Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V3.1
Device Facts
| Record ID | K182679 |
|---|---|
| Device Name | Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V3.1 |
| Applicant | Canon Medical Systems Corporation |
| Product Code | IYN · Radiology |
| Decision Date | Oct 31, 2018 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | AI/ML, Pediatric, 3rd-Party Reviewed |
Intended Use
The Diagnostic Ultrasound Systems Aplio i900 Model TUS-AI900, Aplio i800 Model TUS-AI800, Aplio i700 Model TUS-AI700 and Aplio i600 Model TUS-AI600 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), pediatric, small organs, trans-vaginal, trans-rectal, neonatal cephalic, adult cephalic, cardiac (both adult and pediatric), peripheral vascular, transesophageal, musculo-skeletal (both conventional and superficial) and laparoscopic.
Device Story
Mobile diagnostic ultrasound system; uses various probes (linear, convex, sector) with 2-30 MHz frequency range. Inputs ultrasound signals to visualize structures and dynamic processes. Features include limb volume measurement, contrast vector imaging, breast scan guide, 3D/2D wall motion tracking, and smart fusion. Operated by clinicians in clinical settings. Output displayed on system monitor for diagnostic assessment. Enhances clinical decision-making through improved visualization and automated measurements. Benefits patients via non-invasive diagnostic imaging.
Clinical Evidence
Bench testing and clinical evaluation performed. Bench testing included phantom studies for Limb Volume Measurement, Contrast Vector Imaging, and Breast Scan Guide. Volunteer studies conducted to assess improvements to 3D/2D Wall Motion Tracking and Smart Fusion. Results demonstrate that new and improved features meet design specifications and perform as intended, confirming substantial equivalence to predicate devices.
Technological Characteristics
Mobile diagnostic ultrasound system; flat linear, convex linear, and sector array transducers (2-30 MHz). Software-based image processing. Conforms to AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-37, and ISO 10993 standards. Biocompatible materials used in transducers. Connectivity via standard ultrasound system interfaces.
Indications for Use
Indicated for diagnostic ultrasound imaging and fluid flow analysis of fetal, abdominal, intra-operative (abdominal), pediatric, small organs, trans-vaginal, trans-rectal, neonatal cephalic, adult cephalic, cardiac (adult/pediatric), peripheral vascular, transesophageal, musculo-skeletal (conventional/superficial), and laparoscopic applications.
Regulatory Classification
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.
Predicate Devices
- Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4 (K173090)
Reference Devices
- Philips EPIQ 5 Diagnostic Ultrasound System (K172607)
- Voluson E10 (K172342)
Related Devices
- K191663 — Aplio a550, Aplio a450 and Aplio a, Diagnostic Ultrasound System, V4.0 · Canon Medical Systems Corporation · Sep 18, 2019
- K162187 — Xario 100 Diagnostic Ultrasound System, V5.0 · Toshibamedical Systems Corporation · Sep 30, 2016
- K173090 — Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4 · Toshibamedical Systems Corporation · Jan 11, 2018
- K172276 — Xario 200 Diagnostic Ultrasound System V6.0 · Toshibamedical Systems Corporation · Dec 12, 2017
- K242808 — Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V8.5 · Canon Medical Systems Corporation · May 13, 2025
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Canon Medical Systems Corporation % Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street, NW BUFFALO, MN 55313
October 31, 2018
Re: K182679
Trade/Device Name: Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V3.1 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: October 26, 2018 Received: October 30, 2018
Dear Mark Job:
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
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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. Digitally signed by Date: 2018.10.31 For O'hara -S 15:52:07 -04'00' 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
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# Indications for Use
510(k) Number (if known)
K182679
Device Name
Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V3.1
#### Indications for Use (Describe)
The Diagnostic Ultrasound Systems Aplio i900 Model TUS-AI900, Aplio i800 Model TUS-AI800, Aplio i700 Model TUS-AI700 and Aplio i600 Model TUS-AI600 are indication 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), pediatric, small organs, trans-rectal, neonatal cephalic, adult cephalic, cardiac (both adult and pediat, transesophageal, musculo-skeletal (both conventional and superficial) and laparoscopic
| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| <span style="font-size: 10pt;"> <span style="font-family: Wingdings;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D)</span> | <span style="font-size: 10pt;"> <span style="font-family: Wingdings;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C)</span> |
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Transducer:
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | | | | | | | | | | | | | | | | | | | | | | |
|--------------------------------|-------------------|---|-----|-----|---------------|-----------------------------------------|-----------|------------|------|-------|-----|--------------|----------|------------|----|----------------------------|------|------------|--------|------------------|--------|-----------------|----------|
| Specific<br>(Tracks 3) | B | M | PWD | CWD | Color Doppler | Precision Imaging<br>Combined (Specify) | Apli Pure | Micro Pure | BEAM | Power | TDI | Elastography | SMI(ADF) | Shear wave | 4D | 3D Color<br>(Volume color) | STIC | STIC Color | Fusion | Smart Navigation | 2D WMT | Other<br>[Note] | |
| Ophthalmic | | | | | | | | | | | | | | | | | | | | | | | |
| Fetal | P | P | P | | P | 2 | P | P | | P | N | | P | | P | P | P | P | P | | N | 6,8 | |
| Abdominal | P | P | P | P | P | 2,3 | P | P | | P | | P | P | P | P | P | P | P | P | P | | 4,5,6,7,8 | |
| Intra-operative (Abdominal) | P | P | P | | P | 2 | P | P | | P | | | P | | | | | | P | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | | | | | | | | | | | | |
| Laparoscopic | P | P | P | | P | 2 | P | P | | P | | P | P | | | | | | | | | | |
| Pediatric | P | P | P | P | P | 2,3 | P | P | | P | | | P | P | P | P | P | P | P | P | | 6,8 | |
| Small Organ (Note 1) | P | P | P | | P | 2 | P | P | P | P | P | | P | P | | | | | P | P | P | | 6 |
| Neonatal Cephalic | P | P | P | P | P | 3 | P | | | P | | | | | | | | | | | | | |
| Adult Cephalic | P | P | P | P | P | 3 | N | | | P | | | P | | P | | | | | P | | | 6, |
| Trans-rectal | P | P | P | | P | 2 | P | P | | P | | P | P | P | P | P | | | | P | P | | 8 |
| Trans-vaginal | P | P | P | | P | 2 | P | P | | P | | P | P | P | P | P | | | | P | P | | 8 |
| Trans-urethral | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | | | | | | | | | | | | |
| Musculo-skeletal(Conventional) | P | P | P | | P | 2 | P | P | P | P | P | | P | P | | | | | P | P | P | | 6,8(N) |
| Musculo-skeletal (Superficial) | P | P | P | | P | 2 | P | P | P | P | P | | P | P | | | | | P | P | P | | 6,8(N) |
| Intravascular | | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | |
| Cardiac Adult | P | P | P | P | P | 3 | P | | | P | P | | | | P | P | | | | P | | P | 7,8,9,10 |
| Cardiac Pediatric | P | P | P | P | P | 3 | P | | | P | P | | | | P | P | | | | | | P | 7,8,9,10 |
| Intravascular (Cardiac) | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | P | P | P | P | P | 3 | P | | | | P | | | | P | P | | | | | | P | 8,10,11 |
| Intra-cardiac | | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | |
| Peripheral vessel | P | P | P | P | P | 2 | P | P | P | P | P | | P | P | | | | | P | P | P | | 6 |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K173090 Prescription Use Only (Per 21 CFR 801.109)
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 ATI
Note 5 Tissue Intensity Analysis
Note 6 Sensor3D
Note 7 CHI (Per FDA approved contrast agent prescribing information)
Note 8 Shadow Glass
Note 9 3D Wall Motion Tracking
Note 10 3D ACM
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Transducer: PSI-28BT
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | | | | | | | | | | | | | | Other [Note] | | | | | | | | |
|---------------------------------|-------------------|---|-----|-----|---------------|-------------------------------------------|-----------|------------|------|-------|-----|--------------|----------|------------|----------------------|----------------------------|------|------------|----------|--------|------------------|----------------|--------------|
| Specific<br>(Tracks 3) | B | M | PWD | CWD | Color Doppler | Precision Imaging<br>Combined (Specify) * | Apli Pure | Micro Pure | BEAM | Power | TDI | Elastography | SMI(ADF) | Shear wave | 4D<br>(Volume color) | 3D Color<br>(Volume color) | STIC | STIC Color | Smart 3D | Fusion | Smart Navigation | 2D WMT | Other [Note] |
| Ophthalmic | | | | | | | | | | | | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | | | | | | | | | | | | |
| Abdominal | N | N | N | N | N | 3 | N | N | | N | | N | | | | | | | | N | | 6(N),7(N),8(N) | |
| Intra-operative (Abdominal) | | | | | | | | | | | | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | | | | | | | | | | | | |
| Small Organ (Note 1) | | | | | | | | | | | | | | | | | | | | | | | |
| Neonatal Cephalic | N | N | N | N | N | 3 | N | N | | N | | | | | | | | | | | | | |
| Adult Cephalic | N | N | N | N | N | 3 | N | N | | N | | N | | | | | | | | N | | 6(N) | |
| Trans-rectal | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | | | | | | | | | | | | |
| Musculo-skeletal (Conventional) | | | | | | | | | | | | | | | | | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | | | | | | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | |
| Cardiac Adult | N | N | N | N | N | 3 | N | N | | N | N | | | | | | | | | N | | 7(N),8(N) | |
| Cardiac Pediatric | N | N | N | N | N | 3 | N | N | | N | N | | | | | | | | | | | 7(N),8(N) | |
| 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: N/A Prescription Use Only (Per 21 CFR 801.109)
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 ATI
- Note 5 Tissue Intensity Analysis
- Note 6 Sensor3D
Note 7 CHI (Per FDA approved contrast agent prescribing information)
Note 8 Shadow Glass
Note 9 3D Wall Motion Tracking
Note 10 3D ACM
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Transducer: PSI-30BX
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | | | | | | | | | | | | | | Other [Note] | | | | | | | | |
|---------------------------------|-------------------|---|-----|-----|---------------|-------------------------------------------|-----------|------------|------|-------|-----|--------------|------------|----------|----------------------|----------|------|------------|----------|--------|------------------|--------|------|
| Specific<br>(Tracks 3) | B | M | PWD | CWD | Color Doppler | Precision Imaging<br>Combined (Specify) * | Apli Pure | Micro Pure | BEAM | Power | TDI | Elastography | Shear wave | SMI(ADF) | 4D<br>(Volume color) | 3D Color | STIC | STIC Color | Smart 3D | Fusion | Smart Navigation | 2D WMT | |
| Ophthalmic | | | | | | | | | | | | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | | | | | | | | | | | | |
| Abdominal | P | P | P | P | P | 3 | P | | P | | P | | | | | | | | | P | P | | 6(P) |
| Intra-operative (Abdominal) | | | | | | | | | | | | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | | | | | | | | | | | |
| Pediatric | P | P | P | P | P | 3 | P | | P | | P | | | | | | | | | P | P | | 6(P) |
| Small Organ (Note 1) | | | | | | | | | | | | | | | | | | | | | | | |
| Neonatal Cephalic | P | P | P | P | P | 3 | P | | P | | P | | | | | | | | | | | | |
| Adult Cephalic | P | P | P | P | P | 3 | N | | P | | P | | | | | | | | | P | | | 6(P) |
| 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 | P | | | | | | | | | P | | P | 7 |
| Cardiac Pediatric | P | P | P | P | P | 3 | P | | P | P | P | | | | | | | | | P | | P | 7 |
| 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: K173090 Prescription Use Only (Per 21 CFR 801.109)
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 ATI
Note 5 Tissue Intensity Analysis
Note 6 Sensor3D
Note 7 CHI (Per FDA approved contrast agent prescribing information)
Note 8 Shadow Glass
Note 9 3D Wall Motion Tracking
Note 10 3D ACM
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Transducer: PSI-70BT
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application Mode of Operation
| Specific<br>(Tracks 3) | B | M | PWD | CWD | Color Doppler | Combined (Specify) * | Precision Imaging | Apli Pure | Micro Pure | BEAM | Power | TDI | Elastography | SMI(ADF) | Shear wave | 4D | 3D Color<br>(Volume color) | STIC | STIC Color | Smart 3D | Fusion | Smart Navigation | 2D WMT | Other | [Note] |
|---------------------------------|---|---|-----|-----|---------------|----------------------|-------------------|-----------|------------|------|-------|-----|--------------|----------|------------|----|----------------------------|------|------------|----------|--------|------------------|--------|-------|--------|
| Ophthalmic | | | | | | | | | | | | | | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | | | | | | | | | | | | | | |
| Abdominal | P | P | P | P | P | 3 | P | | | | P | | | P | | | | | | | | | | | |
| Intra-operative (Abdominal) | | | | | | | | | | | | | | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | | | | | | | | | | | | | |
| Pediatric | P | P | P | P | P | 3 | P | | | | P | | | P | | | | | | | | | | | |
| Small Organ (Note 1) | | | | | | | | | | | | | | | | | | | | | | | | | |
| Neonatal Cephalic | P | P | P | P | P | 3 | P | | | | P | | | | | | | | | | | | | | |
| Adult Cephalic | P | P | P | P | P | 3 | | | | | P | | | | | | | | | | | | | | |
| 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 | | | | | | | | | | | P 7 | | |
| Cardiac Pediatric | P | P | P | P | P | 3 | P | | | | P | P | | | | | | | | | | | P 7 | | |
| 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: K173090 Prescription Use Only (Per 21 CFR 801.109)
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 ATI
Note 5 Tissue Intensity Analysis
Note 6 Sensor3D
Note 7 CHI (Per FDA approved contrast agent prescribing information)Note8 Shadow Glass
Note 9 3D Wall Motion Tracking
Note 10 3D ACM
{7}------------------------------------------------
Transducer:
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | | | | | | | | | | | | | | Other | Note | | | | | | | |
|---------------------------------|-------------------|---|-----|-----|---------------|-------------------------------------------|-----------|------------|------|-------|-----|--------------|------------------------|----------------------|----------|------|------------|----------|--------|------------------|--------|--|--|
| Specific<br>(Tracks 3) | B | M | PWD | CWD | Color Doppler | Precision Imaging<br>Combined (Specify) * | Apli Pure | Micro Pure | BEAM | Power | TDI | Elastography | Shear wave<br>SMI(ADF) | 4D<br>(Volume color) | 3D Color | STIC | STIC Color | Smart 3D | Fusion | Smart Navigation | 2D WMT | | |
| Ophthalmic | | | | | | | | | | | | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | | | | | | | | | | | | |
| Abdominal | P | P | P | P | P | 3 | P | | | P | | P | | | | | | | | | | | |
| Intra-operative (Abdominal) | | | | | | | | | | | | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | | | | | | | | | | | |
| Pediatric | P | P | P | P | P | 3 | P | | | P | | P | | | | | | | | | | | |
| Small Organ (Note 1) | | | | | | | | | | | | | | | | | | | | | | | |
| Neonatal Cephalic | P | P | P | P | P | 3 | P | | | P | | P | | | | | | | | | | | |
| Adult Cephalic | P | P | P | P | P | 3 | N | | | P | | P | | | | | | | | | | | |
| 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 | | | | | | | | | | P | | |
| Cardiac Pediatric | P | P | P | P | P | 3 | P | | | P | P | | | | | | | | | | P | | |
| 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: K173090 Prescription Use Only (Per 21 CFR 801.109)
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 ATI
Note 5 Tissue Intensity Analysis
Note 6 Sensor3D
Note 7 CHI (Per FDA approved contrast agent prescribing information)
Note 8 Shadow Glass
Note 9 3D Wall Motion Tracking
Note 10 3D ACM
{8}------------------------------------------------
PST-30BT Transducer:
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Op |
|----------------------|------------|
|----------------------|------------|
| Clinical Application<br>Specific<br>(Tracks 3) | Mode of Operation | | | | | | | | | | | | | | | | | | | | | | |
|------------------------------------------------|-------------------|---|-----|-----|---------------|----------------------|-------------------|------------|-----------|------|-------|-----|--------------|------------------------|----------------------|----------|------|------------|----------|--------|------------------|--------|-----------------|
| | B | M | PWD | CWD | Color Doppler | Combined (Specify) * | Precision Imaging | Micro Pure | Apli Pure | BEAM | Power | TDI | Elastography | Shear wave<br>SMI(ADF) | 4D<br>(Volume color) | 3D Color | STIC | STIC Color | Smart 3D | Fusion | Smart Navigation | 2D WMT | Other<br>[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 | | | | | | | | | |
| Small Organ (Note 1) | | | | | | | | | | | | | | | | | | | | | | | |
| Neonatal Cephalic | P | P | P | P | P | 3 | | | | | P | | | | | | | | | | | | |
| Adult Cephalic | P | P | P | P | P | 3 | N | | | | P | | | | | | | | | | | | |
| 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 | 7 |
| Cardiac Pediatric | P | P | P | P | P | 3 | | | | | P | P | | | | | | | | | | P | 7 |
| 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: K173090 Prescription Use Only (Per 21 CFR 801.109)
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 ATI
Note 5 Tissue Intensity Analysis
Note 6 Sensor3D
Note 7 CHI (Per FDA approved contrast agent prescribing information)
Note 8 Shadow Glass
Note 9 3D Wall Motion Tracking
Note 10 3D ACM
{9}------------------------------------------------
PST-50BT Transducer:
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Mode of Operation Clinical Application
| Clinical Application<br>Specific<br>(Tracks 3) | Mode of Operation<br>B | M | PWD | CWD | Color Doppler | Combined (Specify) * | Precision Imaging | Micro Pure | BEAM | Power | TDI | Elastography | Shear wave | SMI(ADF) | 4D | 3D Color<br>(Volume color) | STIC | STIC Color | Smart 3D | Fusion | Smart Navigation | 2D WMT | Other | [Note] |
|------------------------------------------------|------------------------|---|-----|-----|---------------|----------------------|-------------------|------------|------|-------|-----|--------------|------------|----------|----|----------------------------|------|------------|----------|--------|------------------|--------|-------|--------|
| Ophthalmic | | | | | | | | | | | | | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | | | | | | | | | | | | | |
| Abdominal | P | P | P | P | P | 3 | P | | | P | | P | | | | | | | | | | | | |
| Intra-operative (Abdominal) | | | | | | | | | | | | | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | | | | | | | | | | | | |
| Pediatric | P | P | P | P | P | 3 | P | | | P | | P | | | | | | | | | | | | |
| Small Organ (Note 1) | | | | | | | | | | | | | | | | | | | | | | | | |
| Neonatal Cephalic | P | P | P | P | P | 3 | | | | P | | | | | | | | | | | | | | |
| Adult Cephalic | P | P | P | P | P | 3 | | | | P | | | | | | | | | | | | | | |
| 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 | | | |
| Cardiac Pediatric | P | P | P | P | P | 3 | | | | P | P | | | | | | | | | | P | | | |
| Intravascular (Cardiac) | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | |…
