(15 days)
Not Found
No
The summary describes a standard ultrasound system with various imaging modes, measurement capabilities, and data management features. There is no mention of AI or ML in the device description, intended use, or performance study sections. The "digital processing of ultrasound images" is a common feature of modern ultrasound systems and does not necessarily imply AI/ML.
No
The device is described as a "diagnostic ultrasound imaging" system, and its intended use is for "Diagnostic ultrasound imaging or fluid flow analysis." This indicates its purpose is to diagnose conditions, not to treat them.
Yes
The "Intended Use / Indications for Use" section explicitly states "Diagnostic ultrasound imaging or fluid flow analysis of the human body". The "Device Description" also clearly indicates it is a "diagnostic ultrasound system" and provides "measurement capabilities for anatomical structures and fetal biometry that provide information used for clinical diagnostic purposes."
No
The device description explicitly states it is a "diagnostic ultrasound system" and mentions physical components like transducers, a mobile docking system, external monitor, and various peripherals, indicating it is a hardware-based system with software control.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly states "Diagnostic ultrasound imaging or fluid flow analysis of the human body". This describes a device that interacts directly with the patient's body to acquire images and data.
- Device Description: The description details a system that uses ultrasound waves to create images and perform measurements within the body. It mentions transducers that are applied to the patient.
- Lack of IVD Characteristics: An IVD device is typically used to examine specimens (like blood, urine, tissue) outside of the body to provide information about a person's health. This device does not describe the analysis of such specimens.
The device is a diagnostic imaging system used for in-vivo (within the living body) examination.
N/A
Intended Use / Indications for Use
The intended uses of the SonoSite Maxx Series Ultrasound System as defined by FDA guidance documents, are:
Ophthalmic
Fetal - OB/GYN
Abdominal
Intra-operative (Abdominal organs and vascular)
Intra-operative (Neuro.)
Laparoscopic
Pediatric
Small Organ (breast, thyroid, testicles, prostate)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-esophageal (card.)
Musculo-skel. (Conventional)
Musculo-skel. (Superficial)
Cardiac Adult
Cardiac Pediatric
Peripheral vessel
Typical examinations performed using the SonoSite Maxx Series Ultrasound System are:
Abdominal Imaging Applications
Cardiac Imaging Applications
Gynecology and Infertility Imaging Applications
Interventional and Intraoperative Imaging Applications
Obstetrical Imaging Applications
Pediatric and Neonatal Imaging Applications
Prostate Imaging Applications
Superficial Imaging Applications
Transcranial Imaging Applications
Vascular Imaging Applications
Product codes
IYO, IYN, ITX, LLZ
Device Description
The SonoSite Maxx Series Ultrasound System is a full featured, general purpose, software controlled, diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data in 2D, M-Mode, Pulsed Wave (PW) Doppler, Continuous Wave (CW) Doppler, Color Power Doppler, and Velocity Color Doppler or in a combination of these modes. The SonoSite Maxx Series is a design that readily lends itself to be configured to specific ultrasound imaging applications through physical packaging and system feature selections.
The System has an electrocardiography (ECG) display feature and supports a 3-lead ECG cable assembly to collect data for M-mode and Doppler measurements. The System provides measurement capabilities for anatomical structures and fetal biometry that provide information used for clinical diagnostic purposes. The System has a PW and CW Doppler audio output feature and cine review, image zoom, labeling, bionsy, measurements and calculations, image storage and review, printing, and recording capabilities.
The system includes the ability to measure the intima-media thickness (IMT) of the carotid artery using digital ultrasound images. The IMT measurement of the carotid artery may be used adjunctively with other medical data obtained by a physician to help assess the cardiovascular health of a patient.
The system includes Digital Imaging and Communications (DICOM) capabilities as well as general computer communication capabilities to provide the acceptance, transfer, display, storage, and digital processing of ultrasound images and loops. Security support is also provided to facilitate HIPAA compliance.
The system includes a variety of accessories including a mobile docking system, external monitor, bar code reader, digital video disk recorder, printer, VCR, and biopsy/needle guide kits. The system includes USB host support for peripherals such as input devices and storage devices include wired and wired and wireless devices such as keyboard, mouse, remote. Storage devices include wired and wireless devices such as memory sticks, hard drives, CDs, 802.11 devices.
The SonoSite Maxx Series Ultrasound System is designed to accept curved or linear transducers of the types and frequency listed in the table below. All actions affecting the performance of the transducer are activated from the main system control panel.
Frequency Range: 2.0 – 13.0 MHz
Transducer Types: Linear array, Curved array, Intracavitary array, Phased array, Static probes
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Ophthalmic, Fetal - OB/GYN, Abdominal, Intra-operative (Abdominal organs and vascular), Intra-operative (Neuro.), Laparoscopic, Pediatric, Small Organ (breast, thyroid, testicles, prostate), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-esophageal (card.), Musculo-skel. (Conventional), Musculo-skel. (Superficial), Cardiac Adult, Cardiac Pediatric, Peripheral vessel, Aorta, Carotid, Spine, Liver, Kidneys, Pancreas, Spleen, Gallbladder, Bile ducts, Reproductive organs, Thyroid, Lymph nodes, Hernias, Soft tissue structures, Brain.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K043559, K053069, K034003, K011224
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
Image /page/0/Picture/1 description: The image shows the logo for SonoSite. The logo consists of a stylized letter 'S' in black, placed above the word 'SonoSite' in a sans-serif font. A horizontal line extends from the right side of the word 'SonoSite'.
4-8-2007
Image /page/0/Picture/3 description: The image shows a sequence of numbers and letters, specifically 'K071134'. The characters are written in a bold, handwritten style, giving them a distinct and somewhat irregular appearance. The contrast between the dark characters and the light background makes them easily readable.
WA 98021-3904 W
Telephone:1.425.951.1200 csimile:1.425.951.1201 ww.sonosite.com
510(K) Summary of Safety and Effectiveness
This summary of safety and effectiveness is provided as part of this Premarket Notification in compliance with 21 CFR, Part 807, Subpart E, Section 807.92.
1) Submitter's name, address, telephone number, contact person:
SonoSite, Inc. 21919 30th Drive SE Bothell, WA 98021-3904
| Corresponding Official: | Daina L. Graham |
|---|---|
| Vice President, Regulatory Affairs and Quality Assurance | |
| E-mail: | Daina.Graham@sonosite.com |
| Telephone: | (425) 951-1275 |
| Facsimile: | (425) 951-1201 |
| Date prepared: | March 21, 2007 |
2) Name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known:
Common/ Usual Name
Diagnostic Ultrasound System with Accessories
Proprietary Name
SonoSite Maxx™ Series Ultrasound System (subject to change)
Classification Names
| Name | FR Number | Product Code |
|---|---|---|
| Ultrasonic Pulsed Doppler Imaging System | 892.1550 | 90-IYN |
| Ultrasonic Pulsed Echo Imaging System | 892.1560 | 90-IYO |
| Diagnostic Ultrasound Transducer | 892.1570 | 90-ITX |
| Picture Archiving And Communications System | 892.2050 | 90-LLZ |
3) Identification of the predicate or legally marketed device:
SonoSite, Inc. believes that the System described in this Submission is substantially equivalent to a combination of the SonoSite MicroMaxx Series Ultrasound System (K043559 and K053069), and the Philips Medical Systems (formerly Advanced Technology Laboratories) HDP 5000 Ultrasound System (K034003 and K011224).
1
4) Device Description:
The SonoSite Maxx Series Ultrasound System is a full featured, general purpose, software controlled, diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data in 2D, M-Mode, Pulsed Wave (PW) Doppler, Continuous Wave (CW) Doppler, Color Power Doppler, and Velocity Color Doppler or in a combination of these modes. The SonoSite Maxx Series is a design that readily lends itself to be configured to specific ultrasound imaging applications through physical packaging and system feature selections.
The System has an electrocardiography (ECG) display feature and supports a 3-lead ECG cable assembly to collect data for M-mode and Doppler measurements. The System provides measurement capabilities for anatomical structures and fetal biometry that provide information used for clinical diagnostic purposes. The System has a PW and CW Doppler audio output feature and cine review, image zoom, labeling, bionsy, measurements and calculations, image storage and review, printing, and recording capabilities.
The system includes the ability to measure the intima-media thickness (IMT) of the carotid artery using digital ultrasound images. The IMT measurement of the carotid artery may be used adjunctively with other medical data obtained by a physician to help assess the cardiovascular health of a patient.
The system includes Digital Imaging and Communications (DICOM) capabilities as well as general computer communication capabilities to provide the acceptance, transfer, display, storage, and digital processing of ultrasound images and loops. Security support is also provided to facilitate HIPAA compliance.
The system includes a variety of accessories including a mobile docking system, external monitor, bar code reader, digital video disk recorder, printer, VCR, and biopsy/needle guide kits. The system includes USB host support for peripherals such as input devices and storage devices include wired and wired and wireless devices such as keyboard, mouse, remote. Storage devices include wired and wireless devices such as memory sticks, hard drives, CDs, 802.11 devices.
The SonoSite Maxx Series Ultrasound System is designed to accept curved or linear transducers of the types and frequency listed in the table below. All actions affecting the performance of the transducer are activated from the main system control panel.
| Frequency Range: | 2.0 – 13.0 MHz | |
|---|---|---|
| Transducer Types: | Linear array | |
| Curved array | Intracavitary array | |
| Phased array | ||
| Static probes |
| FDA Recognized Consensus Standards | |
|---|---|
| Reference No. | Title |
| AAMI/ANSI/ISO 10993- | |
| 1 | Biological evaluation of medical devices - Part 1: Evaluation and testing (ISO 10993-1:1997) |
| AIUM | AIUM Medical Ultrasound Safety, American Institute of Ultrasound in Medicine (2002) |
| ANSI/AAMI EC53 | ECG Cables and Electrodes except for sections 4.4 and 4.5.9 (1995) |
| EN 980 A1 | Graphical symbols for use in the labeling of medical devices (2003) |
| IEC 60601-1 | Medical electrical equipment. Part 1: General requirements for safety - IEC 601-1:1988 |
| IEC 60601-1/A1 | Medical electrical equipment. Part 1: General requirements for safety - IEC 601-1:1988/A1:1991 |
| IEC 60601-1/A2 | Medical electrical equipment. Part 1: General requirements for safety - IEC 601-1:1988/A2:1995 + |
| corrigendum June 1995 |
The SonoSite Maxx Series Ultrasound System is designed to comply with the following standards.
510(K) Summary Of Safety And Effectiveness
Page 2 of 6
2
| Reference No. | Title |
|---|---|
| requirements for medical electrical systems - IEC 60601-1-1:2000 | |
| IEC 60601-1-2 | Medical electrical equipment - Part 1: General requirements for safety; 2. collateral standard: |
| electromagnetic compatibility; requirements and tests - IEC 60601-1-2:2001 | |
| IEC 60601-1-4 | Medical electrical equipment - Part 1: General requirements for safety - 4. Collateral standard: |
| Programmable electrical medical systems - IEC 60601-1-4:1996 Amendment A1 | |
| IEC 60601-2-25 | Medical Electrical Equipment-Part 2. Particular Requirements for Safety-Section 25. Specification for |
| Electrocardiographs. (1999 | |
| IEC 60601-2-37 | Medical Electrical Equipment - Part 2-37; Particular requirements for the safety of ultrasonic medical |
| diagnostic and monitoring equipment (2001) | |
| IEC 60601-2-37/A1 | Medical Electrical Equipment - Part 2-37; Particular requirements for the safety of ultrasonic medical |
| diagnostic and monitoring equipment (2001)A1: 2004 | |
| NEMA UD 2-2004 | Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment |
| NEMA UD 3-2004 | Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic |
| Ultrasound Equipment, American Institute of Ultrasound in Medicine |
Miscellaneous Design Standards
| Reference No. | Title |
|---|---|
| ASTM D5276-98 | Standard Test Methods for Drop Test of Loaded Containers by Free Fall (1998) |
| ASTM D999-96 | Standard Methods for Vibration Testing of Shipping Containers (1996) |
| CISPR 11 | Industrial, Scientific and Medical (ISM) Radio-Frequency Equipment - Electromagnetic Disturbance |
| Characteristics - Limits and Methods of Measurement (2003) | |
| EN 60529 | Degrees of protection provided by enclosures (IP Code) (1991 |
| JIS T 0601-1 | Medical Electrical Equipment - Part 1: General Requirements for Safety (Japan) (1999) |
| JIS T 1507 | Electronic Linear Scanning Ultrasonic Diagnostic Equipment (Japan) (1989) |
| RTCA/DO160D | Radio Technical Commission for Aeronautics, Environmental Conditions and Test Procedures for Airborne |
| Equipment, Section 21.0 Emission of Radio Frequency Energy, Category B (1997) | |
| UL 60601-1 | Underwriters Laboratories, Medical Electrical Equipment-Part 1: General Requirements for Safety (2003) |
| UL 94 | Underwriters Laboratories, Inc., Tests for Flammability of Plastic Materials for Parts in Devices and |
| Appliances, 5th Edition | |
| EN ISO 13485 | Medical devices - Quality management systems - Requirements for regulatory purposes (2003) |
| EN ISO 14971 | Medical devices - Application of risk management to medical devices (2000) (ISO 14971:2000) (Superseded |
| standard: EN 1441) | |
| ACR-NEMA DICOM | |
| version 3.0 - 2003 | Digital Imaging and Communications in Medicine |
.
: :
.
3
Intended Use: ട്)
The intended uses of the SonoSite Maxx Series Ultrasound System as defined by FDA guidance documents, are:
| Ophthalmic | Adult Cephalic |
|---|---|
| Fetal - OB/GYN | Trans-rectal |
| Abdominal | Trans-vaginal |
| Intra-operative | |
| (Abdominal organs and vascular) | Musculo-skel. (Conventional) |
| Intra-operative (Neuro.) | Musculo-skel. (Superficial) |
| Laparoscopic | Cardiac Adult |
| Pediatric | Cardiac Pediatric |
| Small Organ | |
| (breast, thyroid, testicles, prostate) | Trans-esophageal (card.) |
| Neonatal Cephalic | Peripheral vessel |
Typical examinations performed using the SonoSite Maxx Series Ultrasound System are:
Abdominal Imaging Applications
This system transmits ultrasound energy into the abdomen of patients using 2D, M Mode, color Doppler (Color), color power Doppler (CPD), and pulsed wave (PW) Doppler to obtain ultrasound images. The liver, kidneys, pancreas, spleen, gallbladder, bile ducts, transplanted organs, abdominal vessels, and surrounding anatomical structures can be assessed for the presence or pathology transabdominally.
Cardiac Imaging Applications
This system transmits ultrasound energy into the thorax of patients using 2D, M Mode, color Doppler (Color), pulsed wave (PW) Doppler, and continuous wave (CW) Doppler to obtain ultrasound images. The heart, cardiac valves, great vessels, surrounding anatomical structures, overall cardiac performance, and heatt size can be assessed for the presence or absence of pathology.
The patient's electrocardiogram (ECG) may be obtained and is used for timing of diastolic and systolic function.
- 产 The ECG is not used to diagrose cardiac arrhythmias and is not designed for long term cardiac rhythm monitoring.
Gynecology and Infertility Imaging Applications
This system transmits ultrasound energy in the pelvis and lower abdomen using 2D, M Mode, color power Doppler (CPD), color Doppler (Color), and pulsed wave (PW) Doppler to obtain ultrasound images. The uterus, ovaries, adnexa, and surrounding anatomical structures can be assessed for the presence or absence of pathology transabdominally or transvaginally.
Interventional and Intraoperative Imaging Applications
This system transmits ultrasound energy into the various parts of the body using 2D, color Doppler (Color), color power Doppler (CPD), and pulsed wave (PW) Doppler to obtain ultrasound images that provide guidance during interventional and intraoperative procedures. This system can be used to provide ultrasound guidance for biopsy and drainage procedures, vascular line placement, peripheral nerve blocks, spinal nerve blocks and taps, ova harvesting, amniocentesis and other obstetrical procedures, and provide assistance during abdominal, breast, neurological surgery, and vascular intraoperative procedures.
4
Obstetrical Imaging Applications
This system transmits ultrasound energy into the pelvis of pregnant women using 2D, M Mode, color Doppler (Color), color power Doppler (CPD), and pulsed wave (PW) Doppler to obtain ultrasound images. The fetal anatomy, viability, estimated fetal weight, gestational age, amniotic fluid, and surrounding anatomical structures can be assessed for the presence or absence of pathology fransabdominally or transvaginally. CPD and color Doppler (Color) imaging is intended for high-risk pregnant women. High-risk pregnancy indications include. but are not limited to, multiple pregnancy, fetal hydrops, placental abnormalities, as well as maternal hypertension, diabetes, and lupus,
- 公 To prevent injury or misdiagnosis do not use this system for Percutaneous Umbilical Blood Sampling (PUBS) or in vitro Fertilization (IVF) The system has not been validated to be proven effective for these two uses.
CPD, or Color images can be used as an adjunctive method, not as a screening tool, for the detection of structural anomalies of the fetal heart and as an adjunctive method, not as a screening tool for the diagnosis of Intrauterine Growth Retardation (IUGR).
Pediatric and Neonatal Imaging Applications
This system transmits ultrasound energy into the pediatric patients using 2D, M Mode, color Doppler (Color), color power Doppler (CPD), pulsed wave (PW) Doppler, pulsed wave tissue Doppler (TDI PW), and continuous wave (CW) Doppler to obtain ultrasound images. The pediatric abdominal, pelvic and cardiac anatomy, pediatric hips, neonatal head, and surrounding anatomical structures can be assessed for the presence or absence of pathology.
Prostate Imaging Applications
This system transmits ultrasound energy into the prostate of an adult male using 2D, M Mode, color power Doppler (CPD), color Doppler (Color), and pulsed wave (PW) Doppler to obtain ultrasound images. The prostate gland can be assessed for the presence or absence of pathology.
Superficial Imaging Applications
This system transmits ultrasound energy into various parts of the body using 2D, M Mode, color Doppler (Color), color power Doppler (CPD), and pulsed wave (PW) Doppler to obtain ultrasound images. The breast, thyroid, testicle, lymph nodes, hernias, musculoskeletal structures, soft tissue structures, and surrounding anatomical structures can be assessed for the presence of pathology. This system can be used to provide ultrasound quidance for biopsy and drainage procedures, vascular line placement, peripheral nerve blocks, and spinal nerve blocks and taps.
Transcranial Imaging Applications
This system transmits ultrasound energy into the cranium using 2D, color Doppier (Color), color power Doppler (CPD), and pulsed wave (PW) Doppler to obtain ultrasound images. The anatomical structures and vascular anatomy of the brain can be assessed for presence of pathology. Two exam types support transcranial imaging: TCD and Orb. Imaging can be used temporally, trans-occipitally, or transorbitally.
- A To avoid injury to the patient, use only an orbital exam type (Orb) when performing imaging through the eye. The FDA has established lower acoustic energy limits for opthalmic use. The system will not exceed these limits only if the Orb exam type is selected.
Vascular Imaging Applications
This system transmits ultrasound energy into the various parts of the body using 2D, M Mode, color Doppler (Color), color power Doppler (CPD), and pulsed wave (PW) Doppler to obtain ultrasound images. The carotid arteries, deep veins, and arteries in the arms and legs, superficial veins in the arms and legs, great vessels in the abdomen, and various small vessels feeding organs can be assessed for the presence of pathology.
5
6) Technological Characteristics:
This device operates identically to the predicate devices in that piezoelectric material in the transducer is used as an ultrasound source to transmit sound waves into the body. Sound waves are reflected back to the transducer and converted to electrical signals that are processed and displayed as 2D or M-mode images. Dopler shift caused by blood flow is displayed as Color Flow, or as spectrum analysis. The modes of this device (M-Mode, 2D, PW Doppler, CW Doppler, velocity color Doppler, and Color Power Doppler) are the same as a combination of the predicate devices identified in item 3. Transducer patient contact materials are biocompatible.
This device conforms to the Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment (AIUMINEMA UD 3-2004) for an on-screen display feature that provides information on potential thermal and cavitation bioeffect mechanisms. A user education program provides additional information so users may moderate the system's acoustic output in accordance with the ALARA (as low as reasonably achievable) principle.
The device's acoustic output limits are:
| ISPTA (d) | 720 mW/cm² | Maximum |
|---|---|---|
| Tis/Tlb/Tlc | 0.0 - 4.0 | Range |
| Mechanical Index (MI) | 1.9 | Maximum |
| ISPPA (d) | 0 - 700 W/cm² | Range |
The device's acoustic output limits for when used for ophthalmic applications are:
| ISPTA (d) | 50 mW/cm² | Maximum |
|---|---|---|
| Tls/Tlb/Tlc | 0.0 - 1.0 | Range |
| Mechanical Index (MI) | 0.23 | Maximum |
The limits are the same as predicate Track 3 devices.
6
Image /page/6/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 7 2007
SonoSite, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
Re: K071134
Trade Name: SonoSite MaxxTM Series Ultrasound System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: IYO, IYN, ITX and LLZ Dated: April 20, 2007 Received: April 23, 2007
Dear Mr. Job:
This letter corrects our substantially equivalent letter of May 8, 2007.
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
This determination of substantial equivalence applies to the following transducers intended for use with the SonoSite Maxx™ Series Ultrasound System, as described in your premarket notification:
7
Transducer Model Number
| BPTRTx/8-5 | HFL50x/13-5 | P10x/8-4 |
|---|---|---|
| C8x/8-5 | ICTx/8-5 | P17x/5-1 |
| C11x/8-5 | L25x/13-6 | P21x/5-1 |
| D2x/2 | L38x/10-5 | SLAx/13-6 |
| D5x/5 | L52/x10-5 | SLTx/10-5 |
| C60x/5-2 | LAPx/12-5 | TCDx/2 |
| HFL38x/13-6 | MiniTEEx/7-3 | TEEx/8-3 |
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.
The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:
Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850
This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.
8
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
If you have any questions regarding the content of this letter, please contact Ewa Czerska at (240) 276-3666.
Sincerely yours,
Herbert Lemus
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
9
Table 4.3- 1 Diagnostic Ultrasound Indications for Use Form – SonoSite Maxx™ Series Ultrasound System
| System: | SonoSite Maxx™ Series Ultrasound System | ||||||
|---|---|---|---|---|---|---|---|
| Transducer: | N/A | ||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as | ||||||
| follows: | |||||||
| Clinical Application | Mode of Operation | ||||||
| B | M | PWD | CWD | Color | |||
| Doppler | Combined | ||||||
| (Spec.) | Other | ||||||
| (Spec.) | |||||||
| Ophthalmic | N | N | N | N | B+M; B+PWD; | ||
| B+CD | |||||||
| Fetal | N | N | N | N | B+M; B+PWD; | ||
| B+CD | Note 1 | ||||||
| Abdominal | N | N | N | N | N | B+M; B+PWD; | |
| B+CWD; B+CD | Note 1 | ||||||
| Intra-operative (Abdominal | |||||||
| organs and vascular) | N | N | N | N | B+M; B+PWD; | ||
| B+CD | Note 1 | ||||||
| Intra-operative (Neuro.) | N | N | N | N | B+M; B+PWD; | ||
| B+CD | Note 1 | ||||||
| Laparoscopic | N | N | N | N | B+M; B+PWD; | ||
| B+CD | Note 1 | ||||||
| Pediatric | N | N | N | N | N | B+M; B+PWD; | |
| B+CWD; B+CD | Note 1 | ||||||
| Small Organ (breast, thyroid, | |||||||
| testicles, prostate) | N | N | N | N | B+M; B+PWD; | ||
| B+CD | Note 1 | ||||||
| Neonatal Cephalic | N | N | N | N | B+M; B+PWD; | ||
| B+CD | Note 1 | ||||||
| Adult Cephalic | N | N | N | N | B+M; B+PWD; | ||
| B+CD | Note 1 | ||||||
| Trans-rectal | N | N | N | N | B+M; B+PWD; | ||
| B+CD | Note 1 | ||||||
| Trans-vaginal | |||||||
| Trans-urethral | N | N | N | N | B+M; B+PWD; | ||
| B+CD | Note 1 | ||||||
| Trans-esoph. (non-Card.) | |||||||
| Musculo-skel. (Convent.) | N | N | N | N | B+M; B+PWD; | ||
| B+CD | Note 1 | ||||||
| Musculo-skel. (Superfic.) | N | N | N | N | B+M; B+PWD; | ||
| B+CD | Note 1 | ||||||
| Intra-luminal | |||||||
| Other (spec.) | |||||||
| Cardiac Adult | N | N | N | N | N | B+M; B+PWD; | |
| B+CWD; B+CD | Note 1 | ||||||
| Cardiac Pediatric | N | N | N | N | N | B+M+ B+PWD; | |
| B+CWD; B+CD | Note 1 | ||||||
| Trans-esophageal (card.) | |||||||
| Other (spec.) | N | N | N | N | N | B+M; B+PWD; | |
| B+CWD; B+CD | Note 1 | ||||||
| Peripheral vessel | |||||||
| Other (spec.) | N | N | N | N | B+M+ B+PWD; | ||
| B+CD | Note 1 | ||||||
| System: | SonoSite Maxx™ Series Ultrasound System | ||||||
| Transducer: | BPTRTx/8-5 MHz 8.0-5.0 MHz Transducer | ||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | ||||||
| Clinical Application | Mode of Operation | Other | |||||
| (Spec.) | |||||||
| B | M | PWD | CWD | Color | |||
| Doppler | Combined | ||||||
| (Spec.) | |||||||
| Ophthalmic | |||||||
| Fetal | N | N | N | N | B+M; B+PWD; | ||
| B+CD | Note | ||||||
| 1 | |||||||
| Abdominal | |||||||
| Intra-operative (Abdominal | |||||||
| organs and vascular) | |||||||
| Intra-operative (Neuro.) | |||||||
| Laparoscopic | |||||||
| Pediatric | |||||||
| Small Organ (breast, thyroid, | |||||||
| testicles. prostate) | N | N | N | N | B+M; B+PWD; | ||
| B+CD | Note | ||||||
| 1 | |||||||
| Neonatal Cephalic | |||||||
| Adult Cephalic | |||||||
| Trans-rectal | N | N | N | N | B+M; B+PWD; | ||
| B+CD | Note | ||||||
| 1 | |||||||
| Trans-vaginal | N | N | N | N | B+M; B+PWD; | ||
| B+CD | Note | ||||||
| 1 | |||||||
| Trans-urethral | |||||||
| Trans-esoph. (non-Card.) | |||||||
| Musculo-skel. (Convent.) | |||||||
| Musculo-skel. (Superfic.) | |||||||
| Intra-luminal | |||||||
| Other (spec.) | |||||||
| Cardiac Adult | |||||||
| Cardiac Pediatric | |||||||
| Trans-esophageal (card.) | |||||||
| Other (spec.) | |||||||
| Peripheral vessel | |||||||
| Other (spec.) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
Note 1: Other includes Color Power Dopler, 3-D Imaging, Tissue Hamonis Imaging, Tissue Hamonis Imaging, SonoMB സ്ഥലം സംസ് അവാർ സംസ്ഥം (color contriel in opider) - Color Paring (nastir - Insult - Integrity (naging - Color Dopler - Color Dopler - Color Dopler - Color Dopler - Color Do with any imaging mode. Includes inaging to assist in the dises in teders on vasular o other andomical structures and maging gulatan or peripheral neve block procedures. Includes picture and storage functionality. Includes imaging of spinal cord to provide guitance for central nerve block procedures.
Prescription Use (Per 21 CFR 801.109)
Nancy Broodon
(Division Sign-Off)
Division of Reproductive, Abdominal, and
Radiological Devices
Indications for Use
Radiological Devices
510(k) Number K071134
27 of 1092 pages
Section 4.3
10
Table 4.3- 2 Diagnostic Ultrasound Indications for Use Form – BPTRTx/8-5 Transducer
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
Not 1: Other insucles Color Power Dopler, 3-2 Inaging Tissue Hamnir, inging, Sonolles Inaging, Sonolle
Compund Imaging, Tisue Dopler Imaging fo guitane of viops; Color Dople
Prescription Use (Per 21 CFR 801.109)
Nancy C. Burgdon
ductive. Abd 510(k)
11
| System: | SonoSite Maxx™ Series Ultrasound System | ||||||
|---|---|---|---|---|---|---|---|
| Transducer: | C8x/8-5 8.0-5.0 MHz Curved Array Transducer | ||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | ||||||
| Clinical Application | Mode of Operation | ||||||
| B | M | PWD | CWD | Color Doppler | Combined (Spec.) | Other (Spec.) | |
| Ophthalmic | |||||||
| Fetal | P | P | P | CWD | P | B+M; B+PWD; B+CD | Note 1 |
| Abdominal | |||||||
| Intra-operative (Abdominal organs and vascular) | |||||||
| Intra-operative (Neuro.) | |||||||
| Laparoscopic | |||||||
| Pediatric | |||||||
| Small Organ (breast, thyroid, testicles. prostate) | |||||||
| Neonatal Cephalic | |||||||
| Adult Cephalic | |||||||
| Trans-rectal | P | P | P | P | B+M; B+PWD; B+CD | Note 1 | |
| Trans-vaginal | P | P | P | P | B+M; B+PWD; B+CD | Note 1 | |
| Trans-urethral | |||||||
| Trans-esoph. (non-Card.) | |||||||
| Musculo-skel. (Convent.) | |||||||
| Musculo-skel. (Superfic.) | |||||||
| Intra-luminal | |||||||
| Other (spec.) | |||||||
| Cardiac Adult | |||||||
| Cardiac Pediatric | |||||||
| Trans-esophageal (card.) | |||||||
| Other (spec.) | |||||||
| Peripheral vessel | |||||||
| Other (spec.) |
Table 4.3- 3 Diagnostic Ultrasound Indications for Use Form - C8x/8-5 Transducer
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
Note 1: Other includes Color Power Dopler, 3-0 Inaging, Tissue Hamonic maging, Sondres Imaging, Sonolles Inaging, Sonolla
Color Dopler Imaging and imaging for guidanes of bi with any imaging mode. Imaging to assist in the placed or other anatomical studium swas cleared in K0304G. All tiens marked "P" were previously cleared in 510(k) K043559.
Prescription Use (Per 21 CFR 801.109)
Nancy C. Brogdon
oductive. Abdominal, Divis Rac 510(k
12
| System: | SonoSite Maxx™ Series Ultrasound System | |||||||
|---|---|---|---|---|---|---|---|---|
| Transducer: | C11x/8-5 8.0-5.0 MHz Curved Array | |||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | |||||||
| Clinical Application | Mode of Operation | |||||||
| B | M | PWD | CWD | Color Doppler | Combined (Spec.) | Other (Spec.) | ||
| Ophthalmic | ||||||||
| Fetal | ||||||||
| Abdominal | P | P | P | P | P | B+M; B+PWD; B+CWD; B+CD | Note 1 | |
| Intra-operative (Abdominal organs and vascular) | P | P | P | P | P | B+M; B+PWD; B+CD | Note 1 | |
| Intra-operative (Neuro.) | P | P | P | P | P | B+M; B+PWD; B+CD | Note 1 | |
| Laparoscopic | ||||||||
| Pediatric | P | P | P | P | P | B+M; B+PWD; B+CWD; B+CD | Note 1 | |
| Small Organ (breast, thyroid, testicles. prostate) | P | P | P | P | P | B+M; B+PWD; B+CD | Note 1 | |
| Neonatal Cephalic | P | P | P | P | B+M; B+PWD; B+CD | Note 1 | ||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac Pediatric | P | P | P | P | P | B+M; B+PWD; B+CWD; B+CD | Note 1 | |
| Trans-esophageal (card.) | ||||||||
| Other (spec.) | ||||||||
| Peripheral vessel | P | P | P | P | B+M; B+PWD; B+CD | Note 1 | ||
| Other (spec.) |
Table 4.3- 4 Diagnostic Ultrasound Indications for Use Form - C11x/8-5 Transducer
new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
Note 1: Other includes Color Power Dopler 3-3 linaging, Tissue Harmon in the include in the inn , Sonoles integing, Sonoller . Color Dopler . Olor Dopler : with any imaging mode. Imaging to assist in the placers in vascular or other anatomical structures was previously cleared in 510(), K030849. An expanded intention guidance for peripheral neve block procedures was previously deared in K03367. All items marked "P" were previously cleared in 510(k) K043559.
Prescription Use (Per 21 CFR 801.109)
Nancy Brogdon
(Division Sign-Off) 0
Division of Reproductive, Abdominal, and
Radiological Devices
510(k) Number K071134
13
| System: | SonoSite Maxx™ Series Ultrasound System | ||||||
|---|---|---|---|---|---|---|---|
| Transducer: | D2x/2 2.0 MHz Dual Element Circular Array | ||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | ||||||
| Clinical Application | Mode of Operation | ||||||
| B | M | PWD | CWD | Color | |||
| Doppler | Combined | ||||||
| (Spec.) | Other | ||||||
| (Spec.) | |||||||
| Ophthalmic | |||||||
| Fetal | |||||||
| Abdominal | |||||||
| Intra-operative (Abdominal organs and vascular) | |||||||
| Intra-operative (Neuro.) | |||||||
| Laparoscopic | |||||||
| Pediatric | |||||||
| Small Organ (breast, thyroid, testicles. prostate) | |||||||
| Neonatal Cephalic | |||||||
| Adult Cephalic | |||||||
| Trans-rectal | |||||||
| Trans-vaginal | |||||||
| Trans-urethral | |||||||
| Trans-esoph. (non-Card.) | |||||||
| Musculo-skel. (Convent.) | |||||||
| Musculo-skel. (Superfic.) | |||||||
| Intra-luminal | |||||||
| Other (spec.) | |||||||
| Cardiac Adult | P | ||||||
| Cardiac Pediatric | P | ||||||
| Trans-esophageal (card.) | |||||||
| Other (spec.) | |||||||
| Peripheral vessel | |||||||
| Other (spec.) |
Table 4.3- 5 Diagnostic Ultrasound Indications for Use Form - D2x/2 Transducer
by FDA; E= added under Appendix E
Additional Comments:
All items marked "P" were previously cleared in 510(k) K053069.
Prescription Use (Per 21 CFR 801.109)
Nancy Broadon
uctive, Abdominal, and
14
| System: | SonoSite Maxx TM Series Ultrasound System |
|---|---|
| Transducer: | D5x/5 5.0 MHz Dual Element Circular Array |
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: |
| Clinical Application | B | M | PWD | CWD | Color Doppler | Combined (Spec.) | Other (Spec.) |
|---|---|---|---|---|---|---|---|
| Ophthalmic | |||||||
| Fetal | |||||||
| Abdominal | |||||||
| Intra-operative (Abdominal organs and vascular) | |||||||
| Intra-operative (Neuro.) | |||||||
| Laparoscopic | |||||||
| Pediatric | |||||||
| Small Organ (breast, thyroid, testicles. prostate) | |||||||
| Neonatal Cephalic | |||||||
| Adult Cephalic | |||||||
| Trans-rectal | |||||||
| Trans-vaginal | |||||||
| Trans-urethral | |||||||
| Trans-esoph. (non-Card.) | |||||||
| Musculo-skel. (Convent.) | |||||||
| Musculo-skel. (Superfic.) | |||||||
| Intra-luminal | |||||||
| Other (spec.) | |||||||
| Cardiac Adult | N | ||||||
| Cardiac Pediatric | N | ||||||
| Trans-esophageal (card.) | |||||||
| Other (spec.) | |||||||
| Peripheral vessel | |||||||
| Other (spec.) |
Table 4.3- 6 Diagnostic Ultrasound Indications for Use Form – D5xJ5 Transducer
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Prescription Use (Per 21 CFR 801.109)
Nancy Brogdon
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
15
| System: | SonoSite Maxx ™ Series Ultrasound System | ||||||
|---|---|---|---|---|---|---|---|
| Transducer: | C60x/5-2 5.0-2.0 MHz Curved Array | ||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | ||||||
| Clinical Application | Mode of Operation | ||||||
| B | M | PWD | CWD | Color Doppler | Combined (Spec.) | Other (Spec.) | |
| Ophthalmic | |||||||
| Fetal | P | P | P | P | B+M; B+PWD; | ||
| B+CD | Note 1 | ||||||
| Abdominal | P | P | P | P | B+M; B+PWD; | ||
| B+CD | Note 1 | ||||||
| Intra-operative (Abdominal organs and vascular) | P | P | P | P | B+M; B+PWD; | ||
| B+CD | Note 1 | ||||||
| Intra-operative (Neuro.) | |||||||
| Laparoscopic | |||||||
| Pediatric | P | P | P | P | B+M; B+PWD; | ||
| B+CD | Note 1 | ||||||
| Small Organ (breast, thyroid, testicles, prostate) | |||||||
| Neonatal Cephalic | |||||||
| Adult Cephalic | |||||||
| Trans-rectal | |||||||
| Trans-vaginal | |||||||
| Trans-urethral | |||||||
| Trans-esoph. (non-Card.) | |||||||
| Musculo-skel. (Convent.) | P | P | P | P | B+M; B+PWD; | ||
| B+CD | Note 1 | ||||||
| Musculo-skel. (Superfic.) | |||||||
| Intra-luminal | |||||||
| Other (spec.) | |||||||
| Cardiac Adult | |||||||
| Cardiac Pediatric | |||||||
| Trans-esophageal (card.) | |||||||
| Other (spec.) | |||||||
| Peripheral vessel | P | P | P | P | B+M; B+PWD; | ||
| B+CD | Note 1 | ||||||
| Other (spec.) |
Table 4.3- 7 Diagnostic Ultrasound Indications for Use Form - C60x/5-2 Transducer
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
Note 1: Other includes Color Power Doppler, contined B and Color Power Doppler, 3-D Imaging, Tissue Harmonic Imaging, SonoRes Imaging, SonoMB Compound Imaging, Tissue Dopler Imaging for guidance of biopsy. Color Doppler includes Velocity Color Doppler can be combined with any imaging mode. Includes imaging to assist in the placement of necessar or other anatomical stuctures. Includes inaging of spinal cord to provide guidance for central neve block procedures. All items marked "P" were previously cleared in 510(k) K053069.
Prescription Use (Per 21 CFR 801.109)
Nancy C. Hodson
ctive, Abdominal, and 510
16
| System: | SonoSite Maxx™ Series Ultrasound System | ||||||
|---|---|---|---|---|---|---|---|
| Transducer: | HFL38x/13-6 13.0-6.0 MHz Linear Array Transducer | ||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the | ||||||
| human body as follows: | |||||||
| Clinical Application | Mode of Operation | Other | |||||
| (Spec.) | |||||||
| B | M | PWD | CWD | Color | |||
| Doppler | Combined | ||||||
| (Spec.) | |||||||
| Ophthalmic | |||||||
| Fetal | |||||||
| Abdominal | P | P | P | P | B+M; B+PWD; | ||
| B+CD | Note 1 | ||||||
| Intra-operative (Abdominal organs and vascular) | P | P | P | P | B+M; B+PWD; | ||
| B+CD | Note 1 | ||||||
| Intra-operative (Neuro.) | |||||||
| Laparoscopic | |||||||
| Pediatric | P | P | P | P | B+M; B+PWD; | ||
| B+CD | Note 1 | ||||||
| Small Organ (breast, thyroid, testicles. prostate) | P | P | P | P | B+M; B+PWD; | ||
| B+CD | Note 1 | ||||||
| Neonatal Cephalic | |||||||
| Adult Cephalic | |||||||
| Trans-rectal | |||||||
| Trans-vaginal | |||||||
| Trans-urethral | |||||||
| Trans-esoph. (non-Card.) | |||||||
| Musculo-skel. (Convent.) | P | P | P | P | B+M; B+PWD; | ||
| B+CD | Note 1 | ||||||
| Musculo-skel. (Superfic.) | P | P | P | P | B+M; B+PWD; | ||
| B+CD | Note 1 | ||||||
| Intra-luminal | |||||||
| Other (spec.) | |||||||
| Cardiac Adult | |||||||
| Cardiac Pediatric | |||||||
| Trans-esophageal (card.) | |||||||
| Other (spec.) | |||||||
| Peripheral vessel | P | P | P | P | B+M; B+PWD; | ||
| B+CD | Note 1 | ||||||
| Other (spec.) |
Table 4.3- 8 Diagnostic Ultrasound Indications for Use Form - HFL38x/13-6 Transducer
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
Note 1: Other includes Color Power Doppler, combined B and Color Power Doppler, 3-D Imaging, Tissue Harmonic Imaging, SonoRes Imaging, SonoMB Compound Imaging, Tissue Doppler Imaging for guidance of biopsy. Color Doppler includes Velcoty Color Doppler. Color Doppler can be combined with any imaging mode. Includes inaging to assist in the placement of needles and cather anatomical structures and an imaging guidance for peripheral nerve block procedures. Includes imaging of spiral cord to central nerve block procedures. All tems marked "P" were previously cleared in 510(k) K043559.
Prescription Use (Per 21 CFR 801.109)
Nancy C. Brandon
(Division Sign-Off)
Div ive, Abdominal, and 510/k)
17
| System: | SonoSite Maxx™ Series Ultrasound System | |||||||
|---|---|---|---|---|---|---|---|---|
| Transducer: | HFL50x/13-5 13.0-5.0 MHz Linear Array Transducer | |||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the | |||||||
| human body as follows: | ||||||||
| Clinical Application | Mode of Operation | |||||||
| B | M | PWD | CWD | Color | ||||
| Doppler | Combined | |||||||
| (Spec.) | Other | |||||||
| (Spec.) | ||||||||
| Ophthalmic | ||||||||
| Fetal | ||||||||
| Abdominal | N | N | N | N | B+M; B+PWD; | |||
| B+CD | Note 1 | |||||||
| Intra-operative (Abdominal organs and | ||||||||
| vascular) | N | N | N | N | B+M; B+PWD; | |||
| B+CD | Note 1 | |||||||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | N | N | N | N | B+M; B+PWD; | |||
| B+CD | Note 1 | |||||||
| Small Organ (breast, thyroid, testicles. prostate) | N | N | N | N | B+M; B+PWD; | |||
| B+CD | Note 1 | |||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Convent.) | N | N | N | N | B+M; B+PWD; | |||
| B+CD | Note 1 | |||||||
| Musculo-skel. (Superfic.) | N | N | N | N | B+M; B+PWD; | |||
| B+CD | Note 1 | |||||||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac Pediatric | ||||||||
| Trans-esophageal (card.) | ||||||||
| Other (spec.) | ||||||||
| Peripheral vessel | N | N | N | N | B+M; B+PWD; | |||
| B+CD | Note 1 | |||||||
| Other (spec.) |
Table 4.3- 9 Diagnostic Ultrasound Indications for Use Form - HFL50x/13-5 Transducer
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
Note 1: Other includes Color Power Doppler, combined B and Color Power Doppler, 3-D Imaging, SonoRes Imaging, SonoRes Imaging, SonoMB Compound Imaging, Tissue Doppler Imaging for guidance of biopsy. Color Doppler includes Velocity Color Doppler. Color Doppler can be combined with any imaging mode. Includes inaging to assist in the placement of neacular or other analomical structures and an imaging guidance for peripheral nerve block procedures. Includes imaging of spinal cord to provide guidance for central nerve block procedures.
Nancy C. Boynton
Di 510
18
| System: | SonoSite Maxx™ Series Ultrasound System | ||||||
|---|---|---|---|---|---|---|---|
| Transducer: | ICTx/8-5 8.0-5.0 MHz Intracavitary Transducer | ||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the | ||||||
| human body as follows: | |||||||
| Clinical Application | Mode of Operation | ||||||
| B | M | PWD | CWD | Color Doppler | Combined (Spec.) | Other (Spec.) | |
| Ophthalmic | |||||||
| Fetal | P | P | P | P | B+M; B+PWD; | ||
| B+CD | Note 1 | ||||||
| Abdominal | |||||||
| Intra-operative (Abdominal organs and vascular) | |||||||
| Intra-operative (Neuro.) | |||||||
| Laparoscopic | |||||||
| Pediatric | |||||||
| Small Organ (breast, thyroid, testicles. prostate) | |||||||
| Neonatal Cephalic | |||||||
| Adult Cephalic | |||||||
| Trans-rectal | P | P | P | P | B+M; B+PWD; | ||
| B+CD | Note 1 | ||||||
| Trans-vaginal | P | P | P | P | B+M; B+PWD; | ||
| B+CD | Note 1 | ||||||
| Trans-urethral | |||||||
| Trans-esoph. (non-Card.) | |||||||
| Musculo-skel. (Convent.) | |||||||
| Musculo-skel. (Superfic.) | |||||||
| Intra-luminal | |||||||
| Other (spec.) | |||||||
| Cardiac Adult | |||||||
| Cardiac Pediatric | |||||||
| Trans-esophageal (card.) | |||||||
| Other (spec.) | |||||||
| Peripheral vessel | |||||||
| Other (spec.) |
Table 4.3- 10 Diagnostic Ultrasound Indications for Use Form – ICTx/8-5 Transducer
new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
Not 1: Ober hudes Color Power Dopler, 3-2 maging Tissus Harmon inaging, Sondes magn, Sondes
Compund maging Tisan or maging truping on coper includes Veloiry Color Dopler Colo
Prescription Use (Per 21 CFR 801.109)
Nancy C Roogdon
oductive, Abdominal, and 510(k) N
19
| System: | SonoSite Maxx™ Series Ultrasound System | |||||||
|---|---|---|---|---|---|---|---|---|
| Transducer: | L25x/13-6 13.0-6.0 MHz Linear Array | |||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the | |||||||
| human body as follows: | ||||||||
| Mode of Operation | ||||||||
| Clinical Application | B | M | PWD | CWD | Color | |||
| Doppler | Combined | |||||||
| (Spec.) | Other | |||||||
| (Spec.) | ||||||||
| Ophthalmic | ||||||||
| Fetal | P | P | P | B+M; B+CD | Note 1 | |||
| Abdominal | ||||||||
| Intra-operative (Abdominal organs and | ||||||||
| vascular) | P | P | P | B+M; B+CD | Note 1 | |||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| B+M; B+CWD; | ||||||||
| B+CD | ||||||||
| Pediatric | P | P | P | B+M; B+CD | Note 1 | |||
| Small Organ (breast, thyroid, testicles. prostate) | P | P | P | B+M; B+CD | Note 1 | |||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Convent.) | P | P | P | B+M; B+CD | Note 1 | |||
| Musculo-skel. (Superfic.) | P | P | P | B+M; B+CD | Note 1 | |||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac Pediatric | ||||||||
| Trans-esophageal (card.) | ||||||||
| Other (spec.) | ||||||||
| Peripheral vessel | P | P | P | B+M; B+CD | Note 1 | |||
| Other (spec.) |
Table 4.3- 11 Diagnostic Ultrasound Indications for Use Form – L25x/13-6 Transducer
N= new indication; P= previously cleared by P
Additional Comments:
Note 1: Other includes Color Power Doppler, combined B and Color Power Dopler, 3-D Imaging, SonoMes Inaging, SonoMB Noder France Malaoo Octor Portal Bopper Includes of hippy. Color Dopler includes Velocity Color Doppler. Olor Doppler Color Dopler and espiring and in William Computer in and Oupler maging in galable on and collect in results on and post of the was we sever we sever on K03040.
wh expired integring guidanes for periores nerve block cleared in 510(k) K043559.
Nancy Brogdon
(Division ductive, Abdominal, and Radiolo 510(k) Nu
20
| System: | SonoSite Maxx™ Series Ultrasound System | |||||||
|---|---|---|---|---|---|---|---|---|
| Transducer: | L38x/10-5 10.0-5.0 MHz Linear Array Transducer | |||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the | |||||||
| human body as follows: | ||||||||
| Clinical Application | Mode of Operation | |||||||
| B | M | PWD | CWD | Color | ||||
| Doppler | Combined | |||||||
| (Spec.) | Other | |||||||
| (Spec.) | ||||||||
| Ophthalmic | ||||||||
| Fetal | ||||||||
| Abdominal | P | P | P | P | B+M; B+PWD; | |||
| B+CD | Note 1 | |||||||
| Intra-operative (Abdominal organs and vascular) | P | P | P | P | B+M; B+PWD; | |||
| B+CD | Note 1 | |||||||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | P | B+M; B+PWD; | |||
| B+CD | Note 1 | |||||||
| Small Organ (breast, thyroid, testicles. prostate) | P | P | P | P | B+M; B+PWD; | |||
| B+CD | Note 1 | |||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Convent.) | P | P | P | P | B+M; B+PWD; | |||
| B+CD | Note 1 | |||||||
| Musculo-skel. (Superfic.) | P | P | P | P | B+M; B+PWD; | |||
| B+CD | Note 1 | |||||||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac Pediatric | ||||||||
| Trans-esophageal (card.) | ||||||||
| Other (spec.) | ||||||||
| Peripheral vessel | P | P | P | P | B+M; B+PWD; | |||
| B+CD | Note 1 | |||||||
| Other (spec.) |
Table 4.3- 12 Diagnostic Ultrasound Indications for Use Form - L38x/10-5 Transducer
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
Not 1: One includes Color Power Dopler, 3-2 Inaging, Tissue Hamoni maging, Sonders maging, Sonders magng, Sonder Donollo
Compund Inaging, Tissue Dopler inaging fo guidaces in peripheral nerve block procedures. Includes imaging of spinal cord to central newe block procedures. A literns marked "P" were previously cleared in 510(k) K053069.
Nancy Thompson
Division of Reproductive, Abdominal, and
Radiological Devices
510(k) Number K171134
21
| System: | SonoSite Maxx™ Series Ultrasound System | ||||||
|---|---|---|---|---|---|---|---|
| Transducer: | L52x/10-5 10.0-5.0 MHz Linear Array | ||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the | ||||||
| human body as follows: | |||||||
| Clinical Application | Mode of Operation | Other | |||||
| (Spec.) | |||||||
| B | M | PWD | CWD | Color | |||
| Doppler | Combined | ||||||
| (Spec.) | |||||||
| Ophthalmic | |||||||
| Fetal | P | P | P | P | B+M; B+PWD; | ||
| B+CD | Note 1 | ||||||
| Abdominal | P | P | P | P | B+M; B+PWD; | ||
| B+CD | Note 1 | ||||||
| Intra-operative (Abdominal organs and vascular) | P | P | P | P | B+M; B+PWD; | ||
| B+CD | Note 1 | ||||||
| Intra-operative (Neuro.) | |||||||
| Laparoscopic | |||||||
| Pediatric | P | P | P | P | B+M; B+PWD; | ||
| B+CD | Note 1 | ||||||
| Small Organ (breast, thyroid, testicles. prostate) | P | P | P | P | B+M; B+PWD; | ||
| B+CD | Note 1 | ||||||
| Neonatal Cephalic | |||||||
| Adult Cephalic | |||||||
| Trans-rectal | |||||||
| Trans-vaginal | |||||||
| Trans-urethral | |||||||
| Trans-esoph. (non-Card.) | |||||||
| Musculo-skel. (Convent.) | P | P | P | P | B+M; B+PWD; | ||
| B+CD | Note 1 | ||||||
| Musculo-skel. (Superfic.) | P | P | P | P | B+M; B+PWD; | ||
| B+CD | Note 1 | ||||||
| Intra-luminal | |||||||
| Other (spec.) | |||||||
| Cardiac Adult | |||||||
| Cardiac Pediatric | |||||||
| Trans-esophageal (card.) | |||||||
| Other (spec.) | |||||||
| Peripheral vessel | P | P | P | P | B+M; B+PWD; | ||
| B+CD | Note 1 | ||||||
| Other (spec.) |
Table 4.3- 13 Diagnostic Ultrasound Indications for Use Form – L52/x10-5 Transducer
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
Note 1: Other includes Color Power Doppler, combined B and Color Power Doppler, 3-D Imaging, SonoRes Imaging, SonoMB reser in the links of online and other of the begin in the programades in the may be only of the may be only of the may be onlines.
wit any maging moses. In the person of ca
Prescription Use (Per 21 CFR 801.109)
Nancy Brogdon
(Divisio ctive, Abdominal, and Divis 510(k) Ni
22
| System: | SonoSite Maxx™ Series Ultrasound System | ||||||
|---|---|---|---|---|---|---|---|
| Transducer: | LAPx/12-5 12.0-5.0 MHz Linear Array Laparoscopic | ||||||
| Transducer | |||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | ||||||
| Clinical Application | Mode of Operation | ||||||
| B | M | PWD | CWD | Color | |||
| Doppler | Combined | ||||||
| (Spec.) | Other | ||||||
| (Spec.) | |||||||
| Ophthalmic | |||||||
| Fetal | |||||||
| Abdominal | |||||||
| Intra-operative (Abdominal organs and vascular) | |||||||
| Intra-operative (Neuro.) | |||||||
| Laparoscopic | P | P | P | P | B+M; B+PWD; | ||
| B+CD | Note 1 | ||||||
| Pediatric | |||||||
| Small Organ (breast, thyroid, testicles. prostate) | |||||||
| Neonatal Cephalic | |||||||
| Adult Cephalic | |||||||
| Trans-rectal | |||||||
| Trans-vaginal | |||||||
| Trans-urethral | |||||||
| Trans-esoph. (non-Card.) | |||||||
| Musculo-skel. (Convent.) | |||||||
| Musculo-skel. (Superfic.) | |||||||
| Intra-luminal | |||||||
| Other (spec.) | |||||||
| Cardiac Adult | |||||||
| Cardiac Pediatric | |||||||
| Trans-esophageal (card.) | |||||||
| Other (spec.) | |||||||
| Peripheral vessel | |||||||
| Other (spec.) |
Table 4.3- 14 Diagnostic Ultrasound Indications for Use Form – LAPx/12-5 Laparoscopic Transducer
N= new Indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
Not 1: Oher insutes Color Power Dopler, 3-2 Inaging, Tissue Hamoni inaging, SonoRes Imaging, Sonoles Imaging, Sonoles Imaging, Sonoles Imaging, Sonoles Inaging, Sonoles Colo
Nancy Brogdon
(Division Sign-off)
Divisio ductive, Abdominal, and Radio 510(k) Number
23
Table 4.3- 15 Diagnostic Ultrasound Indications for Use Form – MiniTEEx/7-3 Transducer
| System: | SonoSite Maxx™ Series Ultrasound System | |||||||
|---|---|---|---|---|---|---|---|---|
| Transducer: | MiniTEEx/7-3 7.0-3.0 MHz Trans-esophageal | |||||||
| Echocardiography Transducer | ||||||||
| Diagnostic ultrasound imaging or fluid flow analysis of the | ||||||||
| human body as follows: | ||||||||
| Intended Use: | ||||||||
| Clinical Application | Mode of Operation | |||||||
| B | M | PWD | CWD | Color | ||||
| Doppler | Combined | |||||||
| (Spec.) | Other | |||||||
| (Spec.) | ||||||||
| Ophthalmic | ||||||||
| Fetal | ||||||||
| Abdominal | ||||||||
| Intra-operative (Abdominal organs and vascular) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (breast, thyroid, testicles. prostate) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac Pediatric | ||||||||
| Trans-esophageal (card.) | N | N | N | N | N | B+M; B+PWD; B+CWD; B+CD | Note 1 | |
| Other (spec.) | ||||||||
| Peripheral vessel | ||||||||
| Other (spec.) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
Note 1: Other includes Color Power Doppler, combined B and Color Power Dopler, 3-D Imaging, SonoRes Imaging, SonoRes Imaging, SonoMB Compound Inaging, Tissue Dopler Imaging for guidance of biopsy. Color Doppler includes Velocity Color Doppler. Color Doppler can be combined with any imaging mode.
Nancy C. Brogdon
(Division Sigh-Off) of Reproductive, Abdominal, and Radioloo 510(k) Number
24
| Table 4.3- 16 Diagnostic Ultrasound Indications for Use Form – P10x/8-4 Phased Array | |
|---|---|
| Transducer |
| System: | SonoSite Maxx™ Series Ultrasound System | ||||||
|---|---|---|---|---|---|---|---|
| Transducer: | P10x/8-4 8.0-4.0 MHz Phased Array Transducer | ||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the | ||||||
| human body as follows: | |||||||
| Clinical Application | Mode of Operation | ||||||
| B | M | PWD | CWD | Color | |||
| Doppler | Combined | ||||||
| (Spec.) | Other | ||||||
| (Spec.) | |||||||
| Ophthalmic | P | P | P | P | B+M; B+PWD; B+CD | ||
| Fetal | P | P | P | P | B+M; B+PWD | ||
| B+CD | Note 1 | ||||||
| Abdominal | P | P | P | P | P | B+M; B+PWD; B+CWD; B+CD | Note 1 |
| Intra-operative (Abdominal organs and vascular) | P | P | P | P | B+M; B+PWD | ||
| B+CD | Note 1 | ||||||
| Intra-operative (Neuro.) | P | P | P | P | B+M; B+PWD; B+CD | Note 1 | |
| Laparoscopic | |||||||
| Pediatric | P | P | P | P | B+M; B+PWD | ||
| B+CD | Note 1 | ||||||
| Small Organ (breast, thyroid, testicles. prostate) | P | P | P | P | B+M; B+PWD | ||
| B+CD | Note 1 | ||||||
| Neonatal Cephalic | P | P | P | P | B+M; B+PWD | ||
| B+CD | Note 1 | ||||||
| Adult Cephalic | P | P | P | P | B+M; B+PWD; B+CD | Note 1 | |
| Trans-rectal | |||||||
| Trans-vaginal | |||||||
| Trans-urethral | |||||||
| Trans-esoph. (non-Card.) | |||||||
| Musculo-skel. (Convent.) | P | P | P | P | B+M; B+PWD | ||
| B+CD | Note 1 | ||||||
| Musculo-skel. (Superfic.) | |||||||
| Intra-luminal | |||||||
| Other (spec.) | |||||||
| Cardiac Adult | P | P | P | P | P | B+M; B+PWD; B+CWD; B+CD | Note 1 |
| Cardiac Pediatric | P | P | P | P | P | B+M; B+PWD; B+CWD; B+CD | Note 1 |
| Trans-esophageal (card.) | |||||||
| Other (spec.) | |||||||
| Peripheral vessel | P | P | P | P | B+M; B+PWD; B+CD | Note 1 | |
| Other (spec.) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
No 1: Cher includes Coler Powr Dopel, 30 Maging Tissus Hamonin inaging, Sondes Inaging, Sonokes Inaging, Sonokes Inaging, Sonokes Inaging, Sonoker Conoper. Color Dopere Col
Prescription Use (Per 21 CFR 801.109)
Nancy C. Bradon
ctive, Abdominal, a
25
Table 4.3- 17 Diagnostic Ultrasound Indications for Use Form – P17x/5-1 Phased Array Transducer
| System: | SonoSite Maxx™ Series Ultrasound System | ||||||
|---|---|---|---|---|---|---|---|
| Transducer: | P17x/5-1 5.0-1.0 MHz Phased Array Transducer | ||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the | ||||||
| human body as follows: | |||||||
| Clinical Application | Mode of Operation | ||||||
| B | M | PWD | CWD | Color | |||
| Doppler | Combined | ||||||
| (Spec.) | Other | ||||||
| (Spec.) | |||||||
| Ophthalmic | P | P | P | P | B+M; B+PWD; B+CD | ||
| Fetal | P | P | P | P | B+M; B+PWD | ||
| B+CD | Note 1 | ||||||
| Abdominal | P | P | P | P | P | B+M; B+PWD; B+CWD; B+CD | Note 1 |
| Intra-operative (Abdominal organs and vascular) | P | P | P | P | B+M; B+PWD | ||
| B+CD | Note 1 | ||||||
| Intra-operative (Neuro.) | |||||||
| Laparoscopic | |||||||
| Pediatric | P | P | P | P | B+M; B+PWD | ||
| B+CD | Note 1 | ||||||
| Small Organ (breast, thyroid, testicles. prostate) | P | P | P | P | B+M; B+PWD | ||
| B+CD | Note 1 | ||||||
| Neonatal Cephalic | P | P | P | P | B+M; B+PWD | ||
| B+CD | Note 1 | ||||||
| Adult Cephalic | P | P | P | P | B+M; B+PWD; B+CD | Note 1 | |
| Trans-rectal | |||||||
| Trans-vaginal | |||||||
| Trans-urethral | |||||||
| Trans-esoph. (non-Card.) | |||||||
| Musculo-skel. (Convent.) | P | P | P | P | B+M; B+PWD | ||
| B+CD | Note 1 | ||||||
| Musculo-skel. (Superfic.) | |||||||
| Intra-luminal | |||||||
| Other (spec.) | |||||||
| Cardiac Adult | P | P | P | P | P | B+M; B+PWD; B+CWD; B+CD | Note 1 |
| Cardiac Pediatric | P | P | P | P | P | B+M; B+PWD; B+CWD; B+CD | Note 1 |
| Trans-esophageal (card.) | |||||||
| Other (spec.) | |||||||
| Peripheral vessel | P | P | P | P | B+M; B+PWD; B+CD | Note 1 | |
| Other (spec.) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
Note 1: Other includes Color Power Doppler, contined B and Color Power Doppler, 3-D Imaging, Tissue Harmonic Imaging, SonoMB Note T. Coller includes Coloner of the report of Copyre, or maincy includes Velocry only on magny conclude on annomic on more commender.
Compund maging mode. Include imaging were previously cleared in 510{k) K053069.
Nancy Brandon
lve, Abdominal, a
26
| System: | SonoSite Maxx™ Series Ultrasound System | ||||||
|---|---|---|---|---|---|---|---|
| Transducer: | P21x/5-1 5.0-1.0 MHz Phased Array Transducer | ||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the | ||||||
| human body as follows: | |||||||
| Clinical Application | Mode of Operation | ||||||
| B | M | PWD | CWD | Color | |||
| Doppler | Combined | ||||||
| (Spec.) | Other | ||||||
| (Spec.) | |||||||
| Ophthalmic | N | N | N | N | B+M; B+PWD; B+CD | ||
| Fetal | N | N | N | N | B+M; B+PWD | ||
| B+CD | Note 1 | ||||||
| Abdominal | N | N | N | N | N | B+M; B+PWD; B+CWD; B+CD | Note 1 |
| Intra-operative (Abdominal organs and vascular) | N | N | N | N | B+M; B+PWD | ||
| B+CD | Note 1 | ||||||
| Intra-operative (Neuro.) | |||||||
| Laparoscopic | |||||||
| Pediatric | N | N | N | N | B+M; B+PWD | Note 1 | |
| Small Organ (breast, thyroid, testicles. prostate) | N | N | N | N | B+M; B+PWD | ||
| B+CD | Note 1 | ||||||
| Neonatal Cephalic | N | N | N | N | B+M; B+PWD | ||
| B+CD | Note 1 | ||||||
| Adult Cephalic | N | N | N | N | B+M; B+PWD; B+CD | Note 1 | |
| Trans-rectal | |||||||
| Trans-vaginal | |||||||
| Trans-urethral | |||||||
| Trans-esoph. (non-Card.) | |||||||
| Musculo-skel. (Convent.) | N | N | N | N | B+M; B+PWD | ||
| B+CD | Note 1 | ||||||
| Musculo-skel. (Superfic.) | |||||||
| Intra-luminal | |||||||
| Other (spec.) | |||||||
| Cardiac Adult | N | N | N | N | N | B+M; B+PWD; B+CWD; B+CD | Note 1 |
| Cardiac Pediatric | N | N | N | N | N | B+M; B+PWD; B+CWD; B+CD | Note 1 |
| Trans-esophageal (card.) | |||||||
| Other (spec.) | |||||||
| Peripheral vessel | N | N | N | N | B+M; B+PWD; B+CD | Note 1 | |
| Other (spec.) |
Table 4.3- 18 Diagnostic Ultrasound Indications for Use Form – P21x/5-1 Phased Array Transducer
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
Not : Che includes Color Power Dopler, 3D Imaging Tissus Harmoni imaging, Sonckes Insains, Sonstes Insains, Sonckes Insains, Soncker Color Dopler. Color Dopler Color Dopler
Nancy Brogdon
27
| System: | SonoSite Maxx™ Series Ultrasound System | ||||||
|---|---|---|---|---|---|---|---|
| Transducer: | SLAx/13-6 13.0-6.0 MHz Linear Array Transducer | ||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the | ||||||
| human body as follows: | |||||||
| Clinical Application | Mode of Operation | ||||||
| B | M | PWD | CWD | Color | |||
| Doppler | Combined | ||||||
| (Spec.) | Other | ||||||
| (Spec.) | |||||||
| Ophthalmic | |||||||
| Fetal | |||||||
| Abdominal | |||||||
| Intra-operative (Abdominal organs and vascular) | P | P | P | P | B+M; B+PWD; | ||
| B+CD | Note 1 | ||||||
| Intra-operative (Neuro.) | P | P | P | P | B+M; B+PWD; | ||
| B+CD | Note 1 | ||||||
| Laparoscopic | |||||||
| Pediatric | P | P | P | P | B+M; B+PWD; | ||
| B+CD | Note 1 | ||||||
| Small Organ (breast, thyroid, testicles. prostate) | P | P | P | P | B+M; B+PWD; | ||
| B+CD | Note 1 | ||||||
| Neonatal Cephalic | |||||||
| Adult Cephalic | |||||||
| Trans-rectal | |||||||
| Trans-vaginal | |||||||
| Trans-urethral | |||||||
| Trans-esoph. (non-Card.) | |||||||
| Musculo-skel. (Convent.) | P | P | P | P | B+M; B+PWD; | ||
| B+CD | Note 1 | ||||||
| Musculo-skel. (Superfic.) | P | P | P | P | B+M; B+PWD; | ||
| B+CD | Note 1 | ||||||
| Intra-luminal | |||||||
| Other (spec.) | |||||||
| Cardiac Adult | |||||||
| Cardiac Pediatric | |||||||
| Trans-esophageal (card.) | |||||||
| Other (spec.) | |||||||
| Peripheral vessel | P | P | P | P | B+M; B+PWD; | ||
| B+CD | Note 1 | ||||||
| Other (spec.) |
Table 4.3- 19 Diagnostic Ultrasound Indications for Use Form – SLAx/13-6 Transducer
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
Note 1: Okter includes Color Power Dopler, 3-D inaging, Tesue Hamonin manno, SonoRes Imaging, SonoRes Imaging, Sonokes Inaging, Sonokes Inaging, Sonokes
with ary inaging mo
Nancy Broadron
(Division Sign-Off)
Division of Reproductive, Abdominal, and
Radiological Devices
510(k) Number K071134
28
| System: | SonoSite Maxx™ Series Ultrasound System | |||||||
|---|---|---|---|---|---|---|---|---|
| Transducer: | SLTx/10-5 10.0-5.0 MHz Linear Array | |||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the | |||||||
| human body as follows: | ||||||||
| Clinical Application | Mode of Operation | |||||||
| B | M | PWD | CWD | Color | ||||
| Doppler | Combined | |||||||
| (Spec.) | Other | |||||||
| (Spec.) | ||||||||
| Ophthalmic | ||||||||
| Fetal | P | P | P | P | B+M; B+PWD; | |||
| B+CD | Note 1 | |||||||
| Abdominal | P | P | P | P | B+M; B+PWD; | |||
| B+CD | Note 1 | |||||||
| Intra-operative (Abdominal organs and vascular) | P | P | P | P | B+M; B+PWD; | |||
| B+CD | Note 1 | |||||||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | P | B+M; B+PWD; | |||
| B+CD | Note 1 | |||||||
| Small Organ (breast, thyroid, testicles. prostate) | P | P | P | P | B+M; B+PWD; | |||
| B+CD | Note 1 | |||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Convent.) | P | P | P | P | B+M; B+PWD; | |||
| B+CD | Note 1 | |||||||
| Musculo-skel. (Superfic.) | P | P | P | P | B+M; B+PWD; | |||
| B+CD | Note 1 | |||||||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac Pediatric | ||||||||
| Trans-esophageal (card.) | ||||||||
| Other (spec.) | ||||||||
| Peripheral vessel | P | P | P | P | B+M; B+PWD; | |||
| B+CD | Note 1 | |||||||
| Other (spec.) |
Table 4.3- 20 Diagnostic Ultrasound Indications for Use Form – SLTx/10-5 Transducer
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
Note 1: Other includes Color Power Doppler, combined B and Color Power Doppler, 3-D Imaging, Tissue Harmonic Imaging, SonoMB Compound Inaging, Tissue Dopler Inaging for guidance of biopsy. Color Doppier includes Velocity Color Doppler. Color Doppler can be combined with any imaging mode. All items marked "P" were previously cleared in 510(k) K053069.
Prescription Use (Per 21 CFR 801.109)
Nancy Brodon
Division Sign Off
and
29
| System: | SonoSite Maxx™ Series Ultrasound System | |||||||
|---|---|---|---|---|---|---|---|---|
| Transducer: | TCDx/2 2.0 MHz Transducer | |||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the | |||||||
| human body as follows: | ||||||||
| Clinical Application | B | M | PWD | CWD | Color | |||
| Doppler | Combined | |||||||
| (Spec.) | Other | |||||||
| (Spec.) | ||||||||
| Ophthalmic | N | |||||||
| Fetal | ||||||||
| Abdominal | ||||||||
| Intra-operative (Abdominal organs and vascular) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (breast, thyroid, testicles. prostate) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac Pediatric | ||||||||
| Trans-esophageal (card.) | ||||||||
| Other (spec.) | ||||||||
| Peripheral vessel | ||||||||
| Other (spec.). |
Table 4.3- 21 Diagnostic Ultrasound Indications for Use Form – TCDx/2 Transducer
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Prescription Use (Per 21 CFR 801.109)
Nancy C. Hogdon
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
30
| System: | SonoSite Maxx™ Series Ultrasound System | ||||||
|---|---|---|---|---|---|---|---|
| Transducer: | TEEx/8-3 8.0-3.0 MHz Trans-esophageal Echocardiography | ||||||
| Transducer | |||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the | ||||||
| human body as follows: | |||||||
| Clinical Application | Mode of Operation | ||||||
| B | M | PWD | CWD | Color | |||
| Doppler | Combined | ||||||
| (Spec.) | Other | ||||||
| (Spec.) | |||||||
| Ophthalmic | |||||||
| Fetal | |||||||
| Abdominal | |||||||
| Intra-operative (Abdominal organs and | |||||||
| vascular) | |||||||
| Intra-operative (Neuro.) | |||||||
| Laparoscopic | |||||||
| Pediatric | |||||||
| Small Organ (breast, thyroid, testicles, prostate) | |||||||
| Neonatal Cephalic | |||||||
| Adult Cephalic | |||||||
| Trans-rectal | |||||||
| Trans-vaginal | |||||||
| Trans-urethral | |||||||
| Trans-esoph. (non-Card.) | |||||||
| Musculo-skel. (Convent.) | |||||||
| Musculo-skel. (Superfic.) | |||||||
| Intra-luminal | |||||||
| Other (spec.) | |||||||
| Cardiac Adult | |||||||
| Cardiac Pediatric | |||||||
| Trans-esophageal (card.) | P | P | P | P | P | B+M; B+PWD; B+CWD; B+CD | Note 1 |
| Other (spec.) | |||||||
| Peripheral vessel | |||||||
| Other (spec.) |
Table 4.3- 22 Diagnostic Ultrasound Indications for Use Form – TEEx/8-3 Transducer
new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
Note 1: Other includes Color Power Dopler, 3-D imaging, 3-D imaging, Tissue Hammin, imaging, SonoRes Imaging, Sonokes Insecombined with any imaging mode. All items marked "P" were previously cleared in 510(k) K053069.
Prescription Use (Per 21 CFR 801.109)
Nancy Brogdon
(Division Sig (Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number