(85 days)
Not Found
Not Found
No
The provided text does not mention AI, ML, or any related terms, nor does it describe features or performance metrics typically associated with AI/ML-powered devices.
No.
The device is intended for diagnostic ultrasound imaging, not for therapeutic treatment. While it can be used in "Invasive diagnostic or therapeutic procedures," its role is for imaging and guidance, not the actual therapeutic action.
Yes
The 'Intended Use / Indications for Use' explicitly states "Diagnostic ultrasound imaging or fluid flow analysis of the human body".
No
The device description and intended use clearly indicate that the eZono 3000 is a diagnostic ultrasound imaging system, which inherently involves hardware components (transducer, processing unit, display, etc.) to acquire and process ultrasound data. It is not described as a software application running on a separate, non-medical device platform.
Based on the provided information, the eZono 3000 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body. They perform tests in vitro (outside the body) to diagnose diseases or conditions.
- The eZono 3000 is a diagnostic ultrasound imaging device. It uses sound waves to create images of internal structures within the human body (in vivo).
The intended uses listed clearly describe imaging of various anatomical sites within the body, which is characteristic of an ultrasound device, not an IVD.
N/A
Intended Use / Indications for Use
The intended use of the eZono 3000, as defined by FDA guidance documents, are: Ophthalmic, Musculo-skeletal (Conventional), Fetal (as enumerated in the IFU Tables), Musculo-skeletal (Superficial), Abdominal, Retroperitoneum, Pediatric, Female reproductive system and foetus, Small Organ (breast, thyroid, testicle), Cardiac (Adult), Invasive diagnostic or therapeutic procedures, Cardiac (Pediatric), Peripheral vessel.
Diagnostic ultrasound imaging or fluid flow analysis of the human body.
Product codes (comma separated list FDA assigned to the subject device)
IYN, IYO, and ITX
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Ophthalmic, Fetal, Abdominal, Intra-operative, Intra-operative (Neuro), Laparoscopic, Pediatric, Small Organ (e.g. testicles, lymph nodes, thyroid), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-urethral, Trans-esoph. (non-Card.), Musculo-skeletal (Conventional), Musculo-skeletal (Superficial), Intravascular, Invasive diagnostic or therapeutic procedures (e.g. biopsies, punctures, free fluid detection, regional anesthesia, vascular access), Superficial structures & pathologies (incl. Lungs), Cardiac Adult, Cardiac Pediatric, Intravascular (Cardiac), Trans-esoph. (Cardiac), Intra-cardiac, Peripheral vessel, Retroperitoneum, female reproductive system and foetus (transcutaneous).
Indicated Patient Age Range
Adult, Pediatric, Neonatal (Cephalic only)
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Not Found
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" is arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Mr. Skip Rimer Director, Quality Assurance & Regulatory Affairs Life-Tech, Inc. 13235 N. Promenade Blvd. STAFFORD TX 77477
APR 1 9 2012
Re: K120234
Trade/Device Name: eZono 3000 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed Doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: January 20, 2012 Received: January 25, 2012
Dear Mr. Rimer:
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 eZono 3000, as described in your premarket notification:
| Transducer Model Number | |
|---|---|
| 8LA | 30CL60 |
| 8LA-SC | 35CL20 |
| 12LA | 35CL60 |
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
1
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/CDRH0ffices/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 Jay Vaishnav at (301) 796-9584.
Sincerely Yours,
Janine M. Morris
Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known):
Device Name: eZono 3000
Indications for Use:
The intended use of the eZono 3000, as defined by FDA guidance documents, are:
| Ophthalmic | Musculo-skeletal (Conventional) |
|---|---|
| Fetal (as enumerated in the IFU Tables) | Musculo-skeletal (Superficial) |
| Abdominal | Retroperitoneum |
| Pediatric | Female reproductive system and foetus |
| Small Organ (breast, thyroid, testicle) | Cardiac (Adult) |
| Invasive diagnostic or therapeutic procedures | Cardiac (Pediatric) |
| Peripheral vessel |
Prescription Use V (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
510(k) Number K120234
Page 1 of 1
3
Transducer: 8LA
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 | ||||||||
| (CD) | Combined | |||||||
| (B + CD) | Other* | |||||||
| (Color | ||||||||
| Power | ||||||||
| Doppler) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Abdominal | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | N | P | P | N | |||
| Small Organ (e.g. testicles, | ||||||||
| lymph nodes, thyroid) | P | N | P | P | N | |||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Fetal | ||||||||
| Imaging | ||||||||
| & Other | Trans-vaginal | |||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skeletal | ||||||||
| (Conventional) | P | N | P | P | N | |||
| Musculo-skeletal | ||||||||
| (Superficial) | P | N | P | P | N | |||
| Intravascular | ||||||||
| Invasive diagnostic or | ||||||||
| therapeutic procedures (e.g. | ||||||||
| biopsies, punctures, free fluid | ||||||||
| detection, regional anesthesia, | ||||||||
| vascular access) | P | N | P | P | N | |||
| Superficial structures & | ||||||||
| pathologies (incl. Lungs) | P | N | P | P | N | |||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | P | N | P | P | N | ||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix
*Examples of other modes of operation may include: A-mode, Amplitude Doppler, 3-D
Imaging, Harmonic Imaging, Tissue Motion Doppler, and Color Velocity Imaging
Samur Madus
510K
(Division Sign-Off)
Division of Radiological Devices Office of In Vitro Diagnostic Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
4
eŻono 3000 System:
Transducer: 8LA-SC
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 | ||||||||
| (CD) | Combined | |||||||
| (B + CD) | Other* | |||||||
| (Color | ||||||||
| Power | ||||||||
| Doppler) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Abdominal | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | N | P | P | N | |||
| Small Organ (e.g. testicles, | ||||||||
| lymph nodes, thyroid) | P | N | P | P | N | |||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Fetal | ||||||||
| Imaging | ||||||||
| & Other | Trans-vaginal | |||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skeletal | ||||||||
| (Conventional) | P | N | P | P | N | |||
| Musculo-skeletal | ||||||||
| (Superficial) | P | N | P | P | N | |||
| Intravascular | ||||||||
| Invasive diagnostic or | ||||||||
| therapeutic procedures (e.g. | ||||||||
| biopsies, punctures, free fluid | ||||||||
| detection, regional anesthesia, | ||||||||
| vascular access) | P | N | P | P | N | |||
| Superficial structures & | ||||||||
| pathologies (incl. Lungs) | P | N | P | P | N | |||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | P | N | P | P | N | ||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix *Examples of other modes of operation may include: A-mode, Amplitude Doppler, 3-D Imaging, Harmonic Imaging, Tissue Motion Doppler, and Color Velocity Imaging
Ranna Mousa
(Division Sign-Off)
Division of Redfological Devices Division of nudiological Evaluation and Safety Office of In
K120234
510K
5
Transducer: 12LA
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 | ||||||||
| (CD) | Combined | |||||||
| (B + CD) | Other* | |||||||
| (Color | ||||||||
| Power | ||||||||
| Doppler) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Abdominal | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| (excluding transcranial) | P | N | P | P | N | |||
| Small Organ (e.g. testicles, | ||||||||
| lymph nodes, thyroid) | P | N | P | P | N | |||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Fetal | ||||||||
| Imaging | ||||||||
| & Other | Trans-rectal | |||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skeletal | ||||||||
| (Conventional) | P | N | P | P | N | |||
| Musculo-skeletal | ||||||||
| (Superficial) | P | N | P | P | N | |||
| Intravascular | ||||||||
| Invasive diagnostic or | ||||||||
| therapeutic procedures (e.g. | ||||||||
| biopsies, punctures, free fluid | ||||||||
| detection, regional anesthesia, | ||||||||
| vascular access) | P | N | P | P | N | |||
| Superficial structures & | ||||||||
| pathologies (incl. Lungs) | P | N | P | P | N | |||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | P | N | P | P | N | ||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix
*Examples of other modes of operation may include: A-mode, Amplitude Doppler, 3-D Imaging, Harmonic Imaging, Tissue Motion Doppler, and Color Velocity Imaging
(Division Sign-Off)
Division of Radiological Devices
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K K120234
6
Transducer: 30CL60
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 | |||||||||
| (CD) | Combined | ||||||||
| (B + CD) | Other* | ||||||||
| (Color | |||||||||
| Power | |||||||||
| Doppler) | |||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | P | N | P | P | N | ||||
| Abdominal | P | N | P | P | N | ||||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | P | N | P | P | N | ||||
| Small Organ (Specify) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Fetal | Trans-urethral | ||||||||
| Imaging | Trans-esoph. (non-Card.) | ||||||||
| & Other | Musculo-skeletal | ||||||||
| (Conventional) | |||||||||
| Musculo-skeletal | |||||||||
| (Superficial) | |||||||||
| Intravascular | |||||||||
| Invasive diagnostic or | P | N | P | P | N | ||||
| therapeutic procedures (e.g. | |||||||||
| biopsies, punctures, free fluid | |||||||||
| detection, regional anesthesia, | |||||||||
| vascular access) | |||||||||
| Retroperitoneum | P | N | P | P | N | ||||
| female reproductive system and | P | N | P | P | N | ||||
| foetus (transcutaneous) | |||||||||
| Cardiac | Cardiac Adult | ||||||||
| Cardiac Pediatric | |||||||||
| 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 *Examples of other modes of operation may include: A-mode, Amplitude Doppler, 3-D
Imaging, Harmonic Imaging, Tissue Motion Doppler, and Color Velocity Imaging
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K
7
System: e Zono 3000 Transducer: 35CL20
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 | |||||||||
| (CD) | Combined | ||||||||
| (B + CD) | Other* | ||||||||
| (Color | |||||||||
| Power | |||||||||
| Doppler) | |||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | N | N | N | N | N | ||||
| Abdominal | N | N | N | N | N | ||||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | N | N | N | N | N | ||||
| Small Organ (Specify) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Fetal | |||||||||
| Imaging | |||||||||
| & Other | Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal | |||||||||
| (Conventional) | |||||||||
| Musculo-skeletal | |||||||||
| (Superficial) | |||||||||
| Intravascular | |||||||||
| Invasive diagnostic or | N | N | N | N | N | ||||
| therapeutic procedures (e.g. | |||||||||
| biopsies, punctures, free fluid | |||||||||
| detection, regional anesthesia, | |||||||||
| vascular access) | |||||||||
| Retroperitoneum | N | N | N | N | N | ||||
| female reproductive system and | |||||||||
| foetus (transcutaneous) | N | N | N | N | N | ||||
| Cardiac | Cardiac Adult | N | N | N | N | N | |||
| Cardiac Pediatric | N | N | N | N | N | ||||
| 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 *Examples of other modes of operation may include: A-mode, Amplitude Doppler, 3-D Imaging, Harmonic maging, Tissue Motion Doppler, and Color Velocity Imaging
(Dwision Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K. K120234
8
Transducer: 35CL60
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 | ||||||||
| (CD) | Combined | |||||||
| (B + CD) | Other* | |||||||
| (Color | ||||||||
| Power | ||||||||
| Doppler) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Imaging | ||||||||
| & Other | Fetal | P | N | P | P | N | ||
| Abdominal | P | N | P | P | N | |||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | N | P | P | N | |||
| Small Organ (Specify) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skeletal | ||||||||
| (Conventional) | ||||||||
| Musculo-skeletal | ||||||||
| (Superficial) | ||||||||
| Intravascular | ||||||||
| Invasive diagnostic or | ||||||||
| therapeutic procedures (e.g. | ||||||||
| biopsies, punctures, free fluid | ||||||||
| detection, regional anesthesia, | ||||||||
| vascular access) | P | N | P | P | N | |||
| Retroperitoneum | P | N | P | P | N | |||
| female reproductive system and | ||||||||
| foetus (transcutaneous) | P | N | P | P | N | |||
| 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 N = new mucatori, 1 = proviosy citance of 1 271, 2 = addo ander = 1 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 =
Division Sign-Off
Division of Radietegieal Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K. K120234
9
currently supported1 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 | ||||||||
| (CD) | Combined | |||||||
| (B + CD) | Other* | |||||||
| (Specify) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | P | N | P | P | N | |||
| Abdominal | P | N | P | P | N | |||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| (excluding transcranial & | ||||||||
| neonatal) | P | N | P | P | N | |||
| Small Organ (e.g. testicles, | ||||||||
| lymph nodes, thyroid) | P | N | P | P | N | |||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Fetal | ||||||||
| Imaging | ||||||||
| & Other | Trans-vaginal | |||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skeletal | ||||||||
| (Conventional) | P | N | P | P | N | |||
| Musculo-skeletal | ||||||||
| (Superficial) | P. | N | P | P | N | |||
| Intravascular | ||||||||
| Invasive diagnostic or | ||||||||
| therapeutic procedures (e.g. | ||||||||
| biopsies, punctures, free fluid | ||||||||
| detection, regional anesthesia, | ||||||||
| vascular access) | P | N | P | P | N | |||
| Retroperitoneum | P | N | P | P | N | |||
| female reproductive system and | ||||||||
| foetus (transcutaneous) | P | N | P | P | N | |||
| Superficial structures & | ||||||||
| pathologies | P | N | P | P | N | |||
| Cardiac | Cardiac Adult | N | N | N | N | N | ||
| Cardiac Pediatric | N | N | N | N | N | |||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | P | N | P | P | N | ||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix
*Examples of other modes of operation may include: A-mode, Amplitude Doppler, 3-D
Imaging, Harmonic Imaging, Tissue Motion Doppler, and Color Velocity Inaging
- supported transducer models are 8LA, 8LA-SC, 12LA, 35CL60, 35CL20 and 30CL60. See their corresponding
IFU's.
(Division Sign-Off)
Division of Radiological Devices
Office office office office office office office office office office office office office office office office office office office office office office office office office Vitro Diagnostie Device Evaluation and Safety
ce &in Vitro Diagnostic Device Evaluation and Sa
510K. K120234