(31 days)
Not Found
No
The document describes a standard diagnostic ultrasound system with various imaging modes and software accessories for image management. There is no mention of AI, ML, or any related technologies in the intended use, device description, or performance study summary. The repeated "Note 1" sections appear to be a formatting error and do not introduce AI/ML concepts.
No
The device is described as a "diagnostic ultrasound system" and its intended use is for "diagnostic ultrasound imaging or fluid flow analysis". There is no mention of therapeutic applications.
Yes
The "Intended Use / Indications for Use" section explicitly states "The device is intended for prescription use... for diagnostic ultrasound imaging". The "Device Description" also refers to it as a "diagnostic ultrasound system".
No
The device description explicitly states it is a "full featured, general purpose, software controlled, diagnostic ultrasound system". While it is software controlled, it is a system that includes hardware components for acquiring and displaying ultrasound data. The software components mentioned (SiteLink™ Image Manager and SonoSite® DICOM/Clips Bundle) are described as accessories or options for the SonoSite Maxx Series medical diagnostic ultrasound systems, which are hardware devices.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use/Indications for Use: The intended use clearly states "for diagnostic ultrasound imaging or fluid flow analysis of the human body". This describes an in vivo diagnostic procedure, where the device interacts directly with the patient's body to obtain information.
- Device Description: The description details a "diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data". This further confirms its function as an in vivo imaging device.
- Lack of mention of in vitro testing: There is no mention of the device being used to examine specimens (like blood, urine, tissue samples) outside of the body, which is the defining characteristic of an IVD.
- Anatomical Site: The listed anatomical sites are all locations within the human body.
In summary, the device is a medical diagnostic ultrasound system used for imaging and analysis within the human body, not for testing samples outside the body. Therefore, it is not an IVD.
N/A
Intended Use / Indications for Use
The device is intended for prescription use (Per 21 CFR 801.109) for diagnostic ultrasound imaging or fluid flow analysis of the human body in the following clinical applications:
Ophthalmic
Fetal - OB/GYN
Abdominal
Intra-operative (Abdominal organs and vascular)
Intra-operative (Neuro.)
Laparoscopic
Pediatric
Small Organ (breast, thyroid, testicles, prostate)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-esophageal (card.)
Musculo-skel. (Conventional)
Musculo-skel. (Superficial)
Cardiac Adult
Cardiac Pediatric
Peripheral vessel
SiteLink™ Image Manager is a software accessory for SonoSite Maxx Series medical diagnostic ultrasound systems. SiteLink enables image download, in full resolution .bmp format or compressed .jpg format, from SonoSite systems to a Windows-based PC.
The SonoSite® DICOM/Clips Bundle is a software option available on SonoSite Maxx Series™ medical diagnostic uitrasound systems. It is intended for acceptance, transfer, display, storage, archive and manipulation of digital medical images, including quantification and report generation.
Product codes (comma separated list FDA assigned to the subject device)
90-IYN, 90-IYO, 90-ITX, 90-LLZ
Device Description
The SonoSite Maxx Series Ultrasound System is a full featured, general purpose, software controlled, diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data in 2D, 2D Chroma, THI, M-Mode, Pulsed Wave (PW) Doppler, Continuous Wave (CW) Doppler, Color Power Doppler, Velocity Color Doppler, Anatomical M-Mode, Color M-Mode, Pulsed Wave Tissue Doppler Imaging (PW-TDI), Color Tissue Doppler Imaging (Color-TDI), Elastography (Strain), Strain Rate Imaging, tissue 4D and flow 3D imaging or in a combination of these modes. The SonoSite Maxx Series is a design that readily lends itself to be configured to specific ultrasound imaging applications through physical packaging and system feature selections.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Ophthalmic, Fetal, Abdominal, Intra-operative (Abdominal organs and vascular), Intra-operative (Neuro.), Laparoscopic, Pediatric, Small Organ (breast, thyroid, testicles, prostate), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-urethral, Trans-esophageal (non-Card.), Musculo-skeletal (Conventional), Musculo-skeletal (Superficial), Intra-luminal, Cardiac (Adult/Pediatric), Peripheral vessel
Indicated Patient Age Range
Not Found
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 device is verified and validated according to the company's design control process.
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.
K071134, K053069, K043559, K034003, K011224, K061129
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.
Not Found
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
Image /page/0/Picture/22 description: The image shows the logo for SonoSite. The logo consists of a stylized, abstract symbol above the word "SonoSite." The symbol is a dark, curved shape that resembles a stylized "S" or a swirling motion. The word "SonoSite" is written in a serif font, with the letters slightly spaced apart.
AUG 2 5 2008
SonoSite, Inc. 21949 30th Drive SF Bothell, WA 98021-3904 USA
Telephone:1.425.951.1200 Facsimile:1 425.951.1201 www.sonnsite.com
510(K) Summary of Safety and Effectiveness
This summary of safety and effectiveness is provided as part of this Premarket Notification in compliance with 21 CFR, Part 807, Subpart E, Section 807.92.
1) Submitter's name, address, telephone number, contact person:
SonoSite, Inc., 21919 30th Drive SE, Bothell, WA 98021-3904 USA
| Corresponding Official: | Christopher J. Hartzog, Sr. Regulatory Affairs Specialist |
|---|---|
| E-mail: | chris hartzog@sonosite.com |
| Telephone: | (425) 951-1419 |
| Facsimile: | (425) 951-1201 |
| Date prepared: | July 1, 2008 |
-
- Name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known:
Common/ Usual Name Diagnostic Ultrasound System with Accessories
- Name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known:
Proprietary Name
SonoSite Maxx™ Series Ultrasound System (subject to change)
Classification Names
| Name | FR Number | Product Code |
|---|---|---|
| Ultrasonic Pulsed Doppler Imaging System | 892.1550 | 90-IYN |
| Ultrasonic Pulsed Echo Imaging System | 892.1560 | 90-IYO |
| Diagnostic Ultrasound Transducer | 892.1570 | 90-ITX |
| Picture Archiving And Communications System | 892.2050 | 90-LLZ |
3) Identification of the predicate or legally marketed device:
SonoSite, Inc. believes that the System described in this Submission is substantially equivalent to a combination of the SonoSite Maxx™ Series Ultrasound System (K071134), the SonoSite MicroMaxx® Ultrasound System (K053069 and K043559), the Philips Medical Systems HDP 5000 Ultrasound System (K034003 and K011224) and the GE Logiq 9 Ultrasound System (K061129),
4) Device Description:
The SonoSite Maxx Series Ultrasound System is a full featured, general purpose, software controlled, diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data in 2D, 2D Chroma, THI, M-Mode, Pulsed Wave (PW) Doppler, Continuous Wave (CW) Doppler, Color Power Doppler, Velocity Color Doppler, Anatomical M-Mode, Color M-Mode, Pulsed Wave Tissue Doppler Imaging (PW-TDI), Color Tissue Doppler Imaging (Color-TDI), Elastography (Strain), Strain Rate Imaging, tissue 4D and flow 3D imaging or in a combination of these modes. The SonoSite Maxx Series is a design that readily lends itself to be configured to specific ultrasound imaging applications through physical packaging and system feature selections.
1
5) Indications for Use
The device is intended for prescription use (Per 21 CFR 801.109) for diagnostic ultrasound imaging or fluid flow analysis of the human body in the following clinical applications:
| Ophthalmic | Adult Cephalic |
|---|---|
| Fetal - OB/GYN | Trans-rectal |
| Abdominal | Trans-vaginal |
| Intra-operative | |
| (Abdominal organs and vascular) | Musculo-skel. (Conventional) |
| Intra-operative (Neuro.) | Musculo-skel. (Superficial) |
| Laparoscopic | Cardiac Adult |
| Pediatric | Cardiac Pediatric |
| Small Organ | |
| (breast, thyroid, testicles, prostate) | Trans-esophageal (card.) |
| Neonatal Cephalic | Peripheral vessel |
5) Comparison with Predicate Devices
The SonoSite Maxx™ Series Ultrasound System is of a comparable type and substantially equivalent to the current SonoSite Maxx™ Series Ultrasound System. It has the same technological characteristics, safety and effectiveness features, the same physical design and materials. The system has the same intended use and basic operating modes as the SonoSite, Philips HD15000 and GE Logiq 9 predicate devices.
6) Performance Data
The device is verified and validated according to the company's design control process.
7) Conclusion
Intended uses and other key features are consistent with traditional clinical practice and FDA guidance. The product development process conforms with 21 CFR 820, ISO 9001:2000 and ISO 13485 quality systems. The device conforms to applicable electromedical device safety standards with compliance verified through independent evaluation and ongoing factory audits. Medical diagnostic ultrasound has an established history of safety and effectiveness. It is the opinion of SonoSite, Inc. that the SonoSite Maxx™ Series Ultrasound System is substantially equivalent with regard to safety and effectiveness to other devices already cleared for marketing.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is facing left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged in a circular pattern around the eagle.
Public Health Service
od and Drug Administration 200 Corporate Boulevard Rockville MD 20850
AUG 2 5 2008
SonoSite, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25" Street NW BUFFALO MN 55313
Re: K082098
Trade/Device Name: SonoSite Maxx™ Series Ultrasound System (SiteLink™ Image Manager and SonoSite® DICOM/Clips Bundle) Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX, and LLZ Dated: July 24, 2008 Received: July 25, 2008
Dear Mr. Job:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
This determination of substantial equivalence applies to the following transducers intended for use with the SonoSite Maxx™ Series Ultrasound System (SiteLink™ Image Manager and SonoSite® DICOM/Clips Bundle), as described in your premarket notification:
Transducer Model Number
| BPTRTx/8-5 | D5x/5 | ICTx/8-5 |
|---|---|---|
| C8x/8-5 | C60x/5-2 | L25x-13-6 |
| C11x/8-5 | HFL38x/13-6 | L38x/10-5 |
| D2x/2 | HFL50x/15-6 | L52x/10-5 |
3
| LAPx/12-5 | TCDx/2 | WC40x/6-2 |
|---|---|---|
| MiniTEEx/7-3 | TEEx/8-3 | WC60x/6-2 |
| P10x/8-4 | L25Bx/10-5 | WI.25x/12-5 |
| P17x/5-1 | LFL38x/7-3 | WL40x/12-5 |
| P21x/5-1 | P21Dx/5-1 | WMC15x/12-4 |
| SLAx/13-6 | P21MCx/5-1 | WMC20x/12-4 |
| SLTx/10-5 | P21Sx/7-1 | WTVx/9-3 |
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G. (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.
The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:
Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850
This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.
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,
4
"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
If you have any questions regarding the content of this letter, please contact Andrew Kang, M.D. at (240) 276-3666.
Sincerely yours,
Noyn M. Why
( Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
5
K082098
Table 4.3- 1 Diagnostic Ultrasound Indications for Use Form – SonoSite Maxx™ Series Ultrasound System
| System: | SonoSite Maxx™ Series Ultrasound System | ||||||
|---|---|---|---|---|---|---|---|
| Transducer: | N/A | ||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | ||||||
| Clinical Application | Mode of Operation | ||||||
| B | M | PWD | CWD | Color | |||
| Doppler | Combined | ||||||
| (Spec.) | Other | ||||||
| (Spec.) | |||||||
| Ophthalmic | P | P | P | P | B+M; B+PWD; | ||
| B+CD | |||||||
| Fetal | P | P | P | P | B+M; B+PWD; | ||
| B+CD | Note 1 | ||||||
| Abdominal | |||||||
| Intra-operative (Abdominal | |||||||
| organs and vascular) | P | P | P | P | P | B+M; B+PWD; | |
| B+CWD; B+CD | Note 1 | ||||||
| Intra-operative (Neuro.) | P | P | P | P | B+M; B+PWD; | ||
| B+CD | Note 1 | ||||||
| Laparoscopic | P | P | P | P | B+M; B+PWD; | ||
| B+CD | Note 1 | ||||||
| Pediatric | |||||||
| Small Organ (breast, thyroid, | |||||||
| testicles, prostate) | P | P | P | P | P | B+M; B+PWD; | |
| B+CWD; B+CD | Note 1 | ||||||
| Neonatal Cephalic | P | P | P | P | B+M; B+PWD; | ||
| B+CD | Note 1 | ||||||
| Adult Cephalic | P | P | P | P | B+M; B+PWD; | ||
| B+CD | Note 1 | ||||||
| Trans-rectal | P | P | P | P | B+M; B+PWD; | ||
| B+CD | Note 1 | ||||||
| Trans-vaginal | |||||||
| Trans-urethral | P | P | P | P | B+M; B+PWD; | ||
| B+CD | Note 1 | ||||||
| Trans-esoph. (non-Card.) | |||||||
| Musculo-skel. (Convent.) | P | P | P | P | B+M; B+PWD; | ||
| B+CD | Note 1 | ||||||
| Musculo-skel. (Superfic.) | |||||||
| Intra-luminal | P | P | P | P | B+M; B+PWD; | ||
| B+CD | Note 1 | ||||||
| Other (spec.) | |||||||
| Cardiac Adult | P | P | P | P | P | B+M; B+PWD; | |
| B+CWD; B+CD | Note 1 | ||||||
| Cardiac Pediatric | P | P | P | P | P | B+M; B+PWD; | |
| B+CWD; B+CD | Note 1 | ||||||
| Trans-esophageal (card.) | |||||||
| Other (spec.) | P | P | P | P | P | B+M; B+PWD; | |
| B+CWD; B+CD | Note 1 | ||||||
| Peripheral vessel | |||||||
| Other (spec.) | P | P | P | P | B+M; B+PWD; | ||
| B+CD | Note 1 |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
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All items marked "P" were previously cleared in 510(k) K071134. (DiviSiON
Prescription Use (Per 21 CFR 801.109)
huzd In Whhy
Division of Reproductive, Abdominal and
Indications for Use
Radiological J10(k) Number
Section 4.3
6
INDICATIONS FOR USE
510(k) Number (if known):
Device Name: SiteLink™ Image Manager
Indications for Use: SiteLink™ Image Manager is a software accessory for SonoSite Maxx Series medical diagnostic ultrasound systems. SiteLink enables image download, in full resolution .bmp format or compressed .jpg format, from SonoSite systems to a Windows-based PC.
ਡ Over-The-Counter Use: Prescription Use: or (Part 21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Optional Format 3-10-98)
Arpitk Whan
(Division Sign-Off)
ion of Reproductive, Abdominal and ological Devices J(k) Number __
7
INDICATIONS FOR USE
510(k) Number (if known):
Device Name: SonoSite® DICOM/Clips Bundle
Indications for Use: The SonoSite® DICOM/Clips Bundle is a software option available on SonoSite Maxx Series™ medical diagnostic uitrasound systems. It is intended for acceptance, transfer, display, storage, archive and manipulation of digital medical images, including quantification and report generation.
| Prescription Use: | \u2713 or Over-The-Counter Use: \u25a1 |
|---|---|
| (Part 21 CFR 801 Subpart D) | (Part 21 CFR 807 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Optional Format 3-10-98)
Vorich Whing
(Division Sign-Off)
Division of Reproductive, Abdominal and Radiological Devices 510(k) Number _
8
082010
Table 4.3- 2 Diagnostic Ultrasound Indications for Use Form – BPTRTx/8-5 Transducer
| System: | SonoSite Maxx™ Series Ultrasound System | ||||||
|---|---|---|---|---|---|---|---|
| Transducer: | BPTRTx/8-5 MHz Transducer | ||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as | ||||||
| follows: | |||||||
| Clinical Application | Mode of Operation | ||||||
| B | M | PWD | CWD | Color | |||
| Doppler | Combined | ||||||
| (Spec.) | Other | ||||||
| (Spec.) | |||||||
| Ophthalmic | |||||||
| Fetal | P | P | P | P | B+M; B+PWD; | ||
| B+CD | Note 1 | ||||||
| Abdominal | |||||||
| Intra-operative (Abdominal | |||||||
| organs and vascular) | |||||||
| Intra-operative (Neuro.) | |||||||
| Laparoscopic | |||||||
| Pediatric | |||||||
| Small Organ (breast, thyroid, | |||||||
| testicles. prostate) | P | P | P | P | B+M; B+PWD; | ||
| B+CD | Note 1 | ||||||
| Neonatal Cephalic | |||||||
| Adult Cephalic | |||||||
| Trans-rectal | P | P | P | P | B+M; B+PWD; | ||
| B+CD | Note 1 | ||||||
| Trans-vaginal | P | P | P | P | B+M; B+PWD; | ||
| B+CD | Note 1 | ||||||
| Trans-urethral | |||||||
| Trans-esoph. (non-Card.) | |||||||
| Musculo-skel. (Convent.) | |||||||
| Musculo-skel. (Superfic.) | |||||||
| Intra-luminal | |||||||
| Other (spec.) | |||||||
| Cardiac Adult | |||||||
| Cardiac Pediatric | |||||||
| Trans-esophageal (card.) | |||||||
| Other (spec.) | |||||||
| Peripheral vessel | |||||||
| Other (spec.) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
Note 1: Other includes color power Dopler, combined B and color power Doppler, 3-D/4-D imaging, SonoRes/SonoHD imaging, SonoMB compound imaging (TD), elastography imaging, strain rate imaging, imaging, imaging to asist in the placement of needles and cather in vascular or other and courses. Color Dopler includes velocity color Doppler. Color Doppler Color Doppler Color Doppler Color Do
All items marked "P" were previously cleared in 510(k) K071134.
Hopal M. Whting
n of Reproductive, Abdominal and
iological Devices
510(k) Number K08
9
Table 4.3- 3 Diagnostic Ultrasound Indications for Use Form – C8x/8-5 Transducer
| System: | SonoSite Maxx™ Series Ultrasound System | ||||||
|---|---|---|---|---|---|---|---|
| Transducer: | C8x/8-5 MHz Transducer | ||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the | ||||||
| human body as follows: | |||||||
| Clinical Application | Mode of Operation | ||||||
| B | M | PWD | CWD | Color | |||
| Doppler | Combined | ||||||
| (Spec.) | Other | ||||||
| (Spec.) | |||||||
| Ophthalmic | |||||||
| Fetal | P | P | P | P | B+M; B+PWD; | ||
| B+CD | Note 1 | ||||||
| Abdominal | |||||||
| Intra-operative (Abdominal organs and vascular) | |||||||
| Intra-operative (Neuro.) | |||||||
| Laparoscopic | |||||||
| Pediatric | |||||||
| Small Organ (breast, thyroid, testicles. prostate) | |||||||
| Neonatal Cephalic | |||||||
| Adult Cephalic | |||||||
| Trans-rectal | P | P | P | P | B+M; B+PWD; | ||
| B+CD | Note 1 | ||||||
| Trans-vaginal | P | P | P | P | B+M; B+PWD; | ||
| B+CD | Note 1 | ||||||
| Trans-urethral | |||||||
| Trans-esoph. (non-Card.) | |||||||
| Musculo-skel. (Convent.) | |||||||
| Musculo-skel. (Superfic.) | |||||||
| Intra-luminal | |||||||
| Other (spec.) | |||||||
| Cardiac Adult | |||||||
| Cardiac Pediatric | |||||||
| Trans-esophageal (card.) | |||||||
| Other (spec.) | |||||||
| Peripheral vessel | |||||||
| Other (spec.) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
Note 1: Other includes color power Dopler, combined B and color power Doppier, 3-D/4-D imaging, SonoRes/SonoHD imaging, SonoMB compound imaging, tissue Dopler imaging, strain rate imaging, imaging for guidance of biopsy and imaging to assist in the placement of needles and cather in vascular or other anatomical stuctures. Color Doppler Color Doppler. Color Doppler can be combined with any imaging mode. M-Mode includes anatomical M-Mode, and color M-Mode.
All items marked "P" were previously cleared in 510(k) K071134.
Irmin In Why
tive. Abdominal and
10
Kof2098
Table 4.3- 4 Diagnostic Ultrasound Indications for Use Form - C11x/8-5 Transducer
| System: | SonoSite Maxx™ Series Ultrasound System | ||||||
|---|---|---|---|---|---|---|---|
| Transducer: | C11x/8-5 MHz Transducer | ||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the | ||||||
| human body as follows: | |||||||
| Clinical Application | B | M | PWD | CWD | Color Doppler | Combined (Spec.) | Other (Spec.) |
| Ophthalmic | |||||||
| Fetal | |||||||
| Abdominal | P | P | P | P | P | B+M; B+PWD; | |
| B+CWD; B+CD | Note 1 | ||||||
| Intra-operative (Abdominal organs and vascular) | P | P | P | P | P | B+M; B+PWD; B+CD | Note 1 |
| Intra-operative (Neuro.) | P | P | P | P | P | B+M; B+PWD; B+CD | Note 1 |
| Laparoscopic | |||||||
| Pediatric | P | P | P | P | P | B+M; B+PWD; | |
| B+CWD; B+CD | Note 1 | ||||||
| Small Organ (breast, thyroid, testicles. prostate) | P | P | P | P | P | B+M; B+PWD; B+CD | Note 1 |
| Neonatal Cephalic | P | P | P | P | B+M; B+PWD; B+CD | Note 1 | |
| Adult Cephalic | |||||||
| Trans-rectal | |||||||
| Trans-vaginal | |||||||
| Trans-urethral | |||||||
| Trans-esoph. (non-Card.) | |||||||
| Musculo-skel. (Convent.) | |||||||
| Musculo-skel. (Superfic.) | |||||||
| Intra-luminal | |||||||
| Other (spec.) | |||||||
| Cardiac Adult | |||||||
| Cardiac Pediatric | P | P | P | P | P | B+M; B+PWD; | |
| B+CWD; B+CD | Note 1 | ||||||
| Trans-esophageal (card.) | |||||||
| Other (spec.) | |||||||
| Peripheral vessel | P | P | P | P | B+M; B+PWD; B+CD | Note 1 | |
| Other (spec.) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
Not 1: Ohe includes color power Dopler, Copler, Clarkeringing, Sonces/Sonol inaging, Sonces/SonoHinaging, Sonces/Sonolfor insging, velocity color Doppier. Color Doppler can be combined with any imaging mode. M-Mode, and color M-Mode.
All items marked "P" were previously cleared in 510(k) K071134.
(Divisio productive. Abdominal a Radiolo 510 (k) Nur
11
K082098
Table 4.3- 5 Diagnostic Ultrasound Indications for Use Form - D2x/2 Transducer
| System: | SonoSite Maxx™ Series Ultrasound System | ||||||
|---|---|---|---|---|---|---|---|
| Transducer: | D2x/2 MHz Dual Element Circular Array | ||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the | ||||||
| human body as follows: | |||||||
| Clinical Application | Mode of Operation | ||||||
| B | M | PWD | CWD | Color | |||
| Doppler | Combined | ||||||
| (Spec.) | Other | ||||||
| (Spec.) | |||||||
| Ophthalmic | |||||||
| Fetal | |||||||
| Abdominal | |||||||
| Intra-operative (Abdominal organs and vascular) | |||||||
| Intra-operative (Neuro.) | |||||||
| Laparoscopic | |||||||
| Pediatric | |||||||
| Small Organ (breast, thyroid, testicles. prostate) | |||||||
| Neonatal Cephalic | |||||||
| Adult Cephalic | |||||||
| Trans-rectal | |||||||
| Trans-vaginal | |||||||
| Trans-urethral | |||||||
| Trans-esoph. (non-Card.) | |||||||
| Musculo-skel. (Convent.) | |||||||
| Musculo-skel. (Superfic.) | |||||||
| Intra-luminal | |||||||
| Other (spec.) | |||||||
| Cardiac Adult | P | ||||||
| Cardiac Pediatric | P | ||||||
| Trans-esophageal (card.) | |||||||
| Other (spec.) | |||||||
| Peripheral vessel | |||||||
| Other (spec.) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
All items marked "P" were previously cleared in 510(k) K071134.
Arastm Wh
(Division Sign-Off) ിടിഠന Sign Olym Only adiological Devices 510(k) Number -
12
Table 4.3- 6 Diagnostic Ultrasound Indications for Use Form – D5x/5 Transducer
| System: | SonoSite Maxx™ Series Ultrasound System | ||||||
|---|---|---|---|---|---|---|---|
| Transducer: | D5x/5 MHz Dual Element Circular Array | ||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the | ||||||
| human body as follows: | |||||||
| Clinical Application | Mode of Operation | ||||||
| B | M | PWD | CWD | Color | |||
| Doppler | Combined | ||||||
| (Spec.) | Other | ||||||
| (Spec.) | |||||||
| Ophthalmic | |||||||
| Fetal | |||||||
| Abdominal | |||||||
| Intra-operative (Abdominal organs and vascular) | |||||||
| Intra-operative (Neuro.) | |||||||
| Laparoscopic | |||||||
| Pediatric | |||||||
| Small Organ (breast, thyroid, testicles. prostate) | |||||||
| Neonatal Cephalic | |||||||
| Adult Cephalic | |||||||
| Trans-rectal | |||||||
| Trans-vaginal | |||||||
| Trans-urethral | |||||||
| Trans-esoph. (non-Card.) | |||||||
| Musculo-skel. (Convent.) | |||||||
| Musculo-skel. (Superfic.) | |||||||
| Intra-luminal | |||||||
| Other (spec.) | |||||||
| Cardiac Adult | P | ||||||
| Cardiac Pediatric | P | ||||||
| Trans-esophageal (card.) | |||||||
| Other (spec.) | |||||||
| Peripheral vessel | |||||||
| Other (spec.) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
All items marked "P" were previously cleared in 510(k) K071134.
(Division Sign-Off) "ivision of Reproductive, Abdominal and Radiological Devices 510(k) Number
13
110(k) Number
36
Korzoft
Table 4.3- 30 Diagnostic Ultrasound Indications for Use Form -- WL25x/12-5 Transducer
| System: | SonoSite Maxx™ Series Ultrasound System | ||||||
|---|---|---|---|---|---|---|---|
| Transducer: | WL25x/12-5 MHz Transducer | ||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | ||||||
| Clinical Application | Mode of Operation | ||||||
| B | M | PWD | CWD | Color | |||
| Doppler | Combined | ||||||
| (Spec.) | Other | ||||||
| (Spec.) | |||||||
| Ophthalmic | N | N | N | N | B+M; B+PWD; | ||
| B+CD | Note 1 | ||||||
| Fetal | N | N | N | N | B+M; B+PWD; | ||
| B+CD | Note 1 | ||||||
| Abdominal | N | N | N | N | B+M; B+PWD; | ||
| B+CD | Note 1 | ||||||
| Intra-operative (Abdominal | |||||||
| organs and vascular) | N | N | N | N | B+M; B+PWD; | ||
| B+CD | Note 1 | ||||||
| Intra-operative (Neuro.) | |||||||
| Laparoscopic | N | N | N | N | B+M; B+PWD; | ||
| B+CD | Note 1 | ||||||
| Pediatric | N | N | N | N | B+M; B+PWD; | ||
| B+CD | Note 1 | ||||||
| Small Organ (breast, thyroid, | |||||||
| testicles, prostate) | N | N | N | N | B+M; B+PWD; | ||
| B+CD | Note 1 | ||||||
| Neonatal Cephalic | |||||||
| Adult Cephalic | N | N | N | N | B+M; B+PWD; | ||
| B+CD | Note 1 | ||||||
| Trans-rectal | |||||||
| Trans-vaginal | |||||||
| Trans-urethral | |||||||
| Trans-esoph. (non-Card.) | |||||||
| Musculo-skel. (Convent.) | N | N | N | N | B+M; B+PWD; | ||
| B+CD | Note 1 | ||||||
| Musculo-skel. (Superfic.) | N | N | N | N | B+M; B+PWD; | ||
| B+CD | Note 1 | ||||||
| Intra-luminal | |||||||
| Other (spec.) | |||||||
| Cardiac Adult | |||||||
| Cardiac Pediatric | |||||||
| Trans-esophageal (card.) | |||||||
| Other (spec.) | |||||||
| Peripheral vessel | |||||||
| Other (spec.) | N | N | N | N | B+M; B+PWD; | ||
| B+CD | Note 1 |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
Note 1: Other includes color power Dopler, combined B and color power Dopler, 3-D/4-D imaging, SonoRes/SonoHD imaging, reall nouver boper copper contre coper ooper, colu-ci magin, tragin, cores, soncelsonol-inging, soncelsonol-inging,
Sonde or puici maging (Tha insplement deede an cabent in
Prescription Use (Per 21 CFR 801.109)
logulm Wrz
(Division Sign-Off) Division of Reproductive, Abdominal Radiological Devices 510(k) Number
37
Ko82098
Table 4.3- 31 Diagnostic Ultrasound Indications for Use Form -- WL40x/12-5 Transducer
| System: | SonoSite Maxx™ Series Ultrasound System | ||||||
|---|---|---|---|---|---|---|---|
| Transducer: | WL40x/12-5 MHz Transducer | ||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as | ||||||
| follows: | |||||||
| Clinical Application | Mode of Operation | ||||||
| B | M | PWD | CWD | Color | |||
| Doppler | Combined | ||||||
| (Spec.) | Other | ||||||
| (Spec.) | |||||||
| Ophthalmic | N | N | N | N | N | B+M; B+PWD; | |
| B+CD | Note 1 | ||||||
| Fetal | N | N | N | N | N | B+M; B+PWD; | |
| B+CD | Note 1 | ||||||
| Abdominal | N | N | N | N | N | B+M; B+PWD; | |
| B+CD | Note 1 | ||||||
| Intra-operative (Abdominal | |||||||
| organs and vascular) | N | N | N | N | N | B+M; B+PWD; | |
| B+CD | Note 1 | ||||||
| Intra-operative (Neuro.) | |||||||
| Laparoscopic | N | N | N | N | N | B+M; B+PWD; | |
| B+CD | Note 1 | ||||||
| Pediatric | N | N | N | N | N | B+M; B+PWD; | |
| B+CD | Note 1 | ||||||
| Small Organ (breast, thyroid, | |||||||
| testicles, prostate) | N | N | N | N | N | B+M; B+PWD: | |
| B+CD | Note 1 | ||||||
| Neonatal Cephalic | |||||||
| Adult Cephalic | N | N | N | N | N | B+M; B+PWD; | |
| B+CD | Note 1 | ||||||
| Trans-rectal | |||||||
| Trans-vaginal | |||||||
| Trans-urethral | |||||||
| Trans-esoph. (non-Card.) | |||||||
| Musculo-skel. (Convent.) | N | N | N | N | N | B+M; B+PWD; | |
| B+CD | Note 1 | ||||||
| Musculo-skel. (Superfic.) | N | N | N | N | N | B+M; B+PWD; | |
| B+CD | Note 1 | ||||||
| Intra-luminal | |||||||
| Other (spec.) | |||||||
| Cardiac Adult | |||||||
| Cardiac Pediatric | |||||||
| Trans-esophageal (card.) | |||||||
| Other (spec.) | |||||||
| Peripheral vessel | N | N | N | N | N | B+M; B+PWD; | |
| B+CD | Note 1 | ||||||
| Other (spec.) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
Note 1: Other includes color power Dopler, combinet B and color power Dopler, stare hamonic imaging, Sonreles (Sonolfo imaging, incord ( r conner of con-rolen commer can concress include in the insume maging, Sonnes in the maging, Sonnes in any of maging, o the other maging, base bopper maging issun at maging inaging guidane or perphen enre bock prosedures.
magins of biopsy and imaging ruse in the pleasened nhedes and cathe
Prescription Use (Per 21 CFR 801.109)
(Division Sign-Off)
Division of Reproductive, Abdom Radiological Devices 510(k) Number
38
K082098
Table 4.3- 32 Diagnostic Ultrasound Indications for Use Form -- WMC15x/12-4 Transducer
| System: | SonoSite Maxx™ Series Ultrasound System | ||||||
|---|---|---|---|---|---|---|---|
| Transducer: | WMC15x/12-4 MHz Transducer | ||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | ||||||
| Clinical Application | Mode of Operation | ||||||
| B | M | PWD | CWD | Color Doppler | Combined (Spec.) | Other (Spec.) | |
| Ophthalmic | N | N | N | N | N | B+M; B+PWD; | |
| B+CD; B+CWD | Note 1 | ||||||
| Fetal | N | N | N | N | N | B+M; B+PWD; | |
| B+CD; B+CWD | Note 1 | ||||||
| Abdominal | |||||||
| Intra-operative (Abdominal organs and vascular) | N | N | N | N | N | B+M; B+PWD; | |
| B+CD; B+CWD | Note 1 | ||||||
| Intra-operative (Neuro.) | |||||||
| Laparoscopic | N | N | N | N | N | B+M; B+PWD; | |
| B+CD; B+CWD | Note 1 | ||||||
| Pediatric | |||||||
| Small Organ (breast, thyroid, testicles, prostate) | N | N | N | N | N | B+M; B+PWD; | |
| B+CD; B+CWD | Note 1 | ||||||
| Neonatal Cephalic | N | N | N | N | N | B+M; B+PWD; | |
| B+CD; B+CWD | Note 1 | ||||||
| Adult Cephalic | N | N | N | N | N | B+M; B+PWD; | |
| B+CD; B+CWD | Note 1 | ||||||
| Trans-rectal | |||||||
| Trans-vaginal | |||||||
| Trans-urethral | |||||||
| Trans-esoph. (non-Card.) | |||||||
| Musculo-skel. (Convent.) | N | N | N | N | N | B+M; B+PWD; | |
| B+CD; B+CWD | Note 1 | ||||||
| Musculo-skel. (Superfic.) | |||||||
| Intra-luminal | N | N | N | N | N | B+M; B+PWD; | |
| B+CD; B+CWD | Note 1 | ||||||
| Other (spec.) | |||||||
| Cardiac Adult | |||||||
| Cardiac Pediatric | |||||||
| Trans-esophageal (card.) | |||||||
| Other (spec.) | |||||||
| Peripheral vessel | |||||||
| Other (spec.) | N | N | N | N | N | B+M; B+PWD; | |
| B+CD; B+CWD | Note 1 |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
Note 1: Other includes color power Dopler, 3-D/4-D imaging, tissue hamonis imaging, tissue hamoni imaging, SonoRes/SonoHD imaging, r in Your mantes bother belocorporation in the insing, issue hemnic maying, Soneles Sonles (neging,
Sonole conpund imaging (TD), elsebgent includes and ratheres in version estill onlyon inlight) (10), elasgraphy majns, stan raing uidane or perphean eve bick procedures,
maging to guidane of tinging basistin the placement of resular of the mate be group patibles in toppy the maging to assist in the pacement on resular or other an ascular or other and course.
Welcoty color Dopler. Color Dopler can be combined wit
(Division Sign-Off)
Arque In Why
Divisio ductive. Abdominal Radiolo 510(k) Number
39
KOd2098
Table 4.3- 33 Diagnostic Ultrasound Indications for Use Form – WMC20x/12-4 Transducer
| System: | SonoSite Maxx™ Series Ultrasound System | ||||||
|---|---|---|---|---|---|---|---|
| Transducer: | WMC20x/12-4 MHz Transducer | ||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | ||||||
| Clinical Application | Mode of Operation | ||||||
| B | M | PWD | CWD | Color | |||
| Doppler | Combined | ||||||
| (Spec.) | Other | ||||||
| (Spec.) | |||||||
| Ophthalmic | N | N | N | N | N | B+M; B+PWD; | |
| B+CD; B+CWD | Note 1 | ||||||
| Fetal | N | N | N | N | N | B+M; B+PWD; | |
| B+CD; B+CWD | Note 1 | ||||||
| Abdominal | N | N | N | N | N | B+M; B+PWD; | |
| B+CD; B+CWD | Note 1 | ||||||
| Intra-operative (Abdominal | |||||||
| organs and vascular) | N | N | N | N | N | B+M; B+PWD; | |
| B+CD; B+CWD | Note 1 | ||||||
| Intra-operative (Neuro.) | |||||||
| Laparoscopic | N | N | N | N | N | B+M; B+PWD; | |
| B+CD; B+CWD | Note 1 | ||||||
| Pediatric | N | N | N | N | N | B+M; B+PWD; | |
| B+CD; B+CWD | Note 1 | ||||||
| Small Organ (breast, thyroid, | |||||||
| testicles, prostate) | N | N | N | N | N | B+M; B+PWD; | |
| B+CD; B+CWD | Note 1 | ||||||
| Neonatal Cephalic | N | N | N | N | N | B+M; B+PWD; | |
| B+CD; B+CWD | Note 1 | ||||||
| Adult Cephalic | N | N | N | N | N | B+M; B+PWD: | |
| B+CD; B+CWD | Note 1 | ||||||
| Trans-rectal | |||||||
| Trans-vaginal | |||||||
| Trans-urethral | |||||||
| Trans-esoph. (non-Card.) | |||||||
| Musculo-skel. (Convent.) | N | N | N | N | N | B+M: B+PWD: | |
| B+CD; B+CWD | Note 1 | ||||||
| Musculo-skel. (Superfic.) | N | N | N | N | N | B+M; B+PWD: | |
| B+CD; B+CWD | Note 1 | ||||||
| Intra-luminal | |||||||
| Other (spec.) | |||||||
| Cardiac Adult | |||||||
| Cardiac Pediatric | |||||||
| Trans-esophageal (card.) | |||||||
| Other (spec.) | |||||||
| Peripheral vessel | N | N | N | N | N | B+M; B+PWD; | |
| B+CD; B+CWD | Note 1 | ||||||
| Other (spec.) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
Not 1: Obe indudes oler powr Dopler, S-D4-D maging, S-D4-D inaging, itsue hamnic maging, Soncessontli imaging,
Sonoka conpund imaging (TD), lestograph inaging strainers in in a security and copper maging (10), elser rate inaging innaling guidence or proheal new block procedures,
wear of bopler. Color Dopting to assist in the placement in vacu in given grands of Biopsy and maging in the pacement of neacular or vasular or other an other anatomical stuccures, stucctions, stucctions, stucctions, and olor M-Mode, and
Prescription Use (Per 21 CFR 801.109)
(Division Sign-Off)
Division of oroductive, Abdominal Radiological Devices 510(k) Number
40
K08209R
Table 4.3- 34 Diagnostic Ultrasound Indications for Use Form -- WTVx/9-3 Transducer
| System: | SonoSite Maxx™ Series Ultrasound System | |||||||
|---|---|---|---|---|---|---|---|---|
| Transducer: | WTVx/9-3 MHz Transducer | |||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the | |||||||
| human body as follows: | ||||||||
| Clinical Application | Mode of Operation | |||||||
| B | M | PWD | CWD | Color Doppler | Combined (Spec.) | Other (Spec.) | ||
| Ophthalmic | ||||||||
| Fetal | N | N | N | N | N | B+M; B+PWD; B+CD; | ||
| B+CWD | Note 1 | |||||||
| Abdominal | ||||||||
| Intra-operative (Abdominal organs and vascular) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (breast, thyroid, testicles. prostate) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | N | N | N | N | N | B+M; B+PWD; B+CD; | ||
| B+CWD | Note 1 | |||||||
| Trans-vaginal | N | N | N | N | N | B+M; B+PWD; B+CD; | ||
| B+CWD | Note 1 | |||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac Pediatric | ||||||||
| Trans-esophageal (card.) | ||||||||
| Other (spec.) | ||||||||
| Peripheral vessel | ||||||||
| Other (spec.) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
Note 1: Other includes color power Dopler, 3-0/4-D imaging, itsue hamonic imaging, itsue hamonic imaging, issue hamoni in and the mail be mail be mail b സംഘ സമ്മിന് സംസ് - Doper copper . 3-04-2 maging .issue imaging, SonderSonol maging
Sondo condinaging (TD), lastophy magin, magin, imagin, imaging bayar ingging massic in b with any imaging mode. M-Mode includes anatomical M-Mode, and color M-Mode.
Prescription Use (Per 21 CFR 801.109)
Aoputhtutz
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number