Who is the manufacturer of Aplio a550, Aplio a450 and Aplio a, Diagnostic Ultrasound System, V4.0?

Canon Medical Systems Corporation filed the 510(k) submission for Aplio a550, Aplio a450 and Aplio a, Diagnostic Ultrasound System, V4.0 (K191663).

What is the FDA product code for Aplio a550, Aplio a450 and Aplio a, Diagnostic Ultrasound System, V4.0?

IYN. It is classified under 21 CFR 892.1550 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for Aplio a550, Aplio a450 and Aplio a, Diagnostic Ultrasound System, V4.0?

510(k) clearance (submission type: Traditional).

Does Aplio a550, Aplio a450 and Aplio a, Diagnostic Ultrasound System, V4.0 use AI or machine learning?

Yes. Aplio a550, Aplio a450 and Aplio a, Diagnostic Ultrasound System, V4.0 (K191663) is flagged as an AI/ML-enabled medical device in the FDA's AI/ML device list.

What are the predicate devices for Aplio a550, Aplio a450 and Aplio a, Diagnostic Ultrasound System, V4.0?

Aplio a550 and a450, Software V2.8 Diagnostic Ultrasound System (K182427).

Who can help prepare an FDA 510(k) submission like Aplio a550, Aplio a450 and Aplio a, Diagnostic Ultrasound System, V4.0?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Aplio a550, Aplio a450 and Aplio a, Diagnostic Ultrasound System, V4.0

Q: Can an AI/ML device like Aplio a550, Aplio a450 and Aplio a, Diagnostic Ultrasound System, V4.0 get a guaranteed FDA 510(k) clearance?

Yes. Innolitics offers a guaranteed FDA 510(k) clearance engagement for AI/ML Software as a Medical Device — combining engineering and regulatory execution under one agreement with a guaranteed clearance outcome. Eligibility: the device must be an AI/ML Software as a Medical Device (SaMD), and its performance must meet the criteria Innolitics determines during an initial regulatory strategy engagement to be necessary for FDA clearance. See https://innolitics.com/services/end-to-end-samd/ or contact https://innolitics.com/contact.

K191663 · Canon Medical Systems Corporation · IYN · Sep 18, 2019 · Radiology

Device Facts

Record ID	K191663
Device Name	Aplio a550, Aplio a450 and Aplio a, Diagnostic Ultrasound System, V4.0
Applicant	Canon Medical Systems Corporation
Product Code	IYN · Radiology
Decision Date	Sep 18, 2019
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1550
Device Class	Class 2
Attributes	AI/ML, Pediatric

Intended Use

The Diagnostic Ultrasound Systems Aplio a550 Model CUS-AA550. Aplio a450 Model CUS-AA450, and Aplio a Model CUS-AA000 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 wide array of probes (linear, convex, sector) with 2-20 MHz frequency range. Transforms acoustic signals into diagnostic images/fluid flow analysis. Used in clinical settings (e.g., hospital, clinic) by trained healthcare professionals. Provides real-time visualization of internal structures and dynamic processes; supports advanced imaging modes (e.g., Doppler, Elastography, 4D). Output displayed on system monitor for clinician interpretation; aids in diagnosis and clinical decision-making. Benefits include non-invasive diagnostic imaging and improved workflow through automated measurement features (e.g., Auto E/A, Auto EF).

Clinical Evidence

Bench testing only. No clinical studies were required. Performance testing included bench assessments of Doppler Luminance, Auto E/A, and measurement in volume rendering view to confirm intended improvements in visualization and workflow efficiency.

Technological Characteristics

Mobile ultrasound system; flat linear, convex linear, and sector array transducers (2-20 MHz). Features include Doppler, Elastography, 4D/3D imaging, and automated measurement tools. Connectivity includes standard ultrasound interfaces. Software is moderate level of concern. Conforms to IEC 60601-1, IEC 60601-2-37, IEC 62304, and ISO 10993 standards.

Indications for Use

Indicated for visualization of structures and dynamic processes in the human body using ultrasound for diagnosis in 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 a550 and a450, Software V2.8 Diagnostic Ultrasound System (K182427)

Reference Devices

PST-28BT (K182679)
PVT-574BT (K182679)
PVT-770RT (K182679)
PLT-1204BX (K151451)

Related Devices

K162187 — Xario 100 Diagnostic Ultrasound System, V5.0 · Toshibamedical Systems Corporation · Sep 30, 2016
K133277 — XARIO 100 · Toshibamedical Systems Corporation · Jan 17, 2014
K221117 — RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound System · Samsung Medison Co., Ltd. · Jun 17, 2022
K172276 — Xario 200 Diagnostic Ultrasound System V6.0 · Toshibamedical Systems Corporation · Dec 12, 2017
K173090 — Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4 · Toshibamedical Systems Corporation · Jan 11, 2018

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized symbol. To the right is the FDA logo, with the acronym "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text. September 18, 2019 Canon Medical Systems Corporation % Orlando Tadeo, Jr. Sr. Manager, Regulatory Affairs Canon Medical Systems USA, Inc. 2441 Michelle Drive TUSTIN CA 92780 # Re: K191663 Trade/Device Name: Aplio a550, Aplio a450 and Aplio a, Diagnostic Ultrasound System, V4.0 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: June 20, 2019 Received: June 21, 2019 Dear Mr. 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 801) medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for devices {1}------------------------------------------------ or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. For Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) # K191663 Device Name Aplio a550, Aplio a450 and Aplio a,Diagnostic Ultrasound System, V4.0 Indications for Use (Describe) The Diagnostic Ultrasound Systems Aplio a550 Model CUS-AA550. Aplio a450 Model CUS-AA450, and Aplio a Model CUS-AA000 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. 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) | |------------------------------------------------|---------------------------------------------| |------------------------------------------------|---------------------------------------------| # CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | Clinical Application | Mode of Operation | | | | | | | | | | | | | | | Other | Note | | | | | | | | |---------------------------------|-------------------|---|-----|-----|-------------------------------------|-------------------|------------|------|-------|-----|--------------|-----|------------|----------------------|----------------------------|-------|------------|----------|--------|------------------|--------|---|------------|---| | Specific (Tracks 3) | B | M | PWD | CWD | Color Doppler Combined (Specify) | Precision Imaging | Micro Pure | BEAM | Power | TDI | Elastography | SMI | Shear wave | 4D (Volume color) | 3D Color (Volume color) | STIC | STIC Color | Smart 3D | Fusion | Smart Navigation | 2D WMT | | | | | Ophthalmic | | | | | | | | | | | | | | | | | | | | | | | | | | Fetal | P | P | P | | P | 2 | P | P | | P | N | | P | | P | P | P | P | P | | P | | 4,6 | | | Abdominal | P | P | P | P | P | 2,3 | P | P | | P | | P | P | P | P | P | P | P | P | P | P | | 4,5,6,7(N) | | | Intra-operative (Abdominal) | P | P | P | | P | 2 | P | P | | P | | | P | | | | | | P | P | | | 4 | | | 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 | | 4,6 | | | Small Organ (Note 1) | P | P | P | | P | 2 | P | P | P | P | P | | P | P | P | | | | | P | P | P | | 4 | | Neonatal Cephalic | P | P | P | P | P | 2,3 | P | P | | P | | | | | | | | | P | | | | | | | Adult Cephalic | P | P | P | P | P | 3 | N | | | P | | | N | | | | | | | N | | | 4 | | | Trans-rectal | P | P | P | | P | 2 | P | P | | P | | P | P | P | P | P | | | | P | P | | 4,6 | | | Trans-vaginal | P | P | P | | P | 2 | P | P | | P | | P | P | P | P | P | | | | P | P | | 4,6 | | | Trans-urethral | | | | | | | | | | | | | | | | | | | | | | | | | | Trans-esoph. (non-Card.) | | | | | | | | | | | | | | | | | | | | | | | | | | Musculo-skeletal (Conventional) | P | P | P | | P | 2 | P | P | P | P | P | | P | P | | | | | | P | P | P | | 4 | | Musculo-skeletal (Superficial) | P | P | P | | P | 2 | P | P | P | P | P | | P | P | | | | | | P | P | P | | 4 | | Intravascular | | | | | | | | | | | | | | | | | | | | | | | | | | Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | | | | Cardiac Adult | P | P | P | P | P | 3 | P | | | P | P | | | | | | | | | N | | P | 5,6 | | | Cardiac Pediatric | P | P | P | P | P | 3 | P | | | P | P | | | | | | | | | | | P | 5,6 | | | Intravascular (Cardiac) | | | | | | | | | | | | | | | | | | | | | | | | | | Trans-esoph. (Cardiac) | P | P | P | P | P | 3 | P | | | | P | | | | | | | | | | | P | 6 | | | Intra-cardiac | | | | | | | | | | | | | | | | | | | | | | | | | | Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | | | | Peripheral vessel | P | P | P | P | P | 2 | P | P | P | P | P | | P | P | | | | | | P | P | P | | 4 | | Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | | | N = new indication; P = previously cleared by FDA; E = added under this appendix 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 Smart Sensor 3D Note 5 CHI (Per FDA approved contrast agent prescribing information) Note 6 Shadow Glass {4}------------------------------------------------ | Clinical Application Specific (Tracks 3) | B | M | PWD | CWD | Combined (Specify) * Color Doppler | Precision Imaging Apli Pure | Micro Pure BEAM | Power TDI | Elastography | SMI | Shear wave | 4D (Volume color) 3D Color | STIC | STIC Color | Smart 3D | Fusion Smart Navigation | 2D WMT | Other | [Note] | |------------------------------------------------|---|---|-----|-----|---------------------------------------|--------------------------------|--------------------|--------------|--------------|-----|------------|----------------------------------|------|------------|----------|----------------------------|--------|-------|--------| | Ophthalmic | | | | | | | | | | | | | | | | | | | | | Fetal | | | | | | | | | | | | | | | | | | | | | Abdominal | P | P | P | P | P | 3 | P | P | | | | | | | | | | | | | Intra-operative (Abdominal) | | | | | | | | | | | | | | | | | | | | | Intra-operative (Neuro) | | | | | | | | | | | | | | | | | | | | | Laparoscopic | | | | | | | | | | | | | | | | | | | | | Pediatric | P | P | P | P | P | 3 | 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 | | | 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) | | | | | | | | | | | | | | | | | | | | #### System: Aplio a550, Aplio a450 and Aplio a, SoftwareV4.0 Transducer: PST-25BT Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K182427 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 Smart Sensor 3D Note 5 CHI (Per FDA approved contrast agent prescribing information) Note 6 Shadow Glass {5}------------------------------------------------ Transducer: PST-28BT 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 | Precision Imaging Combined (Specify) * | Micro Pure | Apli Pure | BEAM | Power | TDI | Elastography | SMI | Shear wave | 4D (Volume color) | 3D 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 | | | | | | | P | | | 4,5,6 | | Intra-operative (Abdominal) | | | | | | | | | | | | | | | | | | | | | | | | | Intra-operative (Neuro) | | | | | | | | | | | | | | | | | | | | | | | | | Laparoscopic | | | | | | | | | | | | | | | | | | | | | | | | | Pediatric | | | | | | | | | | | | | | | | | | | | | | | | | Small Organ (Note 1) | | | | | | | | | | | | | | | | | | | | | | | | | Neonatal Cephalic | P | P | P | P | P | 3 | P | | | P | | | | | | | | | | | | | | | Adult Cephalic | P | P | P | P | P | 3 | P | | | P | | | P | | | | | | | P | | | 4 | | 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 | | | 5,6 | | Cardiac Pediatric | P | P | P | P | P | 3 | P | | | P | P | | | | | | | | | | P | | 5,6 | | 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 transducer: K182679 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 Smart Sensor 3D Note 5 CHI (Per FDA approved contrast agent prescribing information) Note 6 Shadow Glass {6}------------------------------------------------ Transducer:_ PST-30BT 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 | Combined (Specify) * | Precision Imaging | Apli Pure | Micro Pure | BEAM | Power | TDI | Elastography | SMI | Shear wave | 4D (Volume color) | 3D Color (Volume color) | STIC | STIC Color | Smart 3D | Fusion | Smart Navigation | 2D WMT | Other | [Note] | | Ophthalmic | | | | | | | | | | | | | | | | | | | | | | | | | | Fetal | | | | | | | | | | | | | | | | | | | | | | | | | | Abdominal | P | P | P | P | 3 | P | | | | P | | | P | | | | | | | | | | P | 5 | | Intra-operative (Abdominal) | | | | | | | | | | | | | | | | | | | | | | | | | | Intra-operative (Neuro) | | | | | | | | | | | | | | | | | | | | | | | | | | Laparoscopic | | | | | | | | | | | | | | | | | | | | | | | | | | Pediatric | P | P | P | P | 3 | P | | | P | | | | P | | | | | | | | | | | | | Small Organ (Note 1) | | | | | | | | | | | | | | | | | | | | | | | | | | Neonatal Cephalic | P | P | P | P | 3 | | | | P | | | | | | | | | | | | | | | | | Adult Cephalic | P | P | P | P | 3 | 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 | 3 | | | P | P | | | | | | | | | | | | | P | 5 | | | Cardiac Pediatric | P | P | P | P | 3 | | | P | P | | | | | | | | | | | | | P | 5 | | | 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 transducer: K182427 and K182679 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 Smart Sensor 3D Note 5 CHI (Per FDA approved contrast agent prescribing information) Note 6 Shadow Glass {7}------------------------------------------------ Transducer: PST-50BT 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 | Precision Imaging Combined (Specify) * | Apli Pure | Micro Pure | BEAM | Power | TDI | Elastography | SMI | Shear wave | 4D | 3D Color (Volume color) | STIC | STIC Color | Smart 3D | Smart Navigation | Fusion | 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) | | | | | | | | | | | | | | | | | | | | | | | | | N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K182427 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/PWD; 2D/CWD; BDF/CWD Note 4 Smart Sensor 3D Note 5 CHI (Per FDA approved contrast agent prescribing information) Note 6 Shadow Glass {8}------------------------------------------------ Transducer: PSI-70BT 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 | Precision Imaging Combined (Specify) * | Micro Pure | BEAM | Power | TDI | Elastography | SMI | Shear wave | 4D (Volume color) | 3D 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 | | 5 | | | Cardiac Pediatric | P | P | P | P | P | 3 | P | | P | P | | | | | | | | | | | P | | 5 | | | 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 transducer: K182427 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 Smart Sensor 3D Note 5 CHI (Per FDA approved contrast agent prescribing information) Note 6 Shadow Glass {9}------------------------------------------------ | Clinical Application | Mode of Operation | | | | | | | | | | | | | Other | [Note] | | | | | | | | | |---------------------------------|-------------------|---|-----|-----|---------------|-------------------------------------------|-----------|------------|------|-------|-----|--------------|-----|------------|--------|----------------------------|------|------------|----------|--------|------------------|--------|------| | Specific (Tracks 3) | B | M | PWD | CWD | Color Doppler | Precision Imaging Combined (Specify) * | Apli Pure | Micro Pure | BEAM | Power | TDI | Elastography | SMI | Shear wave | 4D | 3D Color (Volume color) | STIC | STIC Color | Smart 3D | Fusion | Smart Navigation | 2D WMT | | | Ophthalmic | | | | | | | | | | | | | | | | | | | | | | | | | Fetal | P | P | P | P | P | 2 | P | P | | P | | P | | | | | | P | | P | | | | | Abdominal | P | P | P | P | P | 2 | P | P | | P | P | P | P | P | | | | | P | P | P | | 4, 5 | | Intra-operative (Abdominal) | | | | | | | | | | | | | | | | | | | | | | | | | Intra-operative (Neuro) | | | | | | | | | | | | | | | | | | | | | | | | | Laparoscopic | | | | | | | | | | | | | | | | | | | | | | | | | Pediatric | P | P | P | P | P | 2 | P | P | | P | | | P | | | | | | P | P | P | | 4 | | 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) | | | | | | | | | | | | | | | | | | | | | | | | #### System: Aplio a550, Aplio a450 and Aplio a, SoftwareV4.0 Transducer:__ PVT-375BT Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K182427 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 Smart Sensor 3D Note 5 CHI (Per FDA approved contrast agent prescribing information) Note 6 Shadow Glass {10}------------------------------------------------ #### System: Aplio a550, Aplio a450 and Aplio a, SoftwareV4.0 Transducer: PVT-375SC 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) * | Apli Pure | Micro Pure | BEAM | Power | TDI | Elastography | SMI | Shear wave | 4D (Volume color) | 3D Color (Volume color) |…