(14 days)
K#072164, K#070526, K#060949, K061129
Not Found
No
The document describes a standard ultrasound imaging system and does not mention any AI or ML capabilities in the device description, intended use, or performance studies.
No
The device is described as a "diagnostic imaging system" and its intended use is for "ultrasound evaluation," which are diagnostic rather than therapeutic functions.
Yes
The "Device Description" explicitly states "The DP-6900 Digital Ultrasonic Diagnostic Imaging System is a general purpose, portable, software controlled, ultrasound diagnostic system."
No
The device description explicitly states it is a "Digital Ultrasonic Diagnostic Imaging System" and employs "an array of probes," indicating it includes hardware components beyond just software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The description clearly states the device is an "ultrasound diagnostic system" that "acquire[s] and display[s] ultrasound images." Ultrasound is a non-invasive imaging technique that uses sound waves to create images of internal body structures within the body.
- Intended Use: The intended use describes the device being used for "ultrasound evaluation of abdominal, cardiac, small parts, etc." This is a direct imaging procedure performed on the patient, not a test performed on a specimen.
Therefore, based on the provided information, the DP-6900 Digital Ultrasonic Diagnostic Imaging System is an in vivo diagnostic imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The device is intended for use by a qualified physician for ultrasound evaluation of abdominal, cardiac, small parts (breast, testes, thyroid, etc.), urology, peripheral vascular, intraoperative, pediatric, cephalic, fetal, transrectal, transvaginal, neonatal musculoskeletal (general and superficial).
Product codes (comma separated list FDA assigned to the subject device)
IYO, ITX
Device Description
The DP-6900 Digital Ultrasonic Diagnostic Imaging System is a general purpose, portable, software controlled, ultrasound diagnostic system. Its function is to acquire and display ultrasound images in B-Mode, M-Mode or the combined mode (i.e. B/M Mode). This system is a Track 1 device that employs an array of probes that include linear array and convex array with a frequency range of approximately 2.0 MHz to 10.0 MHz.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
abdominal, cardiac, small parts (breast, testes, thyroid, etc.), urology, peripheral vascular, intraoperative (abdominal, thoracic, vascular, neuro), pediatric, cephalic (neonatal and adult), fetal, transrectal, transvaginal, musculoskeletal (general and superficial)
Indicated Patient Age Range
pediatric, neonatal, adult, fetal
Intended User / Care Setting
qualified physician
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)
The DP-6900 Digital Ultrasonic Diagnostic Imaging System had been tested as Track 1 Device per the FDA Guidance document "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" issued in September 2008. The acoustic output is measured and calculated per NEMA UD 2: 2004 Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment. The device conforms to applicable medical device safety standards, such as IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-2-37, IEC 60601-1-4 and ISO 10993-1.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K#072164, K#070526, K#060949, K061129
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1570 Diagnostic ultrasonic transducer.
(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.
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: K090912
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 2658 2888 Fax: +86 755 2658 2680
Contact Person:
Tan Chuanbin 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: March 6, 2009
- Device Name: DP-6900 Digital Ultrasonic Diagnostic Imaging System
Classification
Regulatory Class: II Review Category: Tier II 21 CFR 892.1560 Ultrasonic Pulsed Echo Imaging System (90-1YO) 21 CFR 892.1570 Diagnostic Ultrasound Transducer (90-ITX)
3. Marketed Device:
DP-6900 Digital Ultrasonic Diagnostic Imaging System is substantially equivalent to the following devices: Mindray DC-6 (K#072164), Mindray DP-9900 (K#070526), Mindray DP-6600 (K#060949) and GE Logiq 9 (K061129).
4. Device Description:
The DP-6900 Digital Ultrasonic Diagnostic Imaging System is a general purpose,
1
portable, software controlled, ultrasound diagnostic system. Its function is to acquire and display ultrasound images in B-Mode, M-Mode or the combined mode (i.e. B/M Mode). This system is a Track 1 device that employs an array of probes that include linear array and convex array with a frequency range of approximately 2.0 MHz to 10.0 MHz.
5. Intended Use:
The device is intended for use by a qualified physician for ultrasound evaluation of abdominal, cardiac, small parts (breast, testes, thyroid, etc.), urology, peripheral vascular, intraoperative, pediatric, cephalic, fetal, transrectal, transvaginal, neonatal musculoskeletal (general and superficial).
6. Safety Considerations:
The DP-6900 Digital Ultrasonic Diagnostic Imaging System had been tested as Track 1 Device per the FDA Guidance document "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" issued in September 2008. The acoustic output is measured and calculated per NEMA UD 2: 2004 Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment. The device conforms to applicable medical device safety standards, such as IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-2-37, IEC 60601-1-4 and ISO 10993-1.
Conclusion:
The conclusions drawn from testing of the DP-6900 Digital Ultrasonic Diagnostic Imaging System demonstrate that the device is as safe and effective as the legally marketed predicate devices.
2
Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is black. The text is centered on the image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 5 2009
Shenzhen Mindray Bio-Medical Electronics Co., Ltd. % Mr. Robert Mosenkis President CITECH 5200 Butler Pike Plymouth Meeting, PA 19462-1298
Re: K090912
Trade/Device Name: DP-6900 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: March 31, 2009 Received: April 1, 2009
Dear Mr. Mosenkis:
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-6900 Digital Ultrasonic Diagnostic Imaging System, as described in your premarket notification:
Transducer Model Number
35C20EA 35C50EA 65EC10EA 65C15EA 65EL60EA
3
Image /page/3/Picture/1 description: The image shows a list of codes. The codes are 75L38EA, 75LT38EA, 75L53EA, and 75L60EA. Each code is underlined. The codes appear to be product or part numbers.
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 Paul Hardy at (240) 276-3666.
Sincerely yours,
Herbet Leiner
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
4
Diagnostic Ultrasound Indications for Use Form
Transducer
System Model:
510(k) Number(s)
×
DP-6900
1090912
| Clinical Application | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| General | Specific | B | M | PWD | CWD | Color | |||
| Doppler | Amplitude | ||||||||
| Doppler | Combined | ||||||||
| (specify) | Other (specify) | ||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | N | N | N | Note 1 | |||||
| Abdominal | N | N | N | Note 1 | |||||
| Intra-operative (Specify)* | N | N | N | ||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | N | N | N | Note 1 | |||||
| Small Organ(Specify) ** | N | N | N | ||||||
| Neonatal Cephalic | N | N | N | ||||||
| Fetal Imaging & Other | Adult Cephalic | N | N | N | |||||
| Trans-rectal | N | N | N | ||||||
| Trans-vaginal | N | N | N | ||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal (Conventional) | N | N | N | Note 1 | |||||
| Musculo-skeletal (Superficial) | N | N | N | ||||||
| Intravascular | |||||||||
| Other (specify) | |||||||||
| Cardiac Adult | N | N | N | ||||||
| Cardiac Pediatric | N | N | N | ||||||
| Cardiac | Intravascular(Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (specify) | |||||||||
| Peripheral vessel | N | N | N | Note 1 | |||||
| Peripheral vessel | Other (Specify) |
- Intraoperative includes abdominal, thoracic, and vascular etc. ** Small organ-breast, thyroid, testes, etc.
Note I : Tissue Harmonic Imaging. The feature does not use contrast agents.
(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)
Heidi Lema
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
KC)
0046
5
Diagnostic Ultrasound Indications for Use Form
Transducer
System Model:
::
35C20EA
k09912
| Clinical Application | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| General | Specific | B | M | PWD | CWD | Color | |||
| Doppler | Amplitude | ||||||||
| Doppler | Combined | ||||||||
| (specify) | Other (specify) | ||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Abdominal | N | N | N | ||||||
| Intra-operative (Specify)* | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | N | N | N | ||||||
| Small Organ(Specify) ** | |||||||||
| Neonatal Cephalic | |||||||||
| Fetal Imaging & Other | Adult Cephalic | ||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph.(non-Card.) | |||||||||
| Musculo-skeletal (Conventional) | N | N | N | ||||||
| Musculo-skeletal (Superficial) | |||||||||
| Intravascular | |||||||||
| Other (specify) | |||||||||
| Cardiac Adult | N | N | N | ||||||
| Cardiac Pediatric | N | N | N | ||||||
| Intravascular(Cardiac) | |||||||||
| Cardiac | Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | |||||||||
| Other (specify) | |||||||||
| Peripheral vessel | N | N | N | ||||||
| Peripheral vessel | Other(Specify) |
- Intraoperative includes abdominal, thoracic, and vascular etc. ** Small organ-breast, thyroid, testes, etc.
Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
(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)
Helene
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Device 510(k) Number
6
| System | Transducer | x | |
|---|---|---|---|
| Model: | 35C50EA | ||
| 510(k) Number(s) | K090912 |
Clinical Application
| Clinical Application | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| General | Specific | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Combined | |||||||||
| (specify) | Other (specify) | |||||||||
| Ophthalmic | Ophthalmic | |||||||||
| Fetal | N | N | N | Note 1 | ||||||
| Abdominal | N | N | N | Note 1 | ||||||
| Intra-operative (Specify)* | ||||||||||
| Intra-operative (Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | N | N | N | Note 1 | ||||||
| Small Organ (Specify)** | ||||||||||
| Neonatal Cephalic | ||||||||||
| Fetal Imaging & Other | Adult Cephalic | |||||||||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph. (non-Card.) | ||||||||||
| Musculo-skeletal (Conventional) | N | N | N | Note 1 | ||||||
| Musculo-skeletal (Superficial) | ||||||||||
| Intravascular | ||||||||||
| Other (specify) | ||||||||||
| Cardiac Adult | ||||||||||
| Cardiac Pediatric | ||||||||||
| Cardiac | Intravascular(Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | ||||||||||
| Intra-cardiac | ||||||||||
| Other (specify) | ||||||||||
| Peripheral vessel | Peripheral vessel | N | N | N | Note 1 | |||||
| Other (Specify) |
V=new indication; P=previously cleared by FDA; E=added under Appendix E
Additional comments: Combined modes: B+M.
- Intraoperative includes abdominal, thoracic, and vascular etc.
** Small organ-breast, thyroid, testes, etc.
Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
(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)
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devic 510(k) Number
7
Mindray Co. Ltd. - DP-6900 Digital Ultrasonic Diagnostic Imaging System
6SECIOEA
Diagnostic Ultrasound Indications for Use Form
System Model: Transducer
510(k) Number(s)
| Clinical Application | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| General | Specific | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Combined | |||||||||
| (specify) | Other (specify) | |||||||||
| Ophthalmic | Ophthalmic | |||||||||
| Fetal Imaging & Other | Fetal | N | N | N | ||||||
| Abdominal | ||||||||||
| Intra-operative (Specify)* | ||||||||||
| Intra-operative (Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | ||||||||||
| Small Organ(Specify) ** | ||||||||||
| Neonatal Cephalic | N | N | N | |||||||
| Adult Cephalic | ||||||||||
| Trans-rectal | N | N | N | |||||||
| Trans-vaginal | N | N | N | |||||||
| Trans-urethral | ||||||||||
| Trans-esoph.(non-Card.) | ||||||||||
| Musculo-skeletal (Conventional) | ||||||||||
| Musculo-skeletal (Superficial) | ||||||||||
| Intravascular | ||||||||||
| Other (specify) | ||||||||||
| Cardiac Adult | ||||||||||
| Cardiac Pediatric | ||||||||||
| Intravascular(Cardiac) | ||||||||||
| Cardiac | Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | ||||||||||
| Other (specify) | ||||||||||
| Peripheral vessel | ||||||||||
| Peripheral vessel | Other(Specify) |
Additional comments:Combined modes: B+M.
- Intraoperative includes abdominal, thoracic, and vascular etc.
** Small organ-breast, thyroid, testes, etc.
Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
(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)
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
8
65C15EA
Diagnostic Ultrasound Indications for Use Form
×
Transducer
System Model: .
| Clinical Application | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| General | Specific | B | M | PWD | CWD | Color | |||
| Doppler | Amplitude | ||||||||
| Doppler | Combined | ||||||||
| (specify) | Other (specify) | ||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Abdominal | N | N | N | ||||||
| Intra-operative (Specify)* | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | N | N | N | ||||||
| Small Organ(Specify) ** | |||||||||
| Neonatal Cephalic | N | N | N | ||||||
| Fetal Imaging & Other | Adult Cephalic | N | N | N | |||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph.(non-Card.) | |||||||||
| Musculo-skeletal (Conventional) | N | N | N | ||||||
| Musculo-skeletal (Superficial) | |||||||||
| Intravascular | |||||||||
| Other (specify) | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | N | N | N | ||||||
| Cardiac | Intravascular(Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (specify) | |||||||||
| Peripheral vessel | Peripheral vessel | N | N | N | |||||
| Other(Specify) |
** Small organ-breast, thyroid, testes, etc.
Note I: Tissue Harmonic Imaging. The feature does not use contrast agents.
(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)
Harlan Leinen
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Device 510(k) Number
9
| System | |
|---|---|
| Model: | 65EL60EA |
| 510(k) Number(s) | K090912 |
Clinical Application
| B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Combined (specify) | Other (specify) | ||
|---|---|---|---|---|---|---|---|---|---|
| General | |||||||||
| Ophthalmic | |||||||||
| Specific | |||||||||
| Ophthalmic | |||||||||
| Fetal | |||||||||
| Abdominal | |||||||||
| Intra-operative (Specify)* | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ(Specify)** | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Fetal Imaging & Other | |||||||||
| Trans-rectal | N | N | N | ||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal (Conventional) | |||||||||
| Musculo-skeletal (Superficial) | |||||||||
| Intravascular | |||||||||
| Other (specify) | |||||||||
| Cardiac | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Intravascular(Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (specify) | |||||||||
| Peripheral vessel | Peripheral vessel | ||||||||
| 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 etc.
**Small organ-breast thyroid testes etc
** Small organ-breast, thyroid, testes, etc.
Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
(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)
Lulu Lemon
(Division Sign-Off) Division of Reproductive, Abdominal a Radiological Devices 510(k) Number
0051
10
ANG
Diagnostic Ultrasound Indications for Use Form
Transducer
System
Model:
510(k) Number(s)
| Clinical Application | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| General | Specific | B | M | PWD | CWD | Color | |||
| Doppler | Amplitude | ||||||||
| Doppler | Combined | ||||||||
| (specify) | Other (specify) | ||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Abdominal | N | N | N | ||||||
| Intra-operative (Specify)* | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | N | N | N | ||||||
| Small Organ(Specify)** | N | N | N | ||||||
| Neonatal Cephalic | N | N | N | ||||||
| Fetal Imaging & Other | Adult Cephalic | ||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph.(non-Card.) | |||||||||
| Musculo-skeletal (Conventional) | N | N | N | ||||||
| Musculo-skeletal (Superficial) | N | N | N | ||||||
| Intravascular | |||||||||
| Other (specify) | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Intravascular(Cardiac) | |||||||||
| Cardiac | Trans-esoph.(Cardiac) | ||||||||
| Intra-cardiac | |||||||||
| Other (specify) | |||||||||
| Peripheral vessel | N | N | N | ||||||
| Peripheral vessel | 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.
Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
(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)
Halut Rener
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
11
Mindray Co. Ltd.- DP-6900 Digital Ultrasonic Diagnostic Imaging System
| System | Transducer | x | |||||||
|---|---|---|---|---|---|---|---|---|---|
| Model: | 75LT38EA | ||||||||
| 510(k) Number(s) | K090912 | ||||||||
| Clinical Application | |||||||||
| General | Specific | B | M | PWD | CWD | Color | |||
| Doppler | Amplitude | ||||||||
| Doppler | Combined | ||||||||
| (specify) | Other (specify) | ||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Abdominal | N | N | N | ||||||
| Intra-operative (Specify)* | N | N | N | ||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | N | N | N | ||||||
| Small Organ(Specify) ** | N | N | N | ||||||
| Neonatal Cephalic | N | N | N | ||||||
| Fetal Imaging & Other | Adult Cephalic | ||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal (Conventional) | N | N | N | ||||||
| Musculo-skeletal (Superficial) | N | N | N | ||||||
| Intravascular | |||||||||
| Other (specify) | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Intravascular(Cardiac) | |||||||||
| Cardiac | Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | |||||||||
| Other (specify) | |||||||||
| Peripheral vessel | N | N | N | ||||||
| Other(Specify) | |||||||||
| Peripheral vessel | N=new indication; P=previously cleared by FDA; E=added under Appendix E |
Additional comments: Combined modes: B+M.Diagnostic Ultrasound Indications for Use Form
· Intraoperative includes abdominal, thoracic, and vascular etc. ** Small organ-breast, thyroid, testes, etc.
Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
(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)
(Division Sign-Off) Division of Reproductive, Abdominal and Radiologic 510(k) Nur
12
Diagnostic Ultrasound Indications for Use Form
Transducer
System Model:
510(k) Number(s)
75L53EA K0909
| Clinical Application | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| General | Specific | B | M | PWD | CWD | Color | |||
| Doppler | Amplitude | ||||||||
| Doppler | Combined | ||||||||
| (specify) | Other (specify) | ||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Abdominal | N | N | N | ||||||
| Intra-operative (Specify)* | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | N | N | N | ||||||
| Small Organ(Specify) ** | N | N | N | ||||||
| Neonatal Cephalic | N | N | N | ||||||
| Fetal Imaging & Other | Adult Cephalic | ||||||||
| Trans-reclal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph (non-Card.) | |||||||||
| Musculo-skeletal (Conventional) | N | N | N | ||||||
| Musculo-skeletal (Superficial) | N | N | N | ||||||
| Intravescular | |||||||||
| Other (specify) | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Intravascular(Cardiac) | |||||||||
| Cardiac | Trans-esoph.(Cardiac) | ||||||||
| Intra-cardiac | |||||||||
| Other (specify) | |||||||||
| Peripheral vessel | Peripheral vessel | N | N | N | |||||
| Other(Specify) |
Additional comments:Combined modes: B+M.
- Intraoperative includes abdominal, thoracic, and vascular etc. ** Small organ-breast, thyroid, testes, etc.
Note I: Tissue Harmonic Imaging. The feature does not use contrast agents.
(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)
Helena
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
13
75L60EA
Diagnostic Ultrasound Indications for Use Form
System
Transducer
· Model:
| Clinical Application | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| General | Specific | B | M | PWD | CWD | Color | |||
| Doppler | Amplitude | ||||||||
| Doppler | Combined | ||||||||
| (specify) | Other (specify) | ||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal Imaging & Other | Fetal | ||||||||
| Abdominal | N | N | N | ||||||
| Intra-operative (Specify)* | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | N | N | N | ||||||
| Small Organ(Specify)** | N | N | N | ||||||
| Neonatal Cephalic | N | N | N | ||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal (Conventional) | N | N | N | ||||||
| Musculo-skeletal (Superficial) | N | N | N | ||||||
| Intravascular | |||||||||
| Other (specify) | |||||||||
| Cardiac | Cardiac Adult | ||||||||
| Cardiac Pediatric | |||||||||
| Intravascular(Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (specify) | |||||||||
| Peripheral vessel | Peripheral vessel | N | N | N | |||||
| Other(Specify) |
the temperature increased as salinity increased.
** Small organ-breast, thyroid, testes, etc.
Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
(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)
(Division Sign=Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
0025