(43 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and provides no other indication of AI/ML technology.
No
The device is described as a "Diagnostic Ultrasound System" indicated for "visualization of structures, and dynamic processes with the human body using ultrasound and to provide image information for diagnosis," which classifies it as a diagnostic device, not a therapeutic one.
Yes
The 'Intended Use / Indications for Use' section explicitly states that the system provides "image information for diagnosis". Additionally, the 'Device Description' identifies it as a "mobile diagnostic ultrasound system."
No
The device description explicitly states it is a "mobile diagnostic ultrasound system" and mentions employing "a wide array of probes," which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body. They are used to detect diseases, conditions, or infections.
- Device Function: The provided description clearly states that the Xario200G and Xario100G are diagnostic ultrasound systems. These systems use ultrasound waves to visualize structures and processes within the human body.
- Lack of Sample Analysis: There is no mention of analyzing samples taken from the body. The device operates by sending and receiving ultrasound waves through the skin and tissues.
Therefore, based on the provided information, this device falls under the category of in vivo diagnostic imaging systems, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Diagnostic Ultrasound System Xario200G Model CUS-X200G and Xario100G Model CUS-X100G are indicated for the visualization of structures, and dynamic processes with the human body using ultrasound and to provide image information for diagnosis in the following clinical applications: fetal, abdominal, intra-operative(abdominal), laparoscopic, pediatric, small organs, neonalic, adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal (conventional), musculo-skeletal(superficial), cardiac pediatric, trans-esoph(cardiac) and peripheral vessel.
Product codes (comma separated list FDA assigned to the subject device)
IYN, IYO, ITX
Device Description
The Xario200G Model CUS-X200G and Xario100G Model CUS-X100G are mobile diagnostic ultrasound systems. These systems are Track 3 devices that employ a wide array of probes including flat linear array, convex linear array, and sector array with frequency ranges between approximately 2 MHz to 12 MHz.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
fetal, abdominal, intra-operative(abdominal), laparoscopic, pediatric, small organs (thyroid, breast and testicle), neonatal cephalic, adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal (conventional), musculo-skeletal (superficial), cardiac adult, cardiac pediatric, trans-esoph (cardiac), peripheral vessel.
Indicated Patient Age Range
pediatric, neonatal, adult, fetal
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)
No clinical studies were required to demonstrate safety and efficacy of the Xario200G/Xario100G systems.
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
Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below.
November 2, 2018
Canon Medical Systems Corporation Orlando Tadeo, Jr. Sr. Manager, Regulatory Affairs 2441 Michelle Drive TUSTIN, CA 92780
Re: K182596
Trade/Device Name: Xario200G and Xario100G, Software V1.1 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic Pulsed Doppler Imaging System Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: September 18, 2018 Received: September 20, 2018
Dear Orlando Tadeo:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice
(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael D. O'Hara For
Robert A. Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
Xario200G and Xario100G, Software V1.1 Diagnostic Ultrasound System
Indications for Use (Describe)
The Diagnostic Ultrasound System Xario200G Model CUS-X200G and Xario100G Model CUS-X100G are indicated for the visualization of structures, and dynamic processes with the human body using ultrasound and to provide image information for diagnosis in the following clinical applications: fetal, abdominal, intra-operative(abdominal), laparoscopic, pediatric, small organs, neonalic, adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal (conventional), musculo-skeletal(superficial), cardiac pediatric, trans-esoph(cardiac) and peripheral vessel.
| Type of Use (Select one or both, as applicable) |
|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
Transducer:
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Specific | ||||||||||||
| (Tracks 3) | B | M | PWD | CWD | Color | |||||||
| Doppler | Combined | |||||||||||
| (Specify) * | THI | Advanced | ||||||||||
| Dynamic | ||||||||||||
| Flow | Power | CHI | 4D | Other [Note] | ||||||||
| Ophthalmic | ||||||||||||
| Fetal | N | N | N | N | 2 | N | N | N | N | 4,5,6,7,8,9,11,12 | ||
| Abdominal | N | N | N | N | N | 2,3 | N | N | N | N | 4,5,6,7,8,9,11,12,14 | |
| Intra-operative (Abdominal) | N | N | N | N | 2 | N | N | N | 5,6,7,8,11 | |||
| Intra-operative (Neuro) | ||||||||||||
| Laparoscopic | N | N | N | N | 2 | N | N | N | 5,7 | |||
| Pediatric | N | N | N | N | N | 2,3 | N | N | N | N | 4,5,6,7,8,9,11,12 | |
| Small Organ (Note 1) | N | N | N | N | 2 | N | N | N | 4,5,6,7,8,9,10,11,12 | |||
| Neonatal Cephalic | N | N | N | N | N | 2,3 | N | N | N | 5,6,7,8,11 | ||
| Adult Cephalic | N | N | N | N | N | 3 | N | N | N | 7 | ||
| Trans-rectal | N | N | N | N | 2 | N | N | N | N | 4,5,6,7,8,9,12 | ||
| Trans-vaginal | N | N | N | N | 2 | N | N | N | N | 4,5,6,7,8,9,12 | ||
| Trans-urethral | ||||||||||||
| Trans-esoph. (non-Card.) | ||||||||||||
| Musculo-skeletal (Conventional) | N | N | N | N | 2 | N | N | N | 4,5,6,7,8,9,10,11,12 | |||
| Musculo-skeletal (Superficial) | N | N | N | N | 2 | N | N | N | 4,5,6,7,8,9,10,11,12 | |||
| Intravascular | ||||||||||||
| Other (Specify) | ||||||||||||
| Cardiac Adult | N | N | N | N | N | 3 | N | N | N | 4, 7, 13 | ||
| Cardiac Pediatric | N | N | N | N | N | 3 | N | N | N | 4, 7, 13 | ||
| Intravascular (Cardiac) | ||||||||||||
| Trans-esoph. (Cardiac) | N | N | N | N | N | 3 | N | 4, 7, 13 | ||||
| Intra-cardiac | ||||||||||||
| Other (Specify) | ||||||||||||
| Peripheral vessel | N | N | N | N | N | 2 | N | N | N | 4,5,6,7,8,9,10,11,12 | ||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Note 1 Small organ includes thyroid, breast and testicle.
Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
- Note 4 TDI
- Note 5 ApliPure
- Note 6 ApliPure Plus
- Note 7 Precision Imaging
- Note 8 Differential THI
- Note 9 Elastography Note 10 BEAM
- Note 11 Smart 3D
- Note 12 SMI
- Note 13 2D Wall Motion Tracking
- Note 14 Shear Wave
4
Transducer: __ PSU-25BT
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application
Specific
(Tracks 3) | B | M | PWD | CWD | Color
Doppler | Combined
(Specify) * | THI | Advanced
Dynamic
Flow | Power | CHI | 4D | Other
[Note] |
|------------------------------------------------|---|---|-----|-----|------------------|-------------------------|-----|-----------------------------|-------|-----|----|-----------------|
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | P | P | P | P | P | 3 | P | P | P | | | 7 |
| Intra-operative (Abdominal) | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Pediatric | P | P | P | P | P | 3 | P | P | P | | | 7 |
| Small Organ (Note 1) | | | | | | | | | | | | |
| Neonatal Cephalic | P | P | P | P | P | 3 | P | P | P | | | 7 |
| Adult Cephalic | P | P | P | P | P | 3 | P | P | P | | | 7 |
| Trans-rectal | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | |
| Musculo-skeletal (Conventional) | | | | | | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Cardiac Adult | P | P | P | P | P | 3 | P | P | P | | | 4, 7, 13 |
| Cardiac Pediatric | P | P | P | P | P | 3 | P | P | P | | | 4, 7, 13 |
| Intravascular (Cardiac) | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K172276
Note 1 Small organ includes thyroid, breast and testicle.
Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
- Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
- Note 4 TDI
- Note 5 ApliPure
- Note 6 ApliPure Plus
- Note 7 Precision Imaging
- Note 8 Differential THI
- Note 9 Elastography
- Note 10 BEAM Note 11 Smart 3D
- Note 12 SMI
- Note 13 2D Wall Motion Tracking Note 14 Shear Wave
5
Transducer: __ PSU-30BT
| Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | ||
|---|---|---|
| Clinical Application
Specific
| (Tracks 3) | Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | Color | ||||||||
| Doppler | Combined | |||||||||||
| (Specify) * | THI | Advanced | ||||||||||
| Dynamic | ||||||||||||
| Flow | Power | CHI | 4D | Other | ||||||||
| [Note] | ||||||||||||
| Ophthalmic | ||||||||||||
| Fetal | ||||||||||||
| Abdominal | P | P | P | P | P | 3 | P | P | P | 7 | ||
| Intra-operative (Abdominal) | ||||||||||||
| Intra-operative (Neuro) | ||||||||||||
| Laparoscopic | ||||||||||||
| Pediatric | P | P | P | P | P | 3 | P | P | P | 7 | ||
| Small Organ (Note 1) | ||||||||||||
| Neonatal Cephalic | P | P | P | P | P | 3 | P | P | P | 7 | ||
| Adult Cephalic | P | P | P | P | P | 3 | P | P | P | 7 | ||
| Trans-rectal | ||||||||||||
| Trans-vaginal | ||||||||||||
| Trans-urethral | ||||||||||||
| Trans-esoph. (non-Card.) | ||||||||||||
| Musculo-skeletal (Conventional) | ||||||||||||
| Musculo-skeletal (Superficial) | ||||||||||||
| Intravascular | ||||||||||||
| Other (Specify) | ||||||||||||
| Cardiac Adult | P | P | P | P | P | 3 | P | P | P | 4, 7, 13 | ||
| Cardiac Pediatric | P | P | P | P | P | 3 | P | P | P | 4, 7, 13 | ||
| Intravascular (Cardiac) | ||||||||||||
| Trans-esoph. (Cardiac) | ||||||||||||
| Intra-cardiac | ||||||||||||
| Other (Specify) | ||||||||||||
| Peripheral vessel | ||||||||||||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K172276
Note 1 Small organ includes thyroid, breast and testicle.
Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
- Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
- Note 4 TDI
- Note 5 ApliPure
- Note 6 ApliPure Plus
- Note 7 Precision Imaging
- Note 8 Differential THI
- Note 9 Elastography
- Note 10 BEAM Note 11 Smart 3D
- Note 12 SMI
- Note 13 2D Wall Motion Tracking Note 14 Shear Wave
6
Transducer: PSU-50BT
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application
Specific
(Tracks 3) | Mode of Operation | B | M | PWD | CWD | Color
Doppler | Combined
(Specify) * | THI | Advanced
Dynamic
Flow | Power | CHI | 4D | Other
[Note] |
|------------------------------------------------|-------------------|---|---|-----|-----|------------------|-------------------------|-----|-----------------------------|-------|-----|----|-----------------|
| Ophthalmic | | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | | |
| Abdominal | | P | P | P | P | P | 3 | P | P | P | | | 7 |
| Intra-operative (Abdominal) | | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | |
| Pediatric | | P | P | P | P | P | 3 | P | P | P | | | 7 |
| Small Organ (Note 1) | | | | | | | | | | | | | |
| Neonatal Cephalic | | P | P | P | P | P | 3 | P | P | P | | | 7 |
| Adult Cephalic | | P | P | P | P | P | 3 | P | P | P | | | 7 |
| Trans-rectal | | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | | |
| Musculo-skeletal (Conventional) | | | | | | | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | |
| Cardiac Adult | | P | P | P | P | P | 3 | P | P | P | | | 4, 7, 13 |
| Cardiac Pediatric | | P | P | P | P | P | 3 | P | P | P | | | 4, 7, 13 |
| Intravascular (Cardiac) | | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K172276
Note 1 Small organ includes thyroid, breast and testicle.
Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
- Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
- Note 4 TDI
- Note 5 ApliPure
- Note 6 ApliPure Plus
- Note 7 Precision Imaging
- Note 8 Differential THI
- Note 9 Elastography
- Note 10 BEAM Note 11 Smart 3D
- Note 12 SMI
- Note 13 2D Wall Motion Tracking Note 14 Shear Wave
7
Transducer: __ PSU-70BT
| Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | |||
|---|---|---|---|
| Clinical Application | Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Specific | ||||||||||||
| (Tracks 3) | B | M | PWD | CWD | Color | |||||||
| Doppler | Combined | |||||||||||
| (Specify) * | THI | Advanced | ||||||||||
| Dynamic | ||||||||||||
| Flow | Power | CHI | 4D | Other | ||||||||
| [Note] | ||||||||||||
| Ophthalmic | ||||||||||||
| Fetal | ||||||||||||
| Abdominal | P | P | P | P | P | 3 | P | P | P | 7 | ||
| Intra-operative (Abdominal) | ||||||||||||
| Intra-operative (Neuro) | ||||||||||||
| Laparoscopic | ||||||||||||
| Pediatric | P | P | P | P | P | 3 | P | P | P | 7 | ||
| Small Organ (Note 1) | ||||||||||||
| Neonatal Cephalic | P | P | P | P | P | 3 | P | P | P | 7 | ||
| Adult Cephalic | P | P | P | P | P | 3 | P | P | P | 7 | ||
| Trans-rectal | ||||||||||||
| Trans-vaginal | ||||||||||||
| Trans-urethral | ||||||||||||
| Trans-esoph. (non-Card.) | ||||||||||||
| Musculo-skeletal (Conventional) | ||||||||||||
| Musculo-skeletal (Superficial) | ||||||||||||
| Intravascular | ||||||||||||
| Other (Specify) | ||||||||||||
| Cardiac Adult | P | P | P | P | P | 3 | P | P | P | 4, 7, 13 | ||
| Cardiac Pediatric | P | P | P | P | P | 3 | P | P | P | 4, 7, 13 | ||
| Intravascular (Cardiac) | ||||||||||||
| Trans-esoph. (Cardiac) | ||||||||||||
| Intra-cardiac | ||||||||||||
| Other (Specify) | ||||||||||||
| Peripheral vessel | ||||||||||||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K172276
Note 1 Small organ includes thyroid, breast and testicle.
Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
- Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
- Note 4 TDI
- Note 5 ApliPure
- Note 6 ApliPure Plus
- Note 7 Precision Imaging
- Note 8 Differential THI
- Note 9 Elastography
- Note 10 BEAM
- Note 11 Smart 3D
- Note 12 SMI
- Note 13 2D Wall Motion Tracking
- Note 14 Shear Wave
8
System: __Xario200G and Xario100G, Software V1.1 Transducer: _ PVU-375BT
| Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | |||
|---|---|---|---|
| Clinical Application | Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Specific | ||||||||||||
| (Tracks 3) | B | M | PWD | CWD | Color | |||||||
| Doppler | Combined | |||||||||||
| (Specify) * | THI | Advanced | ||||||||||
| Dynamic | ||||||||||||
| Flow | Power | CHI | 4D | Other [Note] | ||||||||
| Ophthalmic | ||||||||||||
| Fetal | P | P | P | P | 2 | P | P | P | 4,5,6,7,8,9,11,12 | |||
| Abdominal | P | P | P | P | 2 | P | P | P | 4,5,6,7,8,9,11,12,1- | |||
| Intra-operative (Abdominal) | ||||||||||||
| Intra-operative (Neuro) | ||||||||||||
| Laparoscopic | ||||||||||||
| Pediatric | P | P | P | P | 2 | P | P | P | 4,5,6,7,8,9,11,12 | |||
| Small Organ (Note 1) | ||||||||||||
| Neonatal Cephalic | ||||||||||||
| Adult Cephalic | ||||||||||||
| Trans-rectal | ||||||||||||
| Trans-vaginal | ||||||||||||
| Trans-urethral | ||||||||||||
| Trans-esoph. (non-Card.) | ||||||||||||
| Musculo-skeletal | ||||||||||||
| (Conventional) | ||||||||||||
| Musculo-skeletal | ||||||||||||
| (Superficial) | ||||||||||||
| Intravascular | ||||||||||||
| Other (Specify) | ||||||||||||
| Cardiac Adult | ||||||||||||
| Cardiac Pediatric | ||||||||||||
| Intravascular (Cardiac) | ||||||||||||
| Trans-esoph. (Cardiac) | ||||||||||||
| Intra-cardiac | ||||||||||||
| Other (Specify) | ||||||||||||
| Peripheral vessel | ||||||||||||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K172276
Note 1 Small organ includes thyroid, breast and testicle.
Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
Note 4 TDI
Note 5 ApliPure
Note 6 ApliPure Plus
Note 7 Precision Imaging
Note 8 Differential THI Note 9 Elastography
Note 9 Elastograp
No. 10 BEAM
Note 10 BEAM
Note 11 Smart 3D
Note 12 SMI
Note 13 2D Wall Motion Tracking
Note 14 Shear Wave
9
System: Xario200G and Xario100G, Software V1.1 Transducer: __ PVU-382BT
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Specific | ||||||||||||
| (Tracks 3) | B | M | PWD | CWD | Color | |||||||
| Doppler | Combined | |||||||||||
| (Specify) * | THI | Advanced | ||||||||||
| Dynamic | ||||||||||||
| Flow | Power | CHI | 4D | Other | ||||||||
| [Note] | ||||||||||||
| Ophthalmic | ||||||||||||
| Fetal | P | P | P | P | P | 2 | P | P | P | 5,6,7,8,11 | ||
| Abdominal | P | P | P | P | P | 2 | P | P | P | 5,6,7,8,11 | ||
| Intra-operative (Abdominal) | ||||||||||||
| Intra-operative (Neuro) | ||||||||||||
| Laparoscopic | ||||||||||||
| Pediatric | P | P | P | P | P | 2 | P | P | P | 5,6,7,8,11 | ||
| Small Organ (Note 1) | ||||||||||||
| Neonatal Cephalic | ||||||||||||
| Adult Cephalic | ||||||||||||
| Trans-rectal | ||||||||||||
| Trans-vaginal | ||||||||||||
| Trans-urethral | ||||||||||||
| Trans-esoph. (non-Card.) | ||||||||||||
| Musculo-skeletal (Conventional) | ||||||||||||
| Musculo-skeletal (Superficial) | ||||||||||||
| Intravascular | ||||||||||||
| Other (Specify) | ||||||||||||
| Cardiac Adult | ||||||||||||
| Cardiac Pediatric | ||||||||||||
| Intravascular (Cardiac) | ||||||||||||
| Trans-esoph. (Cardiac) | ||||||||||||
| Intra-cardiac | ||||||||||||
| Other (Specify) | ||||||||||||
| Peripheral vessel | ||||||||||||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K172276
Note 1 Small organ includes thyroid, breast and testicle.
Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
- Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
- Note 4 TDI
- Note 5 ApliPure
- Note 6 ApliPure Plus
- Note 7 Precision Imaging
- Note 8 Differential THI
- Note 9 Elastography
- Note 10 BEAM
- Note 11 Smart 3D
- Note 12 SMI
- Note 13 2D Wall Motion Tracking
- Note 14 Shear Wave
10
System: Xario200G and Xario100G, Software V1.1 Transducer: __ PVU-674BT
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Specific | ||||||||||||
| (Tracks 3) | B | M | PWD | CWD | Color | |||||||
| Doppler | Combined | |||||||||||
| (Specify) * | THI | Advanced | ||||||||||
| Dynamic | ||||||||||||
| Flow | Power | CHI | 4D | Other | ||||||||
| [Note] | ||||||||||||
| Ophthalmic | ||||||||||||
| Fetal | P | P | P | P | 2 | P | P | P | 5,6,7,8,11,12 | |||
| Abdominal | P | P | P | P | 2 | P | P | P | 5,6,7,8,11,12 | |||
| Intra-operative (Abdominal) | ||||||||||||
| Intra-operative (Neuro) | ||||||||||||
| Laparoscopic | ||||||||||||
| Small Organ (Note 1) | P | P | P | P | 2 | P | P | P | 5,6,7,8,11,12 | |||
| Neonatal Cephalic | ||||||||||||
| Adult Cephalic | ||||||||||||
| Trans-rectal | ||||||||||||
| Trans-vaginal | ||||||||||||
| Trans-urethral | ||||||||||||
| Trans-esoph. (non-Card.) | ||||||||||||
| Musculo-skeletal (Conventional) | ||||||||||||
| Musculo-skeletal (Superficial) | ||||||||||||
| Intravascular | ||||||||||||
| Other (Specify) | ||||||||||||
| Cardiac Adult | ||||||||||||
| Cardiac Pediatric | ||||||||||||
| Intravascular (Cardiac) | ||||||||||||
| Trans-esoph. (Cardiac) | ||||||||||||
| Intra-cardiac | ||||||||||||
| Other (Specify) | ||||||||||||
| Peripheral vessel | ||||||||||||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K172276
Note 1 Small organ includes thyroid, breast and testicle.
Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
- Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
- Note 4 TDI
- Note 5 ApliPure
- Note 6 ApliPure Plus
- Note 7 Precision Imaging
- Note 8 Differential THI
- Note 9 Elastography
- Note 10 BEAM
- Note 11 Smart 3D
- Note 12 SMI
- Note 13 2D Wall Motion Tracking
- Note 14 Shear Wave
11
System: __Xario200G and Xario100G, Software V1.1 Transducer: __ PVU-674MV
Transducer. F V U-074MV
| Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | |||||
|---|---|---|---|---|---|
| Clinical Application
Specific
(Tracks 3) | B | M | PWD | CWD | Color
Doppler | Combined
(Specify) * | THI | Advanced
Dynamic
Flow | Power | CHI | 4D | Other
[Note] |
|------------------------------------------------|---|---|-----|-----|------------------|-------------------------|-----|-----------------------------|-------|-----|----|-----------------|
| Ophthalmic | | | | | | | | | | | | |
| Fetal | P | P | P | | P | 2 | P | P | P | | P | 5,6,7,8 |
| Abdominal | P | P | P | | P | 2 | P | P | P | | P | 5,6,7,8 |
| Intra-operative (Abdominal) | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Pediatric | P | P | P | | P | 2 | P | P | P | | P | 5,6,7,8 |
| Small Organ (Note 1) | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | |
| Musculo-skeletal (Conventional) | | | | | | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K172276
Note 1 Small organ includes thyroid, breast and testicle.
Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
- Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
- Note 4 TDI
- Note 5 ApliPure
- Note 6 ApliPure Plus
- Note 7 Precision Imaging
- Note 8 Differential THI
- Note 9 Elastography
- Note 10 BEAM
- Note 11 Smart 3D
- Note 12 SMI
- Note 13 2D Wall Motion Tracking
- Note 14 Shear Wave
12
Transducer: PVU-712BT
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Specific | ||||||||||||
| (Tracks 3) | B | M | PWD | CWD | Color | |||||||
| Doppler | Combined | |||||||||||
| (Specify) * | THI | Advanced | ||||||||||
| Dynamic | ||||||||||||
| Flow | Power | CHI | ||||||||||
| 2D | 4D | Other | ||||||||||
| [Note] | ||||||||||||
| Ophthalmic | ||||||||||||
| Fetal | ||||||||||||
| Abdominal | P | P | P | P | P | 2 | P | P | P | 5,6,7,8,11 | ||
| Intra-operative (Abdominal) | ||||||||||||
| Intra-operative (Neuro) | ||||||||||||
| Laparoscopic | ||||||||||||
| Pediatric | P | P | P | P | P | 2 | P | P | P | 5,6,7,8,11 | ||
| Small Organ (Note 1) | ||||||||||||
| Neonatal Cephalic | P | P | P | P | P | 2 | P | P | P | 5,6,7,8,11 | ||
| Adult Cephalic | ||||||||||||
| Trans-rectal | ||||||||||||
| Trans-vaginal | ||||||||||||
| Trans-urethral | ||||||||||||
| Trans-esoph. (non-Card.) | ||||||||||||
| Musculo-skeletal (Conventional) | ||||||||||||
| Musculo-skeletal (Superficial) | ||||||||||||
| Intravascular | ||||||||||||
| Other (Specify) | ||||||||||||
| Cardiac Adult | ||||||||||||
| Cardiac Pediatric | ||||||||||||
| Intravascular (Cardiac) | ||||||||||||
| Trans-esoph. (Cardiac) | ||||||||||||
| Intra-cardiac | ||||||||||||
| Other (Specify) | ||||||||||||
| Peripheral vessel | ||||||||||||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K172276
Note 1 Small organ includes thyroid, breast and testicle.
Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
- Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
- Note 4 TDI
- Note 5 ApliPure
- Note 6 ApliPure Plus
- Note 7 Precision Imaging
- Note 8 Differential THI
- Note 9 Elastography
- Note 10 BEAM Note 11 Smart 3D
- Note 12 SMI
- Note 13 2D Wall Motion Tracking Note 14 Shear Wave
13
System: Xario200G and Xario100G, Software V1.1 Transducer: __ PVU-745BTF
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Specific | ||||||||||||
| (Tracks 3) | B | M | PWD | CWD | Color | |||||||
| Doppler | Combined | |||||||||||
| (Specify) * | THI | Advanced | ||||||||||
| Dynamic | ||||||||||||
| Flow | Power | CHI | 4D | Other | ||||||||
| [Note] | ||||||||||||
| Ophthalmic | ||||||||||||
| Fetal | ||||||||||||
| Abdominal | P | P | P | P | P | 2 | P | P | P | 5,6,7,8,11 | ||
| Intra-operative (Abdominal) | P | P | P | P | P | 2 | P | P | P | 5,6,7,8,11 | ||
| Intra-operative (Neuro) | ||||||||||||
| Laparoscopic | ||||||||||||
| Pediatric | ||||||||||||
| Small Organ (Note 1) | P | P | P | P | P | 2 | P | P | P | 5,6,7,8,11 | ||
| Neonatal Cephalic | ||||||||||||
| Adult Cephalic | ||||||||||||
| Trans-rectal | ||||||||||||
| Trans-vaginal | ||||||||||||
| Trans-urethral | ||||||||||||
| Trans-esoph. (non-Card.) | ||||||||||||
| Musculo-skeletal (Conventional) | ||||||||||||
| Musculo-skeletal (Superficial) | ||||||||||||
| Intravascular | ||||||||||||
| Other (Specify) | ||||||||||||
| Cardiac Adult | ||||||||||||
| Cardiac Pediatric | ||||||||||||
| Intravascular (Cardiac) | ||||||||||||
| Trans-esoph. (Cardiac) | ||||||||||||
| Intra-cardiac | ||||||||||||
| Other (Specify) | ||||||||||||
| Peripheral vessel | ||||||||||||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K172276
Note 1 Small organ includes thyroid, breast and testicle.
Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
- Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
- Note 4 TDI
- Note 5 ApliPure
- Note 6 ApliPure Plus
- Note 7 Precision Imaging
- Note 8 Differential THI
- Note 9 Elastography
- Note 10 BEAM Note 11 Smart 3D
- Note 12 SMI
- Note 13 2D Wall Motion Tracking
- Note 14 Shear Wave
14
System: Xario200G and Xario100G, Software V1.1 Transducer: __ PVU-745BTH
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Specific | ||||||||||||
| (Tracks 3) | B | M | PWD | CWD | Color | |||||||
| Doppler | Combined | |||||||||||
| (Specify) * | THI | Advanced | ||||||||||
| Dynamic | ||||||||||||
| Flow | Power | CHI | 4D | Other | ||||||||
| [Note] | ||||||||||||
| Ophthalmic | ||||||||||||
| Fetal | ||||||||||||
| Abdominal | P | P | P | P | 2 | P | P | P | 5,6,7,8,11 | |||
| Intra-operative (Abdominal) | P | P | P | P | 2 | P | P | P | 5,6,7,8,11 | |||
| Intra-operative (Neuro) | ||||||||||||
| Laparoscopic | ||||||||||||
| Pediatric | ||||||||||||
| Small Organ (Note 1) | P | P | P | P | 2 | P | P | P | 5,6,7,8,11 | |||
| Neonatal Cephalic | ||||||||||||
| Adult Cephalic | ||||||||||||
| Trans-rectal | ||||||||||||
| Trans-vaginal | ||||||||||||
| Trans-urethral | ||||||||||||
| Trans-esoph. (non-Card.) | ||||||||||||
| Musculo-skeletal (Conventional) | ||||||||||||
| Musculo-skeletal (Superficial) | ||||||||||||
| Intravascular | ||||||||||||
| Other (Specify) | ||||||||||||
| Cardiac Adult | ||||||||||||
| Cardiac Pediatric | ||||||||||||
| Intravascular (Cardiac) | ||||||||||||
| Trans-esoph. (Cardiac) | ||||||||||||
| Intra-cardiac | ||||||||||||
| Other (Specify) | ||||||||||||
| Peripheral vessel | ||||||||||||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K172276
Note 1 Small organ includes thyroid, breast and testicle.
Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
- Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
- Note 4 TDI
- Note 5 ApliPure
- Note 6 ApliPure Plus
- Note 7 Precision Imaging
- Note 8 Differential THI
- Note 9 Elastography
- Note 10 BEAM
- Note 11 Smart 3D
- Note 12 SMI
- Note 13 2D Wall Motion Tracking
- Note 14 Shear Wave
15
System: Xario200G and Xario100G, Software V1.1 Transducer: __ PVU-745BTV
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Specific | ||||||||||||
| (Tracks 3) | B | M | PWD | CWD | Color | |||||||
| Doppler | Combined | |||||||||||
| (Specify) * | THI | Advanced | ||||||||||
| Dynamic | ||||||||||||
| Flow | Power | CHI | 4D | Other | ||||||||
| [Note] | ||||||||||||
| Ophthalmic | ||||||||||||
| Fetal | ||||||||||||
| Abdominal | P | P | P | P | P | 2 | P | P | P | 5,6,7,8,11 | ||
| Intra-operative (Abdominal) | P | P | P | P | P | 2 | P | P | P | 5,6,7,8,11 | ||
| Intra-operative (Neuro) | ||||||||||||
| Laparoscopic | ||||||||||||
| Pediatric | ||||||||||||
| Small Organ (Note 1) | P | P | P | P | P | 2 | P | P | P | 5,6,7,8,11 | ||
| Neonatal Cephalic | ||||||||||||
| Adult Cephalic | ||||||||||||
| Trans-rectal | ||||||||||||
| Trans-vaginal | ||||||||||||
| Trans-urethral | ||||||||||||
| Trans-esoph. (non-Card.) | ||||||||||||
| Musculo-skeletal (Conventional) | ||||||||||||
| Musculo-skeletal (Superficial) | ||||||||||||
| Intravascular | ||||||||||||
| Other (Specify) | ||||||||||||
| Cardiac Adult | ||||||||||||
| Cardiac Pediatric | ||||||||||||
| Intravascular (Cardiac) | ||||||||||||
| Trans-esoph. (Cardiac) | ||||||||||||
| Intra-cardiac | ||||||||||||
| Other (Specify) | ||||||||||||
| Peripheral vessel | ||||||||||||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K172276
Note 1 Small organ includes thyroid, breast and testicle.
Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
- Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
- Note 4 TDI
- Note 5 ApliPure
- Note 6 ApliPure Plus
- Note 7 Precision Imaging
- Note 8 Differential THI
- Note 9 Elastography
- Note 10 BEAM
- Note 11 Smart 3D
- Note 12 SMI
- Note 13 2D Wall Motion Tracking
- Note 14 Shear Wave
16
System: Xario200G and Xario100G, Software V1.1 Transducer: PVU-681MVL
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Specific | |||||||||||||
| (Tracks 3) | B | M | PWD | CWD | Color | ||||||||
| Doppler | Combined | ||||||||||||
| (Specify) * | THI | Advanced | |||||||||||
| Dynamic | |||||||||||||
| Flow | Power | CHI | 4D | Other | |||||||||
| [Note] | |||||||||||||
| Ophthalmic | |||||||||||||
| Fetal | |||||||||||||
| Abdominal | |||||||||||||
| Intra-operative (Abdominal) | |||||||||||||
| Intra-operative (Neuro) | |||||||||||||
| Laparoscopic | |||||||||||||
| Pediatric | |||||||||||||
| Small Organ (Note 1) | |||||||||||||
| Neonatal Cephalic | |||||||||||||
| Adult Cephalic | |||||||||||||
| Trans-rectal | P | P | P | P | 2 | P | P | P | P | P | 5,6,7,8,12 | ||
| Trans-vaginal | P | P | P | P | 2 | P | P | P | P | P | 5,6,7,8,12 | ||
| Trans-urethral | |||||||||||||
| Trans-esoph. (non-Card.) | |||||||||||||
| Musculo-skeletal (Conventional) | |||||||||||||
| Musculo-skeletal (Superficial) | |||||||||||||
| Intravascular | |||||||||||||
| Other (Specify) | |||||||||||||
| Cardiac Adult | |||||||||||||
| Cardiac Pediatric | |||||||||||||
| Intravascular (Cardiac) | |||||||||||||
| Trans-esoph. (Cardiac) | |||||||||||||
| Intra-cardiac | |||||||||||||
| Other (Specify) | |||||||||||||
| Peripheral vessel | |||||||||||||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K172276
Note 1 Small organ includes thyroid, breast and testicle.
Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
- Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
- Note 4 TDI
- Note 5 ApliPure
- Note 6 ApliPure Plus
- Note 7 Precision Imaging
- Note 8 Differential THI
- Note 9 Elastography
- Note 10 BEAM
- Note 11 Smart 3D
- Note 12 SMI
- Note 13 2D Wall Motion Tracking
- Note 14 Shear Wave
17
System: Xario200G and Xario100G, Software V1.1 Transducer: __ PVU-770ST
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Specific | ||||||||||||
| (Tracks 3) | B | M | PWD | CWD | Color | |||||||
| Doppler | Combined | |||||||||||
| (Specify) * | THI | Advanced | ||||||||||
| Dynamic | ||||||||||||
| Flow | Power | CHI | 4D | Other | ||||||||
| [Note] | ||||||||||||
| Ophthalmic | ||||||||||||
| Fetal | ||||||||||||
| Abdominal | ||||||||||||
| Intra-operative (Abdominal) | ||||||||||||
| Intra-operative (Neuro) | ||||||||||||
| Laparoscopic | ||||||||||||
| Pediatric | ||||||||||||
| Small Organ (Note 1) | ||||||||||||
| Neonatal Cephalic | ||||||||||||
| Adult Cephalic | ||||||||||||
| Trans-rectal | P | P | P | P | 2 | P | P | P | 4,5,6,7,8,9 | |||
| Trans-vaginal | P | P | P | P | 2 | P | P | P | 4,5,6,7,8,9 | |||
| Trans-urethral | ||||||||||||
| Trans-esoph. (non-Card.) | ||||||||||||
| Musculo-skeletal (Conventional) | ||||||||||||
| Musculo-skeletal (Superficial) | ||||||||||||
| Intravascular | ||||||||||||
| Other (Specify) | ||||||||||||
| Cardiac Adult | ||||||||||||
| Cardiac Pediatric | ||||||||||||
| Intravascular (Cardiac) | ||||||||||||
| Trans-esoph. (Cardiac) | ||||||||||||
| Intra-cardiac | ||||||||||||
| Other (Specify) | ||||||||||||
| Peripheral vessel | ||||||||||||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K172276
Note 1 Small organ includes thyroid, breast and testicle.
Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
- Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
- Note 4 TDI
- Note 5 ApliPure
- Note 6 ApliPure Plus
- Note 7 Precision Imaging
- Note 8 Differential THI
- Note 9 Elastography
- Note 10 BEAM
- Note 11 Smart 3D
- Note 12 SMI
- Note 13 2D Wall Motion Tracking
- Note 14 Shear Wave
18
System: Xario200G and Xario100G, Software V1.1 Transducer: __ PVU-781VT
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Specific | |||||||||||||
| (Tracks 3) | B | M | PWD | CWD | Color | ||||||||
| Doppler | Combined | ||||||||||||
| (Specify) * | THI | Advanced | |||||||||||
| Dynamic | |||||||||||||
| Flow | Power | CHI | 4D | Other | |||||||||
| [Note] | |||||||||||||
| Ophthalmic | |||||||||||||
| Fetal | |||||||||||||
| Abdominal | |||||||||||||
| Intra-operative (Abdominal) | |||||||||||||
| Intra-operative (Neuro) | |||||||||||||
| Laparoscopic | |||||||||||||
| Pediatric | |||||||||||||
| Small Organ (Note 1) | |||||||||||||
| Neonatal Cephalic | |||||||||||||
| Adult Cephalic | |||||||||||||
| Trans-rectal | P | P | P | P | P | 2 | P | P | P | 4,5,6,7,8,9,12 | |||
| Trans-vaginal | P | P | P | P | P | 2 | P | P | P | 4,5,6,7,8,9,12 | |||
| Trans-urethral | |||||||||||||
| Trans-esoph. (non-Card.) | |||||||||||||
| Musculo-skeletal (Conventional) | |||||||||||||
| Musculo-skeletal (Superficial) | |||||||||||||
| Intravascular | |||||||||||||
| Other (Specify) | |||||||||||||
| Cardiac Adult | |||||||||||||
| Cardiac Pediatric | |||||||||||||
| Intravascular (Cardiac) | |||||||||||||
| Trans-esoph. (Cardiac) | |||||||||||||
| Intra-cardiac | |||||||||||||
| Other (Specify) | |||||||||||||
| Peripheral vessel | |||||||||||||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K172276
Note 1 Small organ includes thyroid, breast and testicle.
Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
- Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
- Note 4 TDI
- Note 5 ApliPure
- Note 6 ApliPure Plus
- Note 7 Precision Imaging
- Note 8 Differential THI
- Note 9 Elastography
- Note 10 BEAM
- Note 11 Smart 3D
- Note 12 SMI
- Note 13 2D Wall Motion Tracking
- Note 14 Shear Wave
19
System: Xario200G and Xario100G, Software V1.1 Transducer: __ PVU-781VTE
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Specific | ||||||||||||
| (Tracks 3) | B | M | PWD | CWD | Color | |||||||
| Doppler | Combined | |||||||||||
| (Specify) * | THI | Advanced | ||||||||||
| Dynamic | ||||||||||||
| Flow | Power | CHI | 4D | Other | ||||||||
| [Note] | ||||||||||||
| Ophthalmic | ||||||||||||
| Fetal | ||||||||||||
| Abdominal | ||||||||||||
| Intra-operative (Abdominal) | ||||||||||||
| Intra-operative (Neuro) | ||||||||||||
| Laparoscopic | ||||||||||||
| Pediatric | ||||||||||||
| Small Organ (Note 1) | ||||||||||||
| Neonatal Cephalic | ||||||||||||
| Adult Cephalic | ||||||||||||
| Trans-rectal | P | P | P | P | 2 | P | P | P | 4,5,6,7,8,9,12 | |||
| Trans-vaginal | P | P | P | P | 2 | P | P | P | 4,5,6,7,8,9,12 | |||
| Trans-urethral | ||||||||||||
| Trans-esoph. (non-Card.) | ||||||||||||
| Musculo-skeletal (Conventional) | ||||||||||||
| Musculo-skeletal (Superficial) | ||||||||||||
| Intravascular | ||||||||||||
| Other (Specify) | ||||||||||||
| Cardiac Adult | ||||||||||||
| Cardiac Pediatric | ||||||||||||
| Intravascular (Cardiac) | ||||||||||||
| Trans-esoph. (Cardiac) | ||||||||||||
| Intra-cardiac | ||||||||||||
| Other (Specify) | ||||||||||||
| Peripheral vessel | ||||||||||||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K172276
Note 1 Small organ includes thyroid, breast and testicle.
Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
- Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
- Note 4 TDI
- Note 5 ApliPure
- Note 6 ApliPure Plus
- Note 7 Precision Imaging
- Note 8 Differential THI
- Note 9 Elastography
- Note 10 BEAM Note 11 Smart 3D
- Note 12 SMI
- Note 13 2D Wall Motion Tracking
- Note 14 Shear Wave
20
System: Xario200G and Xario100G, Software V1.1 Transducer: PVL-715RS
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Specific | |||||||||||||
| (Tracks 3) | B | M | PWD | CWD | Color | ||||||||
| Doppler | Combined | ||||||||||||
| (Specify) * | THI | Advanced | |||||||||||
| Dynamic | |||||||||||||
| Flow | Power | CHI | 4D | Other | |||||||||
| [Note] | |||||||||||||
| Ophthalmic | |||||||||||||
| Fetal | |||||||||||||
| Abdominal | |||||||||||||
| Intra-operative (Abdominal) | |||||||||||||
| Intra-operative (Neuro) | |||||||||||||
| Laparoscopic | |||||||||||||
| Pediatric | |||||||||||||
| Small Organ (Note 1) | |||||||||||||
| Neonatal Cephalic | |||||||||||||
| Adult Cephalic | |||||||||||||
| Trans-rectal | P | P | P | P | P | 2 | P | P | P | 5,6,7,8,12 | |||
| Trans-vaginal | |||||||||||||
| Trans-urethral | |||||||||||||
| Trans-esoph. (non-Card.) | |||||||||||||
| Musculo-skeletal (Conventional) | |||||||||||||
| Musculo-skeletal (Superficial) | |||||||||||||
| Intravascular | |||||||||||||
| Other (Specify) | |||||||||||||
| Cardiac Adult | |||||||||||||
| Cardiac Pediatric | |||||||||||||
| Intravascular (Cardiac) | |||||||||||||
| Trans-esoph. (Cardiac) | |||||||||||||
| Intra-cardiac | |||||||||||||
| Other (Specify) | |||||||||||||
| Peripheral vessel | |||||||||||||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K172276
Note 1 Small organ includes thyroid, breast and testicle.
Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
- Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
- Note 4 TDI
- Note 5 ApliPure
- Note 6 ApliPure Plus
- Note 7 Precision Imaging
- Note 8 Differential THI
- Note 9 Elastography
- Note 10 BEAM
- Note 11 Smart 3D
- Note 12 SMI
- Note 13 2D Wall Motion Tracking
- Note 14 Shear Wave
21
System: Xario200G and Xario100G, Software V1.1 Transducer:_ PLU-704BT
Transducer. FLU-704D1
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Specific | |||||||||||||
| (Tracks 3) | B | M | PWD | CWD | Color | ||||||||
| Doppler | Combined | ||||||||||||
| (Specify) * | THI | Advanced | |||||||||||
| Dynamic | |||||||||||||
| Flow | Power | CHI | 4D | Other | [Note] | ||||||||
| Ophthalmic | |||||||||||||
| Fetal | |||||||||||||
| Abdominal | |||||||||||||
| Intra-operative (Abdominal) | |||||||||||||
| Intra-operative (Neuro) | |||||||||||||
| Laparoscopic | |||||||||||||
| Pediatric | |||||||||||||
| Small Organ (Note 1) | P | P | P | P | P | 2 | P | P | P | 5,6,7,8,10,11,12 | |||
| Neonatal Cephalic | |||||||||||||
| Adult Cephalic | |||||||||||||
| Trans-rectal | |||||||||||||
| Trans-vaginal | |||||||||||||
| Trans-urethral | |||||||||||||
| Trans-esoph. (non-Card.) | |||||||||||||
| Musculo-skeletal (Conventional) | P | P | P | P | P | 2 | P | P | P | 5,6,7,8,10,11,12 | |||
| Musculo-skeletal (Superficial) | P | P | P | P | P | 2 | P | P | P | 5,6,7,8,10,11,12 | |||
| Intravascular | |||||||||||||
| Other (Specify) | |||||||||||||
| Cardiac Adult | |||||||||||||
| Cardiac Pediatric | |||||||||||||
| Intravascular (Cardiac) | |||||||||||||
| Trans-esoph. (Cardiac) | |||||||||||||
| Intra-cardiac | |||||||||||||
| Other (Specify) | |||||||||||||
| Peripheral vessel | P | P | P | P | P | 2 | P | P | P | 5,6,7,8,10,11,12 | |||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K172276
Note 1 Small organ includes thyroid, breast and testicle.
Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
- Note 4 TDI
- Note 5 ApliPure
Note 6 ApliPure Plus
Note 7 Precision Imaging
Note 8 Differential THI
Note 9 Elastography
Note 10 BEAM
Note 11 Smart 3D
Note 12 SMI
Note 13 2D Wall Motion Tracking
Note 14 Shear Wave
22
Transducer:_ PLU-1005BT
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Specific | ||||||||||||
| (Tracks 3) | B | M | PWD | CWD | Color | |||||||
| Doppler | Combined | |||||||||||
| (Specify) * | THI | Advanced | ||||||||||
| Dynamic | ||||||||||||
| Flow | Power | CHI | 4D | Other [Note] | ||||||||
| Ophthalmic | ||||||||||||
| Fetal | ||||||||||||
| Abdominal | ||||||||||||
| Intra-operative (Abdominal) | ||||||||||||
| Intra-operative (Neuro) | ||||||||||||
| Laparoscopic | ||||||||||||
| Pediatric | ||||||||||||
| Small Organ (Note 1) | P | P | P | P | 2 | P | P | P | 4,5,6,7,8,9,10,11,1 | |||
| Neonatal Cephalic | ||||||||||||
| Adult Cephalic | ||||||||||||
| Trans-rectal | ||||||||||||
| Trans-vaginal | ||||||||||||
| Trans-urethral | ||||||||||||
| Trans-esoph. (non-Card.) | ||||||||||||
| Musculo-skeletal (Conventional) | P | P | P | P | 2 | P | P | P | 4,5,6,7,8,9,10,11,1 | |||
| Musculo-skeletal (Superficial) | P | P | P | P | 2 | P | P | P | 4,5,6,7,8,9,10,11,1 | |||
| Intravascular | ||||||||||||
| Other (Specify) | ||||||||||||
| Cardiac Adult | ||||||||||||
| Cardiac Pediatric | ||||||||||||
| Intravascular (Cardiac) | ||||||||||||
| Trans-esoph. (Cardiac) | ||||||||||||
| Intra-cardiac | ||||||||||||
| Other (Specify) | ||||||||||||
| Peripheral vessel | P | P | P | P | 2 | P | P | P | 4,5,6,7,8,9,10,11,1 | |||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K172276
Note 1 Small organ includes thyroid, breast and testicle.
Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
- Note 4 TDI
- Note 5 ApliPure
- Note 6 ApliPure Plus
- Note 7 Precision Imaging
- Note 8 Differential THI
- Note 9 Elastography
- Note 10 BEAM
- Note 11 Smart 3D
- Note 12 SMI
- Note 13 2D Wall Motion Tracking
- Note 14 Shear Wave
23
Transducer: PLU-1202BT
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Specific | ||||||||||||
| (Tracks 3) | B | M | PWD | CWD | Color | |||||||
| Doppler | Combined | |||||||||||
| (Specify) * | THI | Advanced | ||||||||||
| Dynamic | ||||||||||||
| Flow | Power | CHI | 4D | Other | ||||||||
| [Note] | ||||||||||||
| Ophthalmic | ||||||||||||
| Fetal | ||||||||||||
| Abdominal | ||||||||||||
| Intra-operative (Abdominal) | P | P | P | P | 2 | P | P | P | 5,6,7,8,11 | |||
| Intra-operative (Neuro) | ||||||||||||
| Laparoscopic | ||||||||||||
| Pediatric | ||||||||||||
| Small Organ (Note 1) | P | P | P | P | 2 | P | P | P | 4,5,6,7,8,9,11,12 | |||
| Neonatal Cephalic | ||||||||||||
| Adult Cephalic | ||||||||||||
| Trans-rectal | ||||||||||||
| Trans-vaginal | ||||||||||||
| Trans-urethral | ||||||||||||
| Trans-esoph. (non-Card.) | ||||||||||||
| Musculo-skeletal (Conventional) | P | P | P | P | 2 | P | P | P | 4,5,6,7,8,9,11,12 | |||
| Musculo-skeletal (Superficial) | P | P | P | P | 2 | P | P | P | 4,5,6,7,8,9,11,12 | |||
| Intravascular | ||||||||||||
| Other (Specify) | ||||||||||||
| Cardiac Adult | ||||||||||||
| Cardiac Pediatric | ||||||||||||
| Intravascular (Cardiac) | ||||||||||||
| Trans-esoph. (Cardiac) | ||||||||||||
| Intra-cardiac | ||||||||||||
| Other (Specify) | ||||||||||||
| Peripheral vessel | P | P | P | P | 2 | P | P | P | 4,5,6,7,8,9,11,12 | |||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K172276
Note 1 Small organ includes thyroid, breast and testicle.
Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
- Note 4 TDI
- Note 5 ApliPure
- Note 6 ApliPure Plus
- Note 7 Precision Imaging
- Note 8 Differential THI
- Note 9 Elastography
- Note 10 BEAM Note 11 Smart 3D
- Note 12 SMI
- Note 13 2D Wall Motion Tracking
- Note 14 Shear Wave
24
Transducer: PLU-1204BT
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Specific | ||||||||||||
| (Tracks 3) | B | M | PWD | CWD | Color | |||||||
| Doppler | Combined | |||||||||||
| (Specify) * | THI | Advanced | ||||||||||
| Dynamic | ||||||||||||
| Flow | Power | CHI | 4D | Other [Note] | ||||||||
| Ophthalmic | ||||||||||||
| Fetal | ||||||||||||
| Abdominal | ||||||||||||
| Intra-operative (Abdominal) | ||||||||||||
| Intra-operative (Neuro) | ||||||||||||
| Laparoscopic | ||||||||||||
| Pediatric | ||||||||||||
| Small Organ (Note 1) | P | P | P | P | P | 2 | P | P | P | 4,5,6,7,8,9,10,11,12 | ||
| Neonatal Cephalic | ||||||||||||
| Adult Cephalic | ||||||||||||
| Trans-rectal | ||||||||||||
| Trans-vaginal | ||||||||||||
| Trans-urethral | ||||||||||||
| Trans-esoph. (non-Card.) | ||||||||||||
| Musculo-skeletal (Conventional) | P | P | P | P | P | 2 | P | P | P | 4,5,6,7,8,9,10,11,12 | ||
| Musculo-skeletal (Superficial) | P | P | P | P | P | 2 | P | P | P | 4,5,6,7,8,9,10,11,1 | ||
| Intravascular | ||||||||||||
| Other (Specify) | ||||||||||||
| Cardiac Adult | ||||||||||||
| Cardiac Pediatric | ||||||||||||
| Intravascular (Cardiac) | ||||||||||||
| Trans-esoph. (Cardiac) | ||||||||||||
| Intra-cardiac | ||||||||||||
| Other (Specify) | ||||||||||||
| Peripheral vessel | P | P | P | P | P | 2 | P | P | P | 4,5,6,7,8,9,10,11,12 | ||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K172276
Note 1 Small organ includes thyroid, breast and testicle.
Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
- Note 4 TDI
- Note 5 ApliPure
- Note 6 ApliPure Plus
- Note 7 Precision Imaging
- Note 8 Differential THI
- Note 9 Elastography
- Note 10 BEAM Note 11 Smart 3D
- Note 12 SMI
- Note 13 2D Wall Motion Tracking
Note 14 Shear Wave
25
System: Xario200G and Xario100G, Software V1.1 Transducer:
PET-512MC
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application
Specific
| (Tracks 3) | Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | Color | ||||||||
| Doppler | Combined | |||||||||||
| (Specify) * | THI | Advanced | ||||||||||
| Dynamic | ||||||||||||
| Flow | Power | CHI | 4D | Other | ||||||||
| [Note] | ||||||||||||
| Ophthalmic | ||||||||||||
| Fetal | ||||||||||||
| Abdominal | ||||||||||||
| Intra-operative (Abdominal) | ||||||||||||
| Intra-operative (Neuro) | ||||||||||||
| Laparoscopic | ||||||||||||
| Pediatric | ||||||||||||
| Small Organ (Note 1) | ||||||||||||
| Neonatal Cephalic | ||||||||||||
| Adult Cephalic | ||||||||||||
| Trans-rectal | ||||||||||||
| Trans-vaginal | ||||||||||||
| Trans-urethral | ||||||||||||
| Trans-esoph. (non-Card.) | ||||||||||||
| Musculo-skeletal (Conventional) | ||||||||||||
| Musculo-skeletal (Superficial) | ||||||||||||
| Intravascular | ||||||||||||
| Other (Specify) | ||||||||||||
| Cardiac Adult | ||||||||||||
| Cardiac Pediatric | ||||||||||||
| Intravascular (Cardiac) | ||||||||||||
| Trans-esoph. (Cardiac) | P | P | P | P | P | 3 | P | 4, 7, 13 | ||||
| Intra-cardiac | ||||||||||||
| Other (Specify) | ||||||||||||
| Peripheral vessel | ||||||||||||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K172276
Note 1 Small organ includes thyroid, breast and testicle.
Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
- Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
- Note 4 TDI
- Note 5 ApliPure
- Note 6 ApliPure Plus
- Note 7 Precision Imaging
- Note 8 Differential THI
- Note 9 Elastography
- Note 10 BEAM Note 11 Smart 3D
- Note 12 SMI
- Note 13 2D Wall Motion Tracking
- Note 14 Shear Wave
26
System: Xario200G and Xario100G, Software V1.1 Transducer: PET-512MD
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Specific | ||||||||||||
| (Tracks 3) | B | M | PWD | CWD | Color | |||||||
| Doppler | Combined | |||||||||||
| (Specify) * | THI | Advanced | ||||||||||
| Dynamic | ||||||||||||
| Flow | Power | CHI | 4D | Other | ||||||||
| [Note] | ||||||||||||
| Ophthalmic | ||||||||||||
| Fetal | ||||||||||||
| Abdominal | ||||||||||||
| Intra-operative (Abdominal) | ||||||||||||
| Intra-operative (Neuro) | ||||||||||||
| Laparoscopic | ||||||||||||
| Pediatric | ||||||||||||
| Small Organ (Note 1) | ||||||||||||
| Neonatal Cephalic | ||||||||||||
| Adult Cephalic | ||||||||||||
| Trans-rectal | ||||||||||||
| Trans-vaginal | ||||||||||||
| Trans-urethral | ||||||||||||
| Trans-esoph. (non-Card.) | ||||||||||||
| Musculo-skeletal (Conventional) | ||||||||||||
| Musculo-skeletal (Superficial) | ||||||||||||
| Intravascular | ||||||||||||
| Other (Specify) | ||||||||||||
| Cardiac Adult | ||||||||||||
| Cardiac Pediatric | ||||||||||||
| Intravascular (Cardiac) | ||||||||||||
| Trans-esoph. (Cardiac) | P | P | P | P | P | 3 | P | 4, 7, 13 | ||||
| Intra-cardiac | ||||||||||||
| Other (Specify) | ||||||||||||
| Peripheral vessel | ||||||||||||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: N/A
Note 1 Small organ includes thyroid, breast and testicle.
Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
- Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
- Note 4 TDI
- Note 5 ApliPure
- Note 6 ApliPure Plus
- Note 7 Precision Imaging
- Note 8 Differential THI
- Note 9 Elastography
- Note 10 BEAM Note 11 Smart 3D
- Note 12 SMI
- Note 13 2D Wall Motion Tracking
- Note 14 Shear Wave
27
Transducer:_ PET-805LA
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Specific | ||||||||||||
| (Tracks 3) | B | M | PWD | CWD | Color | |||||||
| Doppler | Combined | |||||||||||
| (Specify) * | THI | Dynamic | ||||||||||
| Flow | Power | CHI | 4D | Other [Note] | ||||||||
| Ophthalmic | ||||||||||||
| Fetal | ||||||||||||
| Abdominal | ||||||||||||
| Intra-operative (Abdominal) | ||||||||||||
| Intra-operative (Neuro) | ||||||||||||
| Laparoscopic | P | P | P | P | 2 | P | P | P | 5,7 | |||
| Pediatric | ||||||||||||
| Small Organ (Note 1) | ||||||||||||
| Neonatal Cephalic | ||||||||||||
| Adult Cephalic | ||||||||||||
| Trans-rectal | ||||||||||||
| Trans-vaginal | ||||||||||||
| Trans-urethral | ||||||||||||
| Trans-esoph. (non-Card.) | ||||||||||||
| Musculo-skeletal (Conventional) | ||||||||||||
| Musculo-skeletal (Superficial) | ||||||||||||
| Intravascular | ||||||||||||
| Other (Specify) | ||||||||||||
| Cardiac Adult | ||||||||||||
| Cardiac Pediatric | ||||||||||||
| Intravascular (Cardiac) | ||||||||||||
| Trans-esoph. (Cardiac) | ||||||||||||
| Intra-cardiac | ||||||||||||
| Other (Specify) | ||||||||||||
| Peripheral vessel | ||||||||||||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K172276
Note 1 Small organ includes thyroid, breast and testicle.
Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
- Note 4 TDI
- Note 5 ApliPure
- Note 6 ApliPure Plus
- Note 7 Precision Imaging
- Note 8 Differential THI
- Note 9 Elastography
- Note 10 BEAM
- Note 11 Smart 3D Note 12 SMI
- Note 13 2D Wall Motion Tracking
- Note 14 Shear Wave
28
Transducer: PC-20M
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Specific | |||||||||||||
| (Tracks 3) | B | M | PWD | CWD | Color | ||||||||
| Doppler | Combined | ||||||||||||
| (Specify) * | THI | Advanced | |||||||||||
| Dynamic | |||||||||||||
| Flow | Power | CHI | 4D | Other | |||||||||
| [Note] | |||||||||||||
| Ophthalmic | |||||||||||||
| Fetal | |||||||||||||
| Abdominal | |||||||||||||
| Intra-operative (Abdominal) | |||||||||||||
| Intra-operative (Neuro) | |||||||||||||
| Laparoscopic | |||||||||||||
| Pediatric | |||||||||||||
| Small Organ (Note 1) | |||||||||||||
| Neonatal Cephalic | |||||||||||||
| Adult Cephalic | |||||||||||||
| Trans-rectal | |||||||||||||
| Trans-vaginal | |||||||||||||
| Trans-urethral | |||||||||||||
| Trans-esoph. (non-Card.) | |||||||||||||
| Musculo-skeletal (Conventional) | |||||||||||||
| Musculo-skeletal (Superficial) | |||||||||||||
| Intravascular | |||||||||||||
| Other (Specify) | |||||||||||||
| Cardiac Adult | P | ||||||||||||
| Cardiac Pediatric | P | ||||||||||||
| Intravascular (Cardiac) | |||||||||||||
| Trans-esoph. (Cardiac) | |||||||||||||
| Intra-cardiac | |||||||||||||
| Other (Specify) | |||||||||||||
| Peripheral vessel | P | ||||||||||||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K172276
Note 1 Small organ includes thyroid, breast and testicle.
Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
- Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
- Note 4 TDI
- Note 5 ApliPure
- Note 6 ApliPure Plus
- Note 7 Precision Imaging
- Note 8 Differential THI
- Note 9 Elastography
- Note 10 BEAM
- Note 11 Smart 3D
- Note 12 SMI
- Note 13 2D Wall Motion Tracking
- Note 14 Shear Wave
29
Transducer: PC-50M
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Specific | ||||||||||||
| (Tracks 3) | B | M | PWD | CWD | Color | |||||||
| Doppler | Combined | |||||||||||
| (Specify) * | THI | Advanced | ||||||||||
| Dynamic | ||||||||||||
| Flow | Power | CHI | 4D | Other | ||||||||
| [Note] | ||||||||||||
| Ophthalmic | ||||||||||||
| Fetal | ||||||||||||
| Abdominal | ||||||||||||
| Intra-operative (Abdominal) | ||||||||||||
| Intra-operative (Neuro) | ||||||||||||
| Laparoscopic | ||||||||||||
| Pediatric | ||||||||||||
| Small Organ (Note 1) | ||||||||||||
| Neonatal Cephalic | ||||||||||||
| Adult Cephalic | ||||||||||||
| Trans-rectal | ||||||||||||
| Trans-vaginal | ||||||||||||
| Trans-urethral | ||||||||||||
| Trans-esoph. (non-Card.) | ||||||||||||
| Musculo-skeletal (Conventional) | ||||||||||||
| Musculo-skeletal (Superficial) | ||||||||||||
| Intravascular | ||||||||||||
| Other (Specify) | ||||||||||||
| Cardiac Adult | P | |||||||||||
| Cardiac Pediatric | P | |||||||||||
| Intravascular (Cardiac) | ||||||||||||
| Trans-esoph. (Cardiac) | ||||||||||||
| Intra-cardiac | ||||||||||||
| Other (Specify) | ||||||||||||
| Peripheral vessel | P | |||||||||||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K172276
Note 1 Small organ includes thyroid, breast and testicle.
Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
- Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
- Note 4 TDI
- Note 5 ApliPure
- Note 6 ApliPure Plus
- Note 7 Precision Imaging
- Note 8 Differential THI
- Note 9 Elastography
- Note 10 BEAM Note 11 Smart 3D
- Note 12 SMI
- Note 13 2D Wall Motion Tracking Note 14 Shear Wave
30
MEDICAL SYSTEMS USA, INC.
510(k) SUMMARY
-
- SUBMITTER'S NAME: Canon Medical Systems Corporation 1385 Shimoishigami Otawara-shi, Tochigi-ken, Japan 324-8550
-
- OFFICIAL CORRESPONDENT Naofumi Watanabe
-
- ESTABLISHMENT REGISTRATION: 9614698
4. CONTACT PERSON:
Orlando Tadeo, Jr. Sr. Manager, Regulatory Affairs Canon Medical Systems USA, Inc 2441 Michelle Drive Tustin, CA 92780 (714) 669-7459
5. DATE PREPARED:
September 7, 2018
6. DEVICE NAME:
Xario200G and Xario100G, Software V1.1 Diagnostic Ultrasound System
7. TRADE NAME(S):
Diagnostic Ultrasound System Xario200G Model CUS-X200G Diagnostic Ultrasound System Xario100G Model CUS-X100G
8. COMMON NAME:
System, Diagnostic Ultrasound
PHONE: 800-421-1968 2441 Michelle Drive, Tustin, CA 92780
31
9. DEVICE CLASSIFICATION:
Class II
Ultrasonic Pulsed Doppler Imaging System – Product Code: 90-IYN [per 21 CFR 892.1550] Ultrasonic Pulsed Echo Imaging System – Product Code: 90-IYO [per 21 CFR 892.1560] Diagnostic Ultrasonic Transducer – Product Code: 90-ITX [per 21 CFR 892.1570]
10. PREDICATE DEVICE:
| Product | Marketed by | 510(k) Number | Clearance Date |
|---|---|---|---|
| Xario 200 Diagnostic | |||
| Ultrasound System V6.0 | Canon Medical | ||
| Systems USA, Inc | K172276 | December 12, 2017 |
11. REASON FOR SUBMISSION:
New device
12. DEVICE DESCRIPTION:
The Xario200G Model CUS-X200G and Xario100G Model CUS-X100G are mobile diagnostic ultrasound systems. These systems are Track 3 devices that employ a wide array of probes including flat linear array, convex linear array, and sector array with frequency ranges between approximately 2 MHz to 12 MHz.
13. INDICATIONS FOR USE:
The Diagnostic Ultrasound System Xario200G Model CUS-X200G and Xario100G Model CUS-X100G are indicated for the visualization of structures, and dynamic processes with the human body using ultrasound and to provide image information for diagnosis in the following clinical applications: fetal, abdominal, intra-operative(abdominal), laparoscopic, pediatric, small organs, neonatal cephalic, adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal (conventional), musculo-skeletal(superficial), cardiac adult, cardiac pediatric, trans-esoph(cardiac) and peripheral vessel.
14. SUBSTANTIAL EQUIVALENCE:
This device is substantially equivalent to the Xario200 V6.0 Diagnostic Ultrasound System, 510(k) cleared under K172276, marketed by Canon Medical Systems USA, Inc. The Xario200G and Xario100G, Software V1.1 Diagnostic Ultrasound System functions in a manner similar to and is intended for the same use as the predicate devices referenced within this submission. The subject device is a compact diagnostic ultrasound system that implements the latest technologies.
32
| | Xario200G/Xario100G
Model CUS-X200G
Model CUS-X100G, v1.1 | Xario200
Model TUS-X200 v6.0 | Comments |
|--------------------------------------|------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|-----------------------|
| 510(K) Control Number | This Submission (Subject) | K172276 | |
| Scanning Method | Electronic Convex,
Electronic Sector,
Electronic
Linear/Trapezoid, Pencil | Electronic Convex,
Electronic Sector,
Electronic
Linear/Trapezoid, Pencil | Same |
| Probe Selector | A/B/C Channels
3 connections and Pencil | A/B/C Channels
3 connections and Pencil | Same |
| | Xario200G/Xario100G
Model CUS-X200G
Model CUS-X100G, v1.1 | Xario200
Model TUS-X200 v6.0 | Comments |
| B-Mode Depth | 1cm (min.), 40 cm (max.) | 1cm (min.), 40 cm (max.) | Same |
| Transmission/Reception
Circuitry | | | |
| Beam Formation Control
Processing | Digital
Parallel processing | Digital
Parallel processing | Same |
| Summation | Quad Processing | Quad Processing | Same |
| Maximum Transmission
Channels | 128 Channels (Xario200G)
64 Channels (Xario100G) | 128 Channels | Same for
Xario200G |
| Transmission Frequency | Multiple frequencies are
selectable | Multiple frequencies are
selectable | Same |
| Observation Monitor | 21.5-inch LCD
(LED backlight) | 19-inch LCD
(LED backlight) | Change |
| Reference signal: ECG
Wired | Yes | Yes | Same |
| Wireless | Yes (Xario200G) / No
(Xario100G) | No | Change |
| Foot switch
Wired | Yes | Yes | Same |
| Wireless | Yes (Xario200G) / No
(Xario100G) | No | Change |
| Battery pack | Yes | No | Change |
| Mounting kit for Battery
pack | Yes (Xario200G) / No
(Xario100G) | No | Change |
15. SAFETY:
The device is designed and manufactured under the Quality System Regulations as outlined in 21 CFR § 820 and ISO 13485 Standards. This device is in conformance with the applicable parts of the IEC60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 62304, AIUM RTD2-2004 Output Display and ISO 10993-1 standards.
33
16. TESTING
Risk Analysis, Verification/Validation testing conducted which are included in this submission demonstrates that the requirements for the features have been met.
Software Documentation for a Moderate Level of Concern, per the FDA guidance document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Document" issued on May 11, 2005, is also included as part of this submission.
Additionally, testing of this device was conducted in accordance with the applicable standards published by the International Electrotechnical Commission (IEC) for Medical Devices.
No clinical studies were required to demonstrate safety and efficacy of the Xario200G/Xario100G systems.
17. CONCLUSION
The Xario200G and Xario100G, Software V1.1 Diagnostic Ultrasound System are substantially equivalent to the predicate device. The subject devices function in a manner similar to and is intended for the same use as the predicate device, as described in the labeling. Based upon the successful completion of software validation, application of risk management and design controls, it is concluded that this device is safe and effective for its intended use.