonic Diagnostic Imaging System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatric, small organ(breast, thyroid, testes), neonatal cephalic, adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal(conventional, superficial), cardiac(adult, pediatric), peripheral vascular and urology exams.
5. Comparison with Predicate Devices:
DP-20 and DP-30 Digital Ultrasonic Diagnostic Imaging System is comparable with and substantially equivalent to these predicate devices:
| Predicate
Device | Manufacturer | Model | 510(k)
Number |
|---------------------|--------------|-------------|------------------|
| 1 | Mindray | DP-20/DP-30 | K113153 |
| 2 | Mindray | Z6 | K122010 |
| 3 | Mindray | M7 | K121010 |
They have the same technological characteristics, are comparable in key safety and effectiveness features, and have the same intended uses and basic operating modes as the predicate devices.
The subject devices have been tested under IEC 60601-1-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-1-4, IEC 60601-2-37 and their software has been verified and validated. These tests can support that the subject device is substantial equivalent to the predicate devices in aspect of safety and effectiveness.
6. Non-clinical Tests:
DP-20 and DP-30 Digital Ultrasonic Diagnostic Imaging System has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical and mechanical safety, and has been found to conform with applicable medical safety standards. This device has been designed to meet the following standards: UEMA UD 2, UEMA UD 3, IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-1-4, IEC 60601-2-37,UL 60601-1, ISO14971 and ISO 10993-1, IEC 62366, IEC 62304.
7. Clinical Studies
Not applicable. The subject of this submission, DP-20 and DP-30 Digital Ultrasonic
2
K 130833
Page 3 of 3
Diagnostic Imaging System, does not require clinical studies to support substantial equivelance.
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-20 and DP-30 Digital Ultrasonic Diagnostic Imaging System is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized symbol that resembles a person embracing or supporting another person, often interpreted as representing health and human services.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 21, 2013
Shenzhen Mindray Bio-Medical Electronics Co., Ltd. % Susan D. Goldstein-Falk Official Correspondent MDI Consultants, Inc. 55 Northern Blvd., Suite 200 GREAT NECK NY 11021
Re: K130833
Trade/Device Name: DP-20/DP-30 Digital Ultrasonic Diagnostic Imaging System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: March 1, 2013 Received: March 26, 2013
Dear Ms. Goldstein-Falk:
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.
This determination of substantial equivalence applies to the following transducers intended for use with the DP-20/DP-30 Digital Ultrasonic Diagnostic Imaging System, as described in your premarket notification:
Transducer Model Number
| 35C20EA | 35C50EB | 65C15EA |
|---|---|---|
| SECIOEB | 75L38EB | 75L53EA |
| 35C50EA | 65EC10EA | 75L38EA |
| CALL TULL |
4
Page 2 - Ms. Goldstein-Falk
If your device is classified (see above) into either class 11 (Special Controls) or class 111 (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 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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/McdicalDevices/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industrv/default.htm.
Sincerely yours,
Smh.7)
for
Janine M. Morris Director. Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K130833
Device Name: DP-20 Digital Ultrasonic Diagnostic Imaging System DP-30 Digital Ultrasonic Diagnostic Imaging System
Indications for Use:
The Digital Ultrasonic Diagnostic Imaging System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatric, small organ(breast, thyroid, testes), neonatal cephalic, adult cephalic, trans-rectal, trans-vaginal, trans-vaginal, (conventional, superficial), musculo-skeletal cardiac(adult, pediatric), peripheral vascular and urology exams.
Prescription Use______________________ The - Counter Use_ (21 CFR Part 807 Subpart C) (21 CFR Part 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic and Radiological Health (OJR)
Sm(n,7)
(Division Sign Off) Division of Radiological Health 510(k) == K130833_____________________________________________________________________________________________________________________________________________________________
008-1
6
System Model: 510(k) Number(s) DP-20 Digital Ultrasonic Diagnostic Imaging System DP-20 -
| Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | PWD | CWD | Color | |||
| Doppler | Amplitude | |||||||
| Doppler | Combined | |||||||
| (specify) | Other (specify) | |||||||
| Ophthalmic | ||||||||
| Fetal | P | P | P | Note 1, Note 2 | ||||
| Abdominal | P | P | P | Note 1, Note 2 | ||||
| Intraoperative (specify)* | ||||||||
| Intraoperative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | Note 1, Note 2 | ||||
| Small organ(specify)** | P | P | P | Note 2 | ||||
| Neonatal Cephalic | P | P | P | Note 2 | ||||
| Adult Cephalic | P | P | P | Note 2 | ||||
| Trans-rectal | P | P | P | Note 2 | ||||
| Trans-vaginal | P | P | P | Note 2 | ||||
| Trans-urethral | ||||||||
| Trans-esoph.(non-Card.) | ||||||||
| Musculo-skeletal Conventional | P | P | P | Note 1, Note 2 | ||||
| Musculo-skeletal Superficial | P | P | P | Note 2 | ||||
| Intravascular | ||||||||
| Cardiac Adult | P | P | P | Note 2 | ||||
| Cardiac Pediatric | P | P | P | Note 2 | ||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph (Cardiac) | ||||||||
| Intra-Cardiac | ||||||||
| Peripheral Vascular | P | P | P | Note 2 | ||||
| Other (specify)*** | P | P | P | Note 1, Note 2 | ||||
| N=new indication; P=previously cleared by FDA; E=added under Appendix E | ||||||||
| Additional comments: Combined modes: B+M. | ||||||||
| * Small organ-breast, thyroid, testes, etc. | ||||||||
| ** 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) |
7
System Transducer Model: S10(k) Number(s)
DP-20 Digital Ultrasonic Diagnostic Imaging System 35C20EA
Mode of Operation Clinical Application Amplitude Combined Color PWD CWD B M Other (specify) (specify) Doppler Doppler Ophthalmic Fclal p P P Abdominal Nore 2 Intraoperative (specify)* Intraoperative (Neuro) Laparoscopic Pediatric P P P Note Z Small organ(specify)** Neonatal Cephalic Adult Cephalic Trans-reclai Trans-vaginal Trans-urethral Trans-csoph (non-Card.) P Musculo-skeletal Conventional P P Note 2 Musculo-skeletal Superticial Intravascular Cardiac Adult p p P Note 2 Cardiac Pediatric Intravascular (Cardiac) Trans-esoph (Cardiac) Intra-Cardiac P Peripheral Vascular P P Note 2 Other (specify) *** N=new indication; P=previously cleared by FDA; E=added under Appendix E Additional comments: Combined modes: B+M. *Small organ-breast, thyroid, testes, etc. **Other use includes Urology. Note I : 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)
8
System Transducer Model: 510(k) Number(s)
DP-20 Digital Ultrasonic Diagnostic Imaging System 35C50EB -
.
| Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | PWD | CWD | Color | |||
| Doppler | Amplitude | |||||||
| Doppler | Combined | |||||||
| (specify) | Other (specify) | |||||||
| Ophthalmic | ||||||||
| Fetal | P | P | P | Note 1, Note 2 | ||||
| Abdominal | P | P | P | Note 1, Note 2 | ||||
| Intraoperative (specify)* | ||||||||
| Intraoperative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | Note 1, Note 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, Note 2 | ||||
| Musculo-skeletal Superficial | ||||||||
| Intravascular | ||||||||
| Cardiac Adult | ||||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph (Cardiac) | ||||||||
| Intra-Cardiac | ||||||||
| Peripheral Vascular | ||||||||
| Other (specify)*** | P | P | P | Note 1, Note 2 | ||||
| N=new indication; P=previously cleared by FDA; E=added under Appendix E | ||||||||
| Additional comments: Combined modes: B+M. | ||||||||
| *Small organ-breast, thyroid, testes, etc. | ||||||||
| **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)
008-4
·
9
System Transducer Model: 510(k) Number(s)
DP-20 Digital Ultrasonic Diagnostic Imaging System 65C15EA
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | PWD | CWD | Color | |||||
| Doppler | Amplitude | |||||||||
| Doppler | Combined | |||||||||
| (specify) | Other {specify } | |||||||||
| Ophihalmic | ||||||||||
| Feul | ||||||||||
| Abdominal | p | P | P | Nole 2 | ||||||
| Intraoperative (specify)* | ||||||||||
| Intraoperative (Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | P | P | P | Nole 2 | ||||||
| Small organ(specify)** | ||||||||||
| Neonatal Cephalic | P | P | P | Note 2 | ||||||
| Adult Cephalic | P | P | P | Note 2 | ||||||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph (non-Card.) | ||||||||||
| Musculo-skeletal Conventional | P | P | P | Note 2 | ||||||
| Musculo-skeletal Superficial | ||||||||||
| Intravascular | ||||||||||
| Cardiac Adult | ||||||||||
| Cardiac Pediatric | P | P | P | Note 2 | ||||||
| Intravascular (Cardiac) | ||||||||||
| Trans-esoph (Cardiac) | ||||||||||
| Intra-Cardiac | ||||||||||
| Peripheral Vascular | P | P | P | Note 2 | ||||||
| Other (specify) *** | ||||||||||
| N=new indication: P=previously cleared by FDA: E=added under Appendix 1: . | ||||||||||
| Additional comments: Combined modes: B+M. | ||||||||||
| * Small organ-breast, thyroid, testes, etc. | ||||||||||
| ** 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)
10
System Transducer Model: DP-20 Digital Ultrasonic Diagnostic Imaging System 65EC 10EB
510(k) Number(s)
| Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Combined (specify) | Other (specify) |
| Ophthalmic | ||||||||
| Fetal | P | P | P | Note 2 | ||||
| Abdominal | ||||||||
| Intraoperative (specify)* | ||||||||
| Intraoperative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small organ(specify)** | ||||||||
| Neonatal Cephalic | P | P | P | Note 2 | ||||
| Adult Cephalic | ||||||||
| Trans-rectal | P | P | P | Note 2 | ||||
| Trans-vaginal | P | P | P | Note 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)*** | P | P | P | Note 2 | ||||
| N=new indication; P=previously cleared by FDA; E=added under Appendix E | ||||||||
| Additional comments: Combined modes: B+M. | ||||||||
| * Small organ-breast, thyroid, testes, etc. | ||||||||
| ** 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) |
11
System Transducer Model: DP-20 Digital Ultrasonic Diagnostic Imaging System 751.38FB ·
510(k) Number(s)
| Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | PWD | CWD | Color | |||
| Doppler | Amplitude | |||||||
| Doppler | Combined | |||||||
| (specify) | Other (specify) | |||||||
| Ophthalmic | ||||||||
| Fetal | ||||||||
| Abdominal | P | P | P | Note 2 | ||||
| Intraoperative (specify)* | ||||||||
| Intraoperative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | Note 2 | ||||
| Small organ(specify) ** | P | P | P | Note 2 | ||||
| Neonatal Cephalic | P | P | P | Note 2 | ||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph.(non-Card.) | ||||||||
| Musculo-skeletal Conventional | P | P | P | Note 2 | ||||
| Musculo-skeletal Superficial | P | P | P | Note 2 | ||||
| Intravascular | ||||||||
| Cardiac Adult | ||||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph.(Cardiac) | ||||||||
| Intra-Cardiac | ||||||||
| Peripheral Vascular | P | P | P | Note 2 | ||||
| Other (specify) *** | ||||||||
| N=new indication; P=previously cleared by FDA; E=added under Appendix E | ||||||||
| Additional comments: Combined modes: B+M. | ||||||||
| * Small organ-breast, thyroid, testes, etc. | ||||||||
| ** Other use includes Urology. | ||||||||
| Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents. |
Prescription USE (Per 21 CFR 801.109)
Note 2: Biopsy Guidance
Concurrence of CDRH, Office of Device Evaluation(ODE)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
12
Syslem Transducer Model: 510(k) Number(s)
DP-20 Digital Ultrusonic Diagnostic Imaging System 75L53EA
| Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | PWD | CWD | Color | |||
| Doppler | Amplitude | |||||||
| Doppler | Combined | |||||||
| (specify) | Other (specify) | |||||||
| Ophthalmic | ||||||||
| Fetal | ||||||||
| Abdominal | P | P | P | Note 2 | ||||
| Intraoperative (specify)* | ||||||||
| Intraoperative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | Note 2 | ||||
| Small organ(specify)** | P | P | P | Note 2 | ||||
| Neonatal Cephalic | P | P | P | Note 2 | ||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph.(non-Card.) | ||||||||
| Musculo-skeletal Conventional | P | P | P | Note 2 | ||||
| Musculo-skeletal Superficial | P | P | P | Note 2 | ||||
| Intravascular | ||||||||
| Cardiac Adult | ||||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph (Cardiac) | ||||||||
| Intra-Cardiac | ||||||||
| Peripheral Vascular | P | P | P | Note 2 | ||||
| Other (specify)*** | ||||||||
| N=new indication; P=previously cleared by FDA; E=added under Appendix E | ||||||||
| Additional comments: Combined modes: B+M. | ||||||||
| * Small organ-breast, thyroid, testes, etc. | ||||||||
| ** 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)
.
13
System Model: 510(k) Number(s) DP-30 Digital Ultrasonic Diagnostic Imaging System DP-30
| Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | ||||||||
| Doppler | Combined | ||||||||
| (specify) | Other (specify) | ||||||||
| Ophthalmic | |||||||||
| Fetal | P | P | P | Note 1, Note 2 | |||||
| Abdominal | P | P | P | Note 1, Note 2 | |||||
| Intraoperative (specify)* | |||||||||
| Intraoperative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | P | P | P | Note 1, Note 2 | |||||
| Small organ(specify)** | P | P | P | Note 2 | |||||
| Neonatal Cephalic | P | P | P | Note 2 | |||||
| Adult Cephalic | P | P | P | Note 2 | |||||
| Trans-rectal | P | P | P | Note 2 | |||||
| Trans-vaginal | P | P | P | Note 2 | |||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal Conventional | P | P | P | Note 1, Note 2 | |||||
| Musculo-skeletal Superficial | P | P | P | Note 2 | |||||
| Intravascular | |||||||||
| Cardiac Adult | P | P | P | Note 2 | |||||
| Cardiac Pediatric | P | P | P | Note 2 | |||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-Cardiac | |||||||||
| Peripheral Vascular | P | P | P | Note 2 | |||||
| Other (specify) *** | P | P | P | Note 1, Note 2 | |||||
| N=new indication; P=previously cleared by FDA; E=added under Appendix E | |||||||||
| Additional comments: Combined modes: B+M. | |||||||||
| * Small organ-breast, thyroid, testes, etc. | |||||||||
| ** Other use includes Urology. | |||||||||
| Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents. |
(PLEASE DO NOT WRITE BELOW TIJIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRII, Office of Device Evaluation(ODE)
14
System Transducer Model: DP-30 Digital Ultrasonic Diagnostic Imaging System 35C20FA
510(k) Number(s)
| Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | PWD | CWD | Color | |||
| Doppler | Amplitude | |||||||
| Doppler | Combined | |||||||
| (specify) | Other (specify) | |||||||
| Ophthalmic | ||||||||
| Fetal | ||||||||
| Abdominal | P | P | P | Note 2 | ||||
| Intraoperative (specify)* | ||||||||
| Intraoperative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | Note 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 2 | ||||
| Musculo-skeletal Superficial | ||||||||
| Intravascular | ||||||||
| Cardiac Adult | P | P | P | Note 2 | ||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph.(Cardiac) | ||||||||
| Intra-Cardiac | ||||||||
| Peripheral Vascular | P | P | P | Note 2 | ||||
| Other (specify) *** | ||||||||
| N=new indication; P=previously cleared by FDA; E=added under Appendix E | ||||||||
| Additional comments:Combined modes: B+M. | ||||||||
| *Small organ-breast, thyroid, testes, etc. | ||||||||
| **Other use includes Urology. | ||||||||
| Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents. | ||||||||
| Note 2: Biopsy Guidance |
Concurrence of CDRH, Office of Device Evaluation(ODE)
15
Sysicm Transducer Model: 510(k) Number(s)
.
DP-30 Digital Ultrasonic Diagnostic Imaging System 35C50EA -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
| Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | ||||||||
| Doppler | Combined | ||||||||
| (specify) | Other (specify) | ||||||||
| Ophthalmic | |||||||||
| Fetal | P | P | P | Note1, Note 2 | |||||
| Abdominal | P | P | P | Note1, Note 2 | |||||
| Intraoperative (specify)* | |||||||||
| Intraoperative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | P | P | P | Note1, Note 2 | |||||
| Small organ(specify) ** | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph (non-Card.) | |||||||||
| Musculo-skeletal Conventional | P | P | P | Note1, Note 2 | |||||
| Musculo-skeletal Superficial | |||||||||
| Intravascular | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pedialric | |||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph (Cardiac) | |||||||||
| Intra-Cardiac | |||||||||
| Peripheral Vascular | |||||||||
| Other (specify) ** * | P | P | P | Note1 , Note 2 | |||||
| N=new indication; P=previously cleared by FDA: E=udded under Appendix E | |||||||||
| Additional comments:Combined modes: B+M. | |||||||||
| * Small organ-breast, thyroid, testes, etc. | |||||||||
| ** 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) |
16
System Transducer Model: DP-30 Digital Ultrasonic Diagnostic Imaging System 65C15EA
510(k) Number(s)
| Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | PWD | CWD | Color | |||
| Doppler | Amplitude | |||||||
| Doppler | Combined | |||||||
| (specify) | Other (specify) | |||||||
| Ophthalmic | ||||||||
| Fetal | ||||||||
| Abdominal | P | P | P | Note 2 | ||||
| Intraoperative (specify)* | ||||||||
| Intraoperative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | Note 2 | ||||
| Small organ(specify) ** | ||||||||
| Neonatal Cephalic | P | P | P | Note 2 | ||||
| Adult Cephalic | P | P | P | Note 2 | ||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph (non-Card.) | ||||||||
| Musculo-skeletal Conventional | P | P | P | Note 2 | ||||
| Musculo-skeletal Superficial | ||||||||
| Intravascular | ||||||||
| Cardiac Adult | ||||||||
| Cardiac Pediatric | P | P | P | Note 2 | ||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph.(Cardiac) | ||||||||
| Intra-Cardiac | ||||||||
| Peripheral Vascular | P | P | P | Note 2 | ||||
| Other (specify) *** | ||||||||
| N=new indication: P=previously cleared by FDA: E=added under Appendix E | ||||||||
| Additional comments:Combined modes: B+M. | ||||||||
| * Small organ-breast, thyroid. testes, etc. | ||||||||
| ** 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) |
17
Sysicm Transducer Model: 510(k) Number(s)
DP-30 Digital Ultrasonic Diagnostic Imaging System 65EC10EA
| Clinical Application
Color
Amplitude
Combined
CWD
B
M
PWD
Other (specify)
Doppler
Doppler
(specify)
Ophthalmic
P
Fetal
P
P
Note 2
Abdominal
Intraoperative (specify)*
Intraoperative (Neuro)
Laparoscopic
Pediatric
Small organ(specify) **
Neonatal Cephalic
P
P
P
Nole 2
Adult Cephalic
P
P
P
Note 2
Trans-rectal
P
P
p
Note 2
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Intravascular
Cardiac Adult
| Cardisc Pediatric | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| Intravascular (Cardiac) | ||||||||
| Trans-esoph (Cardiac) | ||||||||
| Intra-Cardiac | ||||||||
| Peripheral Vascular | ||||||||
| Other (specify) *** | ||||||||
| P | ||||||||
| Note 2 | ||||||||
| P | ||||||||
| P | ||||||||
| N=new indication; P=previously cleared by FDA; E=added under Appendix E | ||||||||
| Additional comments: Combined modes: B+M. | ||||||||
| * Small organ-breast, thyroid, testes, etc. | ||||||||
| ** 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) |
Prescription USE (Per 21 CFR 801.109)
Concurrence of CDRH, Office of Device Evaluation(ODE)
18
System Transducer Model: DP-30 Digital Ultrasonic Diagnostic Imaging System 75L38EA
.
・
510(k) Number(s)
| Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | PWD | CWD | Color | |||
| Doppler | Amplitude | |||||||
| Doppler | Combined | |||||||
| (specify) | Other (specify) | |||||||
| Ophthalmic | ||||||||
| Fetal | ||||||||
| Abdominal | P | P | P | Note 2 | ||||
| Intraoperative (specify)* | ||||||||
| Intraoperative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | Note 2 | ||||
| Small organ(specify) ** | P | P | P | Note 2 | ||||
| Neonatal Cephalic | P | P | P | Note 2 | ||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph.(non-Card.) | ||||||||
| Musculo-skeletal Conventional | P | P | P | Note 2 | ||||
| Musculo-skeletal Superficial | P | P | P | Note 2 | ||||
| Intravascular | ||||||||
| Cardiac Adult | ||||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph.(Cardiac) | ||||||||
| Intra-Cardiac | ||||||||
| Peripheral Vascular | P | P | P | Note 2 | ||||
| Other (specify) *** | ||||||||
| N=new indication; P=previously cleared by FDA; E=added under Appendix E. | ||||||||
| Additional comments:Combined modes: B+M. | ||||||||
| ** Small organ-breast, thyroid, testes, etc. | ||||||||
| *** 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) | ||||||||
19
System Transducer Model: 510(k) Number(s)
DP-30 Digital Ultrasonic Diagnostic Imaging System 75L53EA
.
| Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | PWD | CWD | Color | |||
| Doppler | Amplitude | |||||||
| Doppler | Combined | |||||||
| (specify) | Other (specify) | |||||||
| Ophthalmic | ||||||||
| Fetal | ||||||||
| Abdominal | P | P | P | Note 2 | ||||
| Intraoperative (specify)* | ||||||||
| Intraoperative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | Note 2 | ||||
| Small organ(specify)** | P | P | P | Note 2 | ||||
| Neonatal Cephalic | P | P | P | Note 2 | ||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph (non-Card.) | ||||||||
| Musculo-skeletal Conventional | P | P | P | Note 2 | ||||
| Musculo-skeletal Superficial | P | P | P | Note 2 | ||||
| Intravascular | ||||||||
| Cardiac Adult | ||||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-Cardiac | ||||||||
| Peripheral Vascular | P | P | P | Note 2 | ||||
| Other (specify) *** | ||||||||
| N=new indication; P=previously cleared by FDA; E=added under Appendix E | ||||||||
| Additional comments: Combined modes: B+M. | ||||||||
| * Small organ-breast, thyroid, testes, etc. | ||||||||
| ** 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) |
20
System Transducer Model: 510(k) Number(s)
DP-30 Digital Ultrasonic Diagnostic Imaging System IOL24EA
| Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | છે | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | ||||||||
| Doppler | Combined | ||||||||
| (specify) | Other (specify) | ||||||||
| Ophthalmic | |||||||||
| Fetal | |||||||||
| Abdominal | |||||||||
| Intraoperative (specify)® | |||||||||
| Intraoperative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small organ(specify)" | p | P | P | Note 2 | |||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal Conventional | P | P | P | Note 2 | |||||
| Musculo-skeletal Superficial | P | P | P | Note 2 | |||||
| Intravascular | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph (Cardiac) | |||||||||
| Intra-Cardiac | |||||||||
| Peripheral Vascular | P | p | P | Note 2 | |||||
| Other (specify) *** | |||||||||
| N=new indication: P=previously cleared by FDA: E=added under Appendix E | |||||||||
| Additional comments:Combined modes: B+M. | |||||||||
| * Small organ-breast, thyroid, testes, etc. | |||||||||
| * * Other use includes Urology. | |||||||||
| Note I: 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) |