(15 days)
No
The summary explicitly states that the submission does not include any technological or feature changes from previously cleared devices, and the focus is solely on adding a new clinical application (peripheral nerve blocks) to the existing intended uses. There is no mention of AI, ML, or related concepts.
No
The device is described as a "diagnostic ultrasound system" and its intended uses are for "ultrasound evaluation" and "imaging guidance," which are diagnostic rather than therapeutic purposes.
Yes
The "Device Description" explicitly states, "The devices referenced in this Submission are highly portable, software-controlled, diagnostic ultrasound systems with accessories." Additionally, the "Summary of Performance Studies" refers to them as "referenced diagnostic ultrasound systems."
No
The device is described as "highly portable, software-controlled, diagnostic ultrasound systems with accessories" and explicitly mentions transducers, which are hardware components essential for ultrasound imaging. The submission focuses on adding an intended use to existing hardware systems.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Definition of IVD: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Description: The text describes the SonoSite systems as "highly portable, software-controlled, diagnostic ultrasound systems." Ultrasound is an imaging modality that uses sound waves to create images of internal body structures. It does not involve the examination of specimens taken from the body.
- Intended Use: The intended uses listed are all related to imaging internal anatomical structures for diagnostic and guidance purposes (e.g., imaging organs, vessels, nerves, guiding biopsies and needle placement). None of these involve the analysis of biological samples.
Therefore, the SonoSite ultrasound systems described are diagnostic imaging devices, not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
As defined by FDA guidance documents, the intended uses of the SonoSite ultrasound systems referenced herein remain unchanged from previously cleared indications, except for a modification to their labeling to add imaging guidance for peripheral nerve blocks in musculoskeletal and intraoperative imaging applications.
The SonoSite ultrasound systems are intended for use for ultrasound evaluation of fetal - OB/GYN, abdominal, intra-operative (abdominal organs and vascular), laparoscopic, pediatric, small organ (breast, thvroid, testicles), neonatal cephalic, trans-rectal, trans-vaginal, musculoskeletal (conventional and superficial), cardiac (adult and pediatric), and peripheral vessel applications. The TITAN™ Ultrasound System has been additionally cleared for adult cephalic applications. The systems provide imaging for quidance of biopsy and imaging to assist in the placement of needles and catheters in vascular or other anatomical structures.
Product codes (comma separated list FDA assigned to the subject device)
90-IYN, 90-IYO, 90-ITX
Device Description
The devices referenced in this Submission are highly portable, software-controlled, diagnostic ultrasound systems with accessories. This Submission does not include any technological or feature changes from the previously cleared SonoSite devices or transducers.
By this Submission, the clinical application for imaging guidance for peripheral nerve block procedures is being added to previously cleared indications for use for each of these systems and to the following transducers:
| System | Transducer | Transducer Type | Frequency Range |
|---|---|---|---|
| TITAN™ High-Resolution Ultrasound System | C11/8-5 | Curved Array | 8.0 - 5.0 MHz |
| L25/10-5 | Linear Array | 10.0 - 5.0 MHz | |
| L38/10-5 | Linear Array | 10.0 - 5.0 MHz | |
| SonoSite® Ultrasound System | C11/7-4 | Curved Array | 7.0 - 4.0 MHz |
| L38/10-5 | Linear Array | 10.0 - 5.0 MHz | |
| L25/10-5 | Linear Array | 10.0 - 5.0 MHz | |
| iLook™ 25 Ultrasound System | L25/10-5 | Linear Array (integrated) | 10.0 - 5.0 MHz |
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Fetal - OB/GYN, abdominal, intra-operative (abdominal organs and vascular), laparoscopic, pediatric, small organ (breast, thyroid, testicles), neonatal cephalic, trans-rectal, trans-vaginal, musculoskeletal (conventional and superficial), cardiac (adult and pediatric), peripheral vessel, adult cephalic.
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)
No additional clinical testing is required, as the specific indication for use adds no significant risk to the general indication for use of the referenced diagnostic ultrasound systems, in accordance with FDA's Guidance for Industry: General/Specific Intended Use document issued November 4, 1998.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
NOV = 5 2003
K03367
SonoSite. Inc. 21919 30th Drive SE Bothell, WA 98021-3904 USA
Image /page/0/Picture/3 description: The image shows the logo for SonoSite. The logo consists of a square symbol on the left and the word "SonoSite" on the right. Below the word "SonoSite" is the text "Carrying Ultrasound into the Future."
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
Telephone: 1.425.951.1200 Facsimile: 1.425.951.1201 ww.sonosite.com
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.
Submitter's name, address, telephone number, contact person: 1)
Michael A. Hoffman Director - Quality Assurance and Requlatory Affairs SonoSite, Inc. 21919 30th Drive SE Bothell, WA 98021-3904
(425) 951 - 1297
E-mail: michael.hoffman@sonosite.com
Date prepared: October 8, 2003
- Name of the device, including the trade or proprietary name if 2) applicable, the common or usual name, and the classification name, if known:
Common/ Usual Name
Diagnostic Ultrasound System with Accessories
Proprietary Names
TITAN™ High-Resolution Ultrasound System SonoSite® iLook™ 25 Ultrasound System SonoSite® Ultrasound System
1
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 |
ldentification of the predicate or legally marketed device: 3)
The SonoSite Ultrasound System that is the subject of this Submission is the collective term for the legally marketed TITAN™ High-Resolution Ultrasound System (K030949), the SonoSite® Ultrasound System (PowerSeries) (K021628), and the SonoSite® Ultrasound System (K014116).
This 510(k) premarket notification includes no changes, including no new system functions, to the ultrasound systems or accessories that were the subjects of those submissions. K014116 provided clearance for modes of operation that include "imaging for guidance of biopsy". Additionally, the indications for use under K030949 and K021628 specifically include "imaging to assist in the placement of needles and catheters in vascular or other anatomical structures".
This 510(k) premarket notification extends this indication to specifically identify use of the designated SonoSite ultrasound systems as substantially equivalent to the clinical application of the Site~Rite 3 Ultrasound System (K993624) marketed by Bard Access Systems for imaging quidance for peripheral nerve block procedures.
4) Device Description:
The devices referenced in this Submission are highly portable, software-controlled, diagnostic ultrasound systems with accessories. This Submission does not include any technological or feature changes from the previously cleared SonoSite devices or transducers.
By this Submission, the clinical application for imaging guidance for peripheral nerve block procedures is being added to previously cleared indications for use for each of these systems and to the following transducers:
2
| System | Transducer | Transducer
Type | Frequency
Range |
|---------------------------------------------|------------|------------------------------|--------------------|
| TITAN™ High-Resolution
Ultrasound System | C11/8-5 | Curved Array | 8.0 - 5.0 MHz |
| | L25/10-5 | Linear Array | 10.0 - 5.0 MHz |
| | L38/10-5 | Linear Array | 10.0 - 5.0 MHz |
| SonoSite® Ultrasound System | C11/7-4 | Curved Array | 7.0 - 4.0 MHz |
| | L38/10-5 | Linear Array | 10.0 - 5.0 MHz |
| | L25/10-5 | Linear Array | 10.0 - 5.0 MHz |
| iLook™ 25 Ultrasound System | L25/10-5 | Linear Array
(integrated) | 10.0 - 5.0 MHz |
SonoSite ultrasound systems are designed, as applicable to their features, to comply with the standards listed below.
| EN 540:1993 | ISO 9001: 1994 |
|---|---|
| EN 980 A1:1999 | Title 21 CFR Part 820:1996 |
| EN 1041:1998 | CAN/CSA C22.2, No. 601.1:1998 |
| EN 1441:1998 | 93/42/EEC:1993 |
| EN 60529:1992 | UL 2601-1:1999 |
| EN ISO 10993-1:1997 | UL 94, 5th ed. |
| EN 30993-4:1992 | EN ISO 13485:1996 |
| EN ISO 10993-5:1999 | CISPR 11:2003 |
| EN ISO 10993-10:1995 | JIS-T-100x Series |
| EN 30993-11:1993 | RTCA/DO160D:1997 |
| EN ISO 10993-12:1996 | ANSI/AAMI EC53:1995 |
| EN 50103:1994 | ASTM D5276-98 |
| EN 60601-1:1998 | ASTM D999-96 |
| EN 60601-1/A1:1991 | NEMA PS3.15 2000 |
| EN 60601-1/A2:1995 | NEMA UD2-1998 |
| EN 60601-1-1:1993 | NEMA UD3:1998 |
| EN 60601-1-2:2001 | Medical Ultrasound Safety, American |
| Institute of Ultrasound in Medicine, 1994 | |
| EN 60601-1-4:1996 | Acoustic Output Measurement and |
| Labeling Standard for Diagnostic | |
| Ultrasound Equipment, American Institute | |
| of Ultrasound in Medicine, 1993 | |
| EN 60601-2-25:1996 | Medical Devices Regulations of Health |
| Canada, Therapeutic Products | |
| Directorate, 1998 | |
| EN 61157:1992 | --- |
5) Intended Use:
As defined by FDA guidance documents, the intended uses of the SonoSite ultrasound systems referenced herein remain unchanged from previously cleared indications, except for a modification to their labeling to add imaging guidance for peripheral nerve blocks in musculoskeletal and intraoperative imaging applications.
3
The SonoSite ultrasound systems are intended for use for ultrasound evaluation of fetal - OB/GYN, abdominal, intra-operative (abdominal organs and vascular), laparoscopic, pediatric, small organ (breast, thvroid, testicles), neonatal cephalic, trans-rectal, trans-vaginal, musculoskeletal (conventional and superficial), cardiac (adult and pediatric), and peripheral vessel applications. The TITAN™ Ultrasound System has been additionally cleared for adult cephalic applications. The systems provide imaging for quidance of biopsy and imaging to assist in the placement of needles and catheters in vascular or other anatomical structures.
6) Technological Characteristics:
There are no technological or feature changes in this Submission to any of the legally marketed ultrasound systems, transducers, or accessories identified in Section 3 of this Summary.
7) Testing:
Each of the referenced SonoSite systems has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness, as well as thermal, electrical and mechanical safety, and has been found to conform to applicable medical device safety standards. Reports were previously included in the referenced predicate submissions. No additional clinical testing is required, as the specific indication for use adds no significant risk to the general indication for use of the referenced diaqnostic ultrasound systems, in accordance with FDA's Guidance for Industry: General/Specific Intended Use document issued November 4, 1998.
8) Conclusion:
The clinical application and intended use described in this Submission is consistent with current clinical practice and FDA quidelines. Use of diagnostic ultrasound for the evaluation of soft tissue has been well established and its specific clinical application to the discrimination of small soft tissue parts, including nerves and other types of anatomical detail, adds no significant risk to the general indication for use. Therefore, it is SonoSite's opinion that the clinical applications as described in Section 5 of this Summary are substantially equivalent with respect to safety, effectiveness, and intended uses to similar devices currently cleared for market.
4
Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV = 5 2003
SonoSite, Inc. % Mr. Mark Job Responsible Third Party Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
Re: K033367
Trade Name: SonoSite TITAN™ High-Resolution Ultrasound System, SonoSite® iLook Ultrasound System (Power Series), and SonoSite® Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: 90 IYN, IYO, and ITX · Dated: October 20, 2003 Received: October 21, 2003
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 Ultrasound Systems listed below, as described in your premarket notification:
-
- SonoSite TITANTM High-Resolution Ultrasound System:
- C11/8-5 8.0-5.0 MHz Curved Array ●
- L25/10-5 10.0-5.0 MHz Linear Array .
- L38/10-5 10.0-5.0 MHz Linear Array ●
5
-
- SonoSite® iLook Ultrasound System (Power Series):
- L25/10-5 10.0-5.0 MHz Linear Array .
-
- SonoSite® Ultrasound System:
- C11/7-4 7.0-4.0 MHz Curved Array .
- L38/10-5 10.0-5.0 MHz Linear Array .
- L25/10-5 10.0-5.0 MHz Linear Array ●
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.
The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:
Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850
This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.
6
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801, please contact the Office of Compliance at (301) 594-4591. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at (301) 594-1212.
Sincerely yours,
Nancy C Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
7
| System: | SonoSite TITAN™ high-resolution 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 | |||||||
| General | Specific | Color | Combined | Other | ||||
| (Track I only) | (Tracks I & III) | B | M | PWD | CWD | Doppler | (Spec.) | (Spec.) |
| Ophthalmic | Ophthalmic | |||||||
| B+M; B+PWD; | ||||||||
| Fetal | P | P | P | P | B+CD | Note 1 | ||
| B+M; B+PWD; | ||||||||
| Abdominal | P | P | P | P | P | B+CWD; B+CD | Note 1 | |
| Intra-operative (Abdominal | B+M; B+PWD; | |||||||
| organs and vascular) | P | P | P | P | B+CD | Note 1 | ||
| Intra-operative (Neuro.) | ||||||||
| Fetal Imaging | Laparoscopic | P | P | P | B+M; B+PWD | Note 1 | ||
| B+M; B+PWD; | ||||||||
| & Other | Pediatric | P | P | P | P | P | B+CWD; B+CD | Note 1 |
| Small Organ (breast, | B+M; B+PWD; | |||||||
| thyroid, testicles) | P | P | P | P | B+CD | Note 1 | ||
| B+M; B+PWD; | ||||||||
| Neonatal Cephalic | P | P | P | P | B+CD | Note 1 | ||
| B+M; B+PWD; | ||||||||
| Adult Cephalic | P | P | P | P | B+CD | Note 1 | ||
| B+M; B+PWD; | ||||||||
| Trans-rectal | P | P | P | P | B+CD | Note 1 | ||
| B+M; B+PWD; | ||||||||
| Trans-vaginal | P | P | P | P | B+CD | Note 1 | ||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Convent.) | P | P | P | B+M; B+PWD | Note 1 | |||
| B+M; B+PWD; | ||||||||
| Musculo-skel. (Superfic.) | P | P | P | P | B+CD | Note 1 | ||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| B+M; B+PWD; | ||||||||
| Cardiac Adult | P | P | P | P' | P | B+CWD; B+CD | Note 1 | |
| B+M; B+PWD; | ||||||||
| Cardiac | Cardiac Pediatric | P | P | P | P | P | B+CWD; B+CD | Note 1 |
| Trans-esophageal (card.) | ||||||||
| Other (spec.) | ||||||||
| B+M; B+PWD; | ||||||||
| Peripheral | Peripheral vessel | P | P | P | P | B+CD | Note 1 | |
| Vessel | Other (spec.) |
Table 4.3- 1 Diagnostic Ultrasound Indications for Use Form
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
Note 1: Other includes Color Power Doppler, combined B and Color Power Doppler, combined B and Directional Color Power Doppler, 3-D Imaging, Tissue Harmonic Imaging for guidance of biopsy. Color Doppler includes Velocity Color Doppler. Imaging to assist in the placement of needles and catheters in vascular or other anatomical structures, and picture archiving, communications and storage functionality were all previously cleared in K030949. Included in this 510(k) is an expanded intended use for imaging guidance for peripheral nerve block procedures.
Nancy C. Brogdon
(Division Sign Division of Reproductive and Radiological Device 510(k) Number
8
| System: | SonoSite TITAN TM high-resolution ultrasound system | |||||||
|---|---|---|---|---|---|---|---|---|
| Transducer: | C11/8-5 8.0 - 5.0 MHz Curved Array | |||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | |||||||
| Clinical Application | Mode of Operation | |||||||
| General | ||||||||
| (Track I only) | Specific | |||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | |||
| Doppler | Combined | |||||||
| (Spec.) | Other | |||||||
| (Spec.) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | B+M; B+PWD; | |||||||
| B+CWD; | ||||||||
| B+CD | ||||||||
| Abdominal | P | P | P | P | P | B+CD | Note 1 | |
| Intra-operative (Abdominal | ||||||||
| organs and vascular) | N | N | N | N | B+M; | |||
| B+PWD; | ||||||||
| B+CD | Note 1 | |||||||
| Fetal Imaging | ||||||||
| & Other | Intra-operative (Neuro.) | |||||||
| Laparoscopic | B+M; B+PWD; | |||||||
| B+CWD; | ||||||||
| Pediatric | ||||||||
| Small Organ (breast, | ||||||||
| thyroid, testicles) | P | P | P | P | P | 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 | Cardiac Pediatric | |||||||
| Trans-esophageal (card.) | ||||||||
| Other (spec.) | P | P | P | P | P | B+M; B+PWD; | ||
| B+CWD; | ||||||||
| B+CD | Note 1 | |||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (spec.) | P | P | P | P | B+M; B+PWD; | |||
| B+CD | Note 1 |
Table 4.3- 2 Diagnostic Ultrasound Indications for Use Form
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
Note 1: Other includes Color Power Doppler, combined B and Color Power Doppler, combined B and Directional Color Power Doppler, 3-D Imaging, Tissue Harmonic Imaging for guidance of biopsy. Color Doppler includes Velocity Color Doppler. Imaging to assist in the placement of needles and catheters in vascular or other anatomical structures was previously cleared in 510(k) K030949. Included in this 510(k) is an expanded intended use for imaging guidance for peripheral nerve block procedures.
Nancy C. Hogdon
(Divisi Division uctive. and Radiological Device 510(k) Number
9
| System: | SonoSite TITAN™ high-resolution ultrasound system | |||||||
|---|---|---|---|---|---|---|---|---|
| Transducer: | L25/10-5 10.0 - 5.0 MHz Linear Array | |||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | |||||||
| Clinical Application | Mode of Operation | |||||||
| General | ||||||||
| (Track I only) | Specific | |||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | |||
| Doppler | Combined | |||||||
| (Spec.) | Other | |||||||
| (Spec.) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | P | P | P | B+M; B+PWD; | ||||
| B+CD | Note 1 | |||||||
| Abdominal | P | P | P | P | B+M; B+PWD; | |||
| B+CWD; B+CD | Note 1 | |||||||
| Intra-operative (Abdominal | ||||||||
| organs and vascular) | P | P | P | B+M; B+PWD; | ||||
| B+CD | Note 1 | |||||||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | P | P | P | B+M; B+PWD | Note 1 | |||
| Fetal Imaging | ||||||||
| & Other | Pediatric | P | P | P | P | B+M; B+PWD; | ||
| B+CWD; B+CD | Note 1 | |||||||
| Small Organ (breast, | ||||||||
| thyroid, testicles) | P | P | P | P | B+M; B+PWD; | |||
| B+CD | Note 1 | |||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | P | P | P | P | B+M; B+PWD; | |||
| B+CD | Note 1 | |||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Convent.) | P | P | P | B+M; B+PWD | Note 1 | |||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (spec.) | P | P | P | P | B+M; B+PWD; | |||
| B+CD | Note 1 | |||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (card.) | ||||||||
| Other (spec.) | P | P | P | P | B+M; B+PWD; | |||
| B+CWD; B+CD | Note 1 | |||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (spec.) | P | P | P | P | B+M; B+PWD; | |||
| B+CD | Note 1 |
Table 4.3- 3 Diagnostic Ultrasound Indications for Use Form
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
Note 1: Other includes Color Power Doppler, combined B and Color Power Doppler, combined B and Directional Color Noto 1. Other Induse beter . Onse Beppnic Imaging, and imaging for guidance of biopsy. Color Doppler includes Velocity Color Dopler. Imaging to assist in the placement of needles and catheters in vascular or other anatomical v cloudy Object Timaging to doctor in the prace functionality were all previously cleared in K030949. ourceded in this 510(k) is an expanded intended use for imaging guidance for peripheral nerve block procedures.
Nancy Gordon
(Division Division o and Radio 510(k) Number
10
| System: | SonoSite TITAN™ high-resolution ultrasound system | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Transducer: | L38/10-5 10.0- 5.0 MHz Linear Array | ||||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | ||||||||
| Mode of Operation | |||||||||
| Clinical Application | |||||||||
| General | |||||||||
| (Track I only) | Specific | ||||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | ||||
| Doppler | Combined | ||||||||
| (Spec.) | Other | ||||||||
| (Spec.) | |||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | P | P | P | B+M; B+PWD | Note 1 | ||||
| Abdominal | |||||||||
| Intra-operative | |||||||||
| (Abdominal organs and | |||||||||
| vascular) | P | P | P | P | B+M; B+PWD; | ||||
| B+CD | Note 1 | ||||||||
| Intra-operative (Neuro.) | P | P | P | B+M; B+PWD | Note 1 | ||||
| Fetal Imaging | Laparoscopic | P | P | P | B+M; B+PWD | Note 1 | |||
| & Other | Pediatric | P | P | P | P | B+M; B+PWD; | |||
| B+CD | Note 1 | ||||||||
| Small Organ (breast, | |||||||||
| thyroid, testicles) | 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.) | P | P | P | B+M; B+PWD | Note 1 | ||||
| Musculo-skel. (Superfic.) | P | P | P | P | B+M; B+PWD; | ||||
| B+CD | Note 1 | ||||||||
| Intra-luminal | |||||||||
| Other (spec.) | |||||||||
| Cardiac Adult | |||||||||
| Cardiac | Cardiac Pediatric | P | P | P | P | B+M; B+PWD; | |||
| B+CD | Note 1 | ||||||||
| Trans-esophageal (card.) | |||||||||
| Other (spec.) | |||||||||
| Peripheral | |||||||||
| Vessel | Peripheral vessel | P | P | P | P | B+M; B+PWD; | |||
| B+CD | Note 1 | ||||||||
| Other (spec.) |
Table 4.3- 4 Diagnostic Ultrasound Indications for Use Form
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
Note 1: Other includes Color Power Doppler, combined B and Color Power Doppler, combined B and Directional Color Power Doppler, 3-D Imaging, Tissue Harmonic Imaging for guidance of biopsy. Color Doppler includes Velocity Color Doppler. Imaging to assist in the placement of needles and catheters in vascular or other anatomical structures was previously cleared in K030949. Included in this 510(k) is an expanded intended use for imaging guidance for peripheral nerve block procedures.
Nancy Chrogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K033367
11
| System: | SonoSite® iLook Ultrasound System (PowerSeries) | |||||||
|---|---|---|---|---|---|---|---|---|
| Transducer: | N/A | |||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | |||||||
| Clinical Application | Mode of Operation | |||||||
| General | Specific | Color | Combined | Other | ||||
| (Track I only) | (Tracks I & III) | B | M | PWD | CWD | Doppler | (Spec.) | (Spec.) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal | P | P | P | B+M; B+PWD | Note 1 | |||
| Abdominal | P | P | P | P | B+M; B+PWD; | |||
| B+CWD | Note 1 | |||||||
| Intra-operative | ||||||||
| (Abdominal organs and | ||||||||
| vascular) | P | P | P | B+M; B+PWD | Note 1 | |||
| Intra-operative (Neuro.) | ||||||||
| Fetal Imaging | ||||||||
| & Other | Laparoscopic | P | P | P | B+M; B+PWD | Note 1 | ||
| Pediatric | P | P | P | P | B+M; B+PWD | Note 1 | ||
| Small Organ (breast, | ||||||||
| thyroid, testicles) | P | P | P | B+M; B+PWD | Note 1 | |||
| Neonatal Cephalic | P | P | P | B+M; B+PWD | Note 1 | |||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Convent.) | P | P | P | B+M; B+PWD | Note 1 | |||
| Musculo-skel. (Superfic.) | P | P | P | B+M; B+PWD | Note 1 | |||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac Adult | P | P | P | P | B+M; B+PWD; | |||
| B+CWD | Note 1 | |||||||
| Cardiac Pediatric | P | P | P | P | B+M; B+PWD; | |||
| B+CWD | Note 1 | |||||||
| Cardiac | Trans-esophageal (card.) | |||||||
| Other (spec.) | ||||||||
| Peripheral | Peripheral vessel | P | P | P | B+M; B+PWD | Note 1 | ||
| Vessel | Other (spec.) |
Table 4.3- 5 Diagnostic Ultrasound Indications for Use Form
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
Note 1: Other includes Color Power Doppler, combined B and Color Power Doppler, combined B and PowerMap™ Directional Color Power Doppler, 3-D Imaging, Tissue Harmonic Imaging for guidance of biopsy. Imaging to Directional Odor Porter Dopper, o D Integring, 1985 Nationical structures was previously cleared in K021628. Included in this 510(k) is an expanded intended use for imaging guidance for peripheral nerve block procedures.
Nancy C. Brogdon
(Division Sigh-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K033367
12
| System: | SonoSite® iLook Ultrasound System (PowerSeries) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Transducer: | L25/10-5 10.0 - 5.0 MHz Linear Array | ||||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | ||||||||
| Clinical Application | Mode of Operation | ||||||||
| General | Specific | Color | Combined | Other | |||||
| (Track I only) | (Tracks I & III) | B | M | PWD | CWD | Doppler | (Spec.) | (Spec.) | |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | P | P | P | B+M; B+PWD | Note 1 | ||||
| Abdominal | P | P | P | B+M; B+PWD | Note 1 | ||||
| Intra-operative (Abdominal | |||||||||
| organs and vascular) | P | P | P | B+M; B+PWD | Note 1 | ||||
| Intra-operative (Neuro.) | |||||||||
| Fetal Imaging | |||||||||
| & Other | Laparoscopic | P | P | P | B+M; B+PWD | Note 1 | |||
| Pediatric | P | P | P | B+M; B+PWD | Note 1 | ||||
| Small Organ (breast, | |||||||||
| thyroid, testicles) | P | P | P | B+M; B+PWD | Note 1 | ||||
| Neonatal Cephalic | P | P | P | B+M; B+PWD | Note 1 | ||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skel. (Convent.) | P | P | P | B+M; B+PWD | Note 1 | ||||
| Musculo-skel. (Superfic.) | P | P | P | B+M; B+PWD | Note 1 | ||||
| Intra-luminal | |||||||||
| Other (spec.) | |||||||||
| Cardiac Adult | |||||||||
| Cardiac | Cardiac Pediatric | P | P | P | B+M; B+PWD | Note 1 | |||
| Trans-esophageal (card.) | |||||||||
| Other (spec.) | |||||||||
| Peripheral | |||||||||
| Vessel | Peripheral vessel | P | P | P | B+M; B+PWD | Note 1 | |||
| Other (spec.) | P | P | P |
Table 4.3- 6 Diagnostic Ultrasound Indications for Use Form
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
Note 1: Other includes Color Power Doppler, combined B and Color Power Doppler, combined B and PowerMap™ Directional Color Power Doppler, 3-D Imaging, Tissue Harmonic Imaging for guidance of biopsy. Imaging to assist in the placement of needles and catheters in vascular or other anatomical structures was previously cleared in K021628. Included in this 510(k) is an expanded intended use for imaging guidance for peripheral nerve block procedures.
Nancy C. Rooydon
(Division Sigb-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K033367
13
| System: | SonoSite® 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 | |||||||
| General | Specific | Color | Combined | Other | ||||
| (Track I only) | (Tracks I & III) | B | M | PWD | CWD | Doppler | (Spec.) | (Spec.) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal | P | P | P | B+M; B+PWD | Note 1 | |||
| B+M; B+PWD; | ||||||||
| B+CWD | ||||||||
| Abdominal | P | P | P | P | B+M; B+PWD; | |||
| B+CWD | Note 1 | |||||||
| Intra-operative | ||||||||
| (Abdominal organs and | ||||||||
| vascular) | P | P | P | B+M; B+PWD | Note 1 | |||
| Intra-operative (Neuro.) | ||||||||
| Fetal Imaging | Laparoscopic | P | P | P | B+M; B+PWD | Note 1 | ||
| B+M; B+PWD; | ||||||||
| B+CWD | ||||||||
| & Other | Pediatric | P | P | P | P | B+M; B+PWD; | ||
| B+CWD | Note 1 | |||||||
| Small Organ (breast, | ||||||||
| thyroid, testicles) | P | P | P | B+M; B+PWD | Note 1 | |||
| Neonatal Cephalic | P | P | P | B+M; B+PWD | Note 1 | |||
| Adult Cephalic | P | P | P | B+M; B+PWD | Note 1 | |||
| Trans-rectal | P | P | P | B+M; B+PWD | Note 1 | |||
| Trans-vaginal | P | P | P | B+M; B+PWD | Note 1 | |||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | P | P | P | B+M; B+PWD | Note 1 | |||
| Musculo-skel. (Convent.) | P | P | P | B+M; B+PWD | Note 1 | |||
| Musculo-skel. (Superfic.) | P | P | P | B+M; B+PWD | Note 1 | |||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| B+M; B+PWD; | ||||||||
| B+CWD | ||||||||
| Cardiac Adult | P | P | P | P | B+M; B+PWD; | |||
| B+CWD | Note 1 | |||||||
| B+M; B+PWD; | ||||||||
| B+CWD | ||||||||
| Cardiac | Cardiac Pediatric | P | P | P | P | B+M; B+PWD; | ||
| B+CWD | Note 1 | |||||||
| Trans-esophageal (card.) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | Peripheral vessel | P | P | P | B+M; B+PWD | Note 1 | ||
| Vessel | Other (spec.) |
Table 4.3- 7 Diagnostic Ultrasound Indications for Use Form
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
Note 1: Other includes Color Power Doppler, combined B and Color Power Doppler, combined B and PowerMap™ Directional Color Power Doppler, 3-D Imaging, Tissue Harmonic Imaging for guidance of biopsy cleared in K014116. Included in this 510(k) is an expanded intended use for imaging guidance for peripheral nerve block procedures. Also included in this 510(k) is imaging to assist in the placement of needles and catheters in vascular or other anatomical structures.
Nancy C Brogdon
(Division Sigh-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K033367
14
| System: | SonoSite® Ultrasound System | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Transducer: | C11/7-4 7.0 - 4.0 MHz Curved Array | |||||||||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | |||||||||||||
| Clinical Application | Mode of Operation | |||||||||||||
| General | Specific | Color | Combined | Other | ||||||||||
| (Track I only) | (Tracks I & III) | B | M | PWD | CWD | Doppler | (Spec.) | (Spec.) | ||||||
| Ophthalmic | Ophthalmic | |||||||||||||
| Fetal | ||||||||||||||
| Abdominal | P | P | P | P | B+M; B+PWD; | |||||||||
| B+CWD | Note 1 | |||||||||||||
| Intra-operative (Abdominal | ||||||||||||||
| organs and vascular) | P | P | P | B+M; B+PWD | Note 1 | |||||||||
| Intra-operative (Neuro.) | ||||||||||||||
| Fetal Imaging | Laparoscopic | |||||||||||||
| & Other | Pediatric | P | P | P | P | B+M; B+PWD; | ||||||||
| B+CWD | Note 1 | |||||||||||||
| Small Organ (breast, | ||||||||||||||
| thyroid, testicles) | ||||||||||||||
| Neonatal Cephalic | P | P | P | B+M; B+PWD | 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 | Cardiac Pediatric | P | P | P | P | B+M; B+PWD; | ||||||||
| B+CWD | Note 1 | |||||||||||||
| Trans-esophageal (card.) | ||||||||||||||
| Other (spec.) | ||||||||||||||
| Peripheral | Peripheral vessel | P | P | P | B+M; B+PWD | Note 1 | ||||||||
| Vessel | Other (spec.) |
Table 4.3- 8 Diagnostic Ultrasound Indications for Use Form
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
Note 1: Other includes Color Power Doppler, combined B and Color Power Doppler, combined B and PowerMap™ Directional Color Power Doppler, 3-D Imaging, Tissue Harmonic Imaging for guidance of biopsy cleared in K014116. Included in this 510(k) is an expanded intended use for imaging guidance for peripheral nerve block procedures. Also included in this 510(k) is imaging to assist in the placement of needles and catheters in vascular or other anatomical structures.
Nancy C. Hooper
Divis tive. Abdo and Radiolor 510(k) Numbe
15
| System: | SonoSite® Ultrasound System | |||||||
|---|---|---|---|---|---|---|---|---|
| Transducer: | L38/10-5 10.0 - 5.0 MHz Linear Array | |||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | |||||||
| Clinical Application | Mode of Operation | |||||||
| General | ||||||||
| (Track I only) | Specific | |||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | |||
| Doppler | Combined | |||||||
| (Spec.) | Other | |||||||
| (Spec.) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | P | P | P | B+M; B+PWD | Note 1 | |||
| Abdominal | P | P | P | B+M; B+PWD | Note 1 | |||
| Intra-operative | ||||||||
| (Abdominal organs and | ||||||||
| vascular) | P | P | P | B+M; B+PWD | Note 1 | |||
| Intra-operative (Neuro.) | P | P | P | B+M; B+PWD | Note 1 | |||
| Fetal Imaging | ||||||||
| & Other | Laparoscopic | P | P | P | B+M; B+PWD | Note 1 | ||
| Pediatric | P | P | P | B+M; B+PWD | Note 1 | |||
| Small Organ (breast, | ||||||||
| thyroid, testicles) | P | P | P | B+M; B+PWD | Note 1 | |||
| Neonatal Cephalic | P | P | P | B+M; B+PWD | Note 1 | |||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Convent.) | P | P | P | B+M; B+PWD | Note 1 | |||
| Musculo-skel. (Superfic.) | P | P | P | B+M; B+PWD | Note 1 | |||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | P | P | P | B+M; B+PWD | Note 1 | |||
| Trans-esophageal (card.) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | P | P | P | B+M; B+PWD | Note 1 | ||
| Other (spec.) |
Table 4.3- 9 Diagnostic Ultrasound Indications for Use Form
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
Note 1: Other includes Color Power Doppler, combined B and Color Power Doppler, combined B and PowerMap™ Directional Color Power Doppler, 3-D Imaging, Tissue Harmonic Imaging for guidance of biopsy cleared in K010374. Included in this 510(k) is an expanded intended use for imaging guidance for peripheral nerve block procedures. Also included in this 510(k) is imaging to assist in the placement of needles and catheters in vascular or other anatomical structures.
Nancy C. Beagdon
(Division Sign-C Division of Reprod and Radiological Devices 510(k) Number
16
| System: | SonoSite® Ultrasound System | |||||||
|---|---|---|---|---|---|---|---|---|
| Transducer: | L25/10-5 10.0 - 5.0 MHz Linear Array | |||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | |||||||
| Clinical Application | Mode of Operation | |||||||
| General | ||||||||
| (Track I only) | Specific | |||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | |||
| Doppler | Combined | |||||||
| (Spec.) | Other | |||||||
| (Spec.) | ||||||||
| Ophthalmic | Ophthalmic | P | P | B+M; B+PWD | Note 1 | |||
| Fetal | P | P | P | B+M; B+PWD | Note 1 | |||
| Abdominal | P | P | P | B+M; B+PWD | Note 1 | |||
| Intra-operative | ||||||||
| (Abdominal organs and | ||||||||
| vascular) | P | P | P | B+M; B+PWD | Note 1 | |||
| Intra-operative (Neuro.) | ||||||||
| Fetal Imaging | ||||||||
| & Other | Laparoscopic | P | P | P | B+M; B+PWD | Note 1 | ||
| Pediatric | P | P | P | B+M; B+PWD | Note 1 | |||
| Small Organ (breast, | ||||||||
| thyroid, testicles) | P | P | P | B+M; B+PWD | Note 1 | |||
| Neonatal Cephalic | P | P | P | B+M; B+PWD | Note 1 | |||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Convent.) | P | P | P | B+M; B+PWD | Note 1 | |||
| Musculo-skel. (Superfic.) | P | P | P | B+M; B+PWD | Note 1 | |||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | P | P | P | B+M; B+PWD | Note 1 | ||
| Trans-esophageal (card.) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | P | P | P | B+M; B+PWD | Note 1 | ||
| Other (spec.) |
Table 4.3- 10 Diagnostic Ultrasound Indications for Use Form
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
Note 1: Other includes Color Power Doppler, combined B and Color Power Doppler, combined B and PowerMap™ Directional Cclor Power Doppler, 3-D Imaging, Tissue Harmonic Imaging for guidance of biopsy cleared in K010374. Included in this 510(k) is an expanded intended use for imaging guidance for peripheral nerve block procedures. Also included in this 510(k) is imaging to assist in the placement of needles and catheters in vascular or other anatomical structures.
Nancy C. Broughton
(Division Sign Off) Division of Reproductive, Abdon one Radiological Devices ා 10(k) Number