Who is the manufacturer of Terason uSmart3300 Ultrasound System?

Teratech Corp. filed the 510(k) submission for Terason uSmart3300 Ultrasound System (K150148).

What is the FDA product code for Terason uSmart3300 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 Terason uSmart3300 Ultrasound System?

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

What are the predicate devices for Terason uSmart3300 Ultrasound System?

Terason uSmart3300 Ultrasound System (K140773); Terason uSmart3300 Ultrasound System (K071134); Terason t3000 8MC3 transducer (K112953); Philips iE33 S7-3t TE transducer (K132304); Philips iE33 S7-3t TE transducer (K070792); Aloka ProSound-C3 UST-T109 PDOF transducer (K110482); Sonosite Edge L25x transducer (K082098).

Who can help prepare an FDA 510(k) submission like Terason uSmart3300 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.

Terason uSmart3300 Ultrasound System

K150148 · Teratech Corp. · IYN · Feb 20, 2015 · Radiology

Device Facts

Record ID	K150148
Device Name	Terason uSmart3300 Ultrasound System
Applicant	Teratech Corp.
Product Code	IYN · Radiology
Decision Date	Feb 20, 2015
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1550
Device Class	Class 2
Attributes	Pediatric, 3rd-Party Reviewed

Intended Use

The Teratech Corporation Terason™ uSmart3300 is a general purpose Ultrasound System intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include: Ophthalmic, Fetal, Abdominal, Intra-operative (Spec. and Neuro.), Pediatrics, Small Organ (Thyroid, Breast, Testes); Neonatal and Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-esoph. (non-cardiac), Musculo-skeletal (Conventional and Superficial); Cardiac (Adult & Pediatric); Trans-esoph. (cardiac) Peripheral Vascular.

Device Story

The Terason uSmart3300 is a portable, battery-powered ultrasound system (14.6 lbs) featuring a 15.6" backlit screen. It utilizes a proprietary ultrasound engine to control acoustic output and process return echoes in real-time. Data is transferred via FireWire (IEEE 1394) to a single-board computer running Windows 7 for image generation and display. The system is operated by qualified physicians in clinical settings for diagnostic imaging and fluid flow analysis. It supports various transducer types (linear, curved, phased, endocavity, hockey stick, trans-esophageal, and pencil) to provide B-mode, M-mode, Color Doppler, Power Doppler, and Pulsed Wave Doppler imaging. The device aids clinicians in visualizing internal structures and blood flow, facilitating diagnostic decision-making and ultrasound-guided procedures (e.g., needle/catheter placement, biopsy, amniocentesis).

Clinical Evidence

Bench testing only. Performance evaluated via acoustic tank testing for all new transducers (9MC3, 8TE3, PDOF, 15L4, 12L5A) per IEC 60601-2-37. Biocompatibility testing performed per ISO 10993-5 and 10993-10 for patient-contact materials. Electrical safety and EMC compliance verified per IEC 60601-1 and IEC 60601-1-2.

Technological Characteristics

System uses a single-board computer (Windows 7) and custom beamformer engine. Transducers utilize piezoelectric elements. Patient contact materials include silicone and ABS. Connectivity via FireWire (IEEE 1394). Dimensions: 10"x14.5"x2.5". Power: Lithium-Polymer battery. Standards: IEC 60601-1, IEC 60601-2-37, NEMA UD 2/3.

Indications for Use

Indicated for qualified physicians to perform ultrasound imaging or fluid flow analysis of the human body. Clinical applications include Ophthalmic, Fetal, Abdominal, Intra-operative (Spec. and Neuro.), Pediatrics, Small Organ (Thyroid, Breast, Testes), Neonatal and Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-esophageal (cardiac and non-cardiac), Musculo-skeletal (Conventional and Superficial), Cardiac (Adult & Pediatric), and Peripheral Vascular.

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

Terason uSmart3300 Ultrasound System (K140773)
Terason uSmart3300 Ultrasound System (K071134)
Terason t3000 8MC3 transducer (K112953)
Philips iE33 S7-3t TE transducer (K132304)
Philips iE33 S7-3t TE transducer (K070792)
Aloka ProSound-C3 UST-T109 PDOF transducer (K110482)
Sonosite Edge L25x transducer (K082098)

Related Devices

K201633 — Terason uSmart 3200T Plus Ultrasound System · Teratech Corporation · Jul 2, 2020
K030191 — TERASON MODEL 2000/BAS PORTABLE ULTRASOUND SYSTEM · Teratech Corp. · Jan 29, 2003
K140834 — TERASON USMART3400 ULTRASOUND SYSTEM · Teratech Corp. · Apr 25, 2014
K142077 — MYLABGAMMA · Esaote, S.p.A. · Sep 12, 2014
K113156 — SONOSITE EDGE ULTRASOUND SYSTEM · Sonosite,Inc. · Nov 15, 2011

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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a caduceus, a symbol often associated with healthcare, featuring a staff with a serpent entwined around it. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 February 20, 2015 TERATECH CORPORATION C/O MARK JOB 1394 25TH STREET, NW BUFFALO MN 55313 Re: K150148 Trade/Device Name: Terason uSmart3300 Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic Pulsed Doppler Imaging System Regulatory Class: II Product Code: IYN, IYO, ITX Dated: January 22, 2015 Received: January 23, 2015 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. 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. 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 {1}------------------------------------------------ Page 2-Mr. Job 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, Robert A Ochs Robert Ochs, Ph.D. Acting 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) K150148 #### Device Name Terason uSmart3300 Ultrasound System #### Indications for Use (Describe) The Teratech Corporation Terason uSmart3300 is a general purpose Ultrasound System intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include: Ophthalmic, Fetal, Abdominal, Intra-operative (Spec. and Neuro.), Pediatrics, Small Organ (Thyroid, Breast, Testes); Neonatal and Adult Cephalic, Trans-vaginal, Trans-esoph. (non-cardiac), Musculo-skeletal (Conventional and Superficial); Cardiac (Adult & Pediatric); Trans-esoph. (cardiac) Peripheral Vascular. | Type of Use (Select one or both, as applicable) | | |-----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------| | ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ 510(k) Number (if known): | Device Name: | Terason uSmart3300 Ultrasound System | |--------------|--------------------------------------| |--------------|--------------------------------------| Indications For Use: Diagnostic ultrasound imaging system or fluid flow analysis of the human body as follows: | Clinical Application | | Mode of Operation | | | | | | | |----------------------|--------------------------------------------------|-------------------|----|-----|-----|-------|--------|-------| | General | Specific | B | M | PWD | CWD | Color | Comb. | Other | | (Track I Only) | (Tracks I & III) | | | | | Doppa | Modesb | | | Ophthalmic | Ophthalmic | N | N | N | | N | N | N | | | Fetalh | P1 | P1 | P1 | | P1 | P1 | P1 | | | Abdominala: | P1 | p1 | P1 | | P1 | p1 | P1 | | | Intra-operative (Spec.)d,e | P1 | P1 | P1 | | P1 | P1 | P1 | | | Intra-operative (Neuro) | | | | | | | | | | Laparoscopic | | | | | | | | | Fetal | Pediatric®: | P1 | P1 | P1 | | P1 | P1 | P1 | | Imaqinq & Other | Small Organ (Thyroid, Breast, Testes, etc.)ª: | P1 | p1 | P1 | | P1 | P1 | P1 | | | Neonatal Cephalice: | P1 | P1 | P1 | p2 | P1 | P1 | P1 | | | Adult Cephalica: | P1 | P1 | P1 | p2 | P1 | P1 | P1 | | | Trans-rectal*: | P1 | P1 | P1 | | P1 | P1 | P1 | | | Trans-vaginal9: | P1 | P1 | P1 | | P1 | P1 | P1 | | | Trans-urethral | | | | | | | | | | Trans-esoph. (non-Card.) | N | N | N | | N | N | N | | | Musculo-skel. (Convent.)d: | P1 | P1 | P1 | | P1 | P1 | P1 | | | Musculo-skel. (Superfic)d: | P1 | P1 | P1 | | P1 | P1 | P1 | | | Intra-luminal | | | | | | | | | | Other (Specify) | | | | | | | | | | Cardiac Adult | P1 | P1 | P1 | P1 | P1 | P1 | P1 | | Cardiac | Cardiac Pediatric | P1 | P1 | P1 | p2 | P1 | P1 | P1 | | | Trans-esoph. (Cardiac) | N | N | N | N | N | N | N | | | Other (Specify) | | | | | | | | | Peripheral | Peripheral vesseld: | P1 | p1 | P1 | N | P1 | P1 | P1 | | Vessel | Other (Specify) | | | | | | | | N= new indication: P= previously cleared by FDA; E= added under Appendix E a Includes Color Doppler (CD), Directional Power Doppler (DPD), and (non-directional) Power Doppler. b B+M; B+PWD; B+CD; B+DPD; B+PD. ° Harmonic Imaging (HI) d Includes ultrasound guidance for placement of needles, catheters. e Abdominal, thoracic and peripheral vessel. f Includes ultrasound guidance for placement of needles, catheters, cryosurgery, and brachytherapy 9 Includes ultrasound guidance of transvaginal biopsy, infertility monitoring of follicle development. b Includes guidance of amniocentesis, infertility monitoring of follicle development. Additional Comments: P1: uses previously cleared under K140773 P2: uses previously cleared under K051334 Prescription Use __x_ AND/OR -Over-The-Counter Use _ (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) (Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k) Page 2 of 13 {4}------------------------------------------------ 510(k) Number (if known): _________ #### Device Name: Terason uSmart3300 - 9MC3 Transducer Indications For Use: Diagnostic ultrasound imaging system or fluid flow analysis of the human body as follows: | Clinical Application | | | Mode of Operation | | | | | | |-----------------------------|--------------------------------------------------|---|-------------------|-----|-----|-----------------|-----------------|--------| | General (Track I Only) | Specific (Tracks I & III) | B | M | PWD | CWD | Color Doppaa | Comb. Modesb | Otherc | | Ophthalmic | Ophthalmic | | | | | | | | | | Fetalh | N | N | N | | N | N | N | | | Abdominald: | | | | | | | | | | Intra-operative (Spec.)d,e | | | | | | | | | | Intra-operative (Neuro) | | | | | | | | | | Laparoscopic | | | | | | | | | Fetal Imaging & Other | Pediatricd: | N | N | N | | N | N | N | | | Small Organ (Thyroid, Breast, Testes, etc.)d: | N | N | N | | N | N | N | | | Neonatal Cephalicd: | N | N | N | | N | N | N | | | Adult Cephalicd: | N | N | N | | N | N | N | | | Trans-rectalf: | | | | | | | | | | Trans-vaginalg: | | | | | | | | | | Trans-urethral | | | | | | | | | | Trans-esoph. (non-Card.) | | | | | | | | | | Musculo-skel. (Convent.)d: | | | | | | | | | | Musculo-skel. (Superfic)d: | | | | | | | | | | Intra-luminal | | | | | | | | | | Other (Specify) | | | | | | | | | Cardiac | Cardiac Adult | N | N | | N | N | N | N | | | Cardiac Pediatric | N | N | | N | N | N | N | | | Trans-esoph. (Cardiac) | | | | | | | | | | Other (Specify) | | | | | | | | | Peripheral Vessel | Peripheral vesseld: | N | N | N | N | N | N | N | | | Other (Specify) | | | | | | | | N= new indication; P= previously cleared by FDA; E= added under Appendix E a Includes Color Doppler (CD), Directional Power Doppler (DPD), and (non-directional) Power Doppler. b B+M; B+PWD; B+CD; B+DPD; B+PD. ° Harmonic Imaging (HI) d Includes ultrasound guidance for placement of needles, catheters. e Abdominal, thoracic and peripheral vessel. 1 Includes ultrasound guidance for placement of needles, catheters, cryosurgery, and brachytherapy 9 Includes ultrasound guidance of transvaginal biopsy, infertility monitoring of follicle development. In Includes guidance of amniocentesis, infertility monitoring of follicle development. Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use _ (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) (Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k)_ Page 3 of 13 {5}------------------------------------------------ #### 510(k) Number (if known): #### Device Name: Terason uSmart3300 - 8TE3 Transducer Indications For Use: Diagnostic ultrasound imaging system or fluid flow analysis of the human body as follows: | Clinical Application | Mode of Operation | | | | | | | | |-----------------------------|--------------------------------------------------|---|---|-----|-----|-----------------|-----------------|--------| | General (Track I Only) | Specific (Tracks I & III) | B | M | PWD | CWD | Color Doppaa | Comb. Modesb | Otherc | | Ophthalmic | Ophthalmic | | | | | | | | | | Fetalh | | | | | | | | | | Abdominald: | | | | | | | | | | Intra-operative (Spec.)d,e | | | | | | | | | | Intra-operative (Neuro) | | | | | | | | | | Laparoscopic | | | | | | | | | Fetal Imaging & Other | Pediatricd: | | | | | | | | | | Small Organ (Thyroid, Breast, Testes, etc.)d: | | | | | | | | | | Neonatal Cephalicd: | | | | | | | | | | Adult Cephalicd: | | | | | | | | | | Trans-rectalf: | | | | | | | | | | Trans-vaginalg: | | | | | | | | | | Trans-urethral | | | | | | | | | | Trans-esoph. (non-Card.) | N | N | N | N | N | N | N | | | Musculo-skel. (Convent.)d: | | | | | | | | | | Musculo-skel. (Superfic)d: | | | | | | | | | | Intra-luminal | | | | | | | | | | Other (Specify) | | | | | | | | | | Cardiac Adult | | | | | | | | | Cardiac | Cardiac Pediatric | | | | | | | | | | Trans-esoph. (Cardiac) | N | N | N | N | N | N | N | | | Other (Specify) | | | | | | | | | Peripheral Vessel | Peripheral vesseld: | | | | | | | | | | Other (Specify) | | | | | | | | N= new indication; P= previously cleared by FDA; E= added under Appendix E a Includes Color Doppler (CD), Directional Power Doppler (DPD), and (non-directional) Power Doppler. b B+M; B+PWD; B+CD; B+DPD; B+PD. º Harmonic Imaging (HI) d Includes ultrasound guidance for placement of needles, catheters. e Abdominal, thoracic and peripheral vessel. Includes ultrasound guidance for placement of needles, catheters, cryosurgery, and brachytherapy 9 Includes ultrasound guidance of transvaginal biopsy, infertility monitoring of follicle development. b Includes guidance of amniocentesis, infertility monitoring of follicle development. Prescription Use ____x_ (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use _ (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) (Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k)_ Page 4 of 13 {6}------------------------------------------------ #### 510(k) Number (if known): ### Device Name: Terason uSmart3300 – PDOF Transducer Indications For Use: Diagnostic ultrasound imaging system or fluid flow analysis of the human body as follows: | Clinical Application | | Mode of Operation | | | | | | | |-----------------------------|--------------------------------------------------|-------------------|---|-----|-----|-----------------|-----------------|--------| | General (Track I Only) | Specific (Tracks I & III) | B | M | PWD | CWD | Color Doppaa | Comb. Modesb | Otherc | | | Ophthalmic | | | | | | | | | Fetal Imaging & Other | Fetalh | | | | | | | | | | Abdominald: | | | | | | | | | | Intra-operative (Spec.)d,e | | | | | | | | | | Intra-operative (Neuro) | | | | | | | | | | Laparoscopic | | | | | | | | | | Pediatricd: | | | | | | | | | | Small Organ (Thyroid, Breast, Testes, etc.)d: | | | | | | | | | | Neonatal Cephalicd: | | | | | | | | | | Adult Cephalicd: | | | | | | | | | | Trans-rectalf: | | | | | | | | | | Trans-vaginalg: | | | | | | | | | | Trans-urethral | | | | | | | | | | Trans-esoph. (non-Card.) | | | | | | | | | | Musculo-skel. (Convent.)d: | | | | | | | | | | Musculo-skel. (Superfic)d: | | | | | | | | | | Intra-luminal | | | | | | | | | | Other (Specify) | | | | | | | | | Cardiac | Cardiac Adult | | | | N | | | | | | Cardiac Pediatric | | | | N | | | | | | Trans-esoph. (Cardiac) | | | | | | | | | | Other (Specify) | | | | | | | | | Peripheral Vessel | Peripheral vesseld: | | | | | | | | | | Other (Specify) | | | | | | | | N= new indication; P= previously cleared by FDA; E= added under Appendix E a Includes Color Doppler (CD), Directional Power Doppler (DPD), and (non-directional) Power Doppler. b B+M; B+PWD; B+CD; B+DPD; B+PD. º Harmonic Imaging (HI) d Includes ultrasound guidance for placement of needles, catheters. e Abdominal, thoracic and peripheral vessel. Includes ultrasound guidance for placement of needles, catheters, cryosurgery, and brachytherapy 9 Includes ultrasound guidance of transvaginal biopsy, infertility monitoring of follicle development. b Includes guidance of amniocentesis, infertility monitoring of follicle development. Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use _ (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) (Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k)_ Page 5 of 13 {7}------------------------------------------------ #### 510(k) Number (if known): #### Device Name: Terason uSmart3300 - 15L4 Transducer Indications For Use: Diagnostic ultrasound imaging system or fluid flow analysis of the human body as follows: | Clinical Application | | Mode of Operation | | | | | | | |---------------------------|-------------------------------|-------------------|----|-----|-----|-----------------|-----------------|--------| | General (Track I Only) | Specific (Tracks I & III) | B | M | PWD | CWD | Color Doppaa | Comb. Modesb | Otherc | | Ophthalmic | Ophthalmic | N | N | N | | N | N | N | | | Fetalh | | | | | | | | | | Abdominald: | P1 | P1 | P1 | | P1 | P1 | P1 | | | Intra-operative (Spec.)d,e | | | | | | | | | | Intra-operative (Neuro) | | | | | | | | | | Laparoscopic | | | | | | | | | Fetal | Pediatricd: | P1 | P1 | P1 | | P1 | P1 | P1 | | Imaging | Small Organ (Thyroid, Breast, | P1 | P1 | P1 | | P1 | P1 | P1 | | & Other | Testes, etc.)d: | | | | | | | | | | Neonatal Cephalicd: | | | | | | | | | | Adult Cephalicd: | | | | | | | | | | Trans-rectalf: | | | | | | | | | | Trans-vaginalg: | | | | | | | | | | Trans-urethral | | | | | | | | | | Trans-esoph. (non-Card.) | | | | | | | | | | Musculo-skel. (Convent.)d: | P1 | P1 | P1 | | P1 | P1 | P1 | | | Musculo-skel. (Superfic)d: | P1 | P1 | P1 | | P1 | P1 | P1 | | | Intra-luminal | | | | | | | | | | Other (Specify) | | | | | | | | | | Cardiac Adult | | | | | | | | | Cardiac | Cardiac Pediatric | | | | | | | | | | Trans-esoph. (Cardiac) | | | | | | | | | | Other (Specify) | | | | | | | | | Peripheral | Peripheral vesseld: | P1 | P1 | P1 | | P1 | P1 | P1 | | Vessel | Other (Specify) | | | | | | | | N= new indication; P= previously cleared by FDA; E= added under Appendix E a Includes Color Doppler (CD), Directional Power Doppler (DPD), and (non-directional) Power Doppler. b B+M; B+PWD; B+CD; B+DPD; B+PD. º Harmonic Imaging (HI) d Includes ultrasound guidance for placement of needles, catheters. e Abdominal, thoracic and peripheral vessel. Includes ultrasound guidance for placement of needles, catheters, cryosurgery, and brachytherapy 9 Includes ultrasound guidance of transvaginal biopsy, infertility monitoring of follicle development. b Includes guidance of amniocentesis, infertility monitoring of follicle development. Additional Comments: P1: uses previously cleared under K140773 Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use _ (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) (Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k)_ Page 6 of 13 {8}------------------------------------------------ #### 510(k) Number (if known): #### Device Name: Terason uSmart3300 – 12L5A Transducer Indications For Use: Diagnostic ultrasound imaging system or fluid flow analysis of the human body as follows: | Clinical Application | | Mode of Operation | | | | | | | |-----------------------------|--------------------------------------------------|-------------------|----|-----|-----|-----------------|-----------------|--------| | General (Track I Only) | Specific (Tracks I & III) | B | M | PWD | CWD | Color Doppaa | Comb. Modesb | Otherc | | Ophthalmic | Ophthalmic | N | N | N | | N | N | N | | | Fetalh | | | | | | | | | | Abdominald: | P1 | P1 | P1 | | P1 | P1 | P1 | | | Intra-operative (Spec.)d,e | | | | | | | | | | Intra-operative (Neuro) | | | | | | | | | | Laparoscopic | | | | | | | | | Fetal Imaging & Other | Pediatricd: | P1 | P1 | P1 | | P1 | P1 | P1 | | | Small Organ (Thyroid, Breast, Testes, etc.)d: | P1 | P1 | P1 | | P1 | P1 | P1 | | | Neonatal Cephalicd: | | | | | | | | | | Adult Cephalicd: | | | | | | | | | | Trans-rectalf: | | | | | | | | | | Trans-vaginalg: | | | | | | | | | | Trans-urethral | | | | | | | | | | Trans-esoph. (non-Card.) | | | | | | | | | | Musculo-skel. (Convent.)d: | P1 | P1 | P1 | | P1 | P1 | P1 | | | Musculo-skel. (Superfic)d: | P1 | P1 | P1 | | P1 | P1 | P1 | | | Intra-luminal | | | | | | | | | | Other (Specify) | | | | | | | | | | Cardiac Adult | | | | | | | | | Cardiac | Cardiac Pediatric | | | | | | | | | | Trans-esoph. (Cardiac) | | | | | | | | | | Other (Specify) | | | | | | | | | | | | | | | | | | | Peripheral Vessel | Peripheral vesseld: | P1 | P1 | P1 | | P1 | P1 | P1 | | | Other (Specify) | | | | | | | | N= new indication; P= previously cleared by FDA; E= added under Appendix E a Includes Color Doppler (CD), Directional Power Doppler (DPD), and (non-directional) Power Doppler. b B+M; B+PWD; B+CD; B+DPD; B+PD. º Harmonic Imaging (HI) d Includes ultrasound guidance for placement of needles, catheters. e Abdominal, thoracic and peripheral vessel. Includes ultrasound guidance for placement of needles, catheters, cryosurgery, and brachytherapy 9 Includes ultrasound guidance of transvaginal biopsy, infertility monitoring of follicle development. b Includes guidance of amniocentesis, infertility monitoring of follicle development. Additional Comments: P1: uses previously cleared under K140773 Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use _ (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) (Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k)_ Page 7 of 13 {9}------------------------------------------------ #### 510(k) Number (if known): #### Device Name: Terason uSmart3300 - 4V2A Transducer Indications For Use: Diagnostic ultrasound imaging system or fluid flow analysis of the human body as follows: | Clinical Application | | Mode of Operation | | | | | | | |-----------------------------|--------------------------------------------------|-------------------|----|-----|-----|-----------------|-----------------|--------| | General (Track I Only) | Specific (Tracks I & III) | B | M | PWD | CWD | Color Doppaa | Comb. Modesb | Otherc | | Ophthalmic | Ophthalmic | | | | | | | | | | Fetalh | P1 | P1 | P1 | | P1 | P1 | P1 | | | Abdominald: | P1 | P1 | P1 | | P1 | P1 | P1 | | | Intra-operative (Spec.)d,e | | | | | | | | | | Intra-operative (Neuro) | | | | | | | | | | Laparoscopic | | | | | | | | | Fetal Imaging & Other | Pediatricd: | P1 | P1 | P1 | | P1 | P1 | P1 | | | Small Organ (Thyroid, Breast, Testes, etc.)d: | | | | | | | | | | Neonatal Cephalicd: | P1 | P1 | P1 | | P1 | P1 | P1 | | | Adult Cephalicd: | P1 | P1 | P1 | | P1 | P1 | P1 | | | Trans-rectalf: | | | | | | | | | | Trans-vaginalg: | | | | | | | | | | Trans-urethral | | | | | | | | | | Trans-esoph. (non-Card.) | | | | | | | | | | Musculo-skel. (Convent.)d: | | | | | | | | | | Musculo-skel. (Superfic)d: | | | | | | | | | | Intra-luminal | | | | | | | | | | Other (Specify) | | | | | | | | | Cardiac | Cardiac Adult | P1 | P1 | P1 | P1 | P1 | P1 | P1 | | | Cardiac Pediatric | P1 | P1 | P1 | | P1 | P1 | P1 | | | Trans-esoph. (Cardiac) | | | | | | | | | | Other (Specify) | | | | | | | | | Peripheral Vessel | Peripheral vesseld: | | | | | | | | | | Other (Specify) | | | | | | | | N= new indication; P= previously cleared by FDA; E= added under Appendix E a Includes Color Doppler (CD), Directional Power Doppler (DPD), and (non-directional) Power Doppler. b B+M; B+PWD; B+CD; B+DPD; B+PD. º Harmonic Imaging (HI) d Includes ultrasound guidance for placement of needles, catheters. e Abdominal, thoracic and peripheral vessel. Includes ultrasound guidance for placement of needles, catheters, cryosurgery, and brachytherapy 9 Includes ultrasound guidance of transvaginal biopsy, infertility monitoring of follicle development. b Includes guidance of amniocentesis, infertility monitoring of follicle development. Additional Comments: P1: uses previously cleared under K112953 Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use _ (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) (Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k)_ Page 8 of 13 {10}------------------------------------------------ #### 510(k) Number (if known): #### Device Name: Terason uSmart3300 - 5C2A Transducer Indications For Use: Diagnostic ultrasound imaging system or fluid flow analysis of the human body as follows: | Clinical Application | | | Mode of Operation | | | | | | | |-----------------------------|--------------------------------------------------|----|-------------------|-----|-----|-----------------|-----------------|--------|--| | General (Track I Only) | Specific (Tracks I & III) | B | M | PWD | CWD | Color Doppaa | Comb. Modesb | Otherc | | | Ophthalmic | Ophthalmic | | | | | | | | | | | Fetalh | P1 | P1 | P1 | | P1 | P1 | P1 | | | | Abdominald: | P1 | P1 | P1 | | P1 | P1 | P1 | | | | Intra-operative (Spec.)d,e | | | | | | | | | | | Intra-operative (Neuro) | | | | | | | | | | | Laparoscopic | | | | | | | | | | Fetal Imaging & Other | Pediatricd: | P1 | P1 | P1 | | P1 | P1 | P1 | | | | Small Organ (Thyroid, Breast, Testes, etc.)d: | | | | | | | | | | | Neonatal Cephalicd: | | | | | | | | | | | Adult Cephalicd: | | | | | | | | | | | Trans-rectalf: | | | | | | | | | | | Trans-vaginalg: | | | | | | | | | | | Trans-urethral | | | | | | | | | | | Trans-esoph. (non-Card.) | | | | | | | | | | | Musculo-skel. (Convent.)d: | | | | | | | | | | | Musculo-skel. (Superfic)d: | | | | | | | | | | | Intra-luminal | | | | | | | | | | | Other (Specify) | | | | | | | | | | | Cardiac Adult | | | | | | | | | | Cardiac | Cardiac Pediatric | | | | | | | | | | | Trans-esoph. (Cardiac) | | | | | | | | | | | Other (Specify) | | | | | | | | | | Peripheral Vessel | Peripheral vesseld: | P1 | P1 | P1 | | P1 | P1 | P1 | | | | Other (Specify) | | | | | | | | | N= new indication; P= previously cleared by FDA; E= added under Appendix E a Includes Color Doppler (CD), Directional Power Doppler (DPD), and (non-directional) Power Doppler. b B+M; B+PWD; B+CD; B+DPD; B+PD. º Harmonic Imaging (HI) d Includes ultrasound guidance for placement of needles, catheters. e Abdominal, thoracic and peripheral vessel. Includes ultrasound guidance for placement of needles, catheters, cryosurgery, and brachytherapy 9 Includes ultrasound guidance of transvaginal biopsy, infertility monitoring of follicle development. b Includes guidance of amniocentesis, infertility monitoring of follicle development. Additional Comments: P1: uses previously cleared under K112953 Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use _ (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) (Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k)_ Page 9 of 13 {11}------------------------------------------------ #### 510(k) Number (if known): #### Device Name: Terason uSmart3300 – 8EC4A Transducer Indications For Use: Diagnostic ultrasound imaging system or fluid flow analysis of the human body as follows: | Clinical Application | | Mode of Operation | | | | | | | |-----------------------------|--------------------------------------------------|-------------------|----|-----|-----|-----------------|-----------------|--------| | General (Track I Only) | Specific (Tracks I & III) | B | M | PWD | CWD | Color Doppaa | Comb. Modesb | Otherc | | Ophthalmic | Ophthalmic | | | | | | | | | Fetal Imaging & Other | Fetalh | P1 | P1 | P1 | | P1 | P1 | P1 | | | Abdominald: | | | | | | | | | | Intra-operative (Spec.)d,e | | | | | | | | | | Intra-operative (Neuro) | | | | | | | | | | Laparoscopic | | | | | | | | | | Pediatricd: | | | | | | | | | | Small Organ (Thyroid, Breast, Testes, etc.)d: | | | | | | | | | | Neonatal Cephalicd: | | | | | | | | | | Adult Cephalicd: | | | | | | | | | | Trans-rectalf: | P1 | P1 | P1 | | P1 | P1 | P1 | | | Trans-vaginalg: | P1 | P1 | P1 | | P1 | P1 | P1 | | | Trans-urethral | | | | | | | | | | Trans-esoph. (non-Card.) | | | | | | | | | | Musculo-skel. (Convent.)d: | | | | | | | | | | Musculo-skel. (Superfic)d: | | | | | | | | | | Intra-luminal | | | | | | | | | | Other (Specify) | | | | | | | | | Cardiac | Cardiac Adult | | | | | | | | | | Cardiac Pediatric | | | | | | | | | | Trans-esoph. (Cardiac) | | | | | | | | | | Other (Specify) | | | | | | | | | Peripheral Vessel | Peripheral vesseld: | | | | | | | | | | Other (Specify) | | | | | | | | N= new indication; P= previously cleared by FDA; E= added under Appendix E a Includes Color Doppler (CD), Directional Power Doppler (DPD), and (non-directional) Power Doppler. b B+M; B+PWD; B+CD; B+DPD; B+PD. º Harmonic Imaging (HI) d Includes ultrasound guidance for placement of needles, catheters. e Abdominal, thoracic and peripheral vessel. Includes ultrasound guidance for placement of needles, catheters, cryosurgery, and brachytherapy 9 Includes ultrasound guidance of transvaginal biopsy, infertility monitoring of follicle development. b Includes guidance of amniocentesis, infertility monitoring of follicle development. Additional Comments: P1: uses previously cleared under K112953 Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use _ (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) (Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k)_ Page 10 of 13 {12}------------------------------------------------ #### 510(k) Number (if known): #### Device Name: Terason uSmart3300 -8L2 Transducer Indications For Use: Diagnostic ultrasound imaging system or fluid flow analysis of the human body as follows: | Clinical Application | | Mode of Operation | | | | | | | |-----------------------------|--------------------------------------------------|-------------------|----|-----|-----|-----------------|-----------------|--------| | General (Track I Only) | Specific (Tracks I & III) | B | M | PWD | CWD | Color Doppaa | Comb. Modesb | Otherc | | Ophthalmic | Ophthalmic | | | | | | | | | | Fetalh | | | | | | | | | | Abdominald: | P1 | P1 | P1 | | P1 | P1 | P1 | | | Intra-operative (Spec.)d,e | | | | | | | | | | Intra-operative (Neuro) | | | | | | | | | | Laparoscopic | | | | | | | | | Fetal Imaging & Other | Pediatricd: | P1 | P1 | P1 | | P1 | P1 | P1 | | | Small Organ (Thyroid, Breast, Testes, etc.)d: | | | | | | | | | | Neonatal Cephalicd: | | | | | | | | | | Adult Cephalicd: | | | | | | | | | | Trans-rectalf: | | | | | | | | | | Trans-vaginalg: | | | | | | | | | | Trans-urethral | | | | | | | | | | Trans-esoph. (non-Card.) | | | | | | | | | | Musculo-skel. (Convent.)d: | P1 | P1 | P1 | | P1 | P1 | P1 | | | Musculo-skel. (Superfic) d: | P1 | P1 | P1 | | P1 | P1 | P1 | | | Intra-luminal | | | | | | | | | | Other (Specify) | | | | | | | | | | Cardiac Adult | | | | | | | | | Cardiac | Cardiac Pediatric | | | | | | | | | | Trans-esoph. (Cardiac) | | | | | | | | | | Other (Specify) | | | | | | | | | Peripheral Vessel | Peripheral vesseld: | P1 | P1 | P1 | | P1 | P1 | P1 | | | Other (Specify) | | | | | | | | N= new indication; P= previously cleared by FDA; E= added under Appendix E a Includes Color Doppler (CD), Directional Power Doppler (DPD), and (non-directional) Power Doppler. b B+M; B+PWD; B+CD; B+DPD; B+PD. º Harmonic Imaging (HI) d Includes ultrasound guidance for placement of needles, catheters. e Abdominal, thoracic and peripheral vessel. Includes ultrasound guidance for placement of needles, catheters, cryosurgery, and brachytherapy 9 Includes ultrasound guidance of transvaginal biopsy, infertility monitoring of follicle development. b Includes guidance of amniocentesis, infertility monitoring of follicle development. Additional Comments: P1: uses previously cleared under K140773 Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use _ (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) (Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k)_ Page 11 of 13 {13}------------------------------------------------ #### 510(k) Number (if known): #### Device Name: Terason uSmart3300 -8V3A Transducer Indications For Use: Diagnostic ultrasound imaging system or fluid flow analysis of the human body as follows: | Clinical Application | | Mode of Operation | | | | | | Otherc | |-----------------------------|--------------------------------------------------|-------------------|----|-----|-----|-----------------|-----------------|--------| | General (Track I Only) | Specific (Tracks I & III) | B | M | PWD | CWD | Color Doppaa | Comb. Modesb | | | Ophthalmic | Ophthalmic | | | | | | | | | Fetal Imaging & Other | Fetalh | P1 | P1 | P1 | | P1 | P1 | P1 | | | Abdominald: | P1 | P1 | P1 | | P1 | P1 | P1 | | | Intra-operative (Spec.)d,e | | | | | | | | | | Intra-operative (Neuro) | | | | | | | | | | Laparoscopic | | | | | | | | | | Pediatricd: | P1 | P1 | P1 | | P1 | P1 | P1 | | | Small Organ (Thyroid, Breast, Testes, etc.)d: | | | | | | | | | | Neonatal Cephalicd: | P1 | P1 | P1 | | P1 | P1 | P1 | | | Adult Cephalicd: | P1 | P1 | P1 | | P1 | P1 | P1 | | | Trans-rectalf: | | | | | | | | | | Trans-vaginalg: | | | | | | | | | | Trans-urethral | | | | | | | | | | Trans-esoph. (non-Card.) | | | | | | | | | | Musculo-skel. (Convent.)d: | | | | | | | | | | Musculo-skel. (Superfic)d: | | | | | | | | | | Intra-luminal | | | | | | | | | | Other (Specify) | | | | | | | | | Cardiac | Cardiac Adult | P1 | P1 | P1 | P1 | P1 | P1 | P1 | | | Cardiac Pediatric | P1 | P1 | P1 | P1 | P1 | P1 | P1 | | | Trans-esoph. (Cardiac) | | | | | | | | | | Other (Specify) | | | | | | | | | Peripheral Vessel | Peripheral vesseld: | | | | | | | | | | Other (Specify) | | | | | | | | N= new indication; P= previously cleared by FDA; E= added under Appendix E a Includes Color Doppler (CD), Directional Power Doppler (DPD), and (non-directional) Power Doppler. b B+M; B+PWD; B+CD; B+DPD; B+PD. º Harmonic Imaging (HI) d Includes ultrasound guidance for placement of needles, catheters. e Abdominal, thoracic and peripheral vessel. Includes ultrasound guidance for placement of needles, catheters, cryosurgery, and brachytherapy 9 Includes ultrasound guidance of transvaginal biopsy, infertility monitoring of follicle development. b Includes guidance of amniocentesis, infertility monitoring of follicle development. Additional Comments: P1: uses previously cleared under K140773 Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use _ (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) (Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k)_ Page 12 of 13 {14}------------------------------------------------ #### 510(k) Number (if known): #### Device Name: Terason uSmart3300-16HL7 Transducer Indications For Use: Diagnostic ultrasound imaging system or fluid flow analysis of the human body as follows: | Clinical Application | | Mode of Operation | | | | | | | |-----------------------------|--------------------------------------------------|-------------------|----|-----|-----|----------------|----------------|-------| | General (Track I Only) | Specific (Tracks I & III) | B | M | PWD | CWD | Color Doppa | Comb. Modes | Other | | Ophthalmic | Ophthalmic | | | | | | | | | | Fetalh | | | | | | | | | | Abdominald: | | | | | | | | | | Intra-operative (Spec.)d,e | P1 | P1 | P1 | | P1 | P1 | P1 | | | Intra-operative (Neuro) | | | | | | | | | | Laparoscopic | | | | | | | | | Fetal Imaging & Other | Pediatricd: | | | | | | | | | | Small Organ (Thyroid, Breast, Testes, etc.)d: | P1 | P1 | P1 | | P1 | P1 | P1 | | | Neonatal Cephalicd: | | | | | | | | | | Adult Cephalicd: | | | | | | | | | | Trans-rectalf: | | | | | | | | | | Trans-vaginalg: | | | | | | | | | | Trans-urethral | | | | | | | | | | Trans-esoph. (non-Card.) | | | | | | | | | | Musculo-skel. (Convent.)d: | P1 | P1 | P1 | | P1 | P1 | P1 | | | Musculo-skel. (Superfic)d: | P1 | P1 | P1 | | P1 | P1 | P1 | | | Intra-luminal | | | | | | | | | | Other (Specify) | | | | | | | | | | Cardiac Adult | | | | | | | | | Cardiac | Cardiac Pediatric | | | | | | | | | | Trans-esoph. (Cardiac) | | | | | | | | | | Other (Specify) | | | | | | | | | Peripheral Vessel | Peripheral vesseld: | P1 | P1 | P1 | | P1 | P1 | P1 | | | Other (Specify) | | | | | | | | N= new indication; P= previously cleared by FDA; E= added under Appendix E a Includes Color Doppler (CD), Directional Power Doppler (DPD), and (non-directional) Power Doppler. b B+M; B+PWD; B+CD; B+DPD; B+PD. º Harmonic Imaging (HI) d Includes ultrasound guidance for placement of needles, catheters. e Abdominal, thoracic and peripheral vessel. Includes ultrasound guidance for placement of needles, catheters, cryosurgery, and brachytherapy 9 Includes ultrasound guidance of transvaginal biopsy, infertility monitoring of follicle development. b Includes guidance of amniocentesis, infertility monitoring of follicle development. Additional Comments: P1: uses previously cleared under K110020 Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use _ (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) (Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k)_ Page 13 of 13 {15}------------------------------------------------ ### 510(k) Summary ### Teratech Corporation ## Terason™ uSmart3300 Ultrasound System ### 1. Sponsor: Teratech Corporation 77-79 Terrace Hall Ave. Burlington, MA 01803 Contact Person: Ben Chiampa, Quality Assurance and Regulatory Affairs Telephone: 781-270-4143 Date Prepared: January 20, 2015 ### 2. Device Name Terason™ uSmart3300 Ultrasound System Proprietary Name: Common / Usual Name: Diagnostic Ultrasound System Classification Name: Diagnostic Ultrasound Transducer Ultrasonic Pulsed Doppler Imaging System (21 CFR 892.1550, 90-IYN) Ultrasonic Pulsed Echo Imaging System (21 CFR 892.1560, 90-IYO) Diagnostic Ultrasonic Transducer (21 CFR 892.1570, 90-ITX) ### 3. Predicate Devices Terason uSmart3300 Ultrasound System (K140773, K071134), Terason t3000 8MC3 transducer (K112953), Philips iE33 S7-3t TE transducer (K132304, K070792), Aloka ProSound-C3 UST-T109 PDOF transducer (K110482) and Sonosite Edge L25x transducer (K082098). ### 4. Device Description This system contains a proprietary ultrasound engine for controlling the acoustic output of the transducer and processing the return echoes in real time. These {16}------------------------------------------------ data are then transferred to the host single-board computer over a FireWire (aka IEEE 1394) connection for further processing and generation and display of the ultrasound image. The Terason™ uSmart3300 ultrasound weighs approximately 14.6 pounds and has a 15.6" backlit screen. The system dimensions (10"(H) x 14.5"(W) x 2.5"(D)) are chosen to allow the system to be hand carried. A Lithium-Polymer battery (integrated into the unit) provides 2 hours of continuous ultrasound scanning. The system includes a medical-grade power supply (for battery charging). The ultrasound transducer connector is identical to that used in the Terason™ uSmart3300 predicate device. Optional accessories include a cart and printer. # 5. Intended Use The Teratech Corporation Terason™ uSmart3300 is a general purpose Ultrasound System intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include: Ophthalmic, Fetal, Abdominal, Intraoperative (Spec. and Neuro.), Pediatrics, Small Organ (Thyroid, Breast, Testes); Neonatal and Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-esoph. (noncardiac), Musculo-skeletal (Conventional and Superficial); Cardiac (Adult & Pediatric); Trans-esoph. (cardiac) Peripheral Vascular. # 6. Technology Characteristics The design and construction of the Terason™ uSmart3300 ultrasound system is identical to the Terason™ uSmart3300 predicate system. This system utilizes a single-board computer running Windows 7 to execute the ultrasound application and a custom designed engine for control of the acoustic array and processing of the return echoes. For the uSmart3300, the engine is housed in a compartment that is attached to the base of the chassis. The similarities and differences between the Terason™ uSmart3300 (current filing) and the predicate Terason uSmart3300 Ultrasound System (K140773) include the following: - . The engines are the identical with no modifications. As in the predicate device, the custom beamformer chip provides the processing of the return ultrasound echoes to support wide bandwidth signals and provide enhanced resolution across the entire image field. {17}------------------------------------------------ - The ultrasound application software has been modified to support 3 new transducers (9MC3, 8TE3, PDOF) and the new Ophthalmic indication for use (with the 15L4 and 12L5A transducers). The predicate devices that provide identical Ophthalmic indications for use are: K071134 (system) and K082098 (transducer). Transducers: The Terason uSmart3300 will support 3 new transducers and the new Ophthalmic indication for use (IFU). (The Terason uSmart3300 has been previously cleared with eight transducers in K140773). The new transducers and associated predicate devices include: - . 9MC3: Predicate device 8MC3 cleared in 510k submission K112953 - . 8TE3: Predicate device Philips(Oldelft) S7-3t previously cleared in 510k submissions K132304 and K070792 - PDOF: Predicate device Aloka ProSound-C3 UST-T109 previously clear in 510k submission K110482 - . 15L4: Ophthalmic IFU predicate device Sonosite Edge L25x previously cleared in 510k submission K082098 - 12L5A: Ophthalmic IFU predicate device Sonosite Edge L25x previously cleared in 510k submission K082098. The following provides additional details of the 5 transducers presented in this submission. - . 9MC3: Identical indications for use to the predicate transducer 8MC3. Different frequency range but the shape of the transducer is identical when compared to the predicate. Same manufacturer, same acoustic array and patient contact materials as the predicate 8MC3 transdu…