← Product Code [IYN](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYN) · K110482
# PROSOUND C3 / C3 CV ULTRASOUND SYSTEMS (K110482)
_Teratech Corp. · IYN · Mar 18, 2011 · Radiology · SESE_
**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYN/K110482
## Device Facts
- **Applicant:** Teratech Corp.
- **Product Code:** [IYN](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYN.md)
- **Decision Date:** Mar 18, 2011
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 892.1550
- **Device Class:** Class 2
- **Review Panel:** Radiology
- **Attributes:** Pediatric, 3rd-Party Reviewed
## Intended Use
The Aloka ProSound C3 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.
## Device Story
ProSound C3/C3cv is a modified diagnostic ultrasound system based on the Terason Echo/t3000. It utilizes a laptop running Windows with a custom engine attached to the base for acoustic array control and echo processing. Input consists of ultrasound signals from transducers; the system processes these to produce real-time images for clinical evaluation. Key features include OMNIBeam spatial compounding for improved resolution by combining frames captured at different angles. Used in clinical settings by physicians for imaging and fluid flow analysis. Output is displayed on the laptop screen to assist in diagnosis and clinical decision-making. Modifications from the predicate include foreign language support, updated transmit circuitry for acoustic profile optimization, and new labeling.
## Clinical Evidence
Bench testing only. Compliance with IEC 60601-1 (safety), IEC 60601-1-1 (systems safety), IEC 60601-1-4 (software safety), and IEC 60601-2-37 (ultrasonic diagnostic equipment safety) was verified. Biocompatibility testing performed per ISO 10993 Parts 5 and 10. Acoustic output display verified per NEMA UD 3.
## Technological Characteristics
Laptop-based system running Windows with a custom external engine for acoustic array control. Features OMNIBeam spatial compounding. Transducers are identical to predicate. Compliance with IEC 60601-1, IEC 60601-2-37, and ISO 10993. Connectivity via standard laptop interfaces.
## Regulatory 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™ Echo/t3000 Ultrasound System ([K080234](/device/K080234.md))
## Submission Summary (Full Text)
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#### 510(k) Summary
K110482
#### Teratech Corporation
## ProSound™ C3 Ultrasound System
MAR 1 8 2011
#### 1. Sponsor:
Teratech Corporation 77-79 Terrace Hall Ave. Burlington, MA 01803
Contact Person: Charles F. Hottinger, Ph.D. RAC, Regulatory Affairs Consultant Telephone: 206-780-7945
Date Prepared: October 9, 2010
#### 2. Device Name
Proprietary Name: Aloka ProSound C3 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 Aloka ProSound C3 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;
{1}------------------------------------------------
Trans-rectal and Trans-vaginal; Musculo-skeletal (Conventional and Superficial); Cardiac (Adult & Pediatric); Peripheral Vascular.
#### 5. Device Description
The ProSound C3 is a modified version of the Echo/t3000 Ultrasound System. The modifications include a change in the Product Label (of both the systems and the transducers), addition of Foreign language support (French, German, Italian, and Spanish), a slight modification of Transmit circuitry, providing a slightly different acoustic profile and the introduction of a spatial compounding feature called OMNIBeam .
### 6. Technology Characteristics
The design and construction of the ProSound C3 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 ProSound C3 and the Terason Echo/t3000 Ultrasound System (the predicate device) include the following:
- The engine has a slight modification to the Transmit Chip, providing . different acoustic prodiles. This has been optimized for the ProSound C3 and tested and verified according to the IEC 60601.2.37 standards.
- The ultrasound application software has been modified to support foreign . lanquages (French, German, Italian and Spanish). Translations were made for buttons, pulldown menus, text messages, etc. and integrated and tested with the application software.
- A new feature, equivalent to spatial compounding, was added to the . application software (since the last 510k submission on the predicate device). This feature, called OMNIBeam in the ProSound C3 is used for better resolution by shooting multiple frames at different angles and combining the image into one. This is offered on only the Linear and Curved transducers.
- The System has a different label (Aloka ProSound C3 label) and the . transducers have different names and labels than the predicate device. Other than the labels, the transducers are exactly the same as those used on the Terason Predicate Device.
{2}------------------------------------------------
#### B1. Non Clinical Tests
The ProSound C3 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 3157931BOX-001B
- . 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-002A
- IEC60601-1-4 (2000), Collateral Standard: Safety Requirements for ● Medical Electrical Systems
- Intertek Project: 9157933BOX-003A o
- IEC 60601-2-37 / EN60601-2-37 Medical Electrical Equipment Part 2: . Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment.
- o Transducer Model UST-TL01: Intertek Report Number 9157931BOX-001M
- Transducer Model UST-TL02: Intertek Report Number o 9157931BOX-001N
- Transducer Model UST-TC04: Intertek Report Number 0 9157931BOX-001Q
- Transducer Model UST-TC05: Intertek Report Number o 9157931BOX-001P
- Transducer Model UST-TC06: Intertek Report Number 0 9157931BOX-001J
- Transducer Model UST-TL07: Intertek Report Number o 9157931BOX-0010
- NEMA UD 3 Acoustic Output Display . ProSound C3/C3cv Ultrasound System User Guide (16-5001)
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- Biocompatibility Tests, ISO 10993 Part 5 and Part 10 .
.
- Biocompatibility reports for all transducers included in this o submission.
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### 510(k) Summarv
#### Teratech Corporation
#### ProSound™ C3cv Ultrasound Svstem
#### 1. Sponsor:
Teratech Corporation 77-79 Terrace Hall Ave. Burlington, MA 01803
Contact Person: Charles F. Hottinger, Ph.D. RAC. Regulatory Affairs Consultant Telephone: 206-780-7945
Date Prepared: October 9, 2010
#### 2. Device Name
Proprietary Name: Aloka ProSound C3cv 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 Aloka ProSound C3cv 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;
{5}------------------------------------------------
Trans-rectal and Trans-vaginal; Musculo-skeletal (Conventional and Superficial); Cardiac (Adult & Pediatric); Peripheral Vascular.
### 5. Device Description
The ProSound C3cv is a modified version of the Echo/t3000 Ultrasound System. The modifications include a change in the Product Label (of both the systems and the transducers), addition of Foreign language support (French, German, Italian, and Spanish) and the introduction of a spatial compounding feature called OmniBeam .
## 6. Technology Characteristics
The design and construction of the ProSound C3cv 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 ProSound C3cv and the Terason Echo/t3000 Ultrasound System (the predicate device) include the following:
- The ultrasound application software has been modified to support foreign . languages (French, German, Italian and Spanish). Translations were made for buttons, pulldown menus, text messages, etc. and integrated and tested with the application software.
- · A new feature, equivalent to spatial compounding, was added to the application software (since the last 510k submission on the predicate device). This feature, called OMNIBeam in the ProSound C3cv is used for , better resolution by shooting multiple frames at different angles and combining the image into one. This is offered on only the Linear and Curved transducers.
- . The System has a different label (Aloka ProSound C3cv label) and the transducers have different names and labels than the predicate device. Other than the labels, the transducers are exactly the same as those used on the Terason Predicate Device (Terason Echo/t3000).
{6}------------------------------------------------
#### B1. Non Clinical Tests
The ProSound C3cv 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 3157931BOX-005A
- 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-002B
- IEC60601-1-4 (2000), Collateral Standard: Safety Requirements for � Medical Electrical Systems
- o Intertek Project: 9157933BOX-003B
- 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 UST-TL01: Intertek Report Number 9157931BOX-005G
- Transducer Model UST-TL02: Intertek Report Number O 9157931BOX-005B
- Transducer Model UST-TS03: Intertek Report Number O 9157931BOX-005C
- Transducer Model UST-TC04: Intertek Report Number O 9157931BOX-005D
- Transducer Model UST-TC06: Intertek Report Number O 9157931BOX-005E
- Transducer Model UST-Ti09: Intertek Report Number ಂ 9157931BOX-005F
- . NEMA UD 3 Acoustic Output Display ProSound C3/C3cv Ultrasound System User Guide (16-5001)
{7}------------------------------------------------
- Biocompatibility Tests, ISO 10993 Part 5 and Part 10 .
- o Biocompatibility reports for all transducers included in this submission.
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Image /page/8/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a bird-like figure, possibly representing an eagle or other national symbol, with its wings spread.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Teratech Corporation % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services 1394 25th Street NW BUFFALO MN 55313
MAR 1 8 2511
Re: K110482
Trade/Device Name: Aloka Prosound C3 Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: March 7, 2011 Received: March 8, 2011
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 io!!owing transducers intended for use with the Aloka Prosound C3 Ultrasound System, as described in your premarket notification:
#### Transducer Model Number
| UST-TL01 | UST-TC05 |
|----------|----------|
| UST-TL02 | UST-TC06 |
| UST-TS03 | UST-TL07 |
| UST-TC04 | UST-TI09 |
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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/CDRH0ffices/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 Lauren Hefner at (301) 796-6881.
Sincerely Yours,
Mucy Slastil
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)
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## Indications for Use Form
510(k) Number (if known): ر Device Name: Aloka ProSound C3 Ultrasound System Indications for Use:
The subject-modified device 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/OB; Abdominal (GYN & Urology); Intra-operative (abdominal, thoracic and PV); Laparoscopic; Pediatric; Small Organ (breast, testes, thyroid), Neonatal and Adult Cephalic; Transrectal and Transvaginal; Musculo-skeletal (Conventional and Superficial); Cardiac (adult & pediatric); Peripheral Vascular.
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 OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Mary S Patil
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K110482
Page 1 of _
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## Indications for Use Form
510(k) Number (if known): Aloka ProSound C3cv Ultrasound System Device Name: Indications for Use:
The subject-modified device 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/OB; Andominal (GYN & Urology); Intra-operative (abdominal, thoracic and PV); Laparoscopic; Pedintria; Small Organ (breast, testes, thyroid), Neonatal and Adult Cephalic; Transrects | and Transvaginal; Musculo-skeletal (Conventional and Superficial); Cardiac (adult & pediatric); Peripheral Vascular.
Prescription Use: × 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 OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Mary S. Postel
Division Sign-Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K116482
Page 1 of __
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System: ProSound C3/C3cv Ultrasound Systems
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 | Fetald | P1,4 | P2,4 | P2,4 | P7 | 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.)g: | P2,4 | P2,4 | P2,4 | | P2,4 | P2,4 | P2,4 |
| | Musculo-skel. (Superfic)g: | 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 vesselg: | 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
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
° Harmonic Imaging (HI)
9 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, infortility monitoring of follicle development.
' Incl. stress echo.
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
* 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)
Mary S Postl
Division Sign-Off
Office of In Vitro Diagnostic Device
Evaluation and Safety
510(k) K110482
{13}------------------------------------------------
#### System: ProSound C3/C3cv Ultrasound System
Transducer: UST-TL01
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 | | | | | | | |
| | Fetalf | | | | | | | |
| | 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: | E | E | E | | E | E | E |
| | Neonatal Cephalicc: | E | E | E | | E | E | E |
| | Adult Cephalicc: | E | E | E | | E | E | E |
| | Trans-rectall: | | | | | | | |
| | Trans-vaginalg: | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skel. (Convent.)g: | E | E | E | | E | E | E |
| | Musculo-skel. (Superfic)g: | E | E | E | | E | E | E |
| | Intra-luminal | | | | | | | |
| | Other (Specify) | | | | | | | |
| | Cardiac Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Other (Specify) | | | | | | | |
| | | | | | | | | |
| Peripheral
Vessel | Peripheral vesselg: | E | E | E | | E | E | E |
| | Other (Specify) | | | | | | | |
N= new indication; P= previously cleared by FDA (incl. K080234; E= added under Appendix E
° Includes Color Dopp. (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.
1 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.
1 System uses previously cleared under K992505 with 3MHz. Model L3 (Linear)
్ System uses previously cleared under K012191
3 System uses previously cleared under K010883
* System uses previously cleared under K030191
్ System uses previously cleared under K040840
్ System uses previously cleared under K043278
' System uses previously cleared under K051334
8 System uses previously cleared under K080234
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 Postel
Division Sign-Up
Office of In Vitro Diagnostic Device
Evaluation and Safety
510(k) K11482
{14}------------------------------------------------
| System: | ProSound C3/C3cv Ultrasound System |
|---------|------------------------------------|
|---------|------------------------------------|
Transducer: UST-TL02
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | | Mode of Operation | | | | | | |
|-----------------------------|--------------------------------------------------|---|-------------------|-----|-----|----------------|-----------------|--------|--|
| General | Specific
(Tracks I & III) | B | M | PWD | CWD | Color
Doppa | Comb.
Modesb | Otherc | |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetalf | | | | | | | | |
| | Abdominalc: | E | E | E | | E | E | E | |
| | Intra-operative (Spec.)d,a | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| Fetal
Imaging
& Other | 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 Cephalicc: | E | E | E | | E | E | E | |
| | Trans-rectalf: | | | | | | | | |
| | Trans-vaginalg: | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | |
| | Musculo-skel. (Convent.)c: | E | E | E | | E | E | E | |
| | Musculo-skel. (Superfic)g: | E | E | E | | E | E | E | |
| | Intra-luminal | | | | | | | | |
| | Other (Specify) | | | | | | | | |
| | Cardiac Adult | | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | |
| | Other (Specify) | | | | | | | | |
| Peripheral
Vessel | Peripheral vessele: | E | E | E | | E | E | E | |
| | Other (Specify) | | | | | | | | |
N= new indication; P= previously cleared by FDA (incl. K080234; E= added under Appendix E
ී Includes Color Dopp. (CD), Directional Power Dopp. (DPD), and (non-directional) Power Dopp. (PD). 6 B+M; B+PWD; B+CD; B+OPD; B+PD
° Harmonic Imaging (Hi)
9 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.
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
* System uses previously cleared under K030191
System uses previously cleared under K040840
్ System uses previously cleared under K043278
System Less proviously cleared under K011334
* System uses previously cleared under K081004
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. Pastel
Division Sign-Up
Office of In Vitro Diagnostic Device
Evaluation and Safety
510(k)
10482
{15}------------------------------------------------
System: ProSound C3cv Ultrasound System_
Transducer: UST-TS03
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 |
| | Abdominalo: | E | E | E | | E | E | E |
| | Intra-operative (Spec.)d,e | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| Fetal
Imaging
& Other | Pediatrico: | E | E | E | | E | E | E |
| | Small Organ (Thyroid,
Breast, Testes, etc.)o: | E | E | E | | E | E | E |
| | Neonatal Cephalico: | E | E | E | | E | E | E |
| | Adult Cephalico: | E | E | E | | E | E | E |
| | Trans-rectalp: | | | | | | | |
| | Trans-vaginalp: | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skel. (Convent.)o: | | | | | | | |
| | Musculo-skel. (Superfic)o: | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (Specify) | | | | | | | |
| | Cardiac Adult | E | E | E | E | E | E | E |
| Cardiac | Cardiac Pediatric | E | E | E | | E | E | E |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral
Vessel | Peripheral vesselo: | | | | | | | |
| | Other (Specify) | | | | | | | |
N= new indication; P= previously cleared by FDA (incl. K080234; E= added under Appendix E
4 Includes Color Dopp. (CD), Directional Power Dopp. (DPD), and (non-directional) Power Dopp. (PD).
฿ B+M; B+PWD; B+CD; B+DPD; B+PD
° Harmonic Imaging (HI)
8 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.
1 System uses previously cleared under K992505 with 3MHz. Model L3 (Linear)
* System uses previously cleared under K012191
3 System uses previously cleared under K010883
* System uses previously cleared under K030191
System uses previously cleared under K040840
్ System uses previously cleared under K043278
7 System uses previously cleared under K051334
* 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)
Mary Stodd
Division Sign Off
Division Sign-Off/
Office of In Vitro Diagnostic Device
Evaluation, and Safety
Blacien
510(k) K110482
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
{16}------------------------------------------------
#### ProSound C3/C3cv Ultrasound System_ System:
Transducer: UST-TC04
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 | E | E | E | | E | E | E |
| | 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: | | | | | | | |
| | Neonatal Cephalicc: | | | | | | | |
| | Adult Cephalicd: | | | | | | | |
| | Trans-rectalf: | | | | | | | |
| | 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 vesselc: | E | E | E | | E | E | E |
| | Other (Specify) | | | | | | | |
N= new indication; P= previously cleared by FDA (incl. K080234; 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
° Harmonic Imaging (HI)
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.
System uses previously cleared under K992505 with 3MHz. Model L3 (Linear)
" System uses previously cleared under K052303
" System uses previously cleared under K012191
" System uses previously cleared under K012191
3 System uses previously cleared under K010883
* System uses previously cleared under K010000
* System uses previously cleared under K030191
్ System uses previously cleared under K040840
్ System uses previously cieared under K043278
' System uses previously cleared under K051334
® 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)
Mary S. Pitaf
Division Sign Off
fice of In Vitro Diagnostic Device
(k) K110 c/82
Page 1 of
{17}------------------------------------------------
System: ProSound C3 Ultrasound System_
Transducer: UST-TC05
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 |
| | Abdominalc: | | | | | | | |
| | 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: | E | E | E | | E | E | E |
| | Neonatal Cephalicc: | E | E | E | | E | E | E |
| | Adult Cephalicc: | 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 vessele: | E | E | E | | E | E | E |
| | Other (Specify) | | | | | | | |
N= new indication; P= previously cleared by FDA (incl. K080234; 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+OPD; B+PD
° Harmonic Imaging (HI)
9 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.
System uses previously cleared under K992505 with 3MHz. Model L3 (Linear)
* System uses previously cleared under K012191
3 System uses previously cleared under K010883
4 System uses previously cleared under K030191
్ System uses previously cleared under K040840
§ System uses previously cleared under K043278
T System uses previously cleared under K051334
" System uses proviously cleared under K081004
* 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)
Mary S Patil
Division Sign Off
510(k) K110482
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
{18}------------------------------------------------
#### System: ProSound C3/C3cv Ultrasound System____________________________________________________________________________________________________________________________________________
Transducer: UST-TC06
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 | E | E | E | | E | E | E |
| | Abdominald: | | | | | | | |
| | Intra-operative (Spec.)d,e | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatricd: | | | | | | | |
| | Small Organ (Thyroid,
Breast, Testes, etc.)d: | | | | | | | |
| | Neonatal Cephalico: | | | | | | | |
| | Adult Cephalica: | | | | | | | |
| | Trans-rectalf: | E | E | E | | E | E | E |
| | Trans-vaginalg: | E | E | E | | E | E | E |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skel. (Convent.)d: | | | | | | | |
| | Musculo-skel. (Superfic)e: | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (Specify) | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral
Vessel | Peripheral vesselc: | | | | | | | |
| | Other (Specify) | | | | | | | |
N= new indication; P= previously cleared by FDA (incl. K080234; E= added under Appendix E
් Includes Color Dopp. (CD), Directional Power Dopp. (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
· 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 follice development.
1 Incl. guidance of amniocentesis, infertility monitoring of follicle development.
Incl. stress echo.
System uses previously cleared under K992505 with 3MHz. Model L3 (Linear)
{ System uses previously cleared under K012191
3 System uses previously cleared under K010883
* System uses previously cleared under K030191
5 System uses previously cleared under K040840
6 System uses previously cieared under K043278
7 System uses previously cleared under K051334
® System uses previously cleared under K080234
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 Off
ice of In Vitro Diagnostic Device
510(k) K110482
Page 1 of _
{19}------------------------------------------------
System: ProSound C3 Ultrasound System_
Transducer: UST-TL07
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 | | | | | | | |
| | Fetalf | | | | | | | |
| | Abdominalc: | | | | | | | |
| | Intra-operative (Spec.)d,e | E | E | E | | E | E | E |
| | Intra-operative (Neuro) | E | E | E | | E | E | E |
| | Laparoscopic | E | E | E | | E | E | E |
| Fetal
Imaging
& Other | Pediatricc: | E | E | E | | E | E | E |
| | Small Organ (Thyroid,
Breast, Testes, etc.)d: | E | E | E | | E | E | E |
| | Neonatal Cephalicc: | | | | | | | |
| | Adult Cephalicc: | | | | | | | |
| | Trans-rectalf: | | | | | | | |
| | Trans-vaginalg: | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skel. (Convent.)c: | E | E | E | | E | E | E |
| | Musculo-skel. (Superfic)c: | E | E | E | | E | E | E |
| | Intra-luminal | | | | | | | |
| | Other (Specify) | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral
Vessel | Peripheral vesselc: | E | E | E | | E | E | E |
| | Other (Specify) | | | | | | | |
N= new indication; P= previously cleared by FDA (incl. K080234; E= added under Appendix E
ª Includes Color Dopp. (CD), Directional 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
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.
11 Incl. guidance of amniocentesis, infertility monitoring of follicle development.
'Incl. stress echo.
System uses previously cleared under K992505 with 3MHz. Model L3 (Linear)
* System uses previously cleared under K012191
3 System uses previously cleared under K010883
* System uses previously cleared under K030191
System uses previously cleared under K000191
System uses previously cleared under K040840
& System uses previously cleared under K040040
P =
? System uses previously cleared under K051334
& 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)
Mary S. Pastel
Division Sign Office of In Vitro Diagnostic Device Evaluation and Safe
Evaluation and Safety
510(k) K110482
Page 1 of _
{20}------------------------------------------------
#### System: ProSound C3cv Ultrasound System_
Transducer: UST-TI09
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 | | | | | | | |
| | Abdominalc: | | | | | | | |
| | Intra-operative (Spec.) d.e.) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatricc: | | | | | | | |
| | Small Organ (Thyroid,
Breast, Testes, etc.)q: | | | | | | | |
| | Neonatal Cephalicc: | | | | | | | |
| | Adult Cephalicc: | | | | | | | |
| | Trans-rectall: | | | | | | | |
| | Trans-vaginals: | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skel. (Convent.)q: | | | | | | | |
| | Musculo-skel. (Superfic)q: | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (Specify) | | | | | | | |
| Cardiac | Cardiac Adult | | | | E | | | |
| | Cardiac Pediatric | | | | E | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral
Vessel | Peripheral vesselc: | | | | | | | |
| | Other (Specify) | | | | | | | |
N= new indication; P= previously cleared by FDA (incl. K080234; E= added under Appendix E
4 Includes Color Dopp. (CD), Directional Power Dopp. (DPD), and (non-directional) Power Dopp. (PD). 6 B+M; B+PWD; B+CD; B+DPD; B+PD
° Harmonic Imaging (HI)
° Incl. ultrasound guidance for placement of needles, catheters
· Abdominal organs and peripheral vessel.
in bestimal organs and polipheral voods.
"Incl. ultrasound guidance for placement of needles, catheters, cryosurgery, and brachytherapy
& Incl. ultrasound guidance of transvaginal biopsy, intertility monitoring of follicle bevelopment.
" Incl. guidance of amniocentesis, infertility monitoring of follicle development.
' Incl. stress echo.
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
System uses previously cleared under K000130
System uses previously cleared under K040840
్ System uses previously cleared under K043278
' System uses previously cleared under K045276
' System uses previously cleared under K051334
I o
8 System uses previously cleared under K080234
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. Pastel
of In Vitro Diagnostic Device
Evaluation and Safety
510(k) K110482
Page 1 of __
---
**Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYN/K110482](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYN/K110482)
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