(40 days)
Ultrasound imaging or fluid flow analysis of the human body as follows: Abdominal, Intraoperative, Small Parts, Transcranial, OB/GYN, Cardiac, Transesophageal, Pelvic, Neonatal/Adult Cephalic, 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.
The G60S system is a multi-purpose diagnostic ultrasound system with accessories and proprietary software, and is substantially equivalent to our current products that are already cleared for USA distribution under the following 510(k) PreMarket Notification number: K040060 (January 28, 2004) cleared as SONOLINE G50TM and SONOLINE G60 STM Ultrasound Systems. The G60S ultrasound system has been designed to conform to the following product safety standards: UL 2601-1, Safety Requirements for Medical Equipment, CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment, AIUM/NEMA UD-2, 1998, Acoustic Output Measurement Standard for Diagnostic Ultrasound, AIUM/NEMA UD-3, 1998, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment, 93/42/EEC Medical Device Directive, Safety and EMC Requirements for Medical Equipment, EN 60601-1, EN 60601-1-1, EN 60601-1-2, IEC 1157 Declaration of Acoustic Power, ISO 10993 Biocompatibility. The system's acoustic output is in accordance with ALARA principle (as low as reasonably achievable).
The provided document is a 510(k) Pre-Market Notification for the Siemens SONOLINE G60 S™ Ultrasound System, dated November 23, 2005. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a study to prove performance against specific acceptance criteria for a novel device. Therefore, much of the requested information regarding detailed acceptance criteria, study methodologies, sample sizes, expert qualifications, and ground truth establishment is not available in this type of submission.
Instead, the submission asserts that the SONOLINE G60 S™ system, including its transducers, is substantially equivalent to existing cleared devices based on its intended use and technological characteristics. The "performance" in this context refers to meeting established safety and functional standards, and having equivalent clinical applications and operational modes to predicate devices.
Here's a breakdown of the available information and areas where the requested details are not present:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) for substantial equivalence, specific quantitative acceptance criteria and detailed performance metrics of the new device are not explicitly outlined in a typical "acceptance criteria vs. reported performance" table for novel device validation. The "acceptance criteria" here are implicitly meeting the performance and safety standards demonstrated by the predicate devices and applicable industry standards.
The "reported device performance" is the assertion that the SONOLINE G60 S™ performs similarly to the predicate devices for the listed clinical applications and modes of operation. The tables provided in Sections 6-31 indicate the clinical applications and modes of operation for which each transducer is intended, with 'P' signifying "previously cleared by the FDA under # K040060" (the primary predicate device) and 'E' signifying "added under Appendix E" (new or modified applications, which would still be compared to existing equivalent technology).
| Acceptance Criteria (Implicit) | Reported Device Performance (Implicit, based on Substantial Equivalence) |
|---|---|
| Safety: Conformance to recognized standards. | The G60S system has been designed to conform to UL 2601-1, CSA C22.2 No. 601-1, AIUM/NEMA UD-2 & UD-3, 93/42/EEC Medical Device Directive, EN 60601-1, EN 60601-1-1, EN 60601-1-2, IEC 1157, and ISO 10993. Acoustic output is in accordance with ALARA principle. |
| Intended Use: Device performs for stated applications. | The SONOLINE G60 S™ is intended for Abdominal, Intraoperative, Small Parts, Transcranial, OB/GYN, Cardiac, Transesophageal, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications, providing anatomical measurements and analysis for clinical diagnosis. Transducer-Specific Performance: As indicated in the detailed tables for each transducer (Sections 6-31), each transducer supports specific clinical applications ('P' for previously cleared functionality under K040060, 'E' for added functions in this submission, implying equivalence to other cleared devices). Modes of operation include B, M, PWD, CWD, Color Doppler, Amplitude Doppler, and Combined (BMDC). Additional features noted include Ensemble tissue harmonic imaging, 3D imaging, B&W SieScape panoramic imaging, Power SieScape panoramic imaging, and Contrast agent imaging. The assumption is that these functions perform comparably to those on the predicate device(s). |
| Technological Equivalence: Functionally similar to predicate. | The G60S™ is substantially equivalent in its technologies and functionality to the SONOLINE G50™ and SONOLINE G60 S™ Diagnostic Ultrasound Systems (K040060). It functions in the same manner by transmitting ultrasonic energy, processing reflected echoes to generate 2D images, and using Doppler principles for blood flow display. Specialized measurements and calculation functions are also equivalent. |
| Acoustic Output: Within safe limits. | A post-clearance special report is required for acoustic output measurements based on production line devices (Appendix G of September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers"). This ensures acoustic output is within approved levels. This is a post-market requirement to confirm manufacturing consistency, not a pre-market performance study comparing the device to a gold standard. |
2. Sample Size Used for the Test Set and the Data Provenance
This submission does not describe a clinical study with a "test set" in the traditional sense of evaluating a novel algorithm's diagnostic performance against a dataset. The focus is on demonstrating engineering and functional equivalence to existing cleared devices. Therefore, details about sample size and data provenance for a test set are not provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Since a clinical study with a test set is not described, there is no information on experts used to establish ground truth.
4. Adjudication Method for the Test Set
As no test set or clinical performance study is described, there is no adjudication method mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
This document describes a diagnostic ultrasound system, not an AI-assisted diagnostic tool. Therefore, an MRMC comparative effectiveness study involving AI assistance is not applicable and not mentioned in this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This submission pertains to a diagnostic ultrasound system and its transducers, which are imaging devices operated by trained medical professionals. It does not describe a standalone algorithm or AI performance.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
Given that this is a substantial equivalence submission for hardware and basic imaging functionalities, the "ground truth" implicitly refers to the established and accepted clinical utility and image interpretation capabilities of the predicate devices. There is no mention of specific ground truth types in the context of a new efficacy study.
8. The Sample Size for the Training Set
This submission does not describe an AI or machine learning model that would require a "training set." Therefore, no information on training set sample size is provided.
9. How the Ground Truth for the Training Set Was Established
As there is no training set described, there is no information on how its ground truth would have been established.
{0}------------------------------------------------
K052894
SONOLINE G60 S
TM Ultrasound System
Special 510(k) Submission
Siemens Medical Solutions USA, Inc. Ultrasound Division
NOV 2 3 2005
SECTION 11
510(k) Summary of Safety and Effectiveness
| Sponsor: | Siemens Medical Solutions USA, Inc., Ultrasound Division1230 Shorebird WayP.O. Box 7393Mountain View, California 94039-7393 |
|---|---|
| Contact Person: | Iskra MrakovićManager, Regulatory AffairsTelephone: (650) 694-5004Fax: (650) 943-7053 |
| Submission Date: | October 13, 2005 |
| Device Name: | SONOLINE G60 STM Ultrasound System |
| Common Name: | Diagnostic Ultrasound System with Accessories |
Classification:
Regulatory Class: II Review Category: Tier II Classification Panel: Radiology
21 CFR 892.1550
| Ultrasonic Pulsed Doppler Imaging System | FR # | Product Code |
|---|---|---|
| Ultrasonic Pulsed Echo Imaging System | ||
| Diagnostic Ultrasound Transducer | ||
| 892.1550 | 90-IYN | |
| 892.1560 | 90-IYO | |
| 892.1570 | 90-ITX |
Predicate Device(s):
-
K040060 (January 28, 2004), cleared as SONOLINE G50™ and SONOLINE G60 . STM Diagnostic Ultrasound Systems.
-
K042833 (October 27, 2004), cleared as SONOLINE G20™ Diagnostic Ultrasound . System.
-
K043016 (November 16, 2004), cleared as SONOLINE Orchid™ Diagnostic . Ultrasound System.
-
K050240 (March 9, 2005), cleared as ACUSO CV70™ Cardiovascular System. .
{1}------------------------------------------------
Device Description:
The G60S system is a multi-purpose diagnostic ultrasound system with accessories and proprietary software, and is substantially equivalent to our current products that are already cleared for USA distribution under the following 510(k) PreMarket Notification number:
-
K040060 (January 28, 2004) cleared as SONOLINE G50TM and SONOLINE . G60 STM Ultrasound Systems.
The G60S ultrasound system has been designed to conform to the following product safety standards:
- UL 2601-1, Safety Requirements for Medical Equipment ●
- CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment .
- AIUM/NEMA UD-2, 1998, Acoustic Output Measurement Standard for Diagnostic ● Ultrasound
- AIUM/NEMA UD-3, 1998, Standard for Real Time Display of Thermal and . Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
- 93/42/EEC Medical Device Directive ●
- . Safety and EMC Requirements for Medical Equipment
- EN 60601-1 ●
- · EN 60601-1-1
- . EN 60601-1-2
- IEC 1157 Declaration of Acoustic Power ●
- ISO 10993 Biocompatibility .
- The system's acoustic output is in accordance with ALARA principle (as low as . reasonably achievable)
Intended Use:
The SONOLINE G60 S™ ultrasound imaging system is intended for the following applications: Abdominal, Intraoperative, Small Parts, Transcranial, OB/GYN, Cardiac, Transesophageal, Pelvic, Neonatal/Adult Cephalic, 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.
{2}------------------------------------------------
Technological Comparison to Predicate Device:
The G60S™ is substantially equivalent in its technologies and functionality to the SONOLINE G50™ and SONOLINE G60 S™ Diagnostic Ultrasound Systems that are already cleared under 510(k) premarket notification number K040060.
The G60S functions in the same manner as other diagnostic ultrasound systems, in that they transmit ultrasonic energy into the body via a transducer. In the body, acoustic impedance of different tissues reflect different amounts of ultrasound energy back to the transducer, where post-processing of received echoes is performed to generate twodimensional on-screen images of anatomic structures and fluid flow within the body. Doppler principles are used to process reflected ultrasound energy to display moving blood as a spectrum, or as color-coded two-dimensional images. All predicate devices listed above, allow for specialized measurements of structures and flow, and provide various calculations' functions.
Remaining of the page left blank intentionally.
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
NOV 2 3 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Iskra Mrakovic Manager, Regulatory Affairs Siemens Medical Solutions USA, Inc., Ultrasound Division 1230 Shorebird Way P.O. Box 7393 MOUNTAIN VIEW CA 94039-7393
Re: K052894
Trade Name: SONOLINE G60 STM Ultrasound System Regulation Number: 21 CFR 892.1550; 892.1560; 892.1570 Regulation Name: Ultrasonic pulsed Doppler imaging system; Ultrasonic pulsed echo imaging system; Diagnostic ultrasonic transducer Regulatory Class: II Product Code: IYN; IYO; ITX Dated: October 13, 2005 Received: November 14, 2005
Dear Ms. Mrakovic:
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 G60 STM Ultrasound System, as described in your premarket notification:
Transducer Model Number
C5-2; C6-2; C8-5; 5.0C50+; C6-3 3D; EV9-4; Endo-VII; Endo-V 3D; EC9-4; 5.0L45; 7.5L70; LB5-2; L10-5; VF13-5; VF13-5SP; 7.5L50I; 7.5L50Q; LAP8-4; P4-2; 5.0P10; MPT7-4; CW2; CW5; P9-4; CH5-2
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.
{4}------------------------------------------------
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, Marvland 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.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}------------------------------------------------
510(k) Number (if known):
Device Name:
SONOLINE G60 S™ Ultrasound System
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | 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 | BMDC | Note 3 | |||
| Intraoperative Neurological | 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 | E | P | P | BMDC | Note 2,3,7 | ||
| 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 | P | P | P | P | P | P | BMDC | Note 2,3,4,5 | ||
| Laparoscopic | 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 # K040060; E = added under Appendix E.
For example: breast, testes, thyroid, penis, prostate, etc. Note 1
Note 2 Ensemble tissue harmonic imaging
3D imaging Note 3
B&W SieScape panoramic imaging Note 4
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)
Maneye Brogdon
ivision Sign-Off)
vision of Reproductive, Abdominal,
ad Rod
Radiological Devices
510(k) Number KA52894
Indications for Use Forms
··············································································································································································
{6}------------------------------------------------
510(k) Number (if known):
Device Name:
Intended Use:
C5-2 Convex Array Transducer for use with: SONOLINE G60 S Ultrasound System Ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | 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.
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
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)
Nancy C. Beardon
(Division Sign Division of Reproductive, Abdominal, and Radiological Devices 51(%) Number
{7}------------------------------------------------
510(k) Number (if known):
Device Name:
Intended Use:
C6-2 Convex Array Transducer for use with: SONOLINE G60 S Ultrasound System Ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | 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 | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| 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
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
(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)
Danny C. Brandon
(Division Sig Division of Reproductive, A and Radiological Device 510(k) Number
Section 6
Indications for Use Forms
Pg. 3 of 27
{8}------------------------------------------------
510(k) Number (if known):
Device Name:
Intended Use:
C8-5 Convex Array Transducer for use with: SONOLINE G60 S Ultrasound System Ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | 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
B&W SieScape panoramic imaging Note 4
Note 5 Power SieScape panoramic imaging
Note 6 For example: abdominal, vascular
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)
Nancy C. Broughton
(Division Sign-Off Division of Reproc and Radio 510(k) Num
Indications for Use Forms
{9}------------------------------------------------
510(k) Number (if known):
'
Device Name:
Intended Use:
5.0C50+ Convex Array Transducer for use with: SONOLINE G60 S Ultrasound System Ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | 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
B&W SieScape panoramic imaging Note 4
Note S Power SieScape panoramic imaging
Note 6 For example: abdominal, vascular
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)
Mauree Gordon
(DMsion Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K052894
Section 6
Indications for Use Forms
{10}------------------------------------------------
510(k) Number (if known):
Device Name:
C6-3 3D Mechanically Driven 3D Convex Array Transducer for use with: SONOLINE G60 S 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 | ColorDoppler | AmplitudeDoppler | 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.
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
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)
Nancy Brogdon
(Division Sign-Division of Reproductiv and Radiological Device 510(k) Number
Indications for Use Forms
Pg. 6 of 27
{11}------------------------------------------------
.
Diagnostic Ultrasound Indications for Use Form
510(k) Number (if known):
Device Name:
Intended Use:
EV9-4 Convex Array Endovaginal Transducer for use with: SONOLINE G60 S Ultrasound System Ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | 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 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
(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. broadin
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number
$\qquad$ K052894
Indications for Use Forms
{12}------------------------------------------------
510(k) Number (if known):
Device Name:
Endo-VII Mechanical Sector Endovaginal Transducer for use with: SONOLINE G60 S 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 | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | 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 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 S Power SieScape panoramic imaging
- Note 6 For example: abdominal, vascular
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)
Vancy C. Hogdon
(Division Sign-Off)
Division of Reproductive, Abd and Radiological Devices 510(k) Number
{13}------------------------------------------------
510(k) Number (if known):
Device Name:
Endo-V 3D Mechanical Sector Endovaginal Transducer for use with:
Intended Use:
SONOLINE G60 S Ultrasound System
Ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | 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 I
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
(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)
Nawyc trogdon
(Division Sign-Off)
Division of B
Division of Reproductive, Abdominal, and Radiological Devices ் 1 (k) Number
{14}------------------------------------------------
510(k) Number (if known):
Device Name:
Intended Use:
EC9-4 Convex Array Endovaginal Transducer for use with: SONOLINE G60 S Ultrasound System
Ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | 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 l 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 S Power SieScape panoramic imaging
Note 6 For example: abdominal, vascular
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)
Daveyc Hogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number
K052894
{15}------------------------------------------------
510(k) Number (if known):
Device Name:
Intended Use:
BE9-4 Convex Array Endocavity Transducer for use with: SONOLINE G60 S Ultrasound System
Ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | 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 l 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
(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 Brigdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number
K062899
{16}------------------------------------------------
510(k) Number (if known):
Device Name:
Intended Use:
5.0L45 Linear Array Transducer for use with: SONOLINE G60 S Ultrasound System Ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(Specify) | Other(Specify) |
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | 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 | BMDC | Note 2,3,4,5 | ||
| Laparoscopic | ||||||||||
| Musculo-skeletal (Conventional) | 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 l 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
(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)
Mancy Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
Medical Devices
2052894
Indications for Use Forms
ﻟﻤﺴﺘﻌﻤﺎ ﻋﻠﻰ ﻣﻌﻬﺪ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴ
{17}------------------------------------------------
510(k) Number (if known):
Device Name:
7.5L70 Linear Array Transducer for use with: SONOLINE G60 S 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 | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | 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 I 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
- 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)
Nancy C. Broadron
(Division Sign-Off)
Section 6
{18}------------------------------------------------
510(k) Number (if known):
Device Name:
Intended Use:
LB5-2 Linear Array Transducer for use with: SONOLINE G60 S Ultrasound System Ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | 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.
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
(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
{19}------------------------------------------------
510(k) Number (if known):
Device Name:
Intended Use:
L10-5 Linear Array Transducer for use with: SONOLINE G60 S Ultrasound System Ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(Specify) | Other(Specify) | |
| Ophthalmic | |||||||||||
| Fetal | |||||||||||
| 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) | P | P | P | P | P | BMDC | Note 2,3,4,5 | ||||
| Neonatal Cephalic | P | P | P | P | P | BMDC | Note 2,3,4,5 | ||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral vessel | P | P | P | P | P | BMDC | Note 2,3,4,5 | ||||
| Laparoscopic | |||||||||||
| Musculo-skeletal (Conventional) | P | P | P | P | P | BMDC | Note 2,3,4,5 | ||||
| Musculo-skeletal (Superficial) | P | P | P | P | P | BMDC | Note 2,3,4,5 | ||||
| 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
For example: abdominal, vascular Note 6
Contrast agent imaging Note 7
(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 [K052894](https://510k.innolitics.com/search/K052894)
{20}------------------------------------------------
510(k) Number (if known):
Device Name:
Intended Use:
VF13-5 Linear Array Transducer for use with: SONOLINE G60 S 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<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| 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 | | P | P | P | P | P | P | | BMDC | Note 3,4,5 |
| 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) | | P | P | P | P | P | P | | BMDC | Note 3,4,5 |
| Musculo-skeletal (Superficial) | | P | P | P | P | P | P | | BMDC | Note 3,4,5 |
| Other (specify) | | | | | | | | | | |
P = previously cleared by the FDA under # [K040060](https://510k.innolitics.com/search/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
> (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. Hodson
(Division Sign-Off)
Division of Reproductive, Abdominal.
Division of Reproductive, Abdon and Radiological Devices 510(k) Number
{21}------------------------------------------------
510(k) Number (if known):
Device Name:
Intended Üse:
VF13-5SP Linear Array Transducer for use with: SONOLINE G60 S 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<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative (Note 6) | | P | P | P | | P | P | | BMDC | Note 3,4,5 |
| Intraoperative Neurological | | P | P | P | | P | P | | BMDC | Note 3,4,5 |
| 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 | | | | | | | | | | |
| 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 | | P | P | P | | P | P | | BMDC | Note 3,4,5 |
| Other (specify) | | | | | | | | | | |
P = previously cleared by the FDA under # [K040060](https://510k.innolitics.com/search/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
> (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 Dai
and Radiological Devices 510(k) Number
Section 6
Indications for Use Forms
Pg. 17 of 27
{22}------------------------------------------------
510(k) Number (if known):
Device Name:
Intended Use:
7.5L50I Linear Array Transducer for use with: SONOLINE G60 S 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<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(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](https://510k.innolitics.com/search/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
> (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
with - A - A - A - A - A - A - A - - - - - - - -
Section 6
Indications for Use Forms
Pg. 18 of 27
{23}------------------------------------------------
510(k) Number (if known):
Device Name:
Intended Use:
7.5L50Q Linear Array Transducer for use with: SONOLINE G60 S Ultrasound System Ultrasound imaging or fluid flow analysis of the human body as follows:
Mode of Operation Clinical Application Color Color Amplitude Combined Other A B M PWD CWD Velocity Doppler Doppler (Specify) (Specify) Imaging 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](https://510k.innolitics.com/search/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
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)
Nancy C. Brandon
(Division Sign-Off)
Division of Reproductive, Abd and Radiological Devices 510(k) Number
{24}------------------------------------------------
510(k) Number (if known):
Device Name:
Intended Use:
LAP8-4 Laparoscopic Transducer for use with: SONOLINE G60 S 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<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(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](https://510k.innolitics.com/search/K040060); E = added under Appendix E.
For example: breast, testes, thyroid, penis, prostate, etc. Note I
Note 2 Ensemble tissue harmonic imaging
3D imaging Note 3
B&W SieScape panoramic imaging Note 4
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)
Nancy C. Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number [K152894](https://510k.innolitics.com/search/K152894)
{25}------------------------------------------------
510(k) Number (if known):
Device Name:
Intended Use:
P4-2 Phased Sector Array Transducer for use with: SONOLINE G60 S 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<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(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](https://510k.innolitics.com/search/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
Note 4 B&W SieScape panoramic imaging
Power SieScape panoramic imaging Note 5
Note 6 For example: abdominal, vascular
Contrast agent imaging Note 7
> (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. Horton
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices ా (´)(k) Number _____________________________________________________________________________________________________________________________________________________________
Section 6
Indications for Use Forms
Pg. 21 of 27
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------1000 xizanti and the country
{26}------------------------------------------------
510(k) Number (if known):
Device Name:
5.0P10 Phased Sector Array Transducer for use with: SONOLINE G60 S 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<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(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](https://510k.innolitics.com/search/K040060); E = added under Appendix E.
Note l 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
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)
Nancy C. Thornton
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices b ! Oik) Number ______________________________________________________________________________________________________________________________________________________________
Section 6
Indications for Use Forms
Pg. 22 of 27
{27}------------------------------------------------
510(k) Number (if known):
Device Name:
Intended Use:
MPT7-4 Phased Sector Array TEE Transducer for use with: SONOLINE G60 S 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<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(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](https://510k.innolitics.com/search/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 S Power SieScape panoramic imaging
Nole 6 For example: abdominal, vascular
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)
Nanc C brogdon
`(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices`
510(k) Number
Section 6
Indications for Use Forms
Pg. 23 of 27
{28}------------------------------------------------
510(k) Number (if known):
Device Name:
CW2 Continuous Wave Doppler Transducer for use with: SONOLINE G60 S 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 | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | 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
Note 4 B&W SieScape panoramic imaging
Power SieScape panoramic imaging Note 5
Note 6 For example: abdominal, vascular
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)
Nancy i hoadon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
K Number
K057894
Section 6
Indications for Use Forms
Pg. 24 of 27
{29}------------------------------------------------
510(k) Number (if known):
Device Name:
Intended Use:
CW5 Continuous Wave Doppler Transducer for use with: SONOLINE G60 S Ultrasound System
Ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | 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 l 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
(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. hoadon
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices ි වි(); Number
{30}------------------------------------------------
510(k) Number (if known):
Device Name:
P9-4 Phased Sector Array Transducer for use with: SONOLINE G60 S 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 | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | 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 | P | P | P | P | P | BMDC | Note 2 | |||
| Pediatric | P | P | P | P | P | P | BMDC | Note 2 | ||
| Small Organ (Note 1) | P | P | P | P | P | P | BMDC | Note 2 | ||
| Neonatal Cephalic | P | P | P | P | P | P | BMDC | Note 2 | ||
| Adult Cephalic | P | P | P | P | P | P | BMDC | Note 2 | ||
| Cardiac | P | P | P | P | P | P | BMDC | Note 2,7 | ||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | 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 I 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 S 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)
Nancy Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number
K052894
Section 6
Indications for Use Forms
Pg. 26 of 27
Andrews and
{31}------------------------------------------------
510(k) Number (if known):
Device Name:
CH5-2 Convex Array Transducer for use with: SONOLINE G60 S 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 | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(Specify) | Other(Specify) | |
| Ophthalmic | |||||||||||
| Fetal | P | P | P | P | P | BMDC | Note 2,3 | ||||
| Abdominal | P | P | P | P | P | BMDC | Note 2,3 | ||||
| Intraoperative (Note 6) | |||||||||||
| Intraoperative Neurological | |||||||||||
| Pediatric | P | P | P | P | P | BMDC | Note 2,3 | ||||
| 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 | ||||
| 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.
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
(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. Thompson
(Division Sign-Off tive. Abdom Division of Reproduct ano Radiological Devices · : 'Xki Number
§ 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.