← Product Code [IYN](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYN) · K050034
# SONOLINE ANTARES DIAGNOSTIC ULTRASOUND SYSTEM (K050034)
_Siemens Medical Solutions USA, Inc. · IYN · Jan 13, 2005 · Radiology · SESE_
**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYN/K050034
## Device Facts
- **Applicant:** Siemens Medical Solutions USA, Inc.
- **Product Code:** [IYN](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYN.md)
- **Decision Date:** Jan 13, 2005
- **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 Antares ultrasound imaging system is intended for the following applications: General Radiology, Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Transesophageal, Pelvic, Neonatal/Adult Cephalic, Urology, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications. The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.
## Device Story
The SONOLINE Antares is a mobile, software-controlled diagnostic ultrasound system. It acquires primary or secondary harmonic ultrasound echo data via various transducers and displays it in B-Mode, M-Mode, PWD, CWD, Color Doppler, Amplitude Doppler, 3D, and 4D Basic Imaging. Used in clinical settings by healthcare professionals, the system provides real-time visualization of anatomical structures and fluid flow. It includes on-screen displays for thermal and mechanical indices to monitor bioeffects. The system performs measurements and analysis of anatomical structures to assist clinicians in diagnosis. Benefits include enhanced diagnostic capabilities through various imaging modes and analysis packages, supporting clinical decision-making across multiple medical specialties.
## Clinical Evidence
Bench testing only. The device was evaluated against recognized safety and performance standards, including AIUM/NEMA UD-2 and UD-3 for acoustic output and thermal/mechanical indices, and ISO 10993 for biocompatibility. No clinical data was required for this 510(k) clearance.
## Technological Characteristics
Mobile, software-controlled diagnostic ultrasound system. Features include harmonic imaging, 3D/4D imaging, and various Doppler modes. Complies with UL 60601-1, CSA C22.2 No. 601-1, and IEC 1157. Biocompatibility per ISO 10993. Connectivity includes CRT display and on-screen indices. Transducers include curved, linear, phased, and multi-plane TEE arrays.
## 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
- Elegra Millennium Advanced ([K001400](/device/K001400.md))
- SONOLINE G50/G60 S Diagnostic Ultrasound System ([K040060](/device/K040060.md))
## Submission Summary (Full Text)
> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
> Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/).
{0}------------------------------------------------
# JAN 1 3 2005 510(K) SUMMARY
# Antares Diagnostic Ultrasound System with 4D Basic Imaging
This summary of safety and effectiveness is provided as part of this Premarket Notification in compliance with the Safe Medical Device Act of 1990 revisions to 21 CFR, Part 807.92, Content and Format of a 510(k) Summary.
#### Submitted By: 1.
Siemens Medical Solutions USA, Inc. 22010 S.E. 51st Street Issaquah, WA 98027-7298
Contact Person: Patrick Lynch Regulatory Affairs
Phone: (425) 557-1825 FAX: (425) 391-9198
# Date Prepared:
2.
December 22, 2004
Proprietary Name: SONOLINE Antares™ Ultrasound System
### Common/ Usual Name:
Diagnostic Ultrasound System with Accessories
### Classification Name:
| 21 CFR 892.1550 | | |
|------------------------------------------|---------------|---------------------|
| Ultrasonic Pulsed Doppler Imaging System | FR # 892.1550 | Product Code 90-IYN |
| Ultrasonic Pulsed Echo Imaging System | FR # 892.1560 | Product Code 90-IYO |
| Diagnostic Ultrasound Transducer | FR # 892.1570 | Product Code 90-ITX |
#### 3. Predicate Device: ·
The Antares system is multi-purpose diagnostic ultrasound system with accessories and proprietary software, and is substantially equivalent to the following products which are already cleared for US distribution with the following 510(k) clearances:
- K001400, 8/1/00, cleared as the Elegra Millennium Advanced, marketed as the ■ Antares
- K040060, 01/28/04, cleared as SONOLINE G50/G60 S Diagnostic Ultrasound ■ System
#### 4. Device Description:
The Antares with 4D Basic Imaging is substantially equivalent to the predicates listed herein. The Antares is a general purpose, mobile, software-controlled, diagnostic ultrasound system with an on-screen display for thermal and mechanical indices related to potential bioeffect mechanisms. Its function is to acquire primary or secondary harmonic ultrasound echo data and display it in B-Mode, M-Mode, Pulsed (PWD) Doppler Mode, Continuous (CWD) Doppler Mode, Color Doppler Mode, Amplitude Doppler Mode, a combination of modes, or Harmonic Imaging, 3D imaging, and 4D Basic Imaging on a CRT display.
{1}------------------------------------------------
The Antares has been designed to meet the following product safety standards:
- 제 UL 60601-1, Safety Requirements for Medical Equipment
- 트 CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment
- l AIUM/NEMA UD-3, 1998, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
- AIUM/NEMA UD-2. 1998 Acoustic Output Measurement Standard for Diagnostic Ultrasound
- l 93/42/EEC Medical Devices Directive
- Safety and EMC Requirements for Medical Equipment
- 에 EN 60601-1
- . EN 60601-1-1
- 비 EN 60601-1-2
- 트 IEC 1157 Declaration of Acoustic Power
- ISO 10993 Biocompatibility ■
#### Intended Uses: 5.
:
The Antares ultrasound imaging system is intended for the following applications: General Radiology, Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Transesophageal, Pelvic, Neonatal/Adult Cephalic, Urology, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.
The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.
#### 6. Technological Comparison to Predicate Device:
Antares Avant is substantially equivalent to the SONOLINE Elegra Millennium Enhanced. cleared via K001400, and the SONOLINE G50/G60 S Diagnostic Ultrasound System, cleared via K040060. All systems transmit ultrasonic energy into patients, then perform postprocessing of received echoes to generate on-screen display of anatomic structures and fluid flow within the body. All systems allow for specialized measurements of structures and flow, and calculations.
## End of 510(k) Summary
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three curved lines representing its wings or feathers.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 3 2005
Siemens Medical Solutions USA, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
Re: K050034
Trade Name: SONOLINE Antares™ Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: 90 IYN, IYO, and ITX Dated: January 5, 2005 Received: January 7, 2005
# 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 SONOLINE Antares™ Diagnostic Ultrasound System, as described in vour premarket notification:
Transducer Model Number
CW2 CW5
C5-2 Curved Array CX5-2 Curved Array
{3}------------------------------------------------
VF7-3 Linear Array EC9-4 Curved Array VFX9-4 Linear Array VF10-5 Linear Array VF13-5 Linear Array VFX13-5 Multi-D Array PX4-1 Phased Array MPT7-4 Multiplane TEE
CH6-2 Curved Array PH4-1 Phased Array P10-4 Phased Array VF13-5SP Linear Array C5F1 Curved Array C7F2 Curved Array EV9F4 Curved Array
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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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 determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.
The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:
> Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850
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.
{4}------------------------------------------------
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at (301) 594-1212.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon
Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
{5}------------------------------------------------
# FDA Cleared Indications for Use Forms
510 (k) Number (if known):
Device Name: Intended Use:
SONOLINE Antares Ultrasound imaging or fluid flow analysis of the human body as follows:
| | | Mode of Operation | | | | | | | | | |
|----------------------------------|---|-------------------|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|--|
| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other
(Specify) | |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8 | |
| Abdominal | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8 | |
| Intraoperative
(Note 9) | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8 | |
| Intraoperative
Neurological | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8 | |
| Pediatric | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8 | |
| Small Organ
(Note 1) | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8 | |
| Neonatal Cephalic | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8 | |
| Adult Cephalic | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8 | |
| Cardiac | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,6,7,8 | |
| Trans-esophageal | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,6 | |
| Transrectal | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8 | |
| Transvaginal | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8 | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral vessel | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8 | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal
Conventional | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8 | |
| Musculo-skeletal
Superficial | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8 | |
| Other (specify) | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA K001400; E = added under Appendix E
Additional Comments:
For example: breast, testes, thyroid, penis, prostate, etc. Note 1
Ensemble tissue harmonic imaging Note 2
SieClear multi-view spatial compounding Note 3
Note 4 Tissue Equalization Technology
Note 5 3-Scape real-time 3D imaging
Note 6 Cadence contrast agent imaging
B&W SieScape panoramic imaging Note 7
Power SieScape panoramic imaging Note 8
Note 9 For example: vascular, abdominal
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) | |
|--------------------------------------------------------------------------|--|
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
Prescription Use (Per 21 CFR 801.109)
Nancy C. Brogdon
(Division Sig. Off)
Division of Reproductive. Aticionins
and Radiological Dry
{6}------------------------------------------------
510 (k) Number (if known):
### CW2 Probe for use with SONOLINE Antares
Device Name: Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | |
|----------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other
(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | P | | | | | |
| Abdominal | | | | | P | | | | | |
| Intraoperative
(Note 9) | | | | | P | | | | | |
| Intraoperative
Neurological | | | | | | | | | | |
| Pediatric | | | | P | | | | | | |
| Small Organ
(Note 1) | | | | | P | | | | | |
| Neonatal Cephalic | | | | | P | | | | | |
| Adult Cephalic | | | | | P | | | | | |
| Cardiac | | | | | P | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | | | | P | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal
Conventional | | | | | P | | | | | |
| Musculo-skeletal
Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
N = new indication; P = previously cleared by FDA K001400; E = added under Appendix E
Additional Comments:
For example: breast, testes, thyroid, penis, prostate, etc. Note 1
For example: vascular, abdominal Note 9
> (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C Brogdon
(Division Sign Division of Reproductive, Abdom and Radiological Devices
510(k) Number KD50034
{7}------------------------------------------------
#### 510 (k) Number (if known):
#### CW5 Probe for use with SONOLINE Antares
Device Name: Intended Use:
# Ultrasound imaging or fluid flow analysis of the human body as follows:
Ultrasound imaging of fluid flow analysis of the human body as follows
| | | Mode of Operation | | | | | | | | |
|----------------------------------|---|-------------------|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other
(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | N | | | | | |
| Abdominal | | | | | N | | | | | |
| Intraoperative
(Note 9) | | | | | N | | | | | |
| Intraoperative
Neurological | | | | | | | | | | |
| Pediatric | | | | | N | | | | | |
| Small Organ
(Note 1) | | | | | N | | | | | |
| Neonatal Cephalic | | | | | N | | | | | |
| Adult Cephalic | | | | | N | | | | | |
| Cardiac | | | | | N | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | | | | N | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal
Conventional | | | | | N | | | | | |
| Musculo-skeletal
Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
N = new indication; P = previously cleared by FDA K001400; E = added under Appendix E
Additional Comments:
. .
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
For example: vascular, abdominal Note 9
> (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) 사 : :
> > Prescription Use (Per 21 CFR 801.109)
Nancy Royston
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number K050034
{8}------------------------------------------------
# 510 (k) Number (if known):
# C5-2 Curved Array Transducer for use with SONOLINE: Antares
Device Name: Intended Use: Ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | |
|----------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other
(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8 |
| Abdominal | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8 |
| Intraoperative
Abdominal | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | |
| Pediatric | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8 |
| Small Organ | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8 |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal
Conventional | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8 |
| Musculo-skeletal
Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
N = new indication; P = previously cleared by FDA K001400; E = added under Appendix E
Additional Comments:
Ensemble tissue harmonic imaging Note 2
SieClear multi-view spatial compounding Note 3
Tissue Equalization Technology Note 4
3-Scape real-time 3D imaging Note 5
B&W SieScape panoramic imaging Note 7
Power SieScape panoramic imaging Note 8
> (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C. Langdon
(Division Sigh-O Division of Reproductive, Abdom and Radiological Devices 510(k) Number
{9}------------------------------------------------
.
# Diagnostic Ultrasound Indications for Use Form
510 (k) Number (if known):
CX5-2 Curved Array Transducer for use with SONOLINE Antares ::
Device Name: Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | |
|----------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other
(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8 |
| Abdominal | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8 |
| Intraoperative
Abdominal | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | |
| Pediatric | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8 |
| Small Organ | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8 |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal
Conventional | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8 |
| Musculo-skeletal
Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
N = new indication; P = previously cleared by FDA K001400; E = added under Appendix E
Additional Comments:
Ensemble tissue harmonic imaging Note 2
Note 3 SieClear multi-view spatial compounding
Tissue Equalization Technology Note 4
3-Scape real-time 3D imaging Note 5
B&W SieScape panoramic imaging Note 7
Power SieScape panoramic imaging Note 8
> (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
> > Prescription Use (Per 21 CFR 801.109)
Nancy Thompson
(Division Sign-Off) Division of Reproductive, Abdomina and Radiological Devices
510(k) Number K050034
..
{10}------------------------------------------------
### 510 (k) Number (if known):
Device Name: Intended Use:
VF7-3 Linear Array Transducer for use with SONOLINE Antares Ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | |
|----------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other
(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8 |
| Abdominal | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8 |
| Intraoperative
Abdominal | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | |
| Pediatric | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8 |
| Small Organ
(Note 1) | | E | E | E | | E | E | | BMDC | Note 2,3,4,5,7,8 |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8 |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal
Conventional | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8 |
| Musculo-skeletal
Superficial | | E | E | E | | E | E | | BMDC | Note 2,3,4,5,7,8 |
| Other (specify) | | | | | | | | | | |
N = new indication; P = previously cleared by FDA K001400; E = added under Appendix E
Additional Comments:
For example: breast, testes, thyroid, penis, prostate, etc. Note 1
Note 2 Ensemble tissue harmonic imaging
Note 3 SieClear multi-view spatial compounding
Note 4 Tissue Equalization Technology
3-Scape real-time 3D imaging Note 5
B&W SieScape panoramic imaging Note 7
Note 8 Power SieScape panoramic imaging
> (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
> > Prescription Use (Per 21 CFR 801.109)
Nancy Snowdon
(Division Sign-Off) Division of Reproductive, Abdominal,
Radiological Devices
510(k) Number K050034
{11}------------------------------------------------
510 (k) Number (if known):
EC9-4 Curved Array Transducer for use with SONOLINE Antares
Device Name: Intended Use: ECS:4 Curved Array Transador of the human body as follows:
| | Mode of Operation | | | | | | | | | |
|----------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other
(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | E | E | E | | E | E | | BMDC | Note 2,3,4,5,7,8 |
| Abdominal | | | | | | | | | | |
| Intraoperative
Abdominal | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ
(Note 1) | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8 |
| Neonatal Cephalic | | E | E | E | | E | E | | BMDC | Note 2,3,4,5,7,8 |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8 |
| Transvaginal | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8 |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal
Conventional | | | | | | | | | | |
| Musculo-skeletal
Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
Street (open);
N = new indication; P = previously cleared by FDA K001400; E = added under Appendix E
Additional Comments:
For example: breast, testes, thyroid, penis, prostate, etc. Note 1
Ensemble tissue harmonic imaging Note 2
SieClear multi-view spatial compounding Note 3
Tissue Equalization Technology Note 4
3-Scape real-time 3D imaging Note 5
B&W SieScape panoramic imaging Note 7
Power SieScape panoramic imaging Note 8
> (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANDTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
> > Prescription Use (Per 21 CFR 801.109)
Nancy C Hodgson
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number.
12/22/2004
{12}------------------------------------------------
#### 510 (k) Number (if known):
#### VFX9-4 Linear Array Transducer for use with SONOLINE Antares
Intended Use:
Device Name:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | |
|----------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other
(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8 |
| Abdominal | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8 |
| Intraoperative
Abdominal | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | |
| Pediatric | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8 |
| Small Organ
(Note 1) | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8 |
| Neonatal Cephalic | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8 |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8 |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal
Conventional | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8 |
| Musculo-skeletal
Superficial | | E | E | E | | E | E | | BMDC | Note 2,3,4,5,7,8 |
| Other (specify) | | | | | | | | | | |
N = new indication; P = previously cleared by FDA K001400; E = added under Appendix E
Additional Comments:
For example: breast, testes, thyroid, penis, prostate, etc. Note 1
Ensemble tissue harmonic imaging Note 2
SieClear multi-view spatial compounding Note 3
Tissue Equalization Technology Note 4
Note 5 3-Scape real-time 3D imaging
B&W SieScape panoramic imaging Note 7
Note 8 Power SieScape panoramic imaging
> (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Nancy C. Snowdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number .
12/22/2004
{13}------------------------------------------------
510 (k) Number (if known):
Device Name:
Intended Use:
# VF10-5 Linear Array Transducer for use with SONOLINE Antares
Ultrasound imaging or fluid flow analysis of the human body as follows:
| | | Mode of Operation | | | | | | | | |
|----------------------------------|---|-------------------|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other
(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8 |
| Abdominal | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8 |
| Intraoperative
Abdominal | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | |
| Pediatric | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8 |
| Small Organ
(Note 1) | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8 |
| Neonatal Cephalic | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8 |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8 |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal
Conventional | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8 |
| Musculo-skeletal
Superficial | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8 |
| Other (specify) | | | | | | | | | | |
N = new indication; P = previously cleared by FDA K001400; E = added under Appendix E
Additional Comments:
For example: breast, testes, thyroid, penis, prostate, etc. Note 1
Note 2 Ensemble tissue harmonic imaging
SieClear multi-view spatial compounding Note 3
Note 4 Tissue Equalization Technology
Note 5 3-Scape real-time 3D imaging
B&W SieScape panoramic imaging Note 7
Note 8 Power SieScape panoramic imaging
> (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
> > Prescription Use (Per 21 CFR 801.109)
Nancy C Brogdon
(Division Sign-Off)
Division of Reproductive, Abdomina and Radiological Devices
510(k) Number K050034
. !
{14}------------------------------------------------
#### 510 (k) Number (if known):
VF13-5 Linear Array Transducer for use with SONOLINE Antares
Device Name: Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | |
|----------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other
(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | E | E | E | | | E | E | BMDC | Note 2,3,4,5,7,8 |
| Abdominal | | E | E | E | | | E | E | BMDC | Note 2,3,4,5,7,8 |
| Intraoperative
Abdominal | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | |
| Pediatric | | P | P | P | | | P | P | BMDC | Note 2,3,4,5,7,8 |
| Small Organ
(Note 1) | | P | P | P | | | P | P | BMDC | Note 2,3,4,5,7,8 |
| Neonatal Cephalic | | E | E | E | | | E | E | BMDC | Note 2,3,4,5,7,8 |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | P | P | P | | | P | P | BMDC | Note 2,3,4,5,7,8 |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal
Conventional | | P | P | P | | | P | P | BMDC | Note 2,3,4,5,7,8 |
| Musculo-skeletal
Superficial | | P | P | P | | | P | P | BMDC | Note 2,3,4,5,7,8 |
| Other (specify) | | | | | | | | | | |
N = new indication; P = previously cleared by FDA K001400; E = added under Appendix E
Additional Comments:
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
Note 2 Ensemble tissue harmonic imaging
Note 3 SieClear multi-view spatial compounding
Note 4 Tissue Equalization Technology
Note 5 3-Scape real-time 3D imaging
B&W SieScape panoramic imaging Note 7
Note 8 Power SieScape panoramic imaging
> (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Nancy Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number K050034
,
{15}------------------------------------------------
510 (k) Number (if known):
Device Name: Intended Use:
VFX13-5 Multi-D Array Transducer for use with SONOLINE Antares
Ultrasound imaging or fluid flow analysis of the human body as follows:
| | | Mode of Operation | | | | | | | | |
|----------------------------------|---|-------------------|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other
(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | E | E | E | | E | E | | BMDC | Note 2,3,4,5,7,8 |
| Abdominal | | E | E | E | | E | E | | BMDC | Note 2,3,4,5,7,8 |
| Intraoperative
Abdominal | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | |
| Pediatric | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8 |
| Small Organ
(Note 1) | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8 |
| Neonatal Cephalic | | E | E | E | | E | E | | BMDC | Note 2,3,4,5,7,8 |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8 |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal
Conventional | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8 |
| Musculo-skeletal
Superficial | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8 |
| Other (specify) | | | | | | | | | | |
N = new indication; P = previously cleared by FDA K001400; E = added under Appendix E
Additional Comments:
For example: breast, testes, thyroid, penis, prostate, etc. Note 1
Ensemble tissue harmonic imaging Note 2
SieClear multi-view spatial compounding Note 3
Note 4 Tissue Equalization Technology
Note 5 3-Scape real-time 3D imaging
B&W SieScape panoramic imaging Note 7
Note 8 Power SieScape panoramic imaging
> (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C. Brogdon
(Division Sign-Off)
Division of Reproductive, Abdomin
Radiological Devices
510(k) Number K050034
{16}------------------------------------------------
510 (k) Number (if known):
Device Name: Intended Use:
PX4-1 Phased Array Transducer for use with SONOLINE Antares Ultrasound imaging or fluid flow analysis of the human body as follows:
| | | Mode of Operation | | | | | | | | | |
|----------------------------------|---|-------------------|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|--|
| | | | | | | | | | | | |
| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other
(Specify) | |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8 | |
| Abdominal | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8 | |
| Intraoperative
Abdominal | | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | | |
| Pediatric | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8 | |
| Small Organ | | | | | | | | | | | |
| Neonatal Cephalic | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8 | |
| Adult Cephalic | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8 | |
| Cardiac | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,6,7,8 | |
| Trans-esophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral vessel | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8 | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal
Conventional | | | | | | | | | | | |
| Musculo-skeletal
Superficial | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA K001400; E = added under Appendix E
Additional Comments:
Note 2 Ensemble tissue harmonic imaging
Note 3 SieClear multi-view spatial compounding
Tissue Equalization Technology Note 4
3-Scape real-time 3D imaging Note 5
Note 6 Cadence contrast agent imaging
Note 7 B&W SieScape panoramic imaging
Note 8 Power SieScape panoramic imaging
> (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C. Broadlon
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number K650034
{17}------------------------------------------------
510 (k) Number (if known):
Device Name: Intended Use:
MPT7-4 Multiplane TEE Transducer for use with SONOLINE Antares Ultrasound imaging or fluid flow analysis of the human body as follows:
| | | | | | | | Mode of Operation | | | |
|----------------------------------|---|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other
(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative
Abdominal | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Trans-esophageal | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,6 |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal
Conventional | | | | | | | | | | |
| Musculo-skeletal
Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
N = new indication; P = previously cleared by FDA K001400; E = added under Appendix E
Additional Comments:
Note 2 Ensemble tissue harmonic imaging
SieClear multi-view spatial compounding Note 3
Note 4 Tissue Equalization Technology
3-Scape real-time 3D imaging Note 5
Note 6 Cadence contrast agent imaging
> (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
> > Prescription Use (Per 21 CFR 801.109)
Nancy brogdon
(Divis…
---
**Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYN/K050034](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYN/K050034)
**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).
**Cite:** Innolitics at https://innolitics.com