Who is the manufacturer of SonoSite SII Ultrasound System?

FUJIFILM Sonosite, Inc. filed the 510(k) submission for SonoSite SII Ultrasound System (K183235).

What is the FDA product code for SonoSite SII Ultrasound System?

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

What is the regulatory pathway for SonoSite SII Ultrasound System?

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

What are the predicate devices for SonoSite SII Ultrasound System?

SonoSite Edge II Ultrasound System (K162045); SonoSite SII Ultrasound System (K162045).

Who can help prepare an FDA 510(k) submission like SonoSite SII Ultrasound System?

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.

SonoSite SII Ultrasound System

K183235 · FUJIFILM Sonosite, Inc. · IYN · Feb 7, 2019 · Radiology

Device Facts

Record ID	K183235
Device Name	SonoSite SII Ultrasound System
Applicant	FUJIFILM Sonosite, Inc.
Product Code	IYN · Radiology
Decision Date	Feb 7, 2019
Decision	SESE
Submission Type	Abbreviated
Regulation	21 CFR 892.1550
Device Class	Class 2
Attributes	Pediatric, 3rd-Party Reviewed

Intended Use

The SonoSite SII Ultrasound System is a general purpose ultrasound system intended for use by qualified physicians and healthcare professionals for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include: Ophthalmic Fetal - OB/GYN Abdominal Pediatric Small Organ (breast, thyroid, testicle, prostate) Neonatal Cephalic Adult Cephalic Trans-rectal Trans-vaginal Musculo-skeletal (Conventional) Musculo-skeletal (Superficial) Cardiac Adult Cardiac Pediatric Peripheral Vessel

Device Story

SonoSite SII is a mountable, software-controlled diagnostic ultrasound system. It acquires and displays high-resolution, real-time ultrasound data using various imaging modes (B-mode, M-mode, Color Doppler, PW/CW Doppler, Tissue Doppler). The system operates on battery or AC power. It is used by physicians and healthcare professionals in clinical settings. The device processes ultrasound signals to produce images and measurements for clinical evaluation. It supports needle guidance, tissue harmonic imaging, and multi-beam imaging. Output is displayed on a 12.1-inch LCD for clinician review to assist in diagnosis and procedural guidance (e.g., needle/catheter placement).

Clinical Evidence

No clinical data required. Substantial equivalence supported by bench testing, including electrical, thermal, mechanical, and EMC safety evaluations, biocompatibility testing, and acoustic output characterization per FDA-recognized standards.

Technological Characteristics

Digital electronic design; 128 transmit/64 receive channels (128 via synthetic aperture); 12.1" LCD; 1.0-15.0 MHz transducer frequency range. Materials: ABS, Cycoloy, PE Ionomer, PEEK, Polycarbonate, Polysulfone, Polyurethane, PVC, Silicone. Connectivity: 3 USB ports, 802.11 wireless. Standards: IEC 60601-1, IEC 60601-2-37, IEC 62359, ISO 10993-1.

Indications for Use

Indicated for qualified physicians and healthcare professionals for ultrasound imaging or fluid flow analysis of the human body, including ophthalmic, fetal, OB/GYN, abdominal, pediatric, small organ (breast, thyroid, testicle, prostate), neonatal/adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal, cardiac, and peripheral vessel 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

SonoSite Edge II Ultrasound System (K162045)
SonoSite SII Ultrasound System (K162045)

Related Devices

K160734 — SonoSite SII Ultrasound System · FUJIFILM Sonosite, Inc. · Apr 5, 2016
K162045 — SonoSite SII Ultrasound System, SonoSite Edge II Ultrasound System · FUJIFILM Sonosite, Inc. · Aug 18, 2016
K171437 — SonoSite X-Porte Ultrasound System · FUJIFILM Sonosite, Inc. · Jun 12, 2017
K153626 — SonoSite Edge II Ultrasound System · FUJIFILM Sonosite, Inc. · Jan 20, 2016
K063500 — DC-6 DIAGNOSTIC ULTRASOUND SYSTEM · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Dec 6, 2006

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue. Underneath the FDA logo is the word "ADMINISTRATION" in blue. February 7, 2019 FUJIFILM SonoSite, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street, NW BUFFALO MN 55313 Re: K183235 Trade/Device Name: SonoSite SII Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN IYO ITX Dated: January 30, 2019 Received: February 4, 2019 Dear Mr. Job: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's {1}------------------------------------------------ requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Hse 2. Nils for Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K183235 Device Name SonoSite SII Ultrasound System #### Indications for Use (Describe) The SonoSite SII Ultrasound System is a general purpose ultrasound system intended for use by qualified physicians and healthcare professionals for evaluation by ultrasound imaging or thuid flow analysis of the human body. Specific clinical applications and exam types include: Ophthalmic Fetal - OB/GYN Abdominal Pediatric Small Organ (breast, thyroid, testicle, prostate) Neonatal Cephalic Adult Cephalic Trans-rectal Trans-vaginal Musculo-skeletal (Conventional) Musculo-skeletal (Superficial) Cardiac Adult Cardiac Pediatric Peripheral Vessel | Type of Use (Select one or both, as applicable) | | |---------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------| | <div> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | ### 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}------------------------------------------------ ## SonoSite SII Ultrasound System: The following are the Indications for Use for the SonoSite SII Ultrasound System Table 1.3-1: Diagnostic Ultrasound Indications for Use Form – FUJIFILM SonoSite SII Ultrasound System | System: | FUJIFILM SonoSite SII 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 | P | P | N | | P | B+M; B+PWD;B+CD | 1-5 | | Fetal | P | P | N | | P | B+M; B+PWD; B+CD | 1-5 | | Abdominal | P | P | N | | P | B+M; B+PWD; B+CD | 1-5 | | Intra-operative (Abdominal organs and vascular) | | | | | | | | | Intra-operative (Neuro.) | | | | | | | | | Laparoscopic | | | | | | | | | Pediatric | P | P | N | | P | B+M; B+PWD;B+CD | 1-5 | | Small Organ (breast, thyroid, testicles, prostate) | P | P | N | | P | B+M; B+PWD; B+CD | 1-5 | | Neonatal Cephalic | P | P | N | | P | B+M; B+PWD; B+CD | 1-3,5 | | Adult Cephalic | P | P | N | | P | B+M; B+PWD; B+CD | 1-3,5 | | Trans-rectal | P | P | N | | P | B+M; B+PWD; B+CD | 1,5 | | Trans-vaginal | P | P | N | | P | B+M; B+PWD; B+CD | 1,5 | | Trans-urethral | | | | | | | | | Trans-esoph. (non-Card.) | | | | | | | | | Musculo-skel. (Convent.) | P | P | N | | P | B+M; B+PWD; B+CD | 1,2,4,5 | | Musculo-skel. (Superfic.) | P | P | N | | P | B+M; B+PWD; B+CD | 1,4,5 | | Intra-luminal | | | | | | | | | Other (spec.) | | | | | | | | | Cardiac Adult | P | P | N | N | P | B+M; B+PWD; B+CWD;B+CD | 1-5 | | Cardiac Pediatric | P | P | N | N | P | B+M; B+PWD;B+CWD;B+CD | 1-5 | | Trans-esophageal (card.) | | | | | | | | | Other (spec.) | | | | | | | | | Peripheral vessel | P | P | N | | P | B+M;B+PWD;B+CD | 1-5 | | Other (spec.) | | | | | | | | N= new indication; P= previously cleared by FDA; E= added under this appendix #### Additional Comments: 1: Includes imaging to assist in the placement of needles and catheters in vascular or other anatomical structures and imaging guidance for peripheral nerve block procedures. Color Doppler includes Power/Velocity/Variance. M-Mode includes color M-Mode. 2: Tissue Harmonic Imaging (THI) 3: Tissue Doppler Imaging (TDI) 4: Steep Needle Profiling (Sono MBe) 5: Multi-beam Imaging (SonoMB) in B-Mode All items marked "P" were previously cleared in 510(k) K162045 and K160734 {4}------------------------------------------------ | System: | FUJIFILM SonoSite SII Ultrasound System | | | | | | | |----------------------------------------------------|------------------------------------------------------------------------------------|---|-----|-----|---------------|------------------|---------------| | Transducer: | C8x/8-5 MHz 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 | P | P | N | | P | B+M;B+PWD; B+CD | 1,5 | | 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 1.3-2: Diagnostic Ultrasound Indications for Use Form – C8x/8-5 MHz Transducer N= new indication; P= previously cleared by FDA; E= added under this appendix #### Additional Comments: 1: Includes imaging to assist in the placement of needles and catheters in vascular or other anatomical structures and imaging guidance for peripheral nerve block procedures. Color Doppler includes Power/Velocity/Variance. M-Mode includes color M-Mode. - 2: Tissue Harmonic Imaging (THI) - 3: Tissue Doppler Imaging (TDI) - 4: Steep Needle Profiling (Sono MBe) - 5: Multi-beam Imaging (SonoMB) in B-Mode All items marked "P" were previously cleared in 510(k) K160734 (SII). {5}------------------------------------------------ Table 1.3-3: Diagnostic Ultrasound Indications for Use Form – C11x/8-5 MHz Transducer | System: | FUJIFILM SonoSite SII Ultrasound System | | | | | | | |----------------------------------------------------|---------------------------------------------------------------------------------------|---|-----|-----|---------------|------------------|---------------| | Transducer: | C11x/8-5 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 | | | | | | | | | Fetal | | | | | | | | | Abdominal | P | P | N | | P | B+M; B+PWD; B+CD | 1,5 | | Intra-operative (Abdominal organs and vascular) | | | | | | | | | Intra-operative (Neuro.) | | | | | | | | | Laparoscopic | | | | | | | | | Pediatric | P | P | N | | P | B+M; B+PWD; B+CD | 1,5 | | Small Organ (breast, thyroid, testicles, prostate) | | | | | | | | | Neonatal Cephalic | P | P | N | | P | B+M; B+PWD; B+CD | 1,5 | | 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 | N | | P | B+M; B+PWD; B+CD | 1,5 | | Trans-esophageal (card.) | | | | | | | | | Other (spec.) | | | | | | | | | Peripheral vessel | P | P | N | | P | B+M; B+PWD; B+CD | 1,5 | | Other (spec.) | | | | | | | | N= new indication; P= previously cleared by FDA; E= added under this appendix #### Additional Comments: 1: Includes imaging to assist in the placement of needles and catheters in vascular or other anatomical structures and imaging guidance for peripheral nerve block procedures. Color Doppler includes Power/Velocity/Variance. M-Mode includes color M-Mode. 2: Tissue Harmonic Imaging (THI) - 3: Tissue Doppler Imaging (TDI) 4: Steep Needle Profiling (Sono MBe) 5: Multi-beam Imaging (SonoMB) in B-Mode All items marked "P" were previously cleared in 510(k) K160734 (SII). {6}------------------------------------------------ Table 1.3-4: Diagnostic Ultrasound Indications for Use Form – C35x/8-3 MHz Transducer | System: | FUJIFILM SonoSite SII Ultrasound System | | | | | | | |-------------------------------------------------------|---------------------------------------------------------------------------------------|---|-----|-----|------------------|---------------------|------------------| | Transducer: | C35x/8-3 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 | | | | | | | | | Fetal | P | P | N | | P | B+M; B+PWD; B+CD | 1,4,5 | | Abdominal | P | P | N | | P | B+M; B+PWD; B+CD | 1,4,5 | | Intra-operative (Abdominal organs and vascular) | | | | | | | | | Intra-operative (Neuro.) | | | | | | | | | Laparoscopic | | | | | | | | | Pediatric | P | P | N | | P | B+M; B+PWD;B+CD | 1,4,5 | | 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 | N | | P | B+M; B+PWD;B+CD | 1,4,5 | | Musculo-skel. (Superfic.) | P | P | N | | P | B+M; B+PWD; B+CD | 1,4,5 | | Intra-luminal | | | | | | | | | Other (spec.) | | | | | | | | | Cardiac Adult | | | | | | | | | Cardiac Pediatric | | | | | | | | | Trans-esophageal (card.) | | | | | | | | | Other (spec.) | | | | | | | | | Peripheral vessel | P | P | N | | P | B+M; B+PWD;B+CD | 1,4,5 | | Other (spec.) | | | | | | | | N= new indication; P= previously cleared by FDA; E= added under this appendix #### Additional Comments: 1: Includes imaging to assist in the placement of needles and catheters in vascular or other anatomical structures and imaging guidance for peripheral nerve block procedures. Color Doppler includes Power/Velocity/Variance. M-Mode includes color M-Mode. - 2: Tissue Harmonic Imaging (THI) - 3: Tissue Doppler Imaging (TDI) - 4: Steep Needle Profiling (Sono MBe) 5: Multi-beam Imaging (SonoMB) in B-Mode All items marked "P" were previously cleared in 510(k) K160734 (SII). {7}------------------------------------------------ Table 1.3-5: Diagnostic Ultrasound Indications for Use Form – rC60xi/5-2 MHz Transducer, rC60xi/5-2 MHz Armored Transducer | System: | FUJIFILM SonoSite SII Ultrasound System | | | | | | | |----------------------------------------------------|------------------------------------------------------------------------------------|---|-----|-----|------------------|---------------------|------------------| | Transducer: | rC60xi/5-2 MHz Transducer, rC60xi/5-2 MHz Armored 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 | P | | | | P | | | | Fetal | P | P | N | | P | B+M; B+PWD; B+CD | 1,2,4,5 | | Abdominal | P | P | N | | P | B+M; B+PWD; B+CD | 1,2,4,5 | | Intra-operative (Abdominal organs and vascular) | | | | | | | | | Intra-operative (Neuro.) | | | | | | | | | Laparoscopic | | | | | | | | | Pediatric | P | P | N | | P | B+M; B+PWD; B+CD | 1,2,4,5 | | 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 | N | | P | B+M; B+PWD; B+CD | 1,2,4,5 | | Musculo-skel. (Superfic.) | | | | | | | | | Intra-luminal | | | | | | | | | Other (spec.) | | | | | | | | | Cardiac Adult | | | | | | | | | Cardiac Pediatric | | | | | | | | | Trans-esophageal (card.) | | | | | | | | | Other (spec.) | | | | | | | | | Peripheral vessel | P | P | N | | P | B+M; B+PWD; B+CD | 1,2,4,5 | N= new indication; P= previously cleared by FDA; E= added under this appendix #### Additional Comments: 1: Includes imaging to assist in the placement of needles and catheters in vascular or other anatomical structures and imaging guidance for peripheral nerve block procedures. Color Doppler includes Power/Velocity/Variance. M-Mode includes color M-Mode. 2: Tissue Harmonic Imaging (THI) 3: Tissue Doppler Imaging (TDI) 4: Steep Needle Profiling (Sono MBe) 5: Multi-beam Imaging (SonoMB) in B-Mode All items marked "P" were previously cleared in 510(k) K160734 (SII). {8}------------------------------------------------ Table 1.3-6: Diagnostic Ultrasound Indications for Use Form – HFL38xi/13-6 MHz Transducer | System: | FUJIFILM SonoSite SII Ultrasound System | | | | | | | | |-------------------------------------------------------|-----------------------------------------|-------------------------------------------------------------------|-----|-----|------------------|---------------------|------------------|--| | Transducer: | HFL38xi/13-6 MHz Transducer | | | | | | | | | Intended Use: | | Diagnostic ultrasound imaging or fluid flow analysis of the human | | | | | | | | | | body as follows: | | | | | | | | Clinical Application | | Mode of Operation | | | | | | | | | | | | | | Combined (Spec.) | Other (Spec.) | | | | B | M | PWD | CWD | Color Doppler | | | | | Ophthalmic | P | P | N | | P | B+M; B+PWD; B+CD | 1,4,5 | | | Fetal | | | | | | | | | | Abdominal | P | P | N | | P | B+M; B+PWD; B+CD | 1,4,5 | | | Intra-operative (Abdominal organs and vascular) | | | | | | | | | | Intra-operative (Neuro.) | | | | | | | | | | Laparoscopic | | | | | | | | | | Pediatric | P | P | N | | P | B+M; B+PWD; B+CD | 1,4,5 | | | Small Organ (breast, thyroid, testicles, prostate) | P | P | N | | P | B+M; B+PWD; B+CD | 1,4,5 | | | Neonatal Cephalic | | | | | | | | | | Adult Cephalic | | | | | | | | | | Trans-rectal | | | | | | | | | | Trans-vaginal | | | | | | | | | | Trans-urethral | | | | | | | | | | Trans-esoph. (non-Card.) | | | | | | | | | | Musculo-skel. (Convent.) | P | P | N | | P | B+M; B+PWD; B+CD | 1,4,5 | | | Musculo-skel. (Superfic.) | P | P | N | | P | B+M; B+PWD; B+CD | 1,4,5 | | | Intra-luminal | | | | | | | | | | Other (spec.) | | | | | | | | | | Cardiac Adult | P | P | N | | P | B+M; B+PWD; B+CD | 1,4,5 | | | Cardiac Pediatric | P | P | N | | P | B+M; B+PWD; B+CD | 1,4,5 | | | Trans-esophageal (card.) | | | | | | | | | | Other (spec.) | | | | | | | | | | Peripheral vessel | P | P | N | | P | B+M; B+PWD; B+CD | 1,4,5 | | | Other (spec.) | | | | | | | | | N= new indication; P= previously cleared by FDA; E= added under this appendix #### Additional Comments: 1: Includes imaging to assist in the placement of needles and catheters in vascular or other anatomical structures and imaging guidance for peripheral nerve block procedures. Color Doppler includes Power/Velocity/Variance. M-Mode includes color M-Mode. 2: Tissue Harmonic Imaging (THI) 3: Tissue Doppler Imaging (TDI) 4: Steep Needle Profiling (Sono MBe) 5: Multi-beam Imaging (SonoMB) in B-Mode All items marked "P" were previously cleared in 510(k) K160734 & K162045. {9}------------------------------------------------ Table 1.3-7: Diagnostic Ultrasound Indications for Use Form – HFL50x/15-6 MHz Transducer | System: | FUJIFILM SonoSite SII Ultrasound System | | | | | | | | |-------------------------------------------------------|-----------------------------------------|-------------------------------------------------------------------|-----|-----|------------------|---------------------|------------------|--| | Transducer: | HFL50x/15-6 MHz 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 | N | | P | B+M; B+PWD; B+CD | 1,4,5 | | | Intra-operative (Abdominal organs and vascular) | | | | | | | | | | Intra-operative (Neuro.) | | | | | | | | | | Laparoscopic | | | | | | | | | | Pediatric | P | P | N | | P | B+M; B+PWD; B+CD | 1,4,5 | | | Small Organ (breast, thyroid, testicles, prostate) | P | P | N | | P | B+M; B+PWD; B+CD | 1,4,5 | | | Neonatal Cephalic | | | | | | | | | | Adult Cephalic | | | | | | | | | | Trans-rectal | | | | | | | | | | Trans-vaginal | | | | | | | | | | Trans-urethral | | | | | | | | | | Trans-esoph. (non-Card.) | | | | | | | | | | Musculo-skel. (Convent.) | P | P | N | | P | B+M; B+PWD; B+CD | 1,4,5 | | | Musculo-skel. (Superfic.) | P | P | N | | P | B+M; B+PWD; B+CD | 1,4,5 | | | Intra-luminal | | | | | | | | | | Other (spec.) | | | | | | | | | | Cardiac Adult | | | | | | | | | | Cardiac Pediatric | | | | | | | | | | Trans-esophageal (card.) | | | | | | | | | | Other (spec.) | | | | | | | | | | Peripheral vessel | P | P | N | | P | B+M; B+PWD; B+CD | 1,4,5 | | | Other (spec.) | | | | | | | | | N= new indication; P= previously cleared by FDA; E= added under this appendix #### Additional Comments: 1: Includes imaging to assist in the placement of needles and catheters in vascular or other anatomical structures and imaging guidance for peripheral nerve block procedures. Color Doppler includes Power/Velocity/Variance. M-Mode includes color M-Mode. 2: Tissue Harmonic Imaging (THI) 3: Tissue Doppler Imaging (TDI) 4: Steep Needle Profiling (Sono MBe) 5: Multi-beam Imaging (SonoMB) in B-Mode All items marked "P" were previously cleared in 510(k) K160734 (SII). {10}------------------------------------------------ Table 1.3-8: Diagnostic Ultrasound Indications for Use Form – HSL25x/13-6 MHz Transducer | System: | FUJIFILM SonoSite SII Ultrasound System | | | | | | | |-------------------------------------------------------|---------------------------------------------------------------------------------------|---|-----|-----|------------------|---------------------|------------------| | Transducer: | HSL25x/13-6 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 | P | P | N | | P | B+M; B+PWD; B+CD | 1,4,5 | | Fetal | P | P | N | | P | B+M; B+PWD; B+CD | 1,4,5 | | Abdominal | P | P | N | | P | B+M; B+PWD; B+CD | 1,4,5 | | Intra-operative (Abdominal organs and vascular) | | | | | | | | | Intra-operative (Neuro.) | | | | | | | | | Laparoscopic | | | | | | | | | Pediatric | P | P | N | | P | B+M; B+PWD; B+CD | 1,4,5 | | Small Organ (breast, thyroid, testicles, prostate) | P | P | N | | P | B+M; B+PWD; B+CD | 1,4,5 | | Neonatal Cephalic | | | | | | | | | Adult Cephalic | | | | | | | | | Trans-rectal | | | | | | | | | Trans-vaginal | | | | | | | | | Trans-urethral | | | | | | | | | Trans-esoph. (non-Card.) | | | | | | | | | Musculo-skel. (Convent.) | P | P | N | | P | B+M; B+PWD; B+CD | 1,4,5 | | Musculo-skel. (Superfic.) | P | P | N | | P | B+M; B+PWD; B+CD | 1,4,5 | | Intra-luminal | | | | | | | | | Other (spec.) | | | | | | | | | Cardiac Adult | P | P | N | | P | B+M; B+PWD; B+CD | 1,4,5 | | Cardiac Pediatric | P | P | N | | P | B+M; B+PWD; B+CD | 1,4,5 | | Trans-esophageal (card.) | | | | | | | | | Other (spec.) | | | | | | | | | Peripheral vessel | P | P | N | | P | B+M; B+PWD; B+CD | 1,4,5 | | Other (spec.) | | | | | | | | N= new indication; P= previously cleared by FDA; E= added under this appendix #### Additional Comments: 1: Includes imaging to assist in the placement of needles and catheters in vascular or other anatomical structures and imaging guidance for peripheral nerve block procedures. Color Doppler includes Power/Velocity/Variance. M-Mode includes color M-Mode. - 2: Tissue Harmonic Imaging (THI) - 3: Tissue Doppler Imaging (TDI) - 4: Steep Needle Profiling (Sono MBe) - 5: Multi-beam Imaging (SonoMB) in B-Mode All items marked "P" were previously cleared in 510(k) K160734 (SII). {11}------------------------------------------------ Table 1.3-9: Diagnostic Ultrasound Indications for Use Form – ICTx/8-5 MHz Transducer | System: | FUJIFILM SonoSite SII Ultrasound System | | | | | | | | |-------------------------------------------------------|---------------------------------------------------------------------------------------|-------------------|-----|-----|------------------|---------------------|------------------|--| | Transducer: | ICTx/8-5 MHz 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 | N | | P | B+M; B+PWD; B+CD | 1,5 | | | 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 | P | P | N | | P | B+M; B+PWD; B+CD | 1,5 | | | 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 this appendix #### Additional Comments: 1: Includes imaging to assist in the placement of needles and catheters in vascular or other anatomical structures and imaging guidance for peripheral nerve block procedures. Color Doppler includes Power/Velocity/Variance. M-Mode includes color M-Mode. - 2: Tissue Harmonic Imaging (THI) - 3: Tissue Doppler Imaging (TDI) - 4: Steep Needle Profiling (Sono MBe) - 5: Multi-beam Imaging (SonoMB) in B-Mode All items marked "P" were previously cleared in 510(k) K160734 (SII). {12}------------------------------------------------ Table 1.3-10: Diagnostic Ultrasound Indications for Use Form – L25x/13-6 MHz Transducer | System: | FUJIFILM SonoSite SII Ultrasound System | | | | | | | |-------------------------------------------------------|---------------------------------------------------------------------------------------|---|-----|-----|------------------|---------------------|------------------| | Transducer: | L25x/13-6 MHz 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 | N | | P | B+M; B+PWD; B+CD | 1,4,5 | | Fetal | | | | | | | | | Abdominal | P | P | N | | P | B+M; B+PWD; B+CD | 1,4,5 | | Intra-operative (Abdominal organs and vascular) | | | | | | | | | Intra-operative (Neuro.) | | | | | | | | | Laparoscopic | | | | | | | | | Pediatric | P | P | N | | P | B+M; B+PWD; B+CD | 1,4,5 | | Small Organ (breast, thyroid, testicles, prostate) | P | P | N | | P | B+M; B+PWD; B+CD | 1,4,5 | | Neonatal Cephalic | | | | | | | | | Adult Cephalic | | | | | | | | | Trans-rectal | | | | | | | | | Trans-vaginal | | | | | | | | | Trans-urethral | | | | | | | | | Trans-esoph. (non-Card.) | | | | | | | | | Musculo-skel. (Convent.) | P | P | N | | P | B+M; B+PWD; B+CD | 1,4,5 | | Musculo-skel. (Superfic.) | P | P | N | | P | B+M; B+PWD;B+CD | 1,4,5 | | Intra-luminal |…