(37 days)
No
The document does not mention AI, ML, or related terms, nor does it describe training or test sets typically associated with AI/ML development. The focus is on safety standards and performance verification based on design control processes.
No
The device is described as an ultrasound imaging system intended for diagnostic purposes, providing information used for clinical diagnosis rather than direct treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system "provides information that is used for clinical diagnosis purposes." Additionally, the "Device Description" mentions "Diagnostic Ultrasound Safety Standards" and "Diagnostic Ultrasound Equipment," further supporting its role as a diagnostic device.
No
The device is described as an "ultrasound imaging system" and mentions compliance with hardware safety standards (UL 60601-1, IEC 60601-2-37, etc.), indicating it includes hardware components beyond just software.
Based on the provided information, the Acuson Antares ultrasound imaging system is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly describes the system as an imaging system for various anatomical applications. It focuses on visualizing structures and providing measurements and analysis for clinical diagnosis purposes. This is characteristic of medical imaging devices used to acquire images of the body.
- Device Description: The description details the system's compliance with safety standards related to diagnostic ultrasound equipment. This further reinforces its role as an imaging device.
- Lack of IVD Characteristics: IVD devices are typically used to examine specimens (like blood, urine, or tissue) outside the body to provide information for diagnosis. The provided information does not mention any such function or the analysis of biological samples.
Therefore, the Acuson Antares ultrasound imaging system falls under the category of a medical imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Antares ultrasound imaging system is intended for the following applications: Abdominal, Intraoperative, Small Parts, Transcranial, OB/GYN, Cardiac, Transesophageal, Pelvic, Neonatal/Adult Cephalic, Vascular, Intravascular, Musculoskeletal, Superficial Musculoskeletal, Great Vessel, 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.
Product codes (comma separated list FDA assigned to the subject device)
90-IYN, 90-IYO, 90-ITX
Device Description
The Siemens Acuson ANTARES MODIFICATION has been designed to meet the following product safety standards:
- UL 60601-1, Safety Requirements for Medical Equipment
- I IEC 60601-2-37 Diagnostic Ultrasound Safety Standards
- CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment
- 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
- 93/42/EEC Medical Devices Directive
- Safety and EMC Requirements for Medical Equipment
- EN/IEC 60601-1
- EN/IEC 60601-1-1
- EN/IEC 60601-1-2
- IEC 1157 Declaration of Acoustic Power
- ISO 10993-1 Biocompatibility
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound imaging or fluid flow analysis
Anatomical Site
Abdominal, Intraoperative, Small Parts, Transcranial, OB/GYN, Cardiac, Intracardiac, Transesophageal, Pelvic, Neonatal/Adult Cephalic, Vascular, Intravascular, Musculoskeletal, Superficial Musculoskeletal, Great Vessel, Peripheral Vascular, Fetal, Transrectal, Transvaginal, Pediatric
Indicated Patient Age Range
Neonatal/Adult
Intended User / Care Setting
Not Found
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 modifications to the Antares are verified and validated according to the company's design control process as certified in the 510(k) Notification.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
K 063/38
Antares Ultrasound System Special 510(k) Submission
SECTION 11
510(k) Summary
Prepared 10/11/2006
NOV 2 2 2006
| Sponsor: | Siemens Medical Solutions USA, Inc.,
Ultrasound Division
1230 Shorebird Way
P.O. Box 7393
Mountain View, California 94039-7393 |
|-------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Sheila W. Pickering |
| | Telephone: (650) 943 7187 |
| | Fax: (650) 943 7053 |
| Submission Date: | October 13, 2006 |
| Device Name: | Siemens Antares Ultrasound System |
| Common Name: | Diagnostic Ultrasound System with Accessories |
| Classification: | |
| Regulatory Class: | II |
| Review Category: | Tier II |
| 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 |
A. Legally Marketed Predicate Devices
Radiology
The Siemens Antares Ultrasound system is substantially equivalent to the following:
- . K052894, K033196, K023729, 1/1/2005, Antares Diagnostic Ultrasound System
- . K052021, 8/17/2005, Siemens V5M Transesophageal Transducer
- K011252, 5/30/2001, GE Hitachi EUB 8500 with Sonoelastography .
B. Device Description:
Classification Panel:
The Siemens Acuson ANTARES MODIFICATION has been designed to meet the following product safety standards:
- UL 60601-1, Safety Requirements for Medical Equipment
- I IEC 60601-2-37 Diagnostic Ultrasound Safety Standards
- 트 CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment
- 들 AIUM/NEMA UD-3, 1998 Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
- 트 AIUM/NEMA UD-2, 1998 Acoustic Output Measurement Standard for Diagnostic Ultrasound
- 8 93/42/EEC Medical Devices Directive
1
- . Safety and EMC Requirements for Medical Equipment
- EN/IEC 60601-1
- 트 EN/IEC 60601-1-1
- EN/IEC 60601-1-2
- 프 IEC 1157 Declaration of Acoustic Power
- ISO 10993-1 Biocompatibility
C. Intended Use
The Antares ultrasound imaging system is intended for the following applications: Abdominal, Intraoperative, Small Parts, Transcranial, OB/GYN, Cardiac, Transesophageal, Pelvic, Neonatal/Adult Cephalic, Vascular, Intravascular, Musculoskeletal, Superficial Musculoskeletal, Great Vessel, and Peripheral Vascular applications.
D. Substantial Equivalence
The submission device is substantially equivalent to the predicate with regard to both intended use and technological characteristics.
E. Performance Data
The modifications to the Antares are verified and validated according to the company's design control process as certified in the 510(k) Notification.
2
SECTION 11
510(k) Summary
Prepared 10/11/2006
| Sponsor: | Siemens Medical Solutions USA, Inc.,
Ultrasound Division
1230 Shorebird Way
P.O. Box 7393
Mountain View, California 94039-7393 |
|------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Sheila W. Pickering |
| | Telephone: (650) 943 7187 |
| | Fax: (650) 943 7053 |
| Submission Date: | October 13, 2006 |
| Device Name: | Siemens Antares Ultrasound System |
| Common Name: | Diagnostic Ultrasound System with Accessories |
| Classification: | Regulatory Class: II
Review Category: Tier II
Classification Panel: Radiology |
| 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 |
A. Legally Marketed Predicate Devices
The Siemens Antares Ultrasound system is substantially equivalent to the following:
- . K052894, K033196, K023729, 1/1/2005, Antares Diagnostic Ultrasound System
- · K052021, 8/17/2005, Siemens V5M Transesophageal Transducer
- . K011252, 5/30/2001, GE Hitachi EUB 8500 with Sonoelastography
B. Device Description:
The Siemens Acuson ANTARES MODIFICATION has been designed to meet the following product safety standards:
- UL 60601-1, Safety Requirements for Medical Equipment
- 해 IEC 60601-2-37 Diagnostic Ultrasound Safety Standards
- 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
- 제 AIUM/NEMA UD-2, 1998 Acoustic Output Measurement Standard for Diagnostic Ultrasound
- l 93/42/EEC Medical Devices Directive
3
- 트 Safety and EMC Requirements for Medical Equipment
- 비 EN/IEC 60601-1
- I EN/IEC 60601-1-1
- 트 EN/IEC 60601-1-2
- I IEC 1157 Declaration of Acoustic Power
- 트 ISO 10993-1 Biocompatibility
C. Intended Usc
The Antares ultrasound imaging system is intended for the following applications: Abdominal, Intraoperative, Small Parts, Transcranial, OB/GYN, Cardiac, Intracardiac, Transesophageal, Pelvic, Neonatal/Adult Cephalic, Vascular, Intravascular, Musculoskeletal, Transsophagean, Fedric, Vessel, and Peripheral Vascular applications.
D. Substantial Equivalence
The submission device is substantially equivalent to the predicate with regard to both intended use and technological characteristics.
E. Performance Data
The modifications to the Antares are verified and validated according to the company's design control process as certified in the 510(k) Notification.
4
Image /page/4/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes forming its body and wings, symbolizing health, human services, and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Sheila Pickering, Ph.D. Senior Director of Regulatory Affairs Siemens Medical Solutions USA, Inc. P.O. 7393, 1230 Shorebird Wav MOUNTAIN VIEW CA 94039
NOV 2 2 2006
Re: K063138
Trade Name: Siemens ACUSON Antares Modification™ 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: IYN, IYO and IYX Dated: October 13, 2006 Received: October 23, 2006
Dear Dr. Pickering:
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 Siemens ACUSON Antares Modification™ Ultrasound System, as described in your premarket notification:
Transducer Model Number
C5-2 Convex Array C6-2 Convex Array
Image /page/4/Picture/13 description: The image is a circular seal with the text "1906 - 2006" at the top. In the center of the seal is the acronym "FDA" in large, bold letters, with the word "Centennial" written below it in a smaller font. The seal is surrounded by text that appears to be the name of an organization or institution. There are also three stars at the bottom of the seal.
Protecting and Promoting Public Health
5
Page 2-Sheila Pickering, Ph.D.
C8-5 Convex Array 5.0C50+ Convex Array C6-3 3D Mechanically Driven 3D Convex Array EV9-4 Convex Array Endovaginal Endo-VII Mechanical Sector Endovaginal Endo-V 3D Mechanical Sector Endovaginal EC9-4 Convex Array Endovaginal BE9-4 Convex Array Endocavity 5.0L45 Linear Array 7.5L70 Linear Array LB5-2 Linear Array L10-5 Linear Array VF13-5 Linear Array VF13-5SP Linear Array 7.5L50I Linear Array 7.5L50Q Linear Array 8L3 Linear Array C7F2 Curved Array LAP8-4 Laparoscopic P4-2 Phased Sector Array 5.0P10 Phased Array MPT7-4 Phased Sector Array TEE CW2 Continuous Wave Doppler CW5 Continuous Wave Doppler P9-4 Phased Sector Array CH5-2 Convex Array V5M TEE
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.
6
Page 3-Sheila Pickering, Ph.D.
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.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
7
Page 4-Sheila Pickering, Ph.D.
If you have any questions regarding the content of this letter, please contact Sundar Rajan at (240) 276-3666.
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)
8
SECTION 7
Intended Use of the Device
(ACUSON ANTARES ™ Ultrasound System)
Intended Use:
The Acuson Antares ultrasound imaging system is intended for the following applications: Abdominal, Intraoperative, Small Parts, Transcranial, OB/GYN, Cardiac, Intracardiac, Transesophageal, Pelvic, Neonatal/Adult Cephalic, Vascular, Intravascular, Musculoskeletal, Superficial Musculoskeletal, Great Vessel, 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.
Prescription Use
Nancy Brogdon
(Division Sign-Off)
Division of Reproductive, Abdon and Radioloma: Devices 570gu mumber
9
510(k) Number (if known):
Device Name:
SIEMENS ACUSON ANTARES MODIFICATION TM Ultrasound System
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 | P | BMDC | Note 2,3,4,5 | ||
| Abdominal | P | P | P | P | P | P | BMDC | Note 2,3,4,5 | ||
| Intraoperative (Note 6) | P | P | P | P | P | P | BMDC | Note 3 | ||
| Intraoperative Neurological | P | P | P | P | P | P | BMDC | Note 2,3 | ||
| Pediatric | P | P | P | P | P | P | BMDC | Note 2,3,4,5 | ||
| Small Organ (Note 1) | P | P | P | P | P | P | BMDC | Note 2,3,4,5 | ||
| Neonatal Cephalic | P | P | P | P | P | P | BMDC | Note 2,3 | ||
| Adult Cephalic | P | P | P | P | P | P | BMDC | Note 2 | ||
| Cardiac | P | P | P | P | P | P | BMDC | Note 2,7 | ||
| Transesophageal | P | P | P | P | P | P | BMDC | Note 2,3,7 | ||
| Transrectal | P | P | P | P | P | P | BMDC | Note 2,3,4,5 | ||
| Transvaginal | P | P | P | P | P | P | BMDC | Note 2,3,4,5 | ||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | P | P | P | P | P | P | BMDC | Note 2,3,4,5 | ||
| Laparoscopic | P | P | P | P | P | P | BMDC | Note 3 | ||
| Musculo-skeletal (Conventional) | P | P | P | P | P | P | BMDC | Note 2,3,4,5 | ||
| Musculo-skeletal (Superficial) | P | P | P | P | P | P | BMDC | Note 2,3,4,5 | ||
| Other (specify) |
P = previously cleared by the FDA under # K052894) E = added under Appendix E.
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
Note 2 Ensemble tissue harmonic imaging
- Note 3 3D imaging
- Note 4 B&W SieScape panoramic imaging
- Power SieScape panoramic imaging Note 5
- For example: abdominal, vascular Note 6
- Note 7 Contrast agent imaging
- Note 8 Virtual Format
(IPLEASE 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 Chroydon
(Division Sign-Off) Division of Reproductive, A and Radiological Devices 510(k) Number
10
510(k) Number (if known):
Device Name:
Intended Use:
C5-2 Convex Array Transducer for use with: SIEMENS ACUSON ANTARES MODIFICATION Ultrasound System 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, | |||
| Abdominal | P | P | P | P | P | BMDC | Note 2,3,4,5, | |||
| Intraoperative Abdominal | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | P | P | P | P | P | BMDC | Note 2,3,4,5, | |||
| 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, | |||
| Laparoscopic | ||||||||||
| Musculo-skeletal (Conventional) | ||||||||||
| Musculo-skeletal (Superficial) | ||||||||||
| Other (Specify) |
P = previously cleared by the FDA under # K040060; E = added under Appendix E.
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
Note 2 Ensemble tissue harmonic imaging
3D imaging Note 3
B&W SieScape panoramic imaging Note 4
- Power SieScape panoramic imaging Note 5
- Note 6 For example: abdominal, vascular
- Note 7 Contrast agent imaging
Note 8 Virtual format
(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, Abdomi and Radiological Devices 510(k) Number
11
510(k) Number (if known).
Device Name: C6-2 Convex Array Transducer for use with:
SIEMENS ACUSON ANTARES MODIFICATION Ultrasound System
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 | ||||||||||
| Abdominal | P | P | P | P | P | BMDC | Note | |||
| 2,3,4,5,7 | ||||||||||
| Intraoperative (Note 6) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | P | P | P | P | P | BMDC | Note | |||
| 2,3,4,5,7 | ||||||||||
| Small Organ (Note 1) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | P | P | P | P | P | BMDC | Note | |||
| 2,3,4,5,7 | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal (Conventional) | ||||||||||
| Musculo-skeletal (Superficial) | ||||||||||
| Other (specify) |
P = previously cleared by the FDA under # K040060; E = added under Appendix E.
For example: breast, testes, thyroid, penis, prostate, etc. Note 1
Note 2 Ensemble tissue harmonic imaging
- Note 3 3D imaging
Note 4 B&W SieScape panoramic imaging
Power SieScape panoramic imaging Note 5
Note 6 For example: abdominal, vascular
Note 7 Contrast agent imaging
Note 8 Virtual format
(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
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K063/38
Indications for Use Form of 6.30
Pg. 6.3
12
510(k) Number (if
known):
Device Name:
Intended Use:
C8-5 Convex Array Transducer for use with: SIEMENS ACUSON ANTARES MODIFICATION Ultrasound System 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 | P | P | P | P | P | BMDC | Note 3,4,5 | |||
| Intraoperative (Note 6) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | P | P | P | P | P | BMDC | Note 3,4,5 | |||
| Small Organ (Note 1) | P | P | P | P | P | BMDC | Note 3,4,5 | |||
| Neonatal Cephalic | P | P | P | P | P | BMDC | Note 3,4,5 | |||
| Adult Cephalic | ||||||||||
| Cardiac | E | E | E | E | E | BMDC | Note 3,4,5,7 | |||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal (Conventional) | P | P | P | P | P | BMDC | Note 3,4,5 | |||
| Musculo-skeletal (Superficial) | E | E | E | E | E | BMDC | Note 3,4,5 | |||
| Other (specify) |
P = previously cleared by the FDA under # K040060; E = added under Appendix E.
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
Ensemble tissue harmonic imaging Note 2
Note 3 3D imaging
Note 4 B&W SieScape panoramic imaging
Note 5 Power SieScape panoramic imaging
Note 6 For example: abdominal, vascular
Note 7 Contrast agent imaging
Note 8 Virtual format
(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. Bergdon
(Division Sign-Off) Division of Reproductive, Abo and Radiological Devices
Diagnostic Ultrasound Indication Olymper
13
510(k) Number (if known):
Device Name:
5.0C50+ Convex Array Transducer for use with: SIEMENS ACUSON ANTARES MODIFICATION Ultrasound System Ultrasound imaging or fluid flow analysis of the human body as
Intended Use:
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 3,4,5 | ||
| Abdominal | P | P | P | P | P | P | BMDC | Note 3,4,5 | ||
| Intraoperative (Note 6) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | P | P | P | P | P | P | BMDC | Note 3,4,5 | ||
| Small Organ (Note 1) | P | P | P | P | P | P | BMDC | Note 3,4,5 | ||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | P | P | P | P | P | P | BMDC | Note 3,4,5 | ||
| Laparoscopic | ||||||||||
| Musculo-skeletal (Conventional) | E | E | E | E | E | E | BMDC | Note 3,4,5 | ||
| Musculo-skeletal (Superficial) | E | E | E | E | E | E | BMDC | Note 3,4,5 | ||
| Other (specify) |
P = previously cleared by the FDA under # K040060; E = added under Appendix E.
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
Ensemble tissue harmonic imaging Note 2
- Note 3 3D imaging
- Note 4 B&W SieScape panoramic imaging
- Note 5 Power SieScape panoramic imaging
- Note 6 For example: abdominal, vascular
- Contrast agent imaging Note 7
- Note 8 Virtual Format
(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 Chrooden
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number
K06 3138
Po. 6.5 of 6.30
Diagnostic Ultrasound Indications For K
14
510(k) Number (if known):
| Device Name: | C6-3 3D Mechanically Driven 3D Convex Array Transducer for use
with:
SIEMENS ACUSON ANTARES MODIFICATION Ultrasound
System |
|---------------|-------------------------------------------------------------------------------------------------------------------------------------|
| 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 | |||
| Abdominal | P | P | P | P | P | BMDC | Note 2,3,4,5 | |||
| Intraoperative (Note 6) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | P | P | P | P | P | BMDC | Note 2,3,4,5 | |||
| Small Organ (Note 1) | ||||||||||
| Neonatal Cephalic | E | E | E | E | E | BMDC | Note 2,3,4,5 | |||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal (Conventional) | ||||||||||
| Musculo-skeletal (Superficial) | ||||||||||
| Other (specify) |
P = previously cleared by the FDA under # K040060; E = added under Appendix E.
For example: breast, testes, thyroid, penis, prostate, etc. Note I
Ensemble tissue harmonic imaging Note 2
3D imaging Note 3
B&W SieScape panoramic imaging Note 4
Power SieScape panoramic imaging Note 5
Note 6 For example: abdominal, vascular
- Note 7 Contrast agent imaging
Virtual format 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 (Pcr 21 CFR 801.109)
Nancy Bergdon
(Division Sic Division of Reproductive, Abde diological Devices and Ra
Section 6
Diagnostic Ultrasound Indication
15
510(k) Number (if known).
Device Name:
EV9-4 Convex Array Endovaginal Transducer for use with: SIEMENS ACUSON ANTARES MODIFICATION Ultrasound System Ultrasound imaging or fluid flow analysis of the human body as
Intended Use:
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 | |||
| Abdominal | ||||||||||
| Intraoperative (Note 6) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (Note 1) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | P | P | P | P | P | BMDC | Note 2,3,4,5 | |||
| Transvaginal | P | P | P | P | P | BMDC | Note 2,3,4,5 | |||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal (Conventional) | ||||||||||
| Musculo-skeletal (Superficial) | ||||||||||
| Other (specify) |
P = previously cleared by the FDA under # K040060; E = added under Appendix E.
Note l For example: breast, testes, thyroid, penis, prostate, etc.
.
Ensemble tissue harmonic imaging Note 2
- Note 3 3D imaging
- Note 4 B&W SieScape panoramic imaging
- Note 5 Power SieScape panoramic imaging
- Note 6 For example: abdominal, vascular
- Contrast agent imaging Note 7
- Note 8 Virtual format
(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. Bowadon
Division Sign Off
(Division Sian-Off) Division of Reproductive, Abdor and Radiological Devices 510(k) Number
Section 6
Diagnostic Ultrasound Indications for Use Form
Pg. 6.7 of 6.30
16
510(k) Number (if known):
Endo-VII Mechanical Sector Endovaginal Transducer for use with: Device Name: SIEMENS ACUSON ANTARES MODIFICATION Ultrasound System
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 | BM | Note 3 | ||||||
| Abdominal | ||||||||||
| Intraoperative Abdominal | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (Note 1) | ||||||||||
| Neonatal Cephalic | P | P | BM | Note 3 | ||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | P | P | BM | Note 3 | ||||||
| Transvaginal | P | P | BM | Note 3 | ||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal Conventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other (specify) |
P = previously cleared by the FDA under # K040060; E = added under Appendix E.
Note I For example: breast, testes, thyroid, penis, prostate, etc.
Ensemble tissue harmonic imaging Note 2
- Note 3 3D imaging
- B&W SieScape panoramic imaging Note 4
Note 5 Power SieScape panoramic imaging
Note 6 For example: abdominal, vascular
Note 7 Contrast agent imaging
- Note 8 Virtual format
(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. hogdon
(Division Sign-Off)
Division of Reproductive, Abdo and Radiological Devices 510(k) Number _
Diagnostic Ultrasound Indications for Use Form
Pg. 6.8 of 6.30
17
510(k) Number (if known):
Device Name:
Intended Use:
Endo-V 3D Mechanical Sector Endovaginal Transducer for use with: SIEMENS ACUSON ANTARES MODIFICATION Ultrasound System 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 | BM | Note 3 | ||||||
| Abdominal | ||||||||||
| Intraoperative (Note 6) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (Note 1) | ||||||||||
| Neonatal Cephalic | P | P | BM | Note 3 | ||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | P | P | BM | Note 3 | ||||||
| Transvaginal | P | P | BM | Note 3 | ||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal (Conventional) | ||||||||||
| Musculo-skeletal (Superficial) | ||||||||||
| Other (specify) |
P = previously cleared by the FDA under # K040060; E = added under Appendix E.
For example: breast, testes, thyroid, penis, prostate, etc. Note 1
Ensemble tissue harmonic imaging Note 2
Note 3 3D imaging
Note 4 B&W SieScape panoramic imaging
Note S Power SieScape panoramic imaging
For example: abdominal, vascular Note 6
- Note 7 Contrast agent imaging
Note 8 Virtual format
(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. Hogdon
(Division Sign-Off)
Division of Reproductive, Abdo and Radiological Devices 510(k) Number
g. 6.9 of 6.30
18
510(k) Number (if known):
EC9-4 Convex Array Endovaginal Transducer for use with: Device Name: SIEMENS ACUSON ANTARES MODIFICATION Ultrasound System Intended Use: Ultrasound imaging or fluid flow analysis of the human body as
| 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 | |||
| Abdominal | ||||||||||
| Intraoperative Abdominal | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (Note 1) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | P | P | P | P | P | BMDC | Note 2,3,4,5 | |||
| Transvaginal | P | P | P | P | P | BMDC | Note 2,3,4,5 | |||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal Conventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other (specify) |
P = previously cleared by the FDA under # K040060; E = added under Appendix E.
follows:
For example: breast, testes, thyroid, penis, prostate, etc. Note 1
Ensemble tissue harmonic imaging Note 2
- Note 3 3D imaging
B&W SieScape panoramic imaging Note 4
Note 5 Power SieScape panoramic imaging
Note 6 For example: abdominal, vascular
Contrast agent imaging Note 7
Note 8 Virtual format
(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. Hodgson
(Division Sign-Off) Division of Reproductive, Abdo and Radiological Devices 510(k) Number
Pg. 6.10 of 6.30
19
510(k) Number (if known).
Device Name:
BE9-4 Convex Array Endocavity Transducer for use with: SIEMENS ACUSON ANTARES MODIFICATION Ultrasound System Ultrasound imaging or fluid flow analysis of the human body as
Intended Use:
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 | |||
| Abdominal | ||||||||||
| Intraoperative Abdominal | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (Note 1) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | P | P | P | P | P | BMDC | Note 2,3,4,5 | |||
| Transvaginal | P | P | P | P | P | BMDC | Note 2,3,4,5 | |||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal Conventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other (specify) |
P = previously cleared by the FDA under # K040060; E = added under Appendix E.
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
Ensemble tissue harmonic imaging Note 2
- Note 3 3D imaging
- Note 4 B&W SieScape panoramic imaging
Note 5 Power SieScape panoramic imaging
- Note 6 For example: abdominal, vascular
- Note 7 Contrast agent imaging
Note 8 Virtual format
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Pcr 21 CFR 801.109)
(Division Sign-Off)
Nancy C. Brogdon
Division of Reproductive, Abdominal,
and Radiological Devices 1/063138
510(k) Number Diagnostic Ultrasound Indications for Use Form
Pg. 6.11 of 6.30
20
510(k) Number (if known):
Device Name:
5.0L45 Linear Array Transducer for use with:
SIEMENS ACUSON ANTARES MODIFICATION Ultrasound System
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 | |||||||||||
| Abdominal | P | P | P | P | P | P | P | BMDC | Note 2,3,4,5 | ||
| Intraoperative (Note 6) | |||||||||||
| Intraoperative Neurological | |||||||||||
| Pediatric | P | P | P | P | P | P | BMDC | Note 2,3,4,5 | |||
| Small Organ (Note 1) | P | P | P | P | P | P | BMDC | Note 2,3,4,5 | |||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral vessel | P | P | P | P | P | P | P | BMDC | Note 2,3,4,5 | ||
| Laparoscopic | |||||||||||
| Musculo-skeletal (Conventional) | P | P | P | P | P | P | P | BMDC | Note 2,3,4,5 | ||
| Musculo-skeletal (Superficial) | |||||||||||
| Other (specify) |
P = previously cleared by the FDA under # K040060; E = added under Appendix E.
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
Note 2 Ensemble tissue harmonic imaging
Note 3 3D imaging
B&W SieScape panoramic imaging Note 4
Power SieScape panoramic imaging Note 5
Note 6 For example: abdominal, vascular
Notc 7 Contrast agent imaging
Note 8 Virtual format
(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)
Nancyc Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
2 of 6-30
21
510(k) Number (if known):
Device Name:
7.5L70 Linear Array Transducer for use with: SIEMENS ACUSON ANTARES MODIFICATION Ultrasound System
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 | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (Note 6) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | P | P | P | P | P | BMDC | Note 3,4,5 | |||
| Small Organ (Note 1) | P | P | P | P | P | BMDC | Note 3,4,5 | |||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | E | E | E | E | E | BMDC | Note 3,4,5 | |||
| Laparoscopic | ||||||||||
| Musculo-skeletal (Conventional) | P | P | P | P | P | BMDC | Note 3,4,5 | |||
| Musculo-skeletal (Superficial) | P | P | P | P | P | BMDC | Note 3,4,5 | |||
| Other (specify) |
P = previously cleared by the FDA under # K040060; E = added under Appendix E.
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
Note 2 Ensemble tissue harmonic imaging
- 3D imaging Note 3
Note 4 B&W SieScape panoramic imaging
Note 5 Power SieScape panoramic imaging
Note 6 For example: abdominal, vascular
Note 7 Contrast agent imaging
Note 8 Virtual format
(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. Hogdon
(Division Sign-Off)
Division of Reproductive, Abd and Radiological Devices
510(k) Number ________________________________________________________________________________________________________________________________________________________________
Pg. 6.13 of 6.30
22
510(k) Number (if known):
Device Name:
Intended Use:
LB5-2 Linear Array Transducer for use with: SIEMENS ACUSON ANTARES MODIFICATION Ultrasound System 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 4,5 | |||
| Abdominal | P | P | P | P | P | BMDC | Note 4,5 | |||
| Intraoperative Abdominal | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal Conventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other (specify) |
P = previously cleared by the FDA under # K040060; E = added under Appendix E.
Note 1 For cxample: breast, testes, thyroid, penis, prostate, etc.
Ensemble tissue harmonic imaging Note 2
- Note 3 3D imaging
Note 4 B&W SieScape panoramic imaging
Note 5 Power SieScape panoramic imaging
For example: abdominal, vascular Note 6
Note 7 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)
Naveen C. Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________
23
510(k) Number (if known):
Device Name:
L10-5 Linear Array Transducer for use with:
SIEMENS ACUSON ANTARES MODIFICATION Ultrasound System
Intended Usc:
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 | P | P | P | P | P | P | BMDC | Note | ||
| 2,3,4,5,8 | ||||||||||
| Intraoperative (Note 6) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | P | P | P | P | P | P | BMDC | Note | ||
| 2,3,4,5,8 | ||||||||||
| Small Organ (Note 1) | P | P | P | P | P | P | BMDC | Note | ||
| 2,3,4,5,8 | ||||||||||
| Neonatal Cephalic | P | P | P | P | P | P | BMDC | Note | ||
| 2,3,4,5,8 | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | P | P | P | P | P | P | BMDC | Note | ||
| 2,3,4,5,8 | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal (Conventional) | P | P | P | P | P | P | BMDC | Note | ||
| 2,3,4,5,8 | ||||||||||
| Musculo-skeletal (Superficial) | P | P | P | P | P | P | BMDC | Note | ||
| 2,3,4,5,8 | ||||||||||
| Other (specify) |
P = previously cleared by the FDA under # K040060; E = added under Appendix E
For example: breast, testes, thyroid, penis, prostate, etc. Note I
Note 2 Ensemble tissue harmonic imaging
- Note 3 3D imaging
Note 4 B&W SieScape panoramic imaging
Note 5 Power SieScape panoramic imaging
- Note 6 For example: abdominal, vascular
- Note 7 Contrast agent imaging
- Note 8 Virtual format
(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) |
Prescription Use (Per 21 CFR 801.109)
C
*ancy C. Brogd
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
Diagnostic Ultrasound Use Form
K063138
Pg 6.15 of 6.30
24
510(k) Number (if known):
Device Name:
Intended Use:
VF13-5 Linear Array Transducer for use with: SIEMENS ACUSON ANTARES MODIFICATION Ultrasound System 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 (Note 6) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | P | P | P | P | P | P | BMDC | Note 3,4,5,8 | ||
| Small Organ (Note 1) | P | P | P | P | P | P | BMDC | Note 3,4,5,8 | ||
| Neonatal Cephalic | P | P | P | P | P | P | BMDC | Note 3,4,5,8 | ||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | P | P | P | P | P | P | BMDC | Note 3,4,5,8 | ||
| Laparoscopic | ||||||||||
| Musculo-skeletal (Conventional) | P | P | P | P | P | P | BMDC | Note 3,4,5,8 | ||
| Musculo-skeletal (Superficial) | P | P | P | P | P | P | BMDC | Note 3,4,5,8 | ||
| Other (specify) |
P = previously cleared by the FDA under # K040060; E = added under Appendix E.
For example: breast, testes, thyroid, penis, prostate, etc. Note 1
Note 2 Ensemble tissue harmonic imaging
Note 3 3D imaging
- Note 4 B&W SieScape panoramic imaging
- Note 5 Power SieScape panoramic imaging
- For example: abdominal, vascular Note 6
- Note 7 Contrast agent imaging
- Note 8 Virtual format
(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, Abdominal,
and Radiological Devices
510(k) Number
K1663138
25
510(k) Number (if known):
Device Name:
VF13-5SP Linear Array Transducer for use with:
SIEMENS ACUSON ANTARES MODIFICATION Ultrasound System
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 | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (Note 6) | P | P | P | P | P | BMDC | Note 3,4,5,8 | |||
| Intraoperative Neurological | P | P | P | P | P | BMDC | Note 3,4,5,8 | |||
| Pediatric | P | P | P | P | P | BMDC | Note 3,4,5,8 | |||
| Small Organ (Note 1) | P | P | P | P | P | BMDC | Note 3,4,5,8 | |||
| Neonatal Cephalic | P | P | P | P | P | BMDC | Note 3,4,5,8 | |||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | P | P | P | P | P | BMDC | Note 3,4,5,8 | |||
| Laparoscopic | ||||||||||
| Musculo-skeletal Conventional | P | P | P | P | P | BMDC | Note 3,4,5,8 | |||
| Musculo-skeletal Superficial | P | P | P | P | P | BMDC | Note 3,4,5,8 | |||
| Other (specify) |
P = previously cleared by the FDA under # K040060; E = added under Appendix E.
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
Ensemble tissue harmonic imaging Note 2
Note 3 3D imaging
B&W SieScape panoramic imaging Note 4
Power SieScape panoramic imaging Note 5
Note 6 For example: abdominal, vascular
Contrast agent imaging Note 7
Note 8 Virtual format
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE I Concurrence of CDRH, Office of Device Evaluation (QDE Prescription Use (Per 21 CFR 80 Division of Reproductive and Radiological Devices 510(k) Number
26
510(k) Number (if known):
Device Name: 7.5L50I Linear Array Transducer for use with: SIEMENS ACUSON ANTARES MODIFICATION Ultrasound System 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 | ||||||||||
| Abdominal | P | P | P | P | P | BMDC | Note 3,4,5 | |||
| Intraoperative (Note 6) | P | P | P | P | P | BMDC | Note 3,4,5 | |||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (Note 1) | P | P | P | P | P | BMDC | Note 3,4,5 | |||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | P | P | P | P | P | BMDC | Note 3,4,5 | |||
| Laparoscopic | ||||||||||
| Musculo-skeletal Conventional | P | P | P | P | P | BMDC | Note 3,4,5 | |||
| Musculo-skeletal Superficial | ||||||||||
| Other (specify) |
P = previously cleared by the FDA under # K040060; E = added under Appendix E.
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
Ensemble tissue harmonic imaging Note 2
Note 3 3D imaging
Note 4 B&W SieScape panoramic imaging
Power SieScape panoramic imaging Note 5
Note 6 For example: abdominal, vascular
Note 7 Contrast agent imaging
Note 8 Virtual format
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) ﻦ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤ Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
801.109)
(Division Sign-Off)
Nancy C Brogdon
Sign
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K06313
Pg. 6.18 of 6.30
27
510(k) Number (if known):
Device Name:
Intended Use:
7.51.500 Linear Array Transducer for use with: SIEMENS ACUSON ANTARES MODIFICATION Ultrasound System Ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| A | B | M | PWD | CWD | Color | ||||||
| Doppler | Amplitude | ||||||||||
| Doppler | Color | ||||||||||
| Velocity | |||||||||||
| Imaging | Combined | ||||||||||
| (Specify) | Other | ||||||||||
| (Specify) | |||||||||||
| Ophthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | P | P | P | P | P | BMDC | Note 3,4,5 | ||||
| Intraoperative (Note 6) | P | P | P | P | P | BMDC | Note 3,4,5 | ||||
| Intraoperative Neurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ (Note 1) | P | P | P | P | P | BMDC | Note 3,4,5 | ||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral vessel | P | P | P | P | P | BMDC | Note 3,4,5 | ||||
| Laparoscopic | |||||||||||
| Musculo-skeletal (Conventional) | P | P | P | P | P | BMDC | Note 3,4,5 | ||||
| Musculo-skeletal (Superficial) | |||||||||||
| Other (specify) |
P = previously cleared by the FDA under # K040060; E = added under Appendix E.
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
Note 2 Ensemble tissue harmonic imaging
- Note 3 3D imaging
Note 4 B&W SieScape panoramic imaging
Note 5 Power SieScape panoramic imaging
Note 6 For example: abdominal, vascular
Note 7 Contrast agent imaging
Note 8 Virtual format
(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, Abdominal,
and Radiological Devices
510(k) Number N063138
Diagnostic Ultrasound Indications for Use Form
Pg. 6.19 of 6.30
28
510(k) Number (if known):
Device Name:
8L3 Linear Array Transducer for use with:
Siemens Acuson ANTARES MODIFICATION Ultrasound System
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | A | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other
(Specify) | |
|---------------------------------|--|---|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|--|
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | | | P | P | P | P | P | | | BMDC | Note 2,3,4,5,8 | |
| Intraoperative (Note 6) | | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | | |
| Pediatric | | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,8 | |
| Small Organ (Note 1) | | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,8 | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Peripheral vessel | | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,8 | |
| Laparoscopic | | | | | | | | | | | | |
| Musculo-skeletal (Conventional) | | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,8 | |
| Musculo-skeletal (Superficial) | | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | | |
P = previously cleared by the FDA under # K040060; E = added under Appendix E.
For example: breast, testes, thyroid, penis, prostate, etc. Note 1
Note 2 Ensemble tissue harmonic imaging
Note 3 3D imaging
Note 4 B&W SieScape panoramic imaging
Note 5 Power SieScape panoramic imaging
Note 6 For example: abdominal, vascular
Contrast agent imaging Note 7
Note 8 Virtual format
| (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)
(Division Sign-Off) Division of Reproductive Abdon and Radiological Devices 510(k) Number
Diagnostic Ultrasound Indications for Use Form
Pg. 6.20 of 6.30
29
510 (k) Number (if known):
Device Name:
C7F2 Curved array mechanical 3D transducer for use with
Siemens Acuson ANTARES MODIFICATION Ultrasound System
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 | |||
| Abdominal | P | P | P | P | P | BMDC | Note 2,3,4,5,7 | |||
| Intraoperative | ||||||||||
| Abdominal | ||||||||||
| Intraoperative | ||||||||||
| Neurological | ||||||||||
| Pediatric | P | P | P | P | P | BMDC | Note 2,3,4,5,7 | |||
| 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 | |||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | P | P | P | P | P | BMDC | Note 2,3,4,5,7 | |||
| Musculo-skeletal | ||||||||||
| Superficial | ||||||||||
| Other (specify) |
N = new indication; P = previously cleared by FDA K033196; E = added under Appendix E
Additional Comments:
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 imaqinq
Note 7 B&W 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)
Yancy C. Brogdon
(Division Sign-Off)
Division of Reproduc and Radiological Devices 510kj Nomber
Pg. 6.21 of 6.30
Pg. 6.21 of 6.30
30
510(k) Number (if known):
D. W.
Device Name:
LAP8-4 Laparoscopic Transducer for use with: SIEMENS ACUSON ANTARES MODIFICATION Ultrasound System
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other
(Specify) |
|---------------------------------|---|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative (Note 6) | | P | P | P | | P | P | | BMDC | Note 3,4,5 |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (Note 1) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | |
| Laparoscopic | | P | P | P | | P | P | | BMDC | Note 3,4,5 |
| Musculo-skeletal (Conventional) | | | | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
P = previously cleared by the FDA under # K040060; E = added under Appendix E.
Note I For example: breast, testes, thyroid, penis, prostate, etc.
Note 2 Ensemble tissue harmonic imaging
Note 3 3D imaging
B&W SieScape panoramic imaging Note 4
Power SieScape panoramic imaging Note 5
Note 6 For example: abdominal, vascular
Contrast agent imaging Note 7
Note 8 Virtual format
(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
40103128
Radiological Devices
510(k) Number K06313
31
510(k) Number ar known):
Device Name:
P4-2 Phased Sector Array Transducer for use with:
SIEMENS ACUSON ANTARES MODIFICATION Ultrasound System
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 | P | BMDC | |||
| Abdominal | P | P | P | P | P | P | BMDC | Note 2,3 | ||
| Intraoperative (Note 6) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | P | P | P | P | P | P | BMDC | |||
| Small Organ (Note 1) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | P | P | P | P | P | P | BMDC | Note 2,3 | ||
| Cardiac | P | P | P | P | P | P | BMDC | Note 2,3,7 | ||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal (Conventional) | ||||||||||
| Musculo-skeletal (Superficial) | ||||||||||
| Other (specify) |
P = previously cleared by the FDA under # K040060; E = added under Appendix E.
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
Note 2 Ensemble tissue harmonic imaging
Note 3 3D imaging
Note 4 B&W SieScape panoramic imaging
Note 5 Power SieScape panoramic imaging
Note 6 For example: abdominal, vascular
- Note 7 Contrast agent imaging
Note 8 Virtual format
(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)
CFR 801.109)
Nancy C. Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number. K063138
Diagnostic Ultrasound Indications for Use Form
Pg. 6.23 of 6.30
32
510(k) Number (if
known).
Device Name:
5.0P10 Phased Sector Array Transducer for use with:
SIEMENS ACUSON ANTARES MODIFICATION Ultrasound System
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 | P | BMDC | Note 2 | ||
| Abdominal | P | P | P | P | P | P | BMDC | Note 2 | ||
| Intraoperative (Note 6) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | P | P | P | P | P | P | BMDC | Note 2 | ||
| Small Organ (Note 1) | ||||||||||
| Neonatal Cephalic | P | P | P | P | P | P | BMDC | Note 2 | ||
| Adult Cephalic | ||||||||||
| Cardiac | P | P | P | P | P | P | BMDC | Note 2,7 | ||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal (Conventional) | ||||||||||
| Musculo-skeletal (Superficial) | ||||||||||
| Other (specify) |
P = previously cleared by the FDA under # K040060; E = added under Appendix E.
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
Ensemble tissue harmonic imaging Note 2
Note 3 3D imaging
B&W SieScape panoramic imaging Note 4
Note 5 Power SieScape panoramic imaging
Note 6 For example: abdominal, vascular
Note 7 Contrast agent imaging
Note 8 Virtual format
(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, Abdom and Radiological Devices 510(k) Number_
33
510(k) Number (if known).
Device Name:
MPT7-4 Phased Sector Array TEE Transducer for use with:
SIEMENS ACUSON ANTARES MODIFICATION Ultrasound System
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 | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (Note 6) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (Note 1) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | P | P | P | P | P | P | BMDC | Note 2,3,7 | ||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal (Conventional) | ||||||||||
| Musculo-skeletal (Superficial) | ||||||||||
| Other (specify) |
P = previously cleared by the FDA under # K040060; E = added under Appendix E.
Note 1 For example: breast, testes, thyroid, penis, prostate, etc. -
Note 2 Ensemble tissue harmonic imaging
Note 3 3D imaging
Note 4 B&W SieScape panoramic imaging
Power SieScape panoramic imaging Note 5
Note 6 For example: abdominal, vascular
- Note 7 Contrast agent imaging
Note 8 Virtual format
(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 Reproducti ve. Abdor and Radiological Devices 510(k) Number
Pg. 6.25 of 6.30
34
510(k) Number (if known):
Device Name:
CW2 Continuous Wave Doppler Transducer for use with:
SIEMENS ACUSON ANTARES MODIFICATION Ultrasound System
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 | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (Note 6) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (Note 1) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | P | |||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal (Conventional) | ||||||||||
| Musculo-skeletal (Superficial) | ||||||||||
| Other (specify) |
P = previously cleared by the FDA under # K040060; E = added under Appendix E.
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
Note 2 Ensemble tissue harmonic imaging
Note 3 3D imaging
B&W SieScape panoramic imaging Note 4
Note 5 Power SieScape panoramic imaging
Note 6 For example: abdominal, vascular
Note 7 Contrast agent imaging
Note 8 Virtual format
(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)
801.109)
(Division Sign-Off)
Division of Reproductive, Abdominal
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K0631
35
510(k) Number (f known):
Device Name:
CW5 Continuous Wave Doppler Transducer for use with:
SIEMENS ACUSON ANTARES MODIFICATION Ultrasound System
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 | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (Note 6) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (Note 1) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | P | |||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal (Conventional) | ||||||||||
| Musculo-skeletal (Superficial) | ||||||||||
| Other (specify) |
P = previously cleared by the FDA under # K040060; E = added under Appendix E.
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
Note 2 Ensemble tissue harmonic imaging
Note 3 3D imaging
B&W SieScape panoramic imaging Note 4
Note 5 Power SieScape panoramic imaging
For example: abdominal, vascular Note 6
- Note 7 Contrast agent imaging
Note 8 Virtual format
| (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) Diagnostic Ultrasound Indications for Use Form
Nancy C Burgdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K063138
36
510(k) Number (if known).
Device Name:
P9-4 Phased Sector Array Transducer for use with:
SIEMENS ACUSON ANTARES MODIFICATION Ultrasound System
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| 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 | P | P | BMDC | Note 2 |
| Abdominal | | P | P | P | P | P | P | P | P | BMDC | Note 2 |
| Intraoperative (Note 6) | | | | | | | | | | | |
| Intraoperative Neurological | | P | P | P | P | | P | P | P | BMDC | Note 2 |
| Pediatric | | P | P | P | P | P | P | P | P | BMDC | Note 2 |
| Small Organ (Note 1) | | P | P | P | P | P | P | P | P | | |
| Neonatal Cephalic | | P | P | P | P | P | P | P | P | BMDC | Note 2 |
| Adult Cephalic | | P | P | P | P | P | P | P | P | | |
| Cardiac | | P | P | P | P | P | P | P | P | BMDC | Note 2,7 |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral vessel | | P | P | P | P | P | P | P | P | BMDC | Note 2 |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal (Conventional) | | | | | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | |
P = previously cleared by the FDA under # K050240; E = added under Appendix E.
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
- Note 2 Ensemble tissue harmonic imaging
- Note 3 3D imaging
- B&W SieScape panoramic imaging Note 4
- Note 5 Power SieScape panoramic imaging
- Note 6 For example: abdominal, vascular
- Contrast agent imaging Note 7
- Note 8 Virtual format
(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, Abdominal,
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K063130
37
510(k) Number (if known):
Device Name:
CH5-2 Convex Array Transducer for use with:
SIEMENS ACUSON ANTARES MODIFICATION Ultrasound System
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 | |||
| 2,3,7,8 | ||||||||||
| Abdominal | P | P | P | P | P | BMDC | Note | |||
| 2,3,7,8 | ||||||||||
| Intraoperative (Note 6) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | P | P | P | P | P | BMDC | Note | |||
| 2,3,7,8 | ||||||||||
| Small Organ (Note 1) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | P | P | P | P | P | BMDC | Note | |||
| 2,3,7,8 | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal (Conventional) | ||||||||||
| Musculo-skeletal (Superficial) | ||||||||||
| Other (specify) |
P = previously cleared by the FDA under # K043016; E = added under Appendix E.
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
Note 2 Ensemble tissue harmonic imaging
Note 3 3D imaging
Note 4 B&W SieScape panoramic imaging
Power SieScape panoramic imaging Note 5
Note 6 For example: abdominal, vascular
Contrast agent imaging Note 7
Note 8 Virtual format
(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)
(Division Sign-Off)
Division of Reproductive, Abdo
and Radiological Devices
38
Diagnostic Ultrasound Indications for Use Form 510 (k) Number (if known):
Device Name:
Acuson Antares Diagnostic Ultrasound System
V5M TEE
Transducer: 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 | Power | |||||||||||
| (Amplitude) | ||||||||||||
| Doppler | Color | |||||||||||
| Velocity | ||||||||||||
| Imaging | Combined | |||||||||||
| (Specify) | Other : | |||||||||||
| Harmonic | ||||||||||||
| Imaging | Other : | |||||||||||
| 3D | ||||||||||||
| Ophthalmic | ||||||||||||
| Fetal | ||||||||||||
| Abdominal | N | N | N | N | N | N | N* | N | N | |||
| Intraoperative | ||||||||||||
| Abdominal | ||||||||||||
| Intraoperative | ||||||||||||
| Neurological | ||||||||||||
| Pediatric | N | N | N | N | N | N | N | N | N | |||
| Small Organ | ||||||||||||
| (Specify) ** | ||||||||||||
| Neonatal Cephalic | ||||||||||||
| Adult Cephalic | ||||||||||||
| Cardiac | N | N | N | N | N | N | N* | N | N | |||
| Trans-esophageal | N | N | N | N | N | N | N* | N | N | |||
| Transrectal | ||||||||||||
| Transvaginal | ||||||||||||
| Transurethral | ||||||||||||
| Intravascular | ||||||||||||
| Peripheral vessel | ||||||||||||
| Laparoscopic | ||||||||||||
| Musculo-skeletal | ||||||||||||
| Conventional | ||||||||||||
| Musculo-skeletal | ||||||||||||
| Superficial | ||||||||||||
| Other (specify)*** |
N = new indication; P = previously cleared by FDA (K032114); E = added under Appendix E
Additional Comments:
*Combinations include: B+M, B+PWD, B+Color Doppler, B+M+Color Doppler, B+CWD+Color Doppler,
B+PWD+Color Doppler, B+Power Doppler, B+PWD+Power Doppler, B+CWD+Power Doppler, B+M+Power Doppler
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Por 21 CFR 801.109)
(301.109)
(Division Sign-Off)
Division of Nancy C. Brogdon
Division of Reproductive, Abdon and Radiological Devices . Abdominand Radiological . and Radiological . 6.30 of Diagnostic Ultrasound Indications fobox(R)Wumber