(172 days)
Not Found
No
The document does not mention AI, ML, deep learning, or any related terms, and the description focuses on traditional ultrasound imaging modes and architecture.
No.
The device is described as a "diagnostic ultrasound system" and its basic function is to "acquire ultrasound data and display the image," indicating it is used for diagnosis, not treatment.
Yes
The "Device Description" explicitly states, "The SonoScape SSI-8000 ultrasound system is an integrated preprogrammed color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications." Additionally, the "Predicate Device(s)" section lists other devices with "Diagnostic Ultrasound System" in their names.
No
The device description explicitly states it is an "integrated preprogrammed color ultrasound imaging system" and mentions "all digital architecture with progressive dynamic receive focusing," indicating it includes hardware components beyond just software. It also references testing against standards for acoustic output and electrical safety, which are relevant to hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states the device is a "general-purpose ultrasonic imaging instrument." It uses ultrasound waves to create images of internal structures within the body.
- Intended Use: The intended use is for "evaluation of Fetal, Abdominal, Pediatric, Small Organ... etc." This involves imaging the patient directly, not analyzing samples taken from the patient.
- Input Modality: The input modality is "Ultrasound," which is an in-vivo imaging technique, not an in-vitro diagnostic method.
The device is a diagnostic imaging system, specifically an ultrasound machine, which is a different category of medical device than an IVD.
N/A
Intended Use / Indications for Use
The device device is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic(neonatal and adult), Trans-rectal, Trans-vaginal, Trans-esoph (Cardiac), Peripheral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), Urology and OB/Gyn.
Product codes (comma separated list FDA assigned to the subject device)
IYN, IYO, ITX
Device Description
The SonoScape SSI-8000 ultrasound system is an integrated preprogrammed color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications.
The all digital architecture with progressive dynamic receive focusing allows the system to maximize the utility of all imaging transducers to enhance the diagnostic utility and confidence provided by the system. The exam dependent default setting allows the user to have minimum adjustment for imaging the patient, while the in-depth soft-menu control allows the advanced user to set the system for different situations. The architecture allows cost-effective system integration to a variety of upgrade-able options and features.
This SonoScape system is a general purpose, software controlled, diagnostic ultrasound system. Its basic function is to acquire ultrasound data and display the image in-B-Mode (including Tissue Harmonic Image), M-Mode, TDI, Color-Flow Doppler, Pulsed Doppler and Power Doppler, or a combination of these modes, 3D/4D.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic (neonatal and adult), Trans-rectal, Trans-vaginal, Trans-esoph (Cardiac), Peripheral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (Neonatal and adult), Urology, OB/Gyn.
Indicated Patient Age Range
Neonatal, Pediatric, Adult
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
§ 892.1550 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
Tab 21 PREMARKET NOTIFICATION 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.
Manufacturer:
SonoScape Company Limited
Address: 4/F., Yizhe Building, Yuquan Road,Nanshan, Shenzhen 518051,
P.R.China
Tel: (86) 755-26722890
Fax: (86) 755-26722850
Contact Person: Zhigiang Chen
Name of the device:
- Trade/Proprietary Name:
SSI-8000 Mobile Digital Color Doppler Ultrasound System
-
- Common Name: Diagnostic Ultrasound System and Transducers
-
- Classification:
Regulatory Class: II
Review Category: Tier II
- 21 CFR 892.1550 Ultrasonic Pulsed Doppler Imaging System (90-IYN)
- 21 CFR 892.1560 Ultrasonic Pulsed Echo Imaging System (90-IYO)
- 21 CFR 892.1570 Diagnostic Ultrasound Transducer (90-ITX)
Legally Marketed Predicate Device:
Mindray DC-7 Diagnostic Ultrasound System and Transducers - K092691 SonoScape SSI-5000 Diagnostic Ultrasound System and Transducer -K052042 SonoScape S8 Diagnostic Ultrasound System and Transducer -K092922
1
SonoScape Company LTD
Device Description:
The SonoScape SSI-8000 ultrasound system is an integrated preprogrammed color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications.
The all digital architecture with progressive dynamic receive focusing allows the system to maximize the utility of all imaging transducers to enhance the diagnostic utility and confidence provided by the system. The exam dependent default setting allows the user to have minimum adjustment for imaging the patient, while the in-depth soft-menu control allows the advanced user to set the system for different situations. The architecture allows cost-effective system integration to a variety of upgrade-able options and features.
This SonoScape system is a general purpose, software controlled, diagnostic ultrasound system. Its basic function is to acquire ultrasound data and display the image in-B-Mode (including Tissue Harmonic Image), M-Mode, TDI, Color-Flow Doppler, Pulsed Doppler and Power Doppler, or a combination of these modes, 3D/4D.
Intended Use:
The device device is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic(neonatal and adult), Trans-rectal, Trans-vaginal, Trans-esoph (Cardiac), Peripheral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), Urology and OB/Gyn.
2
Safety Considerations:
The SSI-8000 Diagnostic Ultrasound System with added transducer incorporates the same fundamental technology as the predicate device. The device has been tested as Track 3 Device per the FDA Guidance document "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" issued September 9, 2008. The acoustic output is measured and calculated per NEMA UD 2: 2004 Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment and NEMA UD3: 2004 Standards for Real-time Display of Thermal and Mechanical Acoustic Output Indices on 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, ISO 10993-5 and ISO 10993-10.
Conclusion:
The conclusions drawn from testing of the SSI-8000 Diagnostic Ultrasound System with added transducer demonstrate that the device is as safe and effective as the legally marketed predicate devices.
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or other bird-like figure.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
SONOSCAPE COMPANY LIMITED % Ms. Min Yao Official Correspondent SonoScape America 30251 Cedarbrook Road HAYWARD CA 94544
MAR - 4 2011
Re: K102642
Trade/Device Name: SSI-8000 Mobil Digital Color Doppler Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: February 14, 2011 Received: February 16, 2011
Dear Ms. Yao:
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 SSI-8000 Mobil Digital Color Doppler Ultrasound System, as described in your premarket notification:
Transducer Model Number
2P1 Phased Array 5P1 Phased Array 6V1 Micro-curved Array 6V3 Micro-curved Array C611 Micro-curved Array C362 Curved Array C344 Curved Array
VC6-2 Curved Array L743 Linear Array L741 Linear Array L742 Linear Array MPTEE Multi-plane Array MPTEE mini Milti-plane Array
4
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/CDRH/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) 796-6898.
Sincerely Yours,
Mury S Patl
Mary Pastel. ScD. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure(s)
5
Tab 3 Indications For Use
510(k) Number (if known):
· Device Name: SSI-8000 Mobil Digital Color Doppler Ultrasound System
The SonoScape SSI-8000 device is a general-purpose ultrasonic imaging Indications for Use: instrument intended for use by a qualified physician for evaluation of Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic (neonatal and adult), Trans-rectal, Trans-vaginal, Transesoph (Cardiac), Peripheral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), Urology and OB/Gyn.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (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)
Mury Patil
(Division Sign-Off)
Office of In Vit
Indications For Use
510K K102642
3-1
6
System: Sonoscape SSI-8000 Diagnostic Ultrasound Pulsed Echo System Diagnostic Ultrasound Pulsed Doppler Imaging System
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | Other* | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| General | ||||||||||
| (TRACK 1 | ||||||||||
| ONLY) | Specific | |||||||||
| (TRACKS 1 & 3) | B | M | PWD | CWD | Color | |||||
| Doppler | Power | |||||||||
| (Amplitude) | ||||||||||
| Doppler | Combined | Specify | ||||||||
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Imaging& | ||||||||||
| Other | Ophthalmic | |||||||||
| Fetal | N | N | N | N | N | Note 1 | Notes 2,4,5 | |||
| Abdominal | N | N | N | N | N | Note 1 | Notes 2,4,5 | |||
| Intra-operative Specify | ||||||||||
| Intra-operative Neuro | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | N | N | N | N | N | Note 1 | Notes 2,4 | |||
| Small Organ (specify) | N | N | N | N | N | Note 1 | Notes 2,4,6 | |||
| Neonatal Cephalic | N | N | N | N | N | N | Note 1 | Notes 2,3,4 | ||
| Adult Cephalic | N | N | N | N | N | N | Note 1 | Notes 2,3,4 | ||
| Trans-rectal | N | N | N | N | N | Note 1 | Notes 2,4 | |||
| Trans-vaginal | N | N | N | N | N | Note 1 | Notes 2,4 | |||
| Trans-urethral | ||||||||||
| Trans-esoph.(non-Card) | ||||||||||
| Musculo-skeletal | ||||||||||
| (Conventional) | N | N | N | N | N | Note 1 | Notes 2,4 | |||
| Musculo-skeletal | ||||||||||
| (Superficial) | N | N | N | N | N | Note 1 | Notes 2,4 | |||
| Intravascular | ||||||||||
| Other (Ob/GYN) | N | N | N | N | N | Note 1 | Notes 2,4,5 | |||
| Other (Urology) | N | N | N | N | N | Note 1 | Notes 2, 4 | |||
| Cardiac | Cardiac Adult | N | N | N | N | N | N | Note 1 | Notes 2,3,4 | |
| Cardiac Pediatric | N | N | N | N | N | N | Note 1 | Notes 2,3,4 | ||
| Intravascular(Cardiac) | ||||||||||
| Trans-esoph. (Cardiac) | N | N | N | N | N | N | Note 1 | Notes 2,3,4 | ||
| Intra-cardiac | ||||||||||
| Other (specify) | ||||||||||
| Peripheral | ||||||||||
| Vessel | Peripheral vessel | N | N | N | N | N | Note 1 | Notes 2,4 | ||
| Other (specify) | ||||||||||
| N = new indication; | P = previously cleared by FDA; | E = added under this appendix | ||||||||
| Note 1: Other Combined includes: B/M; B/PWD; B/THI (The feature does not use contrast agents); M/Color M ; B/Color | ||||||||||
| Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD | ||||||||||
| Note 2: Tissue Harmonic Imaging | ||||||||||
| Note 3: TDI | ||||||||||
| Note 4: 3D | ||||||||||
| Note 5: 4D | ||||||||||
| Note 6: Small Organ: breast, thyroid, testes | ||||||||||
| Clinical Application | Mode of Operation | |||||||||
| General | Specific | Color | Power | Other* | Other* | |||||
| (TRACK 1 | ||||||||||
| ONLY) | (TRACKS 1 & 3) | B | M | PWD | CWD | Doppler | (Amplitude) | |||
| Doppler | Combined | Specify | ||||||||
| Ophthalmic | Ophthalmic | |||||||||
| Fetal | Fetal | |||||||||
| Imaging& | ||||||||||
| Other | Abdominal | N | N | N | N | N | Note 1 | Notes 2,4 | ||
| Intra-operative Specify | ||||||||||
| Intra-operative Neuro | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | N | N | N | N | N | N | Note 1 | Notes 2,3,4 | ||
| Adult Cephalic | N | N | N | N | N | N | Note 1 | Notes 2,3,4 | ||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph. (non-Card) | ||||||||||
| Musculo-skeletal | ||||||||||
| (Conventional) | ||||||||||
| Musculo-skeletal | ||||||||||
| (Superficial) | ||||||||||
| Intravascular | ||||||||||
| Other (Ob/GYN) | ||||||||||
| Other (Urology) | ||||||||||
| Cardiac | Cardiac Adult | N | N | N | N | ત્વ | N | Note 1 | Notes 2,3,4 | |
| Cardiac Pediatric | N | N | N | N | N | N | Note 1 | Notes 2,3,4 | ||
| Intravascular(Cardiac) | ||||||||||
| Trans-esoph. (Cardiac) | ||||||||||
| Intra-cardiac | ||||||||||
| Other (specify) | ||||||||||
| Peripheral | Peripheral vessel | |||||||||
| Vessel | Other (specify) | |||||||||
| N = new indication; | P = previously cleared by FDA; | E = added under this appendix | ||||||||
| Note 1: Other Combined includes: B/M; B/PWD; B/THI (The feature does not use contrast agents); M/Color M ; B/Color | ||||||||||
| Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD | ||||||||||
| Note 2: Tissue Harmonic Imaging | Note 3: TDI | Note 4: 3D | Note 5: 4D | |||||||
| Note 6: Small Organ: breast, thyroid, testes | ||||||||||
| Prescription Use | X | AND/OR | Over-The-Counter Use | |||||||
| (Part 21 CFR 801 Subpart D) | (21 CFR 807 Subpart C) | |||||||||
| Clinical Application | Mode of Operation | |||||||||
| General | Specific | Color | Power | Other* | Other* | |||||
| (TRACK 1 | (TRACKS 1 & 3) | B | M | PWD | CWD | Doppler | (Amplitude) | Combined | Specify | |
| ONLY) | Doppler | |||||||||
| Ophthalmic | Ophthalmic | |||||||||
| Fetal | Fetal | |||||||||
| Imaging& | ||||||||||
| Other | Abdominal | |||||||||
| Intra-operative Specify | ||||||||||
| Intra-operative Neuro | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | N | N | N | N | N | Note 1 | Notes 2,4 | |||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | N | N | N | N | N | N | Note 1 | Notes 2,3,4 | ||
| Adult Cephalic | ||||||||||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph. (non-Card) | ||||||||||
| Musculo-skeletal | ||||||||||
| (Conventional) | ||||||||||
| Musculo-skeletal | ||||||||||
| (Superficial) | ||||||||||
| Intravascular | ||||||||||
| Other (Ob/GYN) | ||||||||||
| Other (Urology) | ||||||||||
| Cardiac | Cardiac Adult | |||||||||
| Cardiac Pediatric | N | N | N | N | N | N | Note 1 | Notes 2,3,4 | ||
| Intravascular(Cardiac) | ||||||||||
| Trans-esoph. (Cardiac) | ||||||||||
| Intra-cardiac | ||||||||||
| Other (specify) | ||||||||||
| Peripheral | Peripheral vessel | |||||||||
| Vessel | Other (specify) | |||||||||
| N = new indication; | P = previously cleared by FDA; | E = added under this appendix | ||||||||
| Note 1: Other Combined includes: B/M; B/PWD; B/THI (The feature does not use contrast agents); M/Color M ; B/Color | ||||||||||
| Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD | ||||||||||
| Note 2: Tissue Harmonic Imaging | Note 3: TDI | Note 4: 3D | Note 5: 4D | |||||||
| Note 6: Small Organ: breast, thyroid, testes | ||||||||||
| Prescription Use | X | AND/OR | Over-The-Counter Use | |||||||
| (21 CFR 807 Subpart C) | ||||||||||
| (Part 21 CFR 801 Subpart D) | ||||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) | ||||||||||
| Clinical Application | Mode of Operation | |||||||||
| General | ||||||||||
| (TRACK 1 | ||||||||||
| ONLY) | Specific | |||||||||
| (TRACKS 1 & 3) | B | M | PWD | CWD | Color | |||||
| Doppler | Power | |||||||||
| (Amplitude) | ||||||||||
| Doppler | Other* | |||||||||
| Combined | Other* | |||||||||
| Specify | ||||||||||
| Ophthalmic | Ophthalmic | |||||||||
| Fetal | ||||||||||
| Imaging& | ||||||||||
| Other | Fetal | |||||||||
| Abdominal | ||||||||||
| Intra-operative Specify | ||||||||||
| Intra-operative Neuro | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Trans-rectal | N | N | N | N | N | Note 1 | Notes 2,4 | |||
| Trans-vaginal | N | N | N | N | N | Note 1 | Notes 2,4 | |||
| Trans-urethral | ||||||||||
| Trans-esoph.(non-Card) | ||||||||||
| Musculo-skeletal | ||||||||||
| (Conventional) | ||||||||||
| Musculo-skeletal | ||||||||||
| (Superficial) | ||||||||||
| Intravascular | ||||||||||
| Other (Ob/GYN) | ||||||||||
| Other (Urology) | N | N | N | N | N | Note 1 | Notes 2, 4 | |||
| Cardiac | Cardiac Adult | |||||||||
| Cardiac Pediatric | ||||||||||
| Intravascular(Cardiac) | ||||||||||
| Trans-esoph.(Cardiac) | ||||||||||
| Intra-cardiac | ||||||||||
| Other (specify) | ||||||||||
| Peripheral | ||||||||||
| Vessel | Peripheral vessel | |||||||||
| Other (specify) | ||||||||||
| N = new indication; | Note 1: Other Combined includes: B/M; B/PWD; B/THI (The feature does not use contrast agents); M/Color M ; B/Color | |||||||||
| Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD | P = previously cleared by FDA; | E = added under this appendix | ||||||||
| Note 2: Tissue Harmonic Imaging Note 3: TDI Note 4: 3D Note 5: 4D | ||||||||||
| Note 6: Small Organ: breast, thyroid, testes |
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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) | |
|---|---|
| (Division Sign-Off) | |
| Division of Radiological Devices | |
| Office of In Vitro Diagnostic Device Evaluation and Safety | |
| Indications For Use | |
| 510K | K102642 |
| 3-2 |
7
Transducer: 2P1 Phase Array Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
510K
| นักการ 111 สายา เวที่ตรั้งแต่วันที่ 2011 เมื่อ 100 ม.ค. 2017 17 | |
|---|---|
| ion Sian-Off) | |
| and and the country of the county of the country of the county of the county of the county of the county of the county of the country of the county of the county of the count |
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
K162612
3-3
8
Transducer: 5P1 Phase Array Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Concurrence of CDRH, Office of In Vitro Diagnostic Devi
Vitro Diagnostic Devices (CIVD)
(Division Sign-Off)
Safety Office of In
510K K102642
9
Transducer: 6V1 Micro-curved Array Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Prescription Use - X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
510K
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Mun Patel
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
02642
10
Transducer: 6V3 Micro-curved Array Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| General | ||||||||||
| (TRACK 1 | ||||||||||
| ONLY) | Specific | |||||||||
| (TRACKS 1 & 3) | B | M | PWD | CWD | Color | |||||
| Doppler | Power | |||||||||
| (Amplitude) | ||||||||||
| Doppler | Other* | |||||||||
| Combined | Other* | |||||||||
| Specify | ||||||||||
| Ophthalmic | Ophthalmic | |||||||||
| Fetal | ||||||||||
| Imaging& | ||||||||||
| Other | Fetal | |||||||||
| Abdominal | ||||||||||
| Intra-operative Specify | ||||||||||
| Intra-operative Neuro | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Trans-rectal | N | N | N | N | N | Note 1 | Notes 2,4 | |||
| Trans-vaginal | N | N | N | N | N | Note 1 | Notes 2,4 | |||
| Trans-urethral | ||||||||||
| Trans-esoph.(non-Card) | ||||||||||
| Musculo-skeletal | ||||||||||
| (Conventional) | ||||||||||
| Musculo-skeletal | ||||||||||
| (Superficial) | ||||||||||
| Intravascular | ||||||||||
| Other (Ob/GYN) | ||||||||||
| Other (Urology) | N | N | N | N | N | Note 1 | Notes 2, 4 | |||
| Cardiac | Cardiac Adult | |||||||||
| Cardiac Pediatric | ||||||||||
| Intravascular(Cardiac) | ||||||||||
| Trans-esoph.(Cardiac) | ||||||||||
| Intra-cardiac | ||||||||||
| Other (specify) | ||||||||||
| Peripheral | Peripheral vessel | |||||||||
| Vessel | Other (specify) | |||||||||
| Clinical Application | Mode of Operation | Other* | ||||||||
| General | ||||||||||
| (TRACK 1 | ||||||||||
| ONLY) | Specific | |||||||||
| (TRACKS 1 & 3) | B | M | PWD | CWD | Color | |||||
| Doppler | Power | |||||||||
| (Amplitude) | ||||||||||
| Doppler | Combined | Specify | ||||||||
| Ophthalmic | Ophthalmic | |||||||||
| Fetal | ||||||||||
| Imaging& | ||||||||||
| Other | Fetal | |||||||||
| Abdominal | N | N | N | N | N | Note 1 | Notes 2,4 | |||
| Intra-operative Specify | ||||||||||
| Intra-operative Neuro | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | N | N | N | N | N | Note 1 | Notes 2,4 | |||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | N | N | N | N | N | N | Note 1 | Notes 2,3,4 | ||
| Adult Cephalic | ||||||||||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph.(non-Card) | ||||||||||
| Musculo-skeletal | ||||||||||
| (Conventional) | ||||||||||
| Musculo-skeletal | ||||||||||
| (Superficial) | ||||||||||
| Intravascular | ||||||||||
| Other (Ob/GYN) | ||||||||||
| Other (Urology) | ||||||||||
| Cardiac | Cardiac Adult | |||||||||
| Cardiac Pediatric | N | N | N | N | N | N | Note 1 | Notes 2,3,4 | ||
| 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 this appendix | ||||||||
| Note 1: Other Combined includes: B/M; B/PWD; B/THI (The feature does not use contrast agents); M/Color M ; B/Color | ||||||||||
| Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD | ||||||||||
| Note 2: Tissue Harmonic Imaging | Note 3: TDI | Note 4: 3D | Note 5: 4D | |||||||
| Note 6: Small Organ: breast, thyroid, testes | ||||||||||
| Prescription Use | X | AND/OR | Over-The-Counter Use | |||||||
| (Part 21 CFR 801 Subpart D) | (21 CFR 807 Subpart C) | |||||||||
| Clinical Application | Mode of Operation | |||||||||
| General | ||||||||||
| (TRACK 1 | ||||||||||
| ONLY) | Specific | |||||||||
| (TRACKS 1 & 3) | B | M | PWD | CWD | Color | |||||
| Doppler | Power | |||||||||
| (Amplitude) | ||||||||||
| Doppler | Other* | |||||||||
| Combined | Other* | |||||||||
| Specify | ||||||||||
| Ophthalmic | Ophthalmic | |||||||||
| Fetal | ||||||||||
| Imaging & | ||||||||||
| Other | Fetal | N | N | N | N | N | Note 1 | Notes 2,4 | ||
| Abdominal | N | N | N | N | N | Note1 | Notes 2,4 | |||
| Intra-operative Specify | ||||||||||
| Intra-operative Neuro | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph. (non-Card) | ||||||||||
| Musculo-skeletal | ||||||||||
| (Conventional) | ||||||||||
| Musculo-skeletal | ||||||||||
| (Superficial) | ||||||||||
| Intravascular | ||||||||||
| Other (Ob/GYN) | N | N | N | N | N | Note 1 | Notes 2 4 | |||
| Other (Urology) | N | N | N | N | N | Note 1 | Notes 2, 4 | |||
| Cardiac | Cardiac Adult | |||||||||
| Cardiac Pediatric | ||||||||||
| Intravascular(Cardiac) | ||||||||||
| Trans-esoph. (Cardiac) | ||||||||||
| Intra-cardiac | ||||||||||
| Other (specify) | ||||||||||
| Peripheral | ||||||||||
| Vessel | Peripheral vessel | |||||||||
| Other (specify) |
Note 1: Other Combined includes: B/M; B/PWD; B/THI (The feature does not use contrast agents); M/Color M ; B/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD Note 5: 4D Note 4: 3D
Note 2: Tissue Harmonic Imaging Note 3: TDI
Note 6: Small Organ: breast, thyroid, testes
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
Prescription Use X (Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
810K
Mun S. Patel
(Division Sign-Off)
| (Division Sign-Off) |
|---|
| Division of Radiological Devices |
| Office of In Vitro Diagnostic Device Evaluation and Safety |
3-6
2002
11
Transducer: C611 Micro-curved Array Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Indications For Use
Mary S. Patal
vision Sign-Off Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510K K102642
3-8
12
. ﺗﻘ
Diagnostic Ultrasound Indications for Use Form
Transducer: C362 Curved Array Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
new indication; = previously cleared by FDA; E = added under this appendix Note 1: Other Combined includes: B/M; B/PWD; B/THI (The feature does not use contrast agents); M/Color M ; B/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD Note 3: TDI Note 4: 3D Note 5: 4D
Note 2: Tissue Harmonic Imaging Note 6: Small Organ: breast, thyroid, testes
| AND/OR |
|---|
| -------- |
Over-The-Counter Use
Prescription Use X (Part 21 CFR 801 Subpart D)
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 (t
Marys Patel
(Division Sign-Off)
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K. Kb2642
13
Transducer: C344 Curved Array Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General | |||||||||
| (TRACK 1 | |||||||||
| ONLY) | Specific | ||||||||
| (TRACKS 1 & 3) | B | M | PWD | CWD | Color | ||||
| Doppler | Power | ||||||||
| (Amplitude) | |||||||||
| Doppler | Other* | ||||||||
| Combined | Other* | ||||||||
| Specify | |||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Imaging& | |||||||||
| Other | Fetal | N | N | N | N | N | Note 1 | Notes 2, 4 | |
| Abdominal | N | N | N | N | N | Note 1 | Notes 2, 4 | ||
| Intra-operative Specify | |||||||||
| Intra-operative Neuro | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (specify) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph.(non-Card) | |||||||||
| Musculo-skeletal | |||||||||
| (Conventional) | |||||||||
| Musculo-skeletal | |||||||||
| (Superficial) | |||||||||
| Intravascular | |||||||||
| Other (Ob/GYN) | N | N | N | N | N | Note 1 | Notes 2, 4 | ||
| Other (Urology) | N | N | N | N | N | Note 1 | Notes 2, 4 | ||
| 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 this appendix Note 1: Other Combined includes: B/M; B/PWD; B/THI (The feature does not use contrast agents); M/Color M ; B/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD Note 2: Tissue Harmonic Imaging Note 3: TDI Note 4: 3D
Note 6: Small Organ: breast, thyroid, testes
AND/OR
Note 5: 4D
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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
Max S. Patel
(Division Sign-Off)
Office of In
510K K102642
14
Transducer: VC6-2 Curved Array Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| General
(TRACK 1
ONLY) | Specific
(TRACKS 1 & 3) | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Other*
Combined | Other*
Specify |
|------------------------------|------------------------------------|---|---|-----|-----|------------------|---------------------------------|--------------------|-------------------|
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal
Imaging &
Other | Fetal | N | N | N | | N | N | Note 1 | Notes 2,4,5 |
| | Abdominal | N | N | N | | N | N | Note 1 | Notes 2,4,5 |
| | Intra-operative Specify | | | | | | | | |
| | Intra-operative Neuro | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ (specify) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph.(non-Card) | | | | | | | | |
| | Musculo-skeletal
(Conventional) | | | | | | | | |
| | Musculo-skeletal
(Superficial) | | | | | | | | |
| | Intravascular | | | | | | | | |
| | Other (Ob/GYN) | N | N | N | | N | N | Note 1 | Notes 2,4,5 |
| | Other (Urology) | | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| | Intravascular(Cardiac) | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| | Other (specify) | | | | | | | | |
| Peripheral
Vessel | Peripheral vessel | | | | | | | | |
| | Other (specify) | | | | | | | | |
new indication; = previously cleared by FDA; E = added under this appendix Note 1: Other Combined includes: B/M; B/PWD; B/THI (The feature does not use contrast agents); M/Color M ; B/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD Note 3: TDI Note 4: 3D Note 5: 4D
Note 2: Tissue Harmonic Imaging Note 6: Small Organ: breast, thyroid, testes
X
AND/OR
Over-The-Counter Use (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)
(Division Sign-Off)
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
Indications For Use
Prescription Use
(Part 21 CFR 801 Subpart D)
510K [K102642](https://510k.innolitics.com/search/K102642)
**15**
Transducer: L743 Linear Array Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | | | | | | | | |
|----------------------|------------------------------------|---|---|-----|-----|---------|------------------------|----------|------------|
| General | Specific | | | | | Color | Power | Other* | Other* |
| (TRACK 1
ONLY) | (TRACKS 1 & 3) | B | M | PWD | CWD | Doppler | (Amplitude)
Doppler | Combined | Specify |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal | Fetal | | | | | | | | |
| Imaging& | | | | | | | | | |
| Other | Abdominal | | | | | | | | |
| | Intra-operative Specify | | | | | | | | |
| | Intra-operative Neuro | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ (specify) | N | N | N | | N | N | Note 1 | Notes 2, 4 |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card) | | | | | | | | |
| | Musculo-skeletal
(Conventional) | N | N | N | | N | N | Note 1 | Notes 2, 4 |
| | Musculo-skeletal
(Superficial) | N | N | N | | N | N | Note 1 | Notes 2, 4 |
| | Intravascular | | | | | | | | |
| | Other (Ob/GYN) | | | | | | | | |
| | Other (Urology) | | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| | Intravascular(Cardiac) | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| | Other (specify) | | | | | | | | |
| Peripheral | Peripheral vessel | N | N | N | | N | N | Note 1 | Notes 2, 4 |
| Vessel | Other (specify) | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under this appendix Note 1: Other Combined includes: B/M; B/PWD; B/THI (The feature does not use contrast agents); M/Color M ; B/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD Note 3: TDI Note 4: 3D
Note 2: Tissue Harmonic Imaging Note 6: Small Organ: breast, thyroid, testes
AND/OR
Note 5: 4D
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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)
Vitro Diagnostic Devices (OIVD)
---
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K [K102642](https://510k.innolitics.com/search/K102642)
**16**
#### Transducer: L741 Linear Array Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | | | | | | | | | |
|------------------------------|------------------------------------|---|---|-----|-----|------------------|---------------------------------|-------------------------------|-------------------|--|
| General
(TRACK 1
ONLY) | Specific
(TRACKS 1 & 3) | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Other*
Combined | Other*
Specify | |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| Fetal
Imaging&
Other | Fetal | | | | | | | | | |
| | Abdominal | | | | | | | | | |
| | Intra-operative Specify | | | | | | | | | |
| | Intra-operative Neuro | | | | | | | | | |
| | Laparoscopic | | | | | | | | | |
| | Pediatric | | | | | | | | | |
| | Small Organ (specify) | N | N | N | | N | N | Note 1 | Notes 2, 4 | |
| | Neonatal Cephalic | | | | | | | | | |
| | Adult Cephalic | | | | | | | | | |
| | Trans-rectal | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | |
| | Trans-urethral | | | | | | | | | |
| | Trans-esoph.(non-Card) | | | | | | | | | |
| | Musculo-skeletal
(Conventional) | N | N | N | | N | N | Note 1 | Notes 2, 4 | |
| | Musculo-skeletal
(Superficial) | | | | | | | | | |
| | Intravascular | | | | | | | | | |
| | Other (Ob/GYN) | | | | | | | | | |
| | Other (Urology) | | | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | | |
| | Intravascular(Cardiac) | | | | | | | | | |
| | Trans-esoph.(Cardiac) | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | |
| | Other (specify) | | | | | | | | | |
| Peripheral
Vessel | Peripheral vessel | N | N | N | | N | N | Note 1 | Notes 2, 4 | |
| | Other (specify) | | | | | | | | | |
| N = new indication; | P = previously cleared by FDA: | | | | | | | k = added under this annendir | | |
added under this appendix Note 1: Other Combined includes: B/M; B/PWD; B/THI (The feature does not use contrast agents); M/Color M ; B/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD
Note 2: Tissue Harmonic Imaging Note 3: TDI Note 4: 3D Note 5: 4D Note 6: Small Organ: breast, thyroid, testes
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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 S. Pistilli
(Division Sign-Off)
Indications For Use
(Division Sign Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
**17**
#### Transducer: L742 Linear Array Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | | Mode of Operation | | | | | | |
|------------------------------|------------------------------------|---|-------------------|-----|-----|------------------|---------------------------------|--------------------|-------------------|
| General
(TRACK 1
ONLY) | Specific
(TRACKS 1 & 3) | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Other*
Combined | Other*
Specify |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal
Imaging&
Other | Fetal | | | | | | | | |
| | Abdominal | | | | | | | | |
| | Intra-operative Specify | | | | | | | | |
| | Intra-operative Neuro | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ (specify) | N | N | N | N | N | N | Note 1 | Notes 2, 4 |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph.(non-Card) | | | | | | | | |
| | Musculo-skeletal
(Conventional) | N | N | N | N | N | N | Note 1 | Notes 2, 4 |
| | Musculo-skeletal
(Superficial) | N | N | N | N | N | N | Note 1 | Notes 2, 4 |
| | Intravascular | | | | | | | | |
| | Other (Ob/GYN) | | | | | | | | |
| | Other (Urology) | | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| | Intravascular(Cardiac) | | | | | | | | |
| | Trans-esoph.(Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| | Other (specify) | | | | | | | | |
| Peripheral
Vessel | Peripheral vessel | N | N | N | N | N | N | Note 1 | Notes 2, 4 |
| | Other (specify) | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under this appendix Note 1: Other Combined includes: B/M; B/PWD; B/THI (The feature does not use contrast agents); M/Color M ; B/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD Note 3: TDI Note 4: 3D Note 5: 4D
Note 2: Tissue Harmonic Imaging Note 6: Small Organ: breast, thyroid, testes
AND/OR
Prescription Use X
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (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)
510
Mary S. Patal
(Division Sign-Off)
Division of Biological Devices
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
**18**
### Transducer: MPTEE Multi-plane Array Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | | | | | | Other* | | |
|------------------------------|------------------------------------|---|---|-----|-----|------------------|---------------------------------|----------|--------------|
| General
(TRACK 1
ONLY) | Specific
(TRACKS 1 & 3) | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Combined | Specify |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal
Imaging&
Other | Fetal | | | | | | | | |
| | Abdominal | | | | | | | | |
| | Intra-operative Specify | | | | | | | | |
| | Intra-operative Neuro | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ (specify) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph.(non-Card) | | | | | | | | |
| | Musculo-skeletal
(Conventional) | | | | | | | | |
| | Musculo-skeletal
(Superficial) | | | | | | | | |
| | Intravascular | | | | | | | | |
| | Other (Ob/GYN) | | | | | | | | |
| | Other (Urology) | | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| | Intravascular(Cardiac) | | | | | | | | |
| | Trans-esoph.(Cardiac) | N | N | N | N | N | N | Note 1 | Notes 2,3, 4 |
| | Intra-cardiac | | | | | | | | |
| | Other (specify) | | | | | | | | |
| Peripheral
Vessel | Peripheral vessel | | | | | | | | |
| | Other (specify) | | | | | | | | |
P = previously cleared by FDA; N = new indication; E = added under this appendix Note 1: Other Combined includes: B/M; B/PWD; B/THI (The feature does not use contrast agents); M/Color M ; B/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD Note 2: Tissue Harmonic Imaging Note 3: TDI Note 4: 3D Note 5: 4D
Note 6: Small Organ: breast, thyroid, testes
AND/OR
Over-The-Counter Use
Prescription Use X (Part 21 CFR 801 Subpart D) 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 Spatola
(Division Sign-Off)
Indications For Use
(Dision Sign-On)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K [K102642](https://510k.innolitics.com/search/K102642)
3-15
**19**
### Transducer: MPTEE mini Multi-plane Array Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | | | | | | | | |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|---|---|-----|-----|------------------|---------------------------------|--------------------|-------------------------------|
| General
(TRACK 1
ONLY) | Specific
(TRACKS 1 & 3) | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Other*
Combined | Other*
Specify |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal
Imaging &
Other | Fetal | | | | | | | | |
| | Abdominal | | | | | | | | |
| | Intra-operative Specify | | | | | | | | |
| | Intra-operative Neuro | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ (specify) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph.(non-Card) | | | | | | | | |
| | Musculo-skeletal
(Conventional) | | | | | | | | |
| | Musculo-skeletal
(Superficial) | | | | | | | | |
| | Intravascular | | | | | | | | |
| | Other (Ob/GYN) | | | | | | | | |
| | Other (Urology) | | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| | Intravascular(Cardiac) | | | | | | | | |
| | Trans-esoph. (Cardiac) | N | N | N | N | N | N | Note 1 | Notes 2,3, 4 |
| | Intra-cardiac | | | | | | | | |
| | Other (specify) | | | | | | | | |
| Peripheral
Vessel | Peripheral vessel | | | | | | | | |
| | Other (specify) | | | | | | | | |
| N = new indication; | P = previously cleared by FDA;
Note 1: Other Combined includes: B/M; B/PWD; B/THI (The feature does not use contrast agents); M/Color M ; B/Color | | | | | | | | E = added under this appendix |
Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD Note 3: TDI
Note 2: Tissue Harmonic Imaging Note 6: Small Organ: breast, thyroid, testes
Note 4: 3D
Note 5: 4D
Prescription Use ਮ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (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 Shaw
(Division Sign-Off)
Indications For Use
Office office office office offices of 510K