(122 days)
No
The document describes standard ultrasound technology and improved needle guidance using Hall Effect sensors and software for graphic overlay, with no mention of AI or ML.
No.
The device is described as 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." Its purpose is diagnostic imaging and analysis, not direct treatment or therapy.
Yes
The device is described as an "Ultrasound System intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body." Evaluation by imaging or analysis to assess the human body is a diagnostic function.
No
The device description explicitly states it includes hardware components such as transducers, a laptop computer, a custom-designed engine, and Hall Effect sensors integrated into a transducer. It is an ultrasound system, which is inherently a hardware-based medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the living body.
- Device Function: The description clearly states that the Terason t3000 is an Ultrasound System. Ultrasound imaging is a non-invasive technique that uses sound waves to create images of internal body structures. It is performed on the living body.
- Intended Use: The intended use describes the evaluation of the human body through ultrasound imaging and fluid flow analysis. This is a diagnostic imaging modality, not an in vitro test.
- Device Description: The description details transducers, acoustic arrays, and processing of return echoes, all components of an ultrasound system. It also mentions needle guidance technology, which is used during procedures performed on the body.
The device's function and intended use are entirely focused on imaging and analysis performed directly on the patient, which is characteristic of an in vivo diagnostic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Teratech Corporation Terason t3000™ 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: Fetal, Abdominal, Intra-operative (abdominal, thoracic and PV); Pediatrics, Small Organ (Breast, testes, thyroid); Neonatal and Adult Cephalic; Trans-rectal and Trans-vaginal; Musculo-skeletal (Conventional and Superficial); Cardiac (Adult & Pediatric); Peripheral Vascular.
The subject-modified device is a general purpose Ultrasound System intended for use by a qualified physician for the evaluation by ultrasound imaging or fluid-flow analysis of the human body. Specific clinical applications and exam types include: Fetal, Abdominal, Intra-Operative (spec. and Neuro), Laparoscopic, Pediatric, Small Organ (breast, testes, thyroid), Neonatal and Adult Cephalic, Trans-rectal, Trans-vaginal, Musculo-sketetal (Conventional and Superficial), Cardiac (adult and pediatric), and Peripheral Vascular.
Product codes
IYN, IYO, ITX
Device Description
The Terason t3000 is a modified version of the Echo/t3000 Ultrasound System. The modifications include the addition of 6 new transducers (12L5A, 4V2A, 12HL7, 8EC4A, 8EC4V, and 10V5S) and improved needle guidance technology components developed by SOMA Access Systems LLC and integrated into the Terason 10V5S transducer.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Fetal, Abdominal, Intra-operative (abdominal, thoracic and PV), Pediatric, Small Organ (Breast, testes, thyroid), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Musculo-skeletal (Conventional and Superficial), Cardiac (Adult & Pediatric), Peripheral Vascular, Intra-Operative (spec. and Neuro), Laparoscopic
Indicated Patient Age Range
Neonatal, Pediatric, Adult
Intended User / Care Setting
Qualified physician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Terason t3000 system has been tested for compliance to the following standards (with the corresponding report referenced for each standard).
- IEC 60601-1 Medical Electrical Equipment Part 1: General Requirements for Safety.
- o Intertek Test Record Number 3157933BOX-001A
- IEC 60601-1-1, Medical Electrical Equipment Part 1: General Requirements for Safety Collateral Standard: Safety Requirements for Medical Electrical Systems.
- o Intertek Project: 9157933BOX-001B
- IEC60601-1-4 (2000), Collateral Standard: Safety Requirements for Medical Electrical Systems
- o Intertek Project: 9157933BOX-001C
- IEC 60601-2-37 / EN60601-2-37 Medical Electrical Equipment Part 2: Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment.
- Transducer Model 12L5A: Intertek Report Number o 9157933BOX-001E
- o Transducer Model 12HL7: Intertek Report Number 9157933BOX-001F
- o Transducer Model 4V2A: Intertek Report Number 9157933BOX-001N
- o Transducer Model 8EC4A: Intertek Report Number 9157933BOX-001L
- o Transducer Model 8EC4V: Intertek Report Number 3157933BOX-001K
- Transducer Model 10V5S: Intertek Report Number 9157933BOX-001S
- NEMA UD 3 Acoustic Output Display . Terason t3000/Echo Ultrasound System User Guide (16-3031-15)
- . Biocompatibility Tests, ISO 10993 Part 5 and Part 10
- o Biocompatibility reports for the six new transducers included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K992505, K012191, K010883, K030191, K040840, K043278, K051334, K080234
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
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.(b)
Classification. Class II.
0
510(k) Summary
FEB - 3 2012
Teratech Corporation
Terason t3000™ Ultrasound System
1. Sponsor:
Teratech Corporation 77-79 Terrace Hall Ave. Burlington, MA 01803
Contact Person: Ben Chiampa Director of Quality Assurance Telephone: 781-270-4143
Date Prepared: August 15, 2011
Date Modified February 1, 2012
2. Device Name
Proprietary Name: Terason t3000 Ultrasound System Common / Usual Name: Diagnostic Ultrasound System Classification Name: Diagnostic Ultrasound Transducer
(21 CFR 892.1570, 90-ITX) Ultrasonic Pulsed Echo Imaging System (21 CFR 892.1560, 90-IYO) Diagnostic Ultrasonic Transducer (21 CFR 892.1570, 90-ITX)
3. Predicate Device
Terason™ Echo/t3000 Ultrasound System (K080234)
4. Intended Use
The Teratech Corporation Terason t3000™ 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: Fetal, Abdominal, Intra-operative (abdominal, thoracic and PV); Pediatrics, Small Organ (Breast, testes, thyroid); Neonatal and Adult
1
Cephalic; Trans-rectal and Trans-vaginal; Musculo-skeletal (Conventional and Superficial); Cardiac (Adult & Pediatric); Peripheral Vascular.
5. Device Description
The Terason t3000 is a modified version of the Echo/t3000 Ultrasound System. The modifications include the addition of 6 new transducers (12L5A, 4V2A, 12HL7, 8EC4A, 8EC4V, and 10V5S) and improved needle guidance technology components developed by SOMA Access Systems LLC and integrated into the Terason 10V5S transducer.
6. Technology Characteristics
The design and construction of the Terason t3000 is similar to the Terason™ Echo/t3000 Ultrasound system. These systems utilize a laptop computer running Windows to run the ultrasound application and a custom designed engine for control of the acoustic array and processing of the return echoes. The engine is housed in a compartment that is attached to the bottom of the laptop.
The differences between the Terason t3000 and the Terason Echo/t3000 Ultrasound System (the predicate device) include the following:
- Six new transducers have been added to the system. The software has . been modified to control these transducers and ensure compliance to the standards controlling acoustic and thermal power.
- An improved needle guidance technology is provided with the 10V5S . transducer. An array of Hall Effect sensors with a data capture board is integrated into the body of the 10V5S transducer. The sensors track the position of the needle by sensing and determining the position of a magnet located on the needle. This information is transferred through the Terason engine to the application software that generates a graphic overlay upon the ultrasound image showing the position of the tip of the needle to the ultrasound acquired target. The needle tip is a virtual highlight, providing the user with a real time position update, making it easier to insert the needle in the intended target in the first attempt. This improvement is intended to result in significant reductions of multiple insertions, adjustments of needle position during insertions and resultant trauma. infections and ancillary complications from less adequate methods of needle guidance. The needle guidance software component that produces the graphic overlay of needle position is developed by Soma Access
2
Systems LLC of Greenville, S.C. and integrated into the Terason t3000 ultrasound software application.
B1. Non Clinical Tests
The Terason t3000 system has been tested for compliance to the following standards (with the corresponding report referenced for each standard).
- IEC 60601-1 Medical Electrical Equipment Part 1: General . Requirements for Safety.
- o Intertek Test Record Number 3157933BOX-001A
- IEC 60601-1-1, Medical Electrical Equipment Part 1: General . Requirements for Safety Collateral Standard: Safety Requirements for Medical Electrical Systems.
- o Intertek Project: 9157933BOX-001B
- IEC60601-1-4 (2000), Collateral Standard: Safety Requirements for . Medical Electrical Systems
- o Intertek Project: 9157933BOX-001C
- IEC 60601-2-37 / EN60601-2-37 Medical Electrical Equipment Part 2: . Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment.
- Transducer Model 12L5A: Intertek Report Number o 9157933BOX-001E
- o Transducer Model 12HL7: Intertek Report Number 9157933BOX-001F
- o Transducer Model 4V2A: Intertek Report Number 9157933BOX-001N
- o Transducer Model 8EC4A: Intertek Report Number 9157933BOX-001L
- o Transducer Model 8EC4V: Intertek Report Number 3157933BOX-001K
- Transducer Model 10V5S: Intertek Report Number 9157933BOX-001S
3
- NEMA UD 3 Acoustic Output Display . Terason t3000/Echo Ultrasound System User Guide (16-3031-15)
- . Biocompatibility Tests, ISO 10993 Part 5 and Part 10
- o Biocompatibility reports for the six new transducers included in this submission.
4
Image /page/4/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal is circular and contains the department's emblem in the center. The emblem consists of a stylized caduceus, a symbol of medicine, with a double helix representing DNA. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the emblem.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
TERATECH Corporation % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
FEB - 3 2012
Re: K112953
Trade/Device Name: Terason t3000 Ultrasound System with updated Needle Guidance Graphics Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: January 20, 2012 Received: January 23, 2012
Dear Mr. Job:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
This determination of substantial equivalence applies to the following transducers intended for use with the Terason t3000 Ultrasound System with updated Needle Guidance Graphics, as described in your premarket notification:
Transducer Model Number
| 4V2A | 8EC4A | 10V5S |
|---|---|---|
| 5C2A | 8EC4V | 12L5A |
| 7L3V | 8MC3 | 12HL7 |
| 8BP4 | 10V5 | 12L5V |
5
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.
If you have any questions regarding the content of this letter, please contact Camille Vidal at (301) 796-2645.
Sincerely Yours,
Mary Slater
Mary S. Pastel. Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure(s)
6
Indications for Use Form
510(k) Number (if known): K112953
Device Name: Terason t3000 Ultrasound System with updated Needle Guidance Graphics
Indications for Use:
The subject-modified device is a general purpose Ultrasound System intended for use by a qualified physician for the evaluation by ultrasound imaging or fluid-flow analysis of the human body. Specific clinical applications and exam types include: Fetal, Abdominal, Intra-Operative (spec. and Neuro), Laparoscopic, Pediatric, Small Organ (breast, testes, thyroid), Neonatal and Adult Cephalic, Trans-rectal, Trans-vaginal, Musculo-sketetal (Conventional and Superficial), Cardiac (adult and pediatric), and Peripheral Vascular.
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 OF NEEDED)
Concurrence of CDRH, Office on In Vitro Diagnostic Devices (OIVD)
Mary S. Pastel.
Division Sign Off Office of In Vitro Diagnostic Device Evaluation 510(k)
Page 1 of 1
7
Transducer: (see comments)
Intended Use: Diagnostic ultrasound imaging 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 | |||
| Doppa | Comb. | |||||||
| Modesb | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Imaging | ||||||||
| & Other | Fetaln | P1,4 | P2,4 | P2,4 | P2,4 | P2,4 | P2,4 | |
| Abdominald: | P1,4 | P2,4 | P2,4 | P7 | P2,4 | P2,4 | P2,4 | |
| Intra-operative (Spec.)d,e | P4,8 | P4,8 | P4,8 | P4,8 | P4,8 | P4,8 | ||
| Intra-operative (Neuro) | P5 | P5 | P5 | P5 | P5 | P5 | ||
| Laparoscopic | P6 | P6 | P6 | P6 | P6 | P6 | ||
| Pediatricd: | P1,4 | P2,4 | P2,4 | P7 | P2,4 | P2,4 | P2,4 | |
| Small Organ (Thyroid, | ||||||||
| Breast, Testes, etc.)d: | P2,4 | P2,4 | P2,4 | P2,4 | P2,4 | P2,4 | ||
| Neonatal Cephalicd: | P1,4 | P2,4 | P2,4 | P7 | P2,4 | P2,4 | P2,4 | |
| Adult Cephalicd: | P1,4 | P2,4 | P2,4 | P7 | P2,4 | P2,4 | P2,4 | |
| Trans-rectalf: | P2-4 | P3-4 | P3-4 | P3-4 | P3-4 | P3-4 | ||
| Trans-vaginalg: | P2-4 | P3-4 | P3-4 | P3-4 | P3-4 | P3-4 | ||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Convent.)d: | P2,4 | P2,4 | P2,4 | P2,4 | P2,4 | P2,4 | ||
| Musculo-skel. (Superfic)d: | P2,4 | P2,4 | P2,4 | P2,4 | P2,4 | P2,4 | ||
| Intra-luminal | ||||||||
| Other (Specify) | ||||||||
| Cardiac | Cardiac Adult | P1,8 | P2,8 | P2,8 | P7,8 | P2,8 | P2,8 | P2,8 |
| Cardiac Pediatric | P1,8 | P2,8 | P2,8 | P7,8 | P2,8 | P2,8 | P2,8 | |
| Trans-esoph. (Cardiac) | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vesseld: | P1,4 | P2,4 | P2,4 | P2,4 | P2,4 | P2,4 | |
| Other (Specify) |
N= new indication; P= previously cleared by FDA (incl. K080234); E= added under Appendix E
1 now multions of Child Directional Power Dopp. (DPD), and (non-directional) Power Dopp. (PD).
6 B+M; B+PWD; B+CD; B+DPD; B+PD
6 Harmonic Imaging (HI)
d Incl. ultrasound guidance for placement of needles, catheters
& Abdominal organs and peripheral vessel.
f Incl. ultrasound guidance for placement of needles, catheters, cryosurgery, and brachytherapy
9 Incl. ultrasound guidance of transvaginal biopsy, infertility monitoring of follicle development.
" Incl. guidance of amniocentesis, infertility monitoring of follicle development.
1 Incl. stress echo.
1 System uses previously cleared under K992505 with 3MHz Model L3 (Linear)
2 System uses previously cleared under K012191
3 System uses previously cleared under K010883
4 System uses previously cleared under K030191
5 System uses previously cleared under K040840
6 System uses previously cleared under K043278
7 System uses previously cleared under K051334
8 System uses previously cleared under K080234
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Concurrence
Mary Scott
Division Sign-Off
Division Sign Off Office of in Vitro Diagnostic Device ﺮﻛﺔ ﺍﻟﻤ
8
Terason t3000 Ultrasound System_______________________________________________________________________________________________________________________________________________ System:
Transducer: 4V2A
Intended Use: Diagnostic ultrasound imaging 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. | |||||||
| Modesb | Otherc | |||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetald | N | N | N | N | N | N | ||
| Abdominald: | N | N | N | N | N | N | ||
| 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: | ||||||||
| 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: | |||||||
| Other (Specify) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
N= new nalcation, r = previously cleared by Brit, = (DPD), and (non-directional) Power Dopp. (PD).
6 B+M; B+PWD; B+CD; B+DPD; B+PD
° Harmonic Imaging (HI)
4 Incl. ultrasound guidance for placement of needles, catheters
e Abdominal organs and peripheral vessel.
Aboutinal organs and peripherar rooss.
Incl. ultrasound guidance for placement of needles, catheters, cryosurgery, and brachytherapy
Incl. ultrasound guidance of transvaginal biopsy, infertility monitoring of follicle development.
10 Incl. guidance of amniocentesis, infertility monitoring of follicle development.
1 Incl. stress echo.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Mary S Patil
Office of In Vitro Diagnostic Device Evaluatic 510(k)
Page 1 of _
9
Transducer: ' 5C2A
Intended Use: Diagnostic ultrasound imaging 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. | |||||||
| Modesb | Otherc | |||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetaln | E | E | E | E | E | E | ||
| Abdominald: | E | E | E | E | E | E | ||
| Intra-operative (Spec.)d,e | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Fetal | ||||||||
| Imaging | ||||||||
| & Other | Pediatricc: | E | E | E | E | E | E | |
| 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 | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vesseld: | E | E | E | E | E | E | |
| Other (Specify) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
1 Includes Color Dopp. (CD), Directional Power Dopp. (DPD), and (non-directional) Power Dopp. (PD).
0 B+M; B+PWD; B+CD; B+DPD; B+PD
° Harmonic Imaging (HI)
9 Incl. ultrasound guidance for placement of needles, catheters
· ª Abdominal organs and peripheral vessel.
' Incl. ultrasound guidance for placement of needles, catheters, cryosurgery, and brachytherapy 9 Incl. ultrasound guidance of transvaginal biopsy, infertility monitoring of follicle development.
" Incl. guidance of amniocentesis, infertility monitoring of follicle development.
' Incl. stress echo. .
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Mary S. Poole
Division Sign-Off Office of In Vitro Diagnostic Device FV2 112
Evaluation) and Safety
510(k) K112953
10
7L3V Transducer:
Intended Use: Diagnostic ultrasound imaging 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. | ||||||||
| Modesb | Otherc | ||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetaln | |||||||||
| Abdominald: | E | E | E | E | E | E | |||
| Intra-operative (Spec.)d,e | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Fetal | |||||||||
| Imaging | |||||||||
| & Other | Pediatricd: | E | E | E | E | E | E | ||
| Small Organ (Thyroid, | |||||||||
| Breast, Testes, etc.)d: | E | E | E | E | E | E | |||
| Neonatal Cephalicd: | E | E | E | E | E | E | |||
| Adult Cephalicd: | E | E | E | E | E | E | |||
| Trans-rectalf: | |||||||||
| Trans-vaginalg: | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skel. (Convent.)d: | E | E | E | E | E | E | |||
| Musculo-skel. (Superfic)d: | E | E | E | E | E | E | |||
| Intra-luminal | |||||||||
| Other (Specify) | |||||||||
| Cardiac Adult | |||||||||
| Cardiac | Cardiac Pediatric | ||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Other (Specify) | |||||||||
| Peripheral | |||||||||
| Vessel | Peripheral vesseld: | E | E | E | E | E | E | ||
| Other (Specify) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
No new libration;
b +M; B+PWD; B+CD; B+DPD; B+PD
6 Harmonic Imaging (HI)
d Incl. ultrasound guidance for placement of needles, catheters
ª Abdominal organs and peripheral vessel.
" Incl. ultrasound guidance for placement of needles, catheters, cryosurgery, and brachytherapy
This. ultrasound guidance of transvaginal biopsy, infertility monitoring of follicle development.
" Incl. guidance of amniocentesis, infertility monitoring of follicle development.
| Incl. stress echo.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Mary S. Pastit
itro Diagnostic Device Fvaluatio
11
Transducer: 8BP4
Intended Use: Diagnostic ultrasound imaging 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. | |||||||
| Modesb | Otherc | |||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetaln | ||||||||
| 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: | E | E | E | E | E | E | ||
| Trans-vaginalg: | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Convent.)d: | ||||||||
| Musculo-skel. (Superfic)g: | ||||||||
| Intra-luminal | ||||||||
| Other (Specify) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | 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
4 Includes Color Dopp. (CD), Directional Power Dopp. (DPD), and (non-directional) Power Dopp. (PD).
b B+M; B+PWD; B+CD; B+DPD; B+PD
° Harmonic Imaging (HI)
d Incl. ultrasound guidance for placement of needles, catheters
° Abdominal organs and peripheral vessel.
1 Incl. ultrasound guidance for placement of needles, catheters, cryosurgery, and brachytherapy
9 Incl. ultrasound guidance of transvaginal biopsy, infertility monitoring of follicle development.
11 Incl. quidance of amniocentesis, infertility monitoring of follicle development.
' Incl. stress echo.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Mary S Pastil
Division Sign-Office of In Vitro Diagnostic Device Evaluation and
12
8EC4A Transducer:
Intended Use: Diagnostic ultrasound imaging 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. | |||||||
| Modesb | Otherc | |||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Imaging | ||||||||
| & Other | Fetaln | N | N | N | N | N | N | |
| Abdominald: | ||||||||
| Intra-operative (Spec.)d,e | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatricc: | ||||||||
| Small Organ (Thyroid, | ||||||||
| Breast, Testes, etc.)d: | ||||||||
| Neonatal Cephalicc: | ||||||||
| Adult Cephalicd: | ||||||||
| Trans-rectalf: | N | N | N | N | N | N | ||
| Trans-vaginalg: | N | N | N | N | N | N | ||
| 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
N - new maloution, i - providered Power Dopp. (DPD), and (non-directional) Power Dopp. (PD).
6 B+M; B+PWD; B+CD; B+DPD; B+PD
° Harmonic Imaging (HI)
9 Incl. ultrasound guidance for placement of needles, catheters
° Abdominal organs and peripheral vessel.
" Abdominal organs and penpherement of needles, catheters, cryosurgery, and brachytherapy
- ultrasound guidance of transvaginal biopsy, infertility monitoring of follicle development.
Incl. guidance of amniocentesis, infertility monitoring of follicle development.
' Incl. stress echo.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Mary S. Patil
Division Sign-Office of In Vitro Diagnostic Device Evaluati 510(k)
13
System: Terason t3000 Ultrasound System
Transducer: 8EC4V
Intended Use: Diagnostic ultrasound imaging 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. | ||||||||
| Modesb | Otherc | ||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Imaging | |||||||||
| & Other | Fetalh | N | N | N | N | N | N | ||
| Abdominald: | |||||||||
| Intra-operative (Spec.)d,a | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatricc: | |||||||||
| Small Organ (Thyroid, | |||||||||
| Breast, Testes, etc.)d: | |||||||||
| Neonatal Cephalicc: | |||||||||
| Adult Cephalicc: | |||||||||
| Trans-rectalf: | N | N | N | N | N | N | |||
| Trans-vaginalg: | N | N | N | N | N | N | |||
| 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: | ||||||||
| Other (Specify) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
යි Includes Color Dopp. (CD), Directional Power Dopp. (DPD), and (non-directional) Power Dopp. (PD).
b B+M; B+PWD; B+CD; B+DPD; B+PD
° Harmonic Imaging (HI)
d incl. ultrasound guidance for placement of needles, catheters
ీ Abdominal organs and peripheral vessel.
' Incl. ultrasound guidance for placement of needles, catheters, cryosurgery, and brachytherapy 9 Incl. ultrasound guidance of transvaginal biopsy, infertility monitoring of follicle development.
" Incl. guidance of amniocentesis, infertility monitoring of follicle development.
' Incl. stress echo.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Mary Patel
Division Sigh-Off Office of In Vitro Diagnostic Device Evaluation 510(k) of
Page 1
14
8MC3 Transducer:
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | Mode of Operation | B | M | PWD | CWD | Color
Doppa | Comb.
Modesb | Otherc |
|-----------------------------|--------------------------------------------------|-------------------|---|---|-----|-----|----------------|-----------------|--------|
| General
(Track I Only) | Specific
(Tracks I & III) | | | | | | | | |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetalh | E | E | E | | E | E | E | |
| Fetal
Imaging
& Other | Abdominald: | | | | | | | | |
| | Intra-operative (Spec.)d,e | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatricd: | E | E | E | | E | E | E | |
| | Small Organ (Thyroid,
Breast, Testes, etc.)d: | E | E | E | | E | E | E | |
| | Neonatal Cephalicd: | E | E | E | | E | E | E | |
| | Adult Cephalicd: | E | E | E | | E | E | E | |
| | 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 | E | E | E | | E | E | E | |
| | Cardiac Pediatric | E | E | E | | E | E | E | |
| | Trans-esoph. (Cardiac) | | | | | | | | |
| | Other (Specify) | | | | | | | | |
| Peripheral
Vessel | Peripheral vesseld: | E | E | E | | E | E | E | |
| | Other (Specify) | | | | | | | | |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Now Includes Color Dopp. (CD), Directional Power Dopp. (DPD), and (non-directional) Power Dopp. (PD).
0 B+M: B+PWD; B+CD; B+DPD; B+PD
° Harmonic Imaging (HI)
d Incl. ultrasound guidance for placement of needles, catheters
e Abdominal organs and peripheral vessel.
" Abouthinal organs and perfibrarrent of needles, catheters, cryosurgery, and brachytherapy
9 Incl. ultrasound guidance of transvaginal biopsy, infertility monitoring of follicle development.
10 Incl. guidance of amniocentesis, infertility monitoring of follicle development.
' Incl. stress echo.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Mary S. Postel
Division Sign-Off Office of In Vitro Diagnostic Device Evaluatic 510(k)
15
System: Terason t3000 Ultrasound System
Transducer: 10V5
Intended Use: Diagnostic ultrasound imaging 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. | |||||||
| Modesb | Otherc | |||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetaln | ||||||||
| Abdominald: | ||||||||
| Intra-operative (Spec.)d,e) | P | P | P | P | P | P | ||
| Intra-operative (Neuro) | P | P | P | P | P | P | ||
| Laparoscopic | ||||||||
| Fetal | ||||||||
| Imaging | ||||||||
| & Other | Pediatricc: | P | P | P | P | P | P | |
| Small Organ (Thyroid, | ||||||||
| Breast, Testes, etc.)d: | P | P | P | P | P | P | ||
| Neonatal Cephalicc: | P | P | P | P | P | P | ||
| Adult Cephalicc: | P | P | P | P | P | P | ||
| 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 | P | P | P | P | P | P | |
| Cardiac Pediatric | P | P | P | P | P | P | ||
| Trans-esoph. (Cardiac) | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vesseld: | |||||||
| Other (Specify) |
N= new indication: P= previously cleared by FDA (incl. K040840; E= added under Appendix E
3 Includes Color Dopp. (CD), Directional Power Dopp. (DPD), and (non-directional) Power Dopp. (PD).
b B+M; B+PWD; B+CD; B+DPD; B+PD
6 Harmonic Imaging (HI)
d Incl. ultrasound guidance for placement of needles, catheters
- Abdominal organs and peripheral vessel.
Incl. ultrasound guidance for placement of needles, catheters, cryosurgery, and brachytherapy
9 Incl. ultrasound guidance of transvaginal biopsy, infertility monitoring of follicle development.
11 Incl. guidance of amniocentesis, infertility monitoring of follicle development.
Incl. stress echo.
1 System uses previously cleared under K040840
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Mary S Pastil
isinn Sian fice of In Vitro Diagnostic Device Fraluation and
510(k) K112953
16
10V5S Transducer:
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Intended Use: Diagnostic ultrasound imaging of fluid flow analysis of the vascular system | ||||||||
|---|---|---|---|---|---|---|---|---|
| Clinical Application | Mode of Operation | |||||||
| General | ||||||||
| (Track I Only) | Specific | |||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | |||
| Doppa | Comb. | |||||||
| Modesb | Otherc | |||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Imaging | ||||||||
| & Other | Fetaln | |||||||
| Abdominald: | N | N | N | N | N | |||
| Intra-operative (Spec.)d,e,i | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatricd: | N | N | N | N | N | |||
| Small Organ (Thyroid, | ||||||||
| Breast, Testes, etc.)d: | N | N | N | N | N | |||
| Neonatal Cephalicd: | N | N | N | N | N | |||
| Adult Cephalicd: | N | N | N | N | N | |||
| Trans-rectalf: | ||||||||
| Trans-vaginalg: | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Convent.)d: | N | N | N | N | N | |||
| Musculo-skel. (Superfic)d: | N | N | N | N | N | |||
| Intra-luminal | ||||||||
| Other (Specify) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vesseld: | N | N | N | N | N | ||
| Other (Specify) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
1 Includes Color Dopp. (CD), Directional Power Dopp. (DPD), and (non-directional) Power Dopp. (PD).
b B+M; B+PWD; B+CD; B+DPD; B+PD
6 Harmonic Imaging (HI)
8 Incl. ultrasound guidance for placement of needles, catheters
e Abdominal organs and peripheral vessel.
' / nodominal organe and perpheral vost of needles, catheters, cryosurgery, and brachytherapy
9 Incl. ultrasound guidance of transvaginal biopsy, infertility monitoring of follicle development.
" Incl. guidance of amniocentesis, infertility monitoring of follicle development.
' Incl. stress echo.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Mary Scott
Division Sign-Off Office of In Vitro Diagnostic De Evaluatio
Evaluation and Safety
510(k) K112953
17
12L5A Transducer:
Intended Use: Diagnostic ultrasound imaging 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. | |||||||
| Modesb | Otherc | |||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetalh | ||||||||
| Abdominald: | N | N | N | N | N | N | ||
| 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: | N | N | N | N | N | N | ||
| Musculo-skel. (Superfic)d: | N | N | N | N | N | N | ||
| Intra-luminal | ||||||||
| Other (Specify) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esoph. (Cardiac) | ||||||||
| Other (Specify) | ||||||||
| Peripheral | Peripheral vesseld: | N | N | N | N | N | N | |
| Vessel | Other (Specify) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
4 Includes Color Dopp. (CD), Directional Power Dopp. (DPD), and (non-directional) Power Dopp. (PD).
0 B+M; B+PWD; B+CD; B+DPD; B+PD
6 Harmonic Imaging (HI)
d Incl. ultrasound guidance for placement of needles, catheters
e Abdominal organs and peripheral vessel.
' Incl. ultrasound guidance for placement of needles, catheters, cryosurgery, and brachytherapy
9 Inol. ultrasound guidance of transvaginal biopsy, infertility monitoring of follicle development.
" Incl. guidance of amniocentesis, infertility monitoring of follicle development.
' Incl. stress echo.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Mary S Patil
Division Sign-Off Office of In Vitro Diagnostic Device Evaluațic 510(k)
Page 1 of
18
Transducer: 12HL7
Intended Use: Diagnostic ultrasound imaging 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. | |||||||
| Modesb | Otherc | |||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Imaging | ||||||||
| & Other | Fetaln | |||||||
| Abdominald: | ||||||||
| Intra-operative (Spec.)d,e | N | N | N | N | N | N | ||
| Intra-operative (Neuro) | N | N | N | N | N | N | ||
| Laparoscopic | N | N | N | N | N | N | ||
| Pediatricd: | N | N | N | N | N | N | ||
| Small Organ (Thyroid, | ||||||||
| Breast, Testes, etc.)d: | N | N | N | N | N | N | ||
| Neonatal Cephalicd: | ||||||||
| Adult Cephalicd: | ||||||||
| Trans-rectalf: | ||||||||
| Trans-vaginalg: | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Convent.)d: | N | N | N | N | N | N | ||
| Musculo-skel. (Superfic)d: | N | N | N | N | N | N | ||
| Intra-luminal | ||||||||
| Other (Specify) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vesseld: | N | N | N | N | N | N | |
| Other (Specify) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
N = new manager, (CD), Directional Power Dopp. (DPD), and (non-directional) Power Dopp. (PD).
8 B+M; B+PWD; B+CD; B+DPD; B+PD
° Harmonic Imaging (HI)
9 Incl. ultrasound guidance for placement of needles, catheters
° Abdominal organs and peripheral vessel.
Aboominal organo and penphora 1800 of needles, catheters, cryosurgery, and brachytherapy
This. ultrasound guidance of transvaginal biopsy, infertility monitoring of follicle development.
" Incl. guidance of amniocentesis, infertility monitoring of follicle development.
Incl. stress echo.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Mary S Patil
Office of In Vitro Evaluation 510(K)
19
12L5V Transducer:
Intended Use: Diagnostic ultrasound imaging 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. | |||||||
| Modesb | Otherc | |||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Imaging | ||||||||
| & Other | Fetaln | |||||||
| Abdominald: | E | E | E | E | E | E | ||
| Intra-operative (Spec.)d,e | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatricc: | E | E | E | E | E | E | ||
| Small Organ (Thyroid, | ||||||||
| Breast, Testes, etc.)d: | E | E | E | E | E | E | ||
| Neonatal Cephalicc: | E | E | E | E | E | E | ||
| Adult Cephalicd: | E | E | E | E | E | E | ||
| Trans-rectalf: | ||||||||
| Trans-vaginalg: | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Convent.)d: | E | E | E | E | E | E | ||
| Musculo-skel. (Superfic)d: | E | E | E | E | E | E | ||
| Intra-luminal | ||||||||
| Other (Specify) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vesseld: | E | E | E | E | E | E | |
| Other (Specify) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
ª Includes Color Dopp. (CD), Directional Power Dopp. (DPD), and (non-directional) Power Dopp. (PD).
b +M: B+PWD; B+CD; B+DPD; B+PD
6 Harmonic Imaging (HI)
d Incl. ultrasound guidance for placement of needles, catheters
€ Abdominal organs and peripheral vessel.
' Incl. ultrasound guidance for placement of needles, catheters, cryosurgery, and brachytherapy
9 Incl. ultrasound guidance of transvaginal biopsy, infertility monitoring of follicle development.
11 Incl. guidance of amniocentesis, infertility monitoring of follicle development.
' Incl. stress echo
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Mary S. Pastet
Office of In Vitro Diagnostic Devi Evaluation 510(k