Who is the manufacturer of UST-5550-R; UST-5536-R; L43K?

Hitachi Aloka Medical America, Inc. filed the 510(k) submission for UST-5550-R; UST-5536-R; L43K (K152126).

What is the FDA product code for UST-5550-R; UST-5536-R; L43K?

ITX. It is classified under 21 CFR 892.1570 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for UST-5550-R; UST-5536-R; L43K?

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

What are the predicate devices for UST-5550-R; UST-5536-R; L43K?

UST-5536-7.5 Intraoperative Ultrasound Transducer (K111227); EUP-O54J Intraoperative Ultrasound Transducer (K142368).

Who can help prepare an FDA 510(k) submission like UST-5550-R; UST-5536-R; L43K?

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.

UST-5550-R; UST-5536-R; L43K

K152126 · Hitachi Aloka Medical America, Inc. · ITX · Aug 17, 2016 · Radiology

Device Facts

Record ID	K152126
Device Name	UST-5550-R; UST-5536-R; L43K
Applicant	Hitachi Aloka Medical America, Inc.
Product Code	ITX · Radiology
Decision Date	Aug 17, 2016
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1570
Device Class	Class 2

Intended Use

The UST-5550-R and UST-5536-R transducer is intended for use with the PROSOUND ALPHA 7 Diagnostic Ultrasound Systems by trained personnel (doctor, sonography, etc.) for the diagnostic ultrasound evaluation during robotic* and non-robotic** intra-operative and laparoscopic procedures. The L43K transducer is intended for use with the ARIETTA60, ARIETTA 70 and NOBLUS Diagnostic Ultrasound Systems by trained personnel (doctor, sonography, etc.) for diagnostic ultrasound evaluation during robotic* and non-robotic** intra-operative and laparoscopic procedures. This device is not indicated for Ophthalmic applications. *For robotic use, these devices can only be used with the da Vinci™ Surgical System and da Vinci™ 8 mm ProGrasp Forceps. **For non-robotic use, these devices can only be used with the Covidien SILS™ Clinch

Device Story

The UST-5550-R, UST-5536-R, and L43K are reusable linear array diagnostic ultrasound transducers. They function by capturing ultrasonic signals to produce diagnostic images during intra-operative and laparoscopic procedures. The devices feature a modified titanium probe head with a linear ridge, allowing them to be securely grasped and manipulated by either the da Vinci Surgical System (using 8 mm ProGrasp Forceps) or manual surgical instruments (Covidien SILS Clinch). The transducers connect to compatible Hitachi ultrasound systems (PROSOUND ALPHA 7, ARIETTA 60/70, NOBLUS). By enabling stable, remote, or manual positioning of the transducer within the surgical field, the device assists clinicians in visualizing internal organs and structures, thereby supporting real-time clinical decision-making during surgery.

Clinical Evidence

No clinical data required. Substantial equivalence supported by bench testing, including grasp/release and bend/flexibility durability testing with robotic and manual instruments, confirming no loss of imaging performance or physical integrity.

Technological Characteristics

Linear array ultrasound transducers. Materials: Titanium (probe head). Connectivity: Compatible with specific Hitachi ultrasound systems. Operation: B, M, PWD, Color Doppler, PowerFlow. Biocompatibility: Tested per ISO 10993-1. Supplied non-sterile; requires cleaning/disinfection/sterilization per manual.

Indications for Use

Indicated for trained personnel (doctors, sonographers) performing diagnostic ultrasound evaluation during robotic and non-robotic intra-operative and laparoscopic procedures. Not indicated for ophthalmic applications.

Regulatory Classification

Identification

A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.

Predicate Devices

UST-5536-7.5 Intraoperative Ultrasound Transducer (K111227)
EUP-O54J Intraoperative Ultrasound Transducer (K142368)

Related Devices

K142618 — Intra-operative Ultrasound Transducer, PROSOUND ALPHA 7 Diagnostic Ultrasound System, ARIETTA 70 Diagnostic Ultrasound System · Hitachi Aloka Medical America, Inc. · Oct 16, 2014
K981434 — EUP-OL334 LAPARASCOPICPROBE · Hitachi Medical Corp. of America · Jul 27, 1998
K140854 — INTRA-OPERATIVE ULTRASOUND TRANSDUCER · Hitachi Aloka Medical, Ltd. · Jun 11, 2014
K953759 — DIAGNOSTIC ULTRASOUND TRANSDUCER · Biosound, Inc. · Mar 1, 1996
K971116 — SONOS 5500 IMAGING SYSTEM · Hewlett-Packard Co. · Jan 12, 1998

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it. To the left of the caduceus is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 August 17, 2016 Hitachi Aloka Medical America, Inc. % Ms. Angela Van Arsdale RA/QA Manager 10 Fairfield Blvd. WALLINGFORD CT 06492-5903 Re: K152126 Trade/Device Name: UST-5550-R: UST-5536-R: L43K Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: ITX Dated: August 2, 2016 Received: August 3, 2016 Dear Ms. Van Arsdale: 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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21. Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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. {1}------------------------------------------------ If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours. Michael D'Hara 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}------------------------------------------------ | Form Approved: OMB No. 0910-0120 | |-----------------------------------| | Expiration Date: January 31, 2017 | | See PRA Statement below. | DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration **Indications for Use** | 510(k) Number (if known) | K152126 | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------| | Device Name | | | UST-5550-R | | | UST-5536-R | | | L43K | | | Indications for Use (Describe) | | | The UST-5550-R and UST-5536-R transducer is intended for use with the PROSOUND ALPHA 7 Diagnostic Ultrasound Systems by trained personnel (doctor, sonography, etc.) for the diagnostic ultrasound evaluation during robotic* and non-robotic** intra-operative and laparoscopic procedures. | | | The L43K transducer is intended for use with the ARIETTA60, ARIETTA 70 and NOBLUS Diagnostic Ultrasound Systems by trained personnel (doctor, sonography, etc.) for diagnostic ultrasound evaluation during robotic* and non-robotic** intra-operative and laparoscopic procedures. | | | This device is not indicated for Ophthalmic applications. | | | *For robotic use, these devices can only be used with the da Vinci™ Surgical System and da Vinci™ 8 mm ProGrasp Forceps. | | | **For non-robotic use, these devices can only be used with the Covidien SILST™ Clinch | | | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | <svg class="bi bi-check-square" fill="currentColor" height="1em" viewbox="0 0 16 16" width="1em" xmlns="http://www.w3.org/2000/svg"> <path d="M14 1H2a1 1 0 0 0-1 1v12a1 1 0 0 0 1 1h12a1 1 0 0 0 1-1V2a1 1 0 0 0-1-1zM2 0a2 2 0 0 0-2 2v12a2 2 0 0 0 2 2h12a2 2 0 0 0 2-2V2a2 2 0 0 0-2-2H2z" fill-rule="evenodd"></path> <path d="M10.97 4.97a.75.75 0 0 1 1.071 1.05l-3.992 4.99a.75.75 0 0 1-1.08.02L4.324 8.384a.75.75 0 1 1 1.06-1.06l2.094 2.093 3.473-4.425a.75.75 0 0 1 1.08-.022z" fill-rule="evenodd"></path> </svg> Prescription Use (Part 21 CFR 801 Subpart D) | | | <svg class="bi bi-square" fill="currentColor" height="1em" viewbox="0 0 16 16" width="1em" xmlns="http://www.w3.org/2000/svg"> <path d="M14 1H2a1 1 0 0 0-1 1v12a1 1 0 0 0 1 1h12a1 1 0 0 0 1-1V2a1 1 0 0 0-1-1zM2 0a2 2 0 0 0-2 2v12a2 2 0 0 0 2 2h12a2 2 0 0 0 2-2V2a2 2 0 0 0-2-2H2z" fill-rule="evenodd"></path> </svg> Over-The-Counter Use (21 CFR 801 Subpart C) | CONTINUE ON A SEPARATE PAGE IF NEEDED. 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FORM FDA 3881 (8/14) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF 网 065 {3}------------------------------------------------ # ISOF ECU SOF SMOITACIONI ANUOSAAT JU OITSOMDAIO ### : 1991 ps น ธ 1 T Device Name: អ្នកប្រទេសទទួលប្រ UNITED SUNDSELLINE UNIOSON swollog se ypod urunu ath to sissfirme would binn to guigemi prisourgeid :esu popusun | Clinical Application | | | | | | | | | | | | Clinical Application | | | Mode of Operation | | | | | | | | |---------------------------|------------|--------------------------|----------------------|--------------------------------|---|----|-----|-----|------------------|------------------------|----------------------|--------------------------|--------------------------------|------------------------------|-------------------|---|-----|-----|------------------|------------------------|----------------------|--| | General (Track I only) | Ophthalmic | Fetal Imaging & Other | Cardiac | Specific (Tracks I & III) | B | M | PWD | CWD | Color Doppler | Combined* (Specify) | Other** (Specify) | | General (Track I only) | Specific (Tracks I & III) | B | M | PWD | CWD | Color Doppler | Combined* (Specify) | Other** (Specify) | | | Ophthalmic | | | | Ophthalmic | | | | | | | | Ophthalmic | Ophthalmic | | | | | | | | | | | | | Fetal | | Fetal | | | | | | | | Fetal Imaging & Other | Fetal | | | | | | | | | | | | | | | Abdominal | | | | | | | | | Abdominal | | | | | | | | | | | | | | | Intra-operative (Specify) | | Pa | | | Pa | Pa | | | Intra-operative (Specify) | | | | | | Pa | | | | | | | | | Intra-operative (Neurosurgery) | | Pa | | | Pa | Pa | | | Intra-operative (Neurosurgery) | | | | | | Pa | | | | | | | | | Laparoscopic | P | | | | P | P | | | Laparoscopic | | | | | | P | | | | | | | | | Pediatric | | | | | | | | | Pediatric | | | | | | P | | | | | | | | | Small Organ (Specify) | | | | | | | | | Small Organ (Specify) | | | | | | P | | | | | | | | | Neonatal Cephalic | | | | | | | | | Neonatal Cephalic | | | | | | | | | | | | | | | Adult Cephalic | | | | | | | | | Adult Cephalic | | | | | | | | | | | | | | | Trans-rectal | | | | | | | | | Trans-rectal | | | | | | | | | | | | | | | Trans-vaginal | | | | | | | | | Trans-vaginal | | | | | | | | | | | | | | | TEE (non-cardiac) | | | | | | | | | TEE (non-cardiac) | | | | | | | | | | | | | | | Trans-esoph. (non-Card.) | | | | | | | | | Trans-esoph. (non-Card.) | | | | | | | | | | | | | | | Musculo-skel. (Convent.) | | | | | | | | | Musculo-skel. (Convent.) | | | | | | | | | | | | | | | Musculo-skel. (Superfic.) | | | | | | | | | Musculo-skel. (Superfic.) | | | | | | | | | | | | | | | Other: (Specify) | | | | | | | | | Other: (Specify) | | | | | | | | | | | | | | | Other: Gynecological | | | | | | | | | Other: Gynecological | | | | | | | | | | | | Cardiac | | | Cardiac Adult | | | | | | | | Cardiac | Cardiac Adult | | | | | | | | | | | | | | | Cardiac Adult, TEE | | | | | | | | | Cardiac Adult, TEE | | | | | | | | | | | | | | | Cardiac Neonatal | | | | | | | | | Cardiac Neonatal | | | | | | | | | | | | | | | Cardiac Pediatric | | | | | | | | | Cardiac Pediatric | | | | | | | | | | | | | | | Cardiac - Pediatric, TEE | | | | | | | | | Cardiac Pediatric, TEE | | | | | | | | | | | | | | Peripheral Vessel | Peripheral Vascular | | | | | | | | Peripheral Vessel | Peripheral Vascular | | | | | | | | | | | | | | | Other (spec.) | | | | | | | | | Other (spec.) | | | | | | | | | | N = new indication. 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P = previously cleared by FDA in K122537 E added under Appendix 1 - Speci suoinsairiseds - I xibuəddə nəbun bəbbi = H ്തുകയും പ്രാമ്പ് മുന്നുമായ നാടാ 10 അവലംബം അവ 1 * ** 2 Includes: Molow, 8\Blow, Power flow Additional Commands: :squəmmo♡ İstinadlar Respublikasının Distrikçi Şahir Şahir Şahir Şahir Şahir Şahir Şahir Şah Şah Şah Şah Şah Şah Şah Additional Comments: Additional Comments: "s":"s","title":" ə əsasə suranın pəsodxə səxnçının sura surasını səpnisu 1. Introduction This document describes the process for exporting and importing data structures, including tables, views, and stored procedures, from one database to another using SQL Server Management Studio (SSMS). This process is useful for migrating databases, creating backups, or transferring specific database objects between environments. 2. Prerequisites Before you begin, ensure you have the following: - SQL Server Management Studio (SSMS) installed. - Access to both the source and destination SQL Server instances. - Appropriate permissions to export and import database objects. 3. Exporting Data Structures 3.1. Connect to the Source Database - Open SQL Server Management Studio (SSMS). - Connect to the SQL Server instance containing the database you want to export from. - Expand the Databases node in Object Explorer. - Right-click on the database you want to export and select Tasks > Generate Scripts... 3.2. Configure Scripting Options - In the Generate and Publish Scripts wizard, click Next to bypass the Introduction page. - Choose Objects: Select the specific database objects you want to script (e.g., tables, views, stored procedures). You can choose to script the entire database or select specific objects. - Set Scripting Options: Click Next to configure the scripting options. - General Options: - Script DDL ONLY: Set to True to script only the schema (structure) of the objects. - Script Data: Set to False to exclude data from the script. - Script DROP and CREATE: Set to Script DROP and CREATE to include DROP statements before CREATE statements in the script. - Script for Server Version: Choose the appropriate SQL Server version for compatibility. - Advanced Options: Click the Advanced button to configure additional options. - Types of data to script: Select Schema only. - Script Stored Procedures: Set to True if you want to script stored procedures. - Script Triggers: Set to True if you want to script triggers. - Script Indexes: Set to True if you want to script indexes. - Script Primary Keys: Set to True if you want to script primary keys. - Script Foreign Keys: Set to True if you want to script foreign keys. - Script Unique Keys: Set to True if you want to script unique keys. - Script Check Constraints: Set to True if you want to script check constraints. - Script Defaults: Set to True if you want to script defaults. - Script Rules: Set to True if you want to script rules. - Script User-Defined Data Types: Set to True if you want to script user-defined data types. - Script User-Defined Functions: Set to True if you want to script user-defined functions. - Script User-Defined Aggregate Functions: Set to True if you want to script user-defined aggregate functions. - Script User-Defined Table Types: Set to True if you want to script user-defined table types. - Script Full-Text Indexes: Set to True if you want to script full-text indexes. - Script Extended Properties: Set to True if you want to script extended properties. - Script Permissions: Set to True if you want to script permissions. - Script Logins: Set to True if you want to script logins. - Script Database Roles: Set to True if you want to script database roles. - Script Server Roles: Set to True if you want to script server roles. - Script Database Triggers: Set to True if you want to script database triggers. - Script Server Triggers: Set to True if you want to script server triggers. - Script Database Audit Specifications: Set to True if you want to script database audit specifications. - Script Server Audit Specifications: Set to True if you want to script server audit specifications. - Script Database Encryption Key: Set to True if you want to script database encryption key. - Script Server Encryption Key: Set to True if you want to script server encryption key. - Script Database Master Key: Set to True if you want to script database master key. - Script Server Master Key: Set to True if you want to script server master key. - Script Database Credentials: Set to True if you want to script database credentials. - Script Server Credentials: Set to True if you want to script server credentials. - Script Database Symmetric Keys: Set to True if you want to script database symmetric keys. - Script Server Symmetric Keys: Set to True if you want to script server symmetric keys. - Script Database Asymmetric Keys: Set to True if you want to script database asymmetric keys. - Script Server Asymmetric Keys: Set to True if you want to script server asymmetric keys. - Script Database Certificates: Set to True if you want to script database certificates. - Script Server Certificates: Set to True if you want to script server certificates. - Script Database XML Schema Collections: Set to True if you want to script database XML schema collections. - Script Server XML Schema Collections: Set to True if you want to script server XML schema collections. - Script Database Partition Functions: Set to True if you want to script database partition functions. - Script Server Partition Functions: Set to True if you want to script server partition functions. - Script Database Partition Schemes: Set to True if you want to script database partition schemes. - Script Server Partition Schemes: Set to True if you want to script server partition schemes. - Script Database Filegroups: Set to True if you want to script database filegroups. - Script Server Filegroups: Set to True if you want to script server filegroups. - Script Database Assemblies: Set to True if you want to script database assemblies. - Script Server Assemblies: Set to True if you want to script server assemblies. - Script Database User-Defined Types: Set to True if you want to script database user-defined types. - Script Server User-Defined Types: Set to True if you want to script server user-defined types. - Script Database User-Defined Functions: Set to True if you want to script database user-defined functions. - Script Server User-Defined Functions: Set to True if you want to script server user-defined functions. - Script Database User-Defined Aggregate Functions: Set to True if you want to script database user-defined aggregate functions. - Script Server User-Defined Aggregate Functions: Set to True if you want to script server user-defined aggregate functions. - Script Database User-Defined Table Types: Set to True if you want to script database user-defined table types. - Script Server User-Defined Table Types: Set to True if you want to script server user-defined table types. - Script Database Full-Text Catalogs: Set to True if you want to script database full-text catalogs. - Script Server Full-Text Catalogs: Set to True if you want to script server full-text catalogs. - Script Database Full-Text Stoplists: Set to True if you want to script database full-text stoplists. - Script Server Full-Text Stoplists: Set to True if you want to script server full-text stoplists. - Script Database Broker Priorities: Set to True if you want to script database broker priorities. - Script Server Broker Priorities: Set to True if you want to script server broker priorities. - Script Database Service Broker Endpoints: Set to True if you want to script database service broker endpoints. - Script Server Service Broker Endpoints: Set to True if you want to script server service broker endpoints. - Script Database Service Broker Queues: Set to True if you want to script database service broker queues. - Script Server Service Broker Queues: Set to True if you want to script server service broker queues. - Script Database Service Broker Services: Set to True if you want to script database service broker services. - Script Server Service Broker Services: Set to True if you want to script server service broker services. - Script Database Service Broker Routes: Set to True if you want to script database service broker routes. - Script Server Service Broker Routes: Set to True if you want to script server service broker routes. - Script Database Service Broker Contracts: Set to True if you want to script database service broker contracts. - Script Server Service Broker Contracts: Set to True if you want to script server service broker contracts. - Script Database Service Broker Message Types: Set to True if you want to script database service broker message types. - Script Server Service Broker Message Types: Set to True if you want to script server service broker message types. - Script Database Service Broker Remote Service Bindings: Set to True if you want to script database service broker remote service bindings. - Script Server Service Broker Remote Service Bindings: Set to True if you want to script server service broker remote service bindings. - Script Database Service Broker Event Notifications: Set to True if you want to script database service broker event notifications. - Script Server Service Broker Event Notifications: Set to True if you want to script server service broker event notifications. - Script Database Service Broker Activation Stored Procedures: Set to True if you want to script database service broker activation stored procedures. - Script Server Service Broker Activation Stored Procedures: Set to True if you want to script server service broker activation stored procedures. - Script Database Service Broker Target Initiator Authorizations: Set to True if you want to script database service broker target initiator authorizations. - Script Server Service Broker Target Initiator Authorizations: Set to True if you want to script server service broker target initiator authorizations. - Script Database Service Broker External Activator Endpoints: Set to True if you want to script database service broker external activator endpoints. - Script Server Service Broker External Activator Endpoints: Set to True if you want to script server service broker external activator endpoints. - Script Database Service Broker Queues Activation Stored Procedures: Set to True if you want to script database service broker queues activation stored procedures. - Script Server Service Broker Queues Activation Stored Procedures: Set to True if you want to script server service broker queues activation stored procedures. - Script Database Service Broker Queues Activation Service Broker Queues: Set to True if you want to script database service broker queues activation service broker queues. - Script Server Service Broker Queues Activation Service Broker Queues: Set to True if you want to script server service broker queues activation service broker queues. - Script Database Service Broker Queues Activation Service Broker Services: Set to True if you want to script database service broker queues activation service broker services. - Script Server Service Broker Queues Activation Service Broker Services: Set to True if you want to script server service broker queues activation service broker services. - Script Database Service Broker Queues Activation Service Broker Routes: Set to True if you want to script database service broker queues activation service broker routes. - Script Server Service Broker Queues Activation Service Broker Routes: Set to True if you want to script server service broker queues activation service broker routes. - Script Database Service Broker Queues Activation Service Broker Contracts: Set to True if you want to script database service broker queues activation service broker contracts. - Script Server Service Broker Queues Activation Service Broker Contracts: Set to True if you want to script server service broker queues activation service broker contracts. - Script Database Service Broker Queues Activation Service Broker Message Types: Set to True if you want to script database service broker queues activation service broker message types. - Script Server Service Broker Queues Activation Service Broker Message Types: Set to True if you want to script server service broker queues activation service broker message types. - Script Database Service Broker Queues Activation Service Broker Remote Service Bindings: Set to True if you want to script database service broker queues activation service broker remote service bindings. - Script Server Service Broker Queues Activation Service Broker Remote Service Bindings: Set to True if you want to script server service broker queues activation service broker remote service bindings. - Script Database Service Broker Queues Activation Service Broker Event Notifications: Set to True if you want to script database service broker queues activation service broker event notifications. - Script Server Service Broker Queues Activation Service Broker Event Notifications: Set to True if you want to script server service broker queues activation service broker event notifications. - Script Database Service Broker Queues Activation Service Broker Target Initiator Authorizations: Set to True if you want to script database service broker queues activation service broker target initiator authorizations. - Script Server Service Broker Queues Activation Service Broker Target Initiator Authorizations: Set to True if you want to script server service broker queues activation service broker target initiator authorizations. - Script Database Service Broker Queues Activation Service Broker External Activator Endpoints: Set to True if you want to script database service broker queues activation service broker external activator endpoints. - Script Server Service Broker Queues Activation Service Broker External Activator Endpoints: Set to True if you want to script server service broker queues activation service broker external activator endpoints. 3.3. Specify Output Options - Choose where to save the generated script. You can save it to a file, clipboard, or a new query window. - Click Next to review your selections. 3.4. Review and Generate Script - Review the summary of your selections. - Click Next to generate the script. - Once the script is generated, click Finish to close the wizard. 4. Importing Data Structures 4.1. Connect to the Destination Database - Open SQL Server Management Studio (SSMS). - Connect to the SQL Server instance where you want to import the database objects. - Open a new query window by clicking New Query. 4.2. Execute the Script - Open the generated script file in the query window. - Ensure the database context is set to the destination database by using the USE [YourDestinationDatabase] statement at the beginning of the script. - Execute the script by clicking Execute or pressing F5. 4.3. Verify the Imported Objects - After the script execution, refresh the Object Explorer. - Expand the Databases node and the destination database. - Verify that the tables, views, and stored procedures have been created successfully. 5. Troubleshooting - Syntax Errors: If you encounter syntax errors during script execution, review the script for any inconsistencies or compatibility issues with the destination SQL Server version. - Permissions: Ensure that the user executing the script has the necessary permissions to create objects in the destination database. - Dependencies: If there are dependencies between objects, ensure that the objects are created in the correct order to avoid errors. 6. Conclusion By following these steps, you can successfully export and import data structures from one SQL Server database to another using SQL Server Management Studio. This process is essential for database migration, backup, and transferring database objects between different environments. CHILDS-LANGMUIR EQUATION Excluding non-recurring items Excluding neurosurgery procedures. NEUROPATHIC PAIN (Excluding trigeminal neuralgia) EXCLUDING NEURODEGENERATIVE PROCESSES). PSEUDOMONAS AERUGINOSA (EXCLUDING PERITONEAL DIALYSIS ISOLATES) (Excluding non-recurring revenue) (Excluding neurodegenerative processes) Excluding Neurosurgery Procedures) Excluding overlapping periods prostrate or decumbent, much-branched, glabrous or sparsely pubescent. Stems 10-40 cm long. Leaves: Petiole 0.5-2 mm long; blade linear to narrowly elliptic, 5-20 mm long, 1-3 mm wide, apex acute to obtuse. Inflorescences: Flowers solitary or in 2-3-flowered cymes; peduncle 0.5-2 mm long. Flowers: Sepals 5, lanceolate, 2-3 mm long, apex acute; petals 5, white, obovate, 3-5 mm long, 1.5-2.5 mm wide, apex rounded; stamens 10; styles 3. Capsules ovoid, 3-5 mm long, equaling or slightly exceeding sepals, 6-valved. Seeds brown, reniform, 0.5-0.8 mm long, papillate. 10 9 8 7 6 5 4 3 2 1 0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 1.0 Number of scattering events expected per image 1. **What is your primary reason for using the Internet?** (Ex: School, Work, Entertainment, etc.) 2. **What type of Internet connection do you have at home?** (Ex: Cable, DSL, Fiber, Satellite, etc.) 3. **How many hours per day do you typically spend online?** (Ex: 2-3 hours, 5+ hours, etc.) 4. **What are your preferred online platforms or websites?** (Ex: Social Media, Streaming Services, News Outlets, etc.) 5. **How would you rate your overall satisfaction with your current Internet service provider?** (Ex: Very Satisfied, Satisfied, Neutral, Dissatisfied, Very Dissatisfied) proceedings of the 2011 winter simulation conference paul hyden, navonil mustafee, michael rabe, periklis yannou, and jose padillo, eds. Subject: [EXCI] Subject: New processing error itoring strategies Structure and expression of organizing parameters and constraints ctufES exposed auf η της igans and st UrmSTO TO STITS TTTT sanргани a し MOH) . ur camps prior to 10 am (Monday-Friday) or 11 am (Saturday-Sunday). 24 23 22 21 20 19 18 17 16 15 14 13 12 11 10 9 8 7 6 5 4 3 2 1 0 illiliters includes imaging of organs and structures exposed during surgery. ## Summary Results **Sample:** 20230821-001 **Analyte:** Total Petroleum Hydrocarbons **Method:** EPA 8015C | Labels | Values | |-----------------|-------------| | Dilution | 1 | | Result | < 0.5 mg/kg | | Reporting Limit | 0.5 mg/kg | | Units | mg/kg | | Date Analyzed | 08/22/2023 | | Analyst | J. Young | 30rd Annual Meeting of the European Association of Urology (EAU) Approaches (Examples) ISOLATION AND MOLECULAR CHARACTERIZATION OF VIRULENT BACTERIOPHAGES INFECTING MULTIDRUG RESISTANT BACTERIA ## EXPOSURE ASSESSMENT SUMMARY **Exposure Route:** Inhalation **Exposure Scenario:** Occupational exposure during the handling of powder products containing crystalline silica. **Health Hazard:** Crystalline silica is a known respiratory hazard. Chronic inhalation can lead to silicosis, a progressive and irreversible lung disease. Crystalline silica is also classified as a human carcinogen. **Exposure Assessment:** | Labels | Values | |-------------------------------|----------------------------------------------------------------------------------------------------| | Task | Handling of powder products | | Frequency | Daily | | Duration | 8 hours/day | | Engineering Controls | Local exhaust ventilation | | Personal Protective Equipment | Respirator (NIOSH-approved N95) | | Exposure Monitoring Data | Air sampling results indicate an average respirable crystalline silica concentration of 0.04 mg/m³ | | Regulatory Limit | OSHA PEL: 0.05 mg/m³ | **Exposure Risk Characterization:** The measured exposure concentration of 0.04 mg/m³ is below the OSHA Permissible Exposure Limit (PEL) of 0.05 mg/m³. However, it is important to note that crystalline silica is a known carcinogen, and any exposure should be minimized to the extent feasible. The use of a respirator provides additional protection against inhalation exposure. **Recommendations:** 1. Continue to use local exhaust ventilation during the handling of powder products. 2. Ensure that all employees wear a NIOSH-approved N95 respirator when handling powder products. 3. Conduct regular exposure monitoring to verify that exposure levels remain below the OSHA PEL. 4. Provide training to employees on the health hazards of crystalline silica and the proper use of engineering controls and personal protective equipment. 5. Consider implementing additional engineering controls to further reduce exposure levels, such as using a closed-loop system or a wet method. **Prepared by:** [Your Name/Title] **Date:** [Date] APPROXIMATE PERCENTAGE OF TOTAL ENERGY EXPENDITURE EXCLUDING NEUROLOGICAL PROCEDURES (DEXAMETHASONE PHOSPHATE INJECTION, USP) (E) MINIMALLY INVASIVE SURGERY COMPONENT (Excluding Instrument Processing Fees) MOTOR VEHICLE ACCIDENT REPORT (EXCLUDING BICYCLES, PEDESTRIANS, ETC.) Maximum String Length (Excluding Trailing Spaces) \$\beta\$ Normalized Intensity (arb. units) (Excluding neurosurgery procedures) MASSIVE HAMMER WITH MAXIMUM POWER (Excluding Recurrent Disconnects) includes ligaments and structures exposed during removal of ovaries or uterus (E) Excluding neurosurgery procedures (Dexmedetomidine) (Excluding non-surgery procedures). (Excluding neurosurgery procedures). (EXCLUDE NEUROSTIMULATORY PROCEDURES) (Excluding neurosurgery procedures.) (รอมทุ่งออนด์ ์ ( Thousands of barrels per day, excluding condensate) (Excluding re-invoicing procedures) (Excluding neurosurgery procedures.) (601.108 ЯНЭ IZ чэЧ) (quO эггү иолицийнэгэчЧ A manufacturers and summer of continuous in the most and ก็ได้) เป็นโรงห์ โรวเรือไอไม่มีความที่ได้ งานี้เป็นที่ 10 อวริษัท บุคคลิว ใน ออกจากเวนตรี alles H lesigoloibes but soits only al to economia a diffest lessigoloibes for uoisivid (HO-ugist uoisivid) (স)0 I S {5}------------------------------------------------ ## NAOFESU SOFISMOITASIONANIO SAATIU OITSOMOATO swollot se ypod usund ath to sistems woll binfl 10 guigemi punoserthu orisourgeid ... Sur bebrein | Clinical Application | | | | | | | | | |---------------------------|--------------------------------|---|---|-----|-----|------------------|------------------------|----------------------| | General (Track I only) | Specific (Tracks I & III) | B | M | PWD | CWD | Color Doppler | Combined* (Specify) | Other** (Specify) | | Ophthalmic | Ophthalmic | | | | | | | | | Fetal Imaging & Other | Fetal | | | | | | | | | | Abdominal | | | | | | | | | | Intra-operative (Specify) | | | | | Pa | Pa | Pa | | | Intra-operative (Neurosurgery) | | | | | Pa | Pa | Pa | | | Laparoscopic | P | P | P | P | P | P | P | | | Pediatric | | | | | | | | | | Small Organ (Specify) | | | | | | | | | | Neonatal Cephalic | | | | | | | | | | Adult Cephalic | | | | | | | | | | Trans-rectal | | | | | | | | | | Trans-vaginal | | | | | | | | | Cardiac | TEE (non-cardiac) | | | | | | | | | | Trans-esoph. (non-Card.) | | | | | | | | | | Musculo-skel. (Convent.) | | | | | | | | | | Musculo-skel. (Superfic.) | | | | | | | | | | Other: (Specify) | | | | | | | | | | Other: Gynecological | | | | | | | | | | Cardiac Adult | | | | | | | | | | Cardiac Adult, TEE | | | | | | | | | | Cardiac Neonatal | | | | | | | | | | Cardiac - Pediatric | | | | | | | | | | Cardiac - Pediatric, TEE | | | | | | | | | Peripheral Vessel | Peripheral Vascular | | | | | | | | | | Other (spec.) | | | | | | | | enoined] : 1 xipusddy : 1 xipusddy : 1 8052417 x 3 01041 x 1 x 101 x d 1 vd beares (renoverd = 1 ... inchsibui war = N ്തുകയും പ്രാമ്പ് മുന്നുമായ നാടാ 10 അവലംബം അവ COVE SUNAVACOVE (CO/M (AWA/A (M/8 - abom Suitersego U269 10 uoitsuidung) I * ** 2 IIIclide: Moltow, B\B\bow, Power flow. 2. Includes: Mllow, Bllow, F 3. 10% :squəmmo♡ İstinadlar Respublikasının Distrikçi Şahir Şahir Şahir Şahir Şahir Şahir Şahir Şah Şah Şah Şah Şah Şah Şah Additional Comments: itional comments: :"B" എന്നാടുന്നു. əsinə suranın pəsodxə səmçinin bura surasın 10 quişlemi səpnilər script "a". exposed during surge Includes imaging of organs and structures exp cript "a". Includes imaging of organs and structures expose osed during surger imaging of organs and structures exposed during surgery, including "open" and laparoscopic procedures. cript "a": xposed during surg Includes imaging of organs and structures expos transcript "included is. image during of organization and structure res exposed surgeons" structures exposed during surgery include: Imaging of organs and structures exposed during surgery includes "a" script. imaging of organs and structures exposed during surgery includes "a" pt. including structures exposed during organization and management. DONOR'S NAME AND ADDRESS (Include apt. no., street, and city or town. If you are donating securities, see Form 8283, Section B.) includes imaging of organs and structures exposed during "a" laparotomy. script "a" includes imaging of organs and structures exposed during surgery. including major organs and structures exposed during autopsy. including structures and organs of the body exposed during surgery. Represents samples that are exposed during sampling of structures, and includes information relating to number of organisms and their structures. g 221 - Imaging of organs and structures exposed during surgery includes 1. **Introduction** This document describes the data and structure of the **National Cancer Institute (NCI) Thesaurus**, a controlled vocabulary developed by NCI. The NCI Thesaurus is used for indexing and retrieval, data characterization, and application development. It covers a broad range of NCI-related terminology, including cancer-related diseases, findings, and concepts. It also includes terminology related to other biomedical areas, such as anatomy, drugs, and biological processes. The NCI Thesaurus is the source vocabulary for the NCI Metathesaurus and is harmonized with other biomedical vocabularies, such as SNOMED CT and UMLS. The NCI Thesaurus is available in OWL format and can be downloaded from the NCI website. The NCI Thesaurus is a directed acyclic graph (DAG) of concepts. Each concept is represented by a unique code and has a set of properties, such as name, definition, and synonyms. The concepts are organized into a hierarchy, with broader concepts at the top and narrower concepts at the bottom. The NCI Thesaurus also includes relationships between concepts, such as "is a" and "part of". The NCI Thesaurus is used by a variety of applications, including: - Indexing and retrieval of cancer-related information - Data characterization of cancer-related data - Application development for cancer-related applications The NCI Thesaurus is a valuable resource for anyone working with cancer-related information. HOURS MINIMUM OF 0.5 CONTINUOUS CARBON DIOXIDE EXPOSURE DURING SLEEPING HOURS INCLUDES IMAGINE SLEEPING NEXT TO A RUNNING CAR IN A CLOSED GARAGE. Organized structure exposed including the size and structure of organs and structures exposed during surgery. inches MAGNIFIED BORDER, MARKERS & NUMBERS 300 DPI ## INTRODUCTION TO ORGANIC STRUCTURES **Bond-Line Formulas** Bond-line formulas are the standard way of drawing organic molecules. They are faster to draw and easier to read than other types of structural formulas. The following rules apply to bond-line formulas: 1. Carbon atoms are not usually shown. Instead, the end of a line represents a carbon atom, and a vertex (where two lines meet) represents a carbon atom. 2. Hydrogen atoms bonded to carbon are not shown. Each carbon atom is assumed to be bonded to enough hydrogen atoms to give it four bonds. 3. All atoms other than carbon and hydrogen are shown. Hydrogen atoms bonded to atoms other than carbon are also shown. 4. A line represents a bond. A single line represents a single bond, two lines represent a double bond, and three lines represent a triple bond. 5. The zig-zag pattern is used to represent single bonds. This is because the tetrahedral geometry of carbon atoms causes the bonds to be arranged in a zig-zag pattern. 6. Lone pairs are not usually shown. However, they may be shown if they are important for understanding the reactivity of the molecule. Here are some examples of bond-line formulas: ![Bond-line formulas](https://i.imgur.com/example.png) As you can see, bond-line formulas are a very efficient way of drawing organic molecules. They are also very easy to read, once you get used to them. **Functional Groups** A functional group is a specific group of atoms within a molecule that is responsible for a characteristic chemical behavior of that molecule. Functional groups are important because they allow us to predict the reactivity of a molecule based on its structure. Here are some of the most common functional groups: - Alkane: A hydrocarbon containing only single bonds. - Alkene: A hydrocarbon containing at least one double bond. - Alkyne: A hydrocarbon containing at least one triple bond. - Alcohol: A compound containing a hydroxyl group (-OH). - Ether: A compound containing an oxygen atom bonded to two alkyl groups (R-O-R'). - Aldehyde: A compound containing a carbonyl group (C=O) bonded to at least one hydrogen atom. - Ketone: A compound containing a carbonyl group (C=O) bonded to two alkyl groups (R-C=O-R'). - Carboxylic acid: A compound containing a carboxyl group (-COOH). - Ester: A compound containing a carboxyl group (-COOR). - Amine: A compound containing a nitrogen atom bonded to one, two, or three alkyl groups (R-NH2, R2NH, R3N). - Amide: A compound containing a nitrogen atom bonded to a carbonyl group (R-CO-NH2). These are just a few of the many functional groups that exist in organic chemistry. By learning to recognize these functional groups, you will be able to predict the reactivity of a wide variety of organic molecules. CENTIMETERS & MILLIMETERS IMAGING FINDINGS & CLINICAL SIGNIFICANCE Imaging findings of congenital structural anomalies exposed during routine prenatal screening and diagnostic imaging. INCREASING MAGNITUDE OF ORGANIC AND INORGANIC COMPONENTS AND STRUCTURES EXPOSED DURING 0.5 M NaOH TREATMENT Source string magnitude (F) includes imaging of organs and structures exposed during surgery. Includes images of organs and structures exposed during dissection. Includes imaging of organs and structures exposed during routine colonoscopy. MAXIMUM ANNUAL DOSE TO MEMBER OF THE PUBLIC FROM NORMAL OPERATIONS (mrem/year) includes, improves, and structures quality of datasets and public resources exposed during research. • Includes imaging of organs and structures exposed during laparotomy (exploratory laparotomy, exploratory laparoscopy, or open abdominal approach) Includes minerals & organic compounds that are exposed during weathering of rocks. pasodxa sajmanjus pur Surajю о дшави sappia sr (Excluding neurosurgery procedures). REVISED DOSAGES FOR PATIENTS CURRENTLY RECEIVING CARBOPLATIN AND PEMETREXED Include measures to control symptoms of nausea and vomiting during chemotherapy. COLORING, MOISTURIZING, AND PROTECTING LIP GLOSS PACIFICA COSMETICS INC. PORTLAND, OR 97204 MADE IN USA (WITH IMPORTED COMPONENTS) PACIFICA BEAUTY.COM Outer membrane porin structures (Gram-negative bacteria) Includes images of organs and structures exposed during dissection (Courtesy of Anatomy.tv, Primal Pictures) GROUND BASED MEASUREMENTS OF COLUMN OZONE AND STRATOSPHERIC TEMPERATURES EXPOSED DURING THE 2023 ANTARCTIC OZONE HOLE (Extended Abstract) Buinn pasodxa sองทาวทงUS DUR SUBOJю о бшавш sappiaur (Excluding ery pro Hures) nagodro go (Excluding neurosurgery procedures). του ηττη στητο το и дори Includes imagery or data copyright 2023 Planet Labs PBC. All Rights Reserved. includes images of drains and structures exposed during demolition. (Composite: Includes asbestos building materials.) includes images of organs and structures exposed during surgery. Includes images of organs and structures exposed during abdominal dissection. GROUND BEEF CONTAINS UP TO 10% ADDED SOLUTION OF ORGANIC BROTH AND ROSEMARY EXTRACT (INCLUDES INGREDIENTS TO ENHANCE FLAVOR AND TENDERNESS) ANALYTIC SOLUTION FOR THE CONCENTRATION PROFILE DURING AQUEOUS PROCESSING OF A MULTICOMPONENT ALLOY (II. DIFFUSION-CONTROLLED DISSOLUTION) (Excluding nursery processed components). Excluding neurosurgery & radiotherapy procedures (minutes) (Excl. respiratory droplets/aerosols) itoring network surgery (EXCLUDING DEDUCTIBLE PORTIONS). (səxnpəsond xəsərnən saunan suipnləxi]) (601.108 ЯНЭ IZ чэд) (quO ash uoi)diussan A ma นาโอ) นักโธอH ไลว่เรือไปเท่าหลี พรรม เร็ ซึ่งสามารถเป็น เป็นตอนตรีที่ 0 เหตุการะหน ltlesH lesigoloibeA bus soitsongsio oniV ul to echilO dillesH โหวเรียดไงไม้มีความ 10 แบบเริ่มกับ (110-ugi2 noisivi (1) (ڊ)01 ڪ да сарын тараа баратын тараат салатын тараат салатын тараат салатын таратын таратын таратын таратын таратын таратын таратын таратын таратын таратын таратын таратын таратын та {6}------------------------------------------------ ### 510(k) Summary of Safety and Effectiveness in accordance with 21 CFR Part 807, Subpart E, Section 807.92. 21 CFR 807.92, Subsection a | 1. Submitter's Information: | | |---------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Address: | Hitachi Aloka Medical America, Inc. 10 Fairfield Boulevard Wallingford, CT 06492-5903 | | Contact: | Angela Van Arsdale RA/QA Manager | | Telephone: | (203) 269-5088 Ext: 346 | | Fax Number: | (203) 269-6075 | | Date Prepared: | July 28, 2015 | | 2. Device / Common / Classification Name / Classification / Product Code: | | | Device Proprietary Name(s): | L43K | | Manufacturer: | Hitachi, Ltd. Healthcare Tokyo Works 3-7-19 Imai, Ome-Shi, Tokyo 198-8577 Japan | | Common Name: | Diagnostic Ultrasound Transducer | | Classification: | Class II | | Product Code: | 90-ITX 892.1570 Diagnostic Ultrasonic Transducer | | Device Proprietary Name(s): | UST-5550-R; UST-5536-R; | | Manufactured in the U.S.A. by: | MD MedTec, LLC. 14 Inverness Drive E, Suite F140 Englewood, Colorado 80112 U.S.A. | | Manufactured for: | Hitachi, Ltd. 2-16-1, Higashi-Ueno, Taito-ku TOKYO, 110-0015 JAPAN | | Common Name: | Diagnostic Ultrasound Transducer | | Classification: | Class II | | Product Code: | 90-ITX 892.1570 Diagnostic Ultrasonic Transducer | | 3. Legally Marketed Predicate Device(s): | | | | UST-5536-7.5 Intraoperative Ultrasound Transducer [K111227]; EUP-O54J Intraoperative Ultrasound Transducer [K142368] | | 4. Device Description: | | | | Linear Array transducer | | 5. Indication for Use: | | | | The UST-5550-R and UST-5536-R transducer is intended for use with the PROSOUND ALPHA 7 Diagnostic Ultrasound Systems by trained personnel (doctor, sonography, etc.) for the diagnostic ultrasound evaluation during robotic* and non-robotic** intra-operative and laparoscopic procedures. | | | The L43K transducer is intended for use with the ARIETTA60, ARIETTA70 and NOBLUS Diagnostic Ultrasound Systems by trained personnel (doctor, sonography, etc.) for diagnostic ultrasound evaluation during robotic* and non-robotic** intra-operative and laparoscopic procedures. | | | This device is not indicated for Ophthalmic applications. | | | *For robotic use, these devices can only be used with the da Vinci™ Surgical System and da Vinci™ 8 mm ProGrasp Forceps. | | | **For non-robotic use, these devices can only be used with the Covidien SILS™ Clinch | {7}------------------------------------------------ 21 CFR 807.92, Subsection a - Continued ### 6. Comparison to predicate device: The UST-5550-R, UST-5536-R and L43K Intraoperative linear transducers are technically comparable and substantially equivalent to the currently marketed UST-5536-7.5 and EUP-054J. The difference between the subject devices (UST-5550-R, UST-5536-R & L43K) and predicate (UST-5536-7.5) is the material change to Titanium and dimensional/design changes to the probe head to include a linear ridge. The UST-5536-R have the same array dimension, number of elements and element spacing as the predicate UST-5536-7.5. The subject devices UST-5550-R and UST-5536-R are manufactured in the U.S.A. by SOMA Manufacturing, LLC in accordance to specifications and components provided by the manufacturer: Hitachi Aloka Medical, Ltd. located in Tokyo, Japan. The subject device L43K contains the same array diment and element spacing as the predicate EUP-O54J Intraoperative linear transducer with the same probe head design and material as the UST-5550-R. The L43K is manufactured in its entirety by Hitachi, Ltd., Japan. The subject and predicate transducers are compatible with track 3 diagnostic ultrasound systems and incorporate the same fundamental and scientific technologies. The only difference between the subject and predicate devices is a material change: along with minor dimensional and design modifications to probe head at the distal end of the subject devices. The material has been changed to Titanium and the scanning head is modified to add a small linear ridge to allow surgical graspers or robotic arm graspers to hold and control the scanning intraoperative or laparoscopic procedures. Neither the changes to the scanning head (dimensional and material) or the use of either surgical graspers or robotic arm graspers to manipulate the device change the intended use of the device. The following compares the subject and predicate devices: | Subject devices: | Predicate devices: | |---------------------------------------------------|---------------------------------------------------| | Reusable device | Reusable device | | New material: Titanium | All materials previously cleared by FDA | | Intraoperative linear array | Intraoperative linear array | | Modes of operation: B, M, PWD, CD, PowerFlow and | Modes of operation: B, M, PWD, CD, PowerFlow and | | Combination of each operating mode | Combination of each operating mode | {8}------------------------------------------------ ### 21 CFR Part 807.92, Section b | 1. Non-clinical Testing: | No new hazards were identified with the…