Who is the manufacturer of SONOSITE MICROMAXX DIAGNOSTIC ULTRASOUND SYSTEM (C3 SERIES)?

Sonosite,Inc. filed the 510(k) submission for SONOSITE MICROMAXX DIAGNOSTIC ULTRASOUND SYSTEM (C3 SERIES) (K053069).

What is the FDA product code for SONOSITE MICROMAXX DIAGNOSTIC ULTRASOUND SYSTEM (C3 SERIES)?

IYN. It is classified under 21 CFR 892.1550 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for SONOSITE MICROMAXX DIAGNOSTIC ULTRASOUND SYSTEM (C3 SERIES)?

510(k) clearance (submission type: Traditional).

What are the predicate devices for SONOSITE MICROMAXX DIAGNOSTIC ULTRASOUND SYSTEM (C3 SERIES)?

SonoSite MicroMaxx High-Resolution Ultrasound System (C3 Series) (K043559); Philips Medical Systems (formerly Advanced Technology Laboratories) HDI 5000 Ultrasound System (K034003); Philips Medical Systems (formerly Advanced Technology Laboratories) HDI 5000 Ultrasound System (K011224).

Who can help prepare an FDA 510(k) submission like SONOSITE MICROMAXX DIAGNOSTIC ULTRASOUND SYSTEM (C3 SERIES)?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

SONOSITE MICROMAXX DIAGNOSTIC ULTRASOUND SYSTEM (C3 SERIES)

K053069 · Sonosite,Inc. · IYN · Nov 16, 2005 · Radiology

Device Facts

Record ID	K053069
Device Name	SONOSITE MICROMAXX DIAGNOSTIC ULTRASOUND SYSTEM (C3 SERIES)
Applicant	Sonosite,Inc.
Product Code	IYN · Radiology
Decision Date	Nov 16, 2005
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1550
Device Class	Class 2
Attributes	Pediatric, 3rd-Party Reviewed

Intended Use

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Ophthalmic, Fetal - OB/GYN, Abdominal, Intra-operative (Abdominal organs and vascular), Intra-operative (Neuro.), Laparoscopic, Pediatric, Small Organ (breast, thyroid, testicles.), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-urethral, Musculo-skel. (Conventional), Musculo-skel. (Superficial), Cardiac Adult, Cardiac Pediatric, Trans-esophageal (card.), Peripheral vessel.

Device Story

MicroMaxx High-Resolution Ultrasound System (C3 Series) is a software-controlled diagnostic ultrasound system. It uses piezoelectric transducers to transmit ultrasound energy into the body and receive reflected signals. The system processes these signals to display real-time 2D, M-Mode, Pulsed Wave (PW) Doppler, Continuous Wave (CW) Doppler, Color Power Doppler, and Velocity Color Doppler images. It supports ECG input for timing measurements. Used in clinical settings by physicians for anatomical assessment, fetal biometry, and interventional guidance (e.g., biopsy, nerve blocks). Output is displayed on-screen for clinical decision-making regarding pathology assessment and cardiovascular health. Includes DICOM for image transfer and storage. Benefits include non-invasive diagnostic imaging and real-time procedural guidance.

Clinical Evidence

Bench testing only. The device was evaluated for safety and performance according to recognized consensus standards, including IEC 60601-1 (general safety), IEC 60601-2-37 (ultrasonic diagnostic equipment), and NEMA UD 2/3 (acoustic output). Biocompatibility of patient-contact materials was verified per ISO 10993-1. No clinical trial data was required or presented for this 510(k) clearance.

Technological Characteristics

System uses piezoelectric transducers (linear, curved, intracavitary, phased arrays) operating between 2.0-12.0 MHz. Modes: 2D, M-mode, PW/CW Doppler, Color Power/Velocity Doppler, Tissue Harmonic Imaging. Connectivity: DICOM 3.0, general computer communication. Software-controlled. Biocompatible patient-contact materials. Complies with IEC 60601-1, IEC 60601-2-37, NEMA UD 2, NEMA UD 3, and ISO 10993-1.

Indications for Use

Indicated for diagnostic ultrasound imaging and fluid flow analysis in patients requiring assessment of abdominal, cardiac, gynecological, obstetrical, pediatric, neonatal, prostate, superficial, transcranial, and vascular structures. Includes guidance for interventional procedures such as biopsy, drainage, vascular access, and nerve blocks. Contraindicated for Percutaneous Umbilical Blood Sampling (PUBS) or in vitro Fertilization (IVF).

Regulatory Classification

Identification

An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

SonoSite MicroMaxx High-Resolution Ultrasound System (C3 Series) (K043559)
Philips Medical Systems (formerly Advanced Technology Laboratories) HDI 5000 Ultrasound System (K034003)
Philips Medical Systems (formerly Advanced Technology Laboratories) HDI 5000 Ultrasound System (K011224)

Related Devices

K043559 — SONOSITE HIGH-RESOLUTION DIAGNOSTIC ULTRASOUND SYSTEM (C3 SERIES) · Sonosite,Inc. · Jan 12, 2005
K071134 — SONOSITE MAXX SERIES DIAGNOSTIC ULTRASOUND SYSTEM · Sonosite,Inc. · May 8, 2007
K023957 — SONOSITE HAND-CARRIED ULTRASOUND SYSTEM (C2 SERIES) · Sonosite,Inc. · Dec 12, 2002
K021628 — SONOSITE HAND-CARIED UNTRASOUND SYSTEM (POWERSERIES) · Sonosite,Inc. · May 31, 2002
K030949 — TITAN HIGH RESOLUTION ULTRASOUND SYSTEM · Sonosite,Inc. · Apr 7, 2003

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the seal of the Department of Health and Human Services. The seal features the department's name encircling a symbol. The symbol consists of a stylized caduceus-like design with three curved lines representing the department's mission of promoting health and well-being. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 FEB 2 4 2006 Sonosite, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313 Re: K053069 Trade Name: MicroMaxx High-Resolution Ultrasound System (C3 Series) 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 29, 2005 Received: November 1, 2005 Dear Mr. Job: This letter corrects our substantially equivalent letter of November 16, 2005. 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 MicroMaxx High-Resolution Ultrasound System (C3 Series), as described in your premarket notification: Image /page/0/Picture/12 description: The image shows a circular seal with the letters "FDA" in the center. Above the letters, the text "The" and "FDA" are visible. Below the letters, the word "Centennial" is written in cursive. The seal is surrounded by a dotted border. ing and Promoting Public . Sealth {1}------------------------------------------------ # Transducer Model Number D2/2 2.0 MHz Dual Element Circular Array; C60e/5-2 5.0-2.0 MHz Curved Array; HFL38/13-6 13.0-6.0 MHz Linear Array; SLA/13-6 13.0-6.0 MHz Linear Array; LAP/12-5 12.0-5.0 MHz Linear Array Laparoscopic; L38e/10-5 10.0-5.0 MHz Linear Array; TEE/8-3 8.0-3.0 MHz Trans-esophageal Echocardiography; SLT/10-5 10.0-5.0 MHz Linear Array; P10/8-4 8.0-4.0 MHz Phased Array; P17/5-1 5.0-1.0 MHz Phased 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 (OS) 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. {2}------------------------------------------------ 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 Ewa Czerska at (301) 594-1212. Sincerely yours, Nancy Brogdon Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure(s) {3}------------------------------------------------ | System: | | MicroMaxx™ High-Resolution Ultrasound System (C3 Series) | | | | | | | | |--------------------------|------------|------------------------------------------------------------------------------------|------------------------------|---|---|-----|-----|----------------------------|------------------| | Transducer: | | N/A | | | | | | | | | 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.) | | | Ophthalmic | Ophthalmic | N | N | N | | N | B+M; B+PWD; B+CD | Note 1 | | | | Fetal | P | P | P | | P | B+M; B+PWD; B+CD | Note 1 | | | | 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 | B+M; B+PWD; B+CD | Note 1 | | | | Intra-operative (Neuro.) | P | P | P | | P | B+M; B+PWD; B+CD | Note 1 | | Fetal Imaging & Other | | 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 | P | P | P | | P | B+M; B+PWD; B+CD | Note 1 | | | | Trans-urethral Trans-esoph. (non-Card.) | | | | | | | | | | | Musculo-skel. (Convent.) | P | P | P | | P | B+M; B+PWD; B+CD | Note 1 | | | | Musculo-skel. (Superfic.) | P | P | P | | P | B+M; B+PWD; B+CD | Note 1 | | | | Intra-luminal Other (spec.) | | | | | | | | | Cardiac | | Cardiac Adult | P | P | P | P | P | B+M; B+PWD; B+CWD; B+CD | Note 1, 2 | | | | Cardiac Pediatric | P | P | P | P | P | B+M; B+PWD; B+CWD; B+CD | Note 1, 2 | | | | Trans-esophageal (card.) Other (spec.) | P | P | P | P | P | B+M; B+PWD; B+CWD; B+CD | Note 1, 2 | | Peripheral Vessel | | Peripheral vessel Other (spec.) | P | P | P | | P | B+M; B+PWD; B+CD | Note 1 | Table 4.3- 1 Diagnostic Ultrasound Indications for Use Form - C3 System 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 Imaging, Tissue Harmonic Imaging, Tissue Doppler Imaging and inaging for guidance of biopsy. Color Doppler includes Velocity Color Doppler. Color Doppler can be combined with any imaging mode. Imaging to assist in the placement of needles and catheters in vascular or other analomical structures, and picture arching, communications and storage functionality were all previously cleared in K030949. An expanded intended use for imaging guidance for periously procedures was previously cleared in K033367. Includes Imaging of spinal cord to provide guidance for central nerve block procedures. 28 Note 2: PW Doppler Includes PW Tissue Doppler Imaging (TDI). Prescription Use (Per 21 CFR 801.109) ΤΟΙ). Nange Brogdon (Division Sign-Off) Division of Reproductive, Abdominal, co Radiological Devices 10(k) Number 12053069 Indications for Use . of 734 pages :3 {4}------------------------------------------------ | System: | MicroMaxx™ High-Resolution Ultrasound System (C3 Series) | | | | | | | | |---------------------------|------------------------------------------------------------------------------------|-------------------|---|-----|-----|------------------|---------------------|------------------| | Transducer: | D2/2 2.0 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 | | | | | | | | General (Track I only) | Specific (Tracks I & III) | B | M | PWD | CWD | Color Doppler | Combined (Spec.) | Other (Spec.) | | Ophthalmic | Ophthalmic | | | | | | | | | Fetal Imaging & Other | Fetal | | | | | | | | | | Abdominal | | | | | | | | | | Intra-operative (Abdominal organs and vascular) | | | | | | | | | | Intra-operative (Neuro.) | | | | | | | | | | Laparoscopic | | | | | | | | | | Pediatric | | | | | | | | | | Small Organ (breast, thyroid, testicles.) | | | | | | | | | | 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 | Cardiac Adult | | | | P | | | | | | Cardiac Pediatric | | | | P | | | | | | Trans-esophageal (card.) | | | | | | | | | | Other (spec.) | | | | | | | | | Peripheral Vessel | Peripheral vessel | | | | | | | | | | Other (spec.) | | | | | | | | Table 4.3- 2 Diagnostic Ultrasound Indications for Use Form - D2/2 Transducer N= new indication; P= previously cleared by FDA; E= added under Appendix E Note 1: All items marked "P" were previously cleared in 510(k) K043559. Prescription Use (Per 21 CFR 801.109) Janey C. Brogdon (UNISION oductive, Abdominal. and Division of Rep Radiologic 510(k) Numb {5}------------------------------------------------ | System: | MicroMaxx™ High-Resolution Ultrasound System (C3 Series) | | | | | | | | | |---------------------------|---------------------------------------------------------------------------------------|-------------------|---|-----|-----|------------------|---------------------|------------------|--| | Transducer: | C60e/5-2 5.0-2.0 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 | P | P | P | | P | B+M; B+PWD; B+CD | Note 1 | | | | Abdominal | P | P | P | | P | B+M; B+PWD; B+CD | Note 1 | | | | Intra-operative (Abdominal organs and vascular) | P | P | P | | P | B+M; B+PWD; B+CD | Note 1 | | | | Intra-operative (Neuro.) | | | | | | | | | | Fetal Imaging | Laparoscopic | | | | | | | | | | & Other | Pediatric | P | P | P | | P | B+M; B+PWD; B+CD | Note 1 | | | | Small Organ (breast, thyroid, testicles, prostate) | | | | | | | | | | | Neonatal Cephalic | | | | | | | | | | | Adult Cephalic | | | | | | | | | | | Trans-rectal | | | | | | | | | | | Trans-vaginal | | | | | | | | | | | Trans-urethral | | | | | | | | | | | Trans-esoph. (non-Card.) | | | | | | | | | | | Musculo-skel. (Convent.) | P | P | P | | P | B+M; B+PWD; B+CD | Note 1 | | | | Musculo-skel. (Superfic.) | | | | | | | | | | | Intra-luminal | | | | | | | | | | | Other (spec.) | | | | | | | | | | | Cardiac Adult | | | | | | | | | | Cardiac | Cardiac Pediatric | | | | | | | | | | | Trans-esophageal (card.) | | | | | | | | | | | Other (spec.) | | | | | | | | | | Peripheral | Peripheral vessel | P | P | P | | P | B+M; B+PWD; B+CD | Note 1 | | | Vessel | Other (spec.) | | | | | | | | | # Table 4.3- 2 Diagnostic Ultrasound Indications for Use Form - C60e/5-2 Transducer 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 Dopler, 3-D Imaging, Tissue Harmonic Imaging, Tissue Doppler Imaging and imaging for guidance of biopsy. Color Doppler includes Velocity Color Doppler. Color Doppler can be combined with any imaging mode. Imaging to assist in the placement of needles and catherers in vascular or other senatomical structures was previously deared in 510(k) K030949. Includes imaging of spinal cord to central nerve block procedures. Prescription Use (Per 21 CFR 801.109) Nancy Gregon (Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number K053069 Indications for Use 29 of 734 pages i {6}------------------------------------------------ | System: | | | MicroMaxx™ High-Resolution Ultrasound System (C3 Series) | | | | | | |---------------------------|---------------------------------------------------------------------------------|---|------------------------------------------------------------------------------------|-----|-----|---------------|---------------------|------------------| | Transducer: | | | HFL38/13-6 13.0-6.0 MHz Linear Array Transducer | | | | | | | 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 | | | | | | | | | | Abdominal | P | P | P | | P | B+M; B+PWD; B+CD | Note 1 | | | Intra-operative (Abdominal organs and vascular) | P | P | P | | P | B+M; B+PWD; B+CD | Note 1 | | Fetal Imaging | Intra-operative (Neuro.) Laparoscopic | | | | | | | | | & 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 | | | | | | | | | | Adult Cephalic | | | | | | | | | | Trans-rectal | | | | | | | | | | Trans-vaginal | | | | | | | | | | Trans-urethral | | | | | | | | | | Trans-esoph. (non-Card.) | | | | | | | | | | Musculo-skel. (Convent.) | P | P | P | | P | B+M; B+PWD; B+CD | Note 1 | | | Musculo-skel. (Superfic.) | P | P | P | | P | B+M; B+PWD; B+CD | Note 1 | | | Intra-luminal | | | | | | | | | | Other (spec.) | | | | | | | | | Cardiac | Cardiac Adult Cardiac Pediatric Trans-esophageal (card.) Other (spec.) | | | | | | | | | Peripheral Vessel | Peripheral vessel Other (spec.) | P | P | P | | P | B+M; B+PWD; B+CD | Note 1 | ## Table 4.3- 8 Diagnostic Ultrasound Indications for Use Form - HFL38/13-6 Transducer N= new indication; P= previously cleared by FDA; E= added under Appendix E ### Additional Comments: Note 1: Other includes Color Power Dopter, combined B and Color Power Doppler, 3-D Imaging, Tissue Harmonic Imaging, Tissue Doppler Imaging and imaging for guidance of biopsy. Color Doppler includes Velocity Color Doppler can be combined with any imaging mode. Includes imaging to assist in the placement of needles and catheters in vascular or other anatomical structures and an imaging guidance for peripheral neve block procedures. All items marked "P" were previously deared in 510(k) K04359. Includes Imaging of spinal cord to provide guidance for central nerve block procedures. Prescription Use (Per 21 CFR 801.109) Taneyl Boyden (Division Sigh-Off) Division Reproductive, Abcomman and Radionomical Dev 510(k) Number K053069 Indications for Use of 734 pages 31 6 {7}------------------------------------------------ | System: | MicroMaxx™ High-Resolution Ultrasound System (C3 Series) | | | | | | | | | |---------------------------|---------------------------------------------------------------------------------------|--------------------------------------------------------------------|-------------------|---|-----|-----|------------------|---------------------|------------------| | Transducer: | SLA/13-6 13.0-6.0 MHz Linear Array Transducer | | | | | | | | | | 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 | | | | | | | | | | | Abdominal Intra-operative (Abdominal organs and vascular) | P | P | P | | P | B+M; B+PWD; B+CD | Note 1 | | | | Intra-operative (Neuro.) | N | N | N | | N | B+M; B+PWD; B+CD | Note 1 | | Fetal Imaging | | Laparoscopic | | | | | | | | | & 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 | | | | | | | | | | | Adult Cephalic | | | | | | | | | | | Trans-rectal | | | | | | | | | | | Trans-vaginal | | | | | | | | | | | Trans-urethral | | | | | | | | | | | Trans-esoph. (non- Card.) | | | | | | | | | | | Musculo-skel. (Convent.) | P | P | P | | P | B+M; B+PWD; B+CD | Note 1 | | | | Musculo-skel. (Superfic.) | P | P | P | | P | B+M; B+PWD; B+CD | Note 1 | | | | Intra-luminal | | | | | | | | | | | Other (spec.) | | | | | | | | | Cardiac | | Cardiac Adult | | | | | | | | | | | Cardiac Pediatric | | | | | | | | | | | Trans-esophageal (card.) | | | | | | | | | | | Other (spec.) | | | | | | | | | Peripheral Vessel | | Peripheral vessel Other (spec.) | P | P | P | | P | B+M; B+PWD; B+CD | Note 1 | Table 4.3- 4 Diagnostic Ultrasound Indications for Use Form -- SLA/13-6 Transducer N= new indication; P= previously cleared by FDA; E= added under Appendix E ### Additional Comments: Nole 1: Other includes Color Power Doppler, combined B and Color Power Doppler, 3D Imaging, Tissue Hamonic Imaging, Tissue Frod 17 Chick Holledo Soler Portor Bopper of the Over Porter Dopper, Jo Innight, Tisset Timents Integrity, Color Doppler Lan be combined with any imaging mode Prescription Use (Per 21 CFR 801.109) Nancy brogen (DIVISION Sign-Off) Division of Reproductive, Abdominal, Radiological Devices 510(k) Number R0530 Indications for Use 31 of 734 pages {8}------------------------------------------------ Table 4.3- 13 Diagnostic Ultrasound Indications for Use Form – LAP/12-5 Laparoscopic Transducer | System: | MicroMaxx™ High-Resolution Ultrasound System (C3 Series) | | | | | | | | |-----------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|---|-----|-----|------------------|---------------------|------------------| | Transducer: | LAP/12-5 12.0-5.0 MHz Linear Array Laparoscopic Transducer | | | | | | | | | 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 | | | | | | | | | | Abdominal | | | | | | | | | | Intra-operative (Abdominal organs and vascular) | | | | | | | | | | Intra-operative (Neuro.) | | | | | | | | | Fetal Imaging & Other | Laparoscopic Pediatric Small Organ (breast, thyroid, testicles.) 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.) Musculo-skel. (Superfic.) Intra-luminal Other (spec.) | | | | | | | | | Cardiac | Cardiac Adult Cardiac Pediatric Trans-esophageal (card.) Other (spec.) | | | | | | | | | Peripheral Vessel | 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 Imaging, Tissue Doppler Imaging and imaging for guidance of biopsy. Color Doppler includes Velocity Color Doppler. Color Doppler can be combined with any imaging mode. All items marked "P" were previously cleared in 510(k) K043559. Prescription Use (Per 21 CFR 801.109) Haney C. Bragdon . \/ \ uctive Abdomin adi 10(k) {9}------------------------------------------------ | MicroMaxx™ High-Resolution Ultrasound System (C3 Series) System: | | | | | | | | | |--------------------------------------------------------------------------------------------------------|-------------------------------------------------------|-------------------|---|-----|-----|------------------|---------------------|------------------| | Transducer: | L38e/10-5 10.0-5.0 MHz Linear Array Transducer | | | | | | | | | Diagnostic ultrasound imaging or fluid flow analysis of the human Intended Use: 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 | | | | | | | | | | Abdominal | P | P | P | | P | B+M; B+PWD; B+CD | Note 1 | | | Intra-operative (Abdominal organs and vascular) | P | P | P | | P | B+M; B+PWD; B+CD | Note 1 | | | Intra-operative (Neuro.) | | | | | | | | | Fetal Imaging | Laparoscopic | | | | | | | | | & 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 | | | | | | | | | | Adult Cephalic | | | | | | | | | | Trans-rectal Trans-vaginal | | | | | | | | | | Trans-urethral | | | | | | | | | | Trans-esoph. (non- Card.) | | | | | | | | | | Musculo-skel. (Convent) | P | P | P | | P | B+M; B+PWD; B+CD | 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 | | | | | | | | | | Trans-esophageal (card.) | | | | | | | | | | Other (spec.) | | | | | | | | | Peripheral | Peripheral vessel | P | P | P | | P | B+M; B+PWD; B+CD | Note 1 | | Vessel | Other (spec.) | | | | | | | | Table 4.3- 5 Diagnostic Ultrasound Indications for Use Form - L38e/10-5 Transducer 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, 3-0 Imaging, Tissue Harmonic Imaging, Tissue Doppler Imaging and imaging for guidance of biopsy. Color Doppler includes Velocity Color Doppler. Color Doppler can be combined with any imaging mode. Includes imaging to assist in the placement of needles and catherers in vascular or other analomical structures and imaging guidance for peripheral neve block procedures. Includes imaging of spinal cord to provide guidance for central nerve block procedures. Prescription Use (Per 21 CFR 801 109) Darcy C. Brogdon (Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number Indications for Use of 734 pages 32 > : : . {10}------------------------------------------------ # Table 4.3- 6 Diagnostic Ultrasound Indications for Use Form - TEE/8-3 Trans-Esophageal Echocardiography Transducer | System: | | | | MicroMaxx™ High-Resolution Ultrasound System (C3 series) | | | | | | | |--------------------------------------------|--------------------------------------------------------------------|------------------------------------------------------------------|------------------------------------------------------------------------|----------------------------------------------------------|-----|-----|-------------------|----------------------------|------------------|--| | Transducer: | | TEE/8-3 8.0-3.0 MHz Trans-esophageal Echocardiography Transducer | | | | | | | | | | Intended Use: as follows: | | | Diagnostic ultrasound imaging or fluid flow analysis of the human body | | | | | | | | | Clinical Application | | | | | | | Mode of Operation | | | | | General (Track I only) Ophthalmic | Specific (Tracks I & III) Ophthalmic | | B | M | PWD | CWD | Color Doppler | Combined (Spec.) | Other (Spec.) | | | | | | | | | | | | | | | | | Fetal | | | | | | | | | | | Abdominal Intra-operative (Abdominal organs and vascular) | | | | | | | | | | | | | Intra-operative (Neuro.) | | | | | | | | | | Fetal Imaging | Laparoscopic | | | | | | | | | | | & Other | | Pediatric | | | | | | | | | | | Small Organ (breast, thyroid, testicles.) | | | | | | | | | | | | 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 | | | | | | | | | | Cardiac | | Cardiac Pediatric | | | | | | | | | | | | Trans-esophageal (card.) | P | P | P | P | P | B+M; B+PWD; B+CWD; B+CD | Note 1, 2 | | | | | Other (spec.) | | | | | | | | | | Peripheral | Peripheral vessel | | | | | | | | | | | 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 Imaging, Tissue Harmonic Imaging, Tissue Doppler Imaging and imaging for guidance of biopsy. Color Doppler includes Velocity Color Doppler. Color Doppler can be combined with any imaging mode. Note 2: PW Doppler includes PW Tissue Doppler Imaging (TDI). Prescription Use (Per 21 CFR 801.109) Nancy C Brogdon (Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices K053069 510(k) Number Indications for Use 33 of 734 pages {11}------------------------------------------------ | System: | MicroMaxx™ High-Resolution Ultrasound System (C3 Series) | | | | | | | | | | |----------------------|----------------------------------------------------------|------------------------------------|-------------------------------------------------------------------|-----|-----|---------|---------------------|---------|--|--| | Transducer: | | SLT/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 | | P | B+M; B+PWD; B+CD | Note 1 | | | | | | | | | | | | | | | | | Abdominal | P | P | P | | P | B+M; B+PWD; B+CD | Note 1 | | | | | Intra-operative | | | | | | | | | | | | (Abdominal organs and | P | P | P | | P | B+M; B+PWD; B+CD | | | | | | vascular) Intra-operative (Neuro.) | | | | | | B+CD | Note 1 | | | | Fetal Imaging | Laparoscopic | | | | | | | | | | | | | | | | | | | | | | | & Other | Pediatric | P | P | P | | P | B+M; B+PWD; B+CD | Note 1 | | | | | Small Organ (breast, thyroid, testicles.) | | | | | | B+M; B+PWD; | | | | | | thyroid, testicles.) | P | P | P | | P | B+CD | Note 1 | | | | | Neonatal Cephalic | | | | | | | | | | | | Adult Cephalic | | | | | | | | | | | | Trans-rectal | | | | | | | | | | | | Trans-vaginal | | | | | | | | | | | | Trans-urethral | | | | | | | | | | | | Trans-esoph. (non- Card.) | | | | | | | | | | | | Card.) | | | | | | | | | | | | Musculo-skel. | P | P | P | | P | B+M; B+PWD; B+CD | | | | | | (Convent.) | | | | | | | Note 1 | | | | | Musculo-skel. | | | P | | | B+CD | Note 1 | | | | | (Superfic.) | P | P | P | | P | B+M; B+PWD; B+CD | Note 1 | | | | | Intra-luminal | | | | | | | | | | | | Other (spec.) | | | | | | | | | | | | Cardiac Adult | | | | | | | | | | | Cardiac | Cardiac Pediatric | | | | | | | | | | | | Trans-esophageal | | | | | | | | | | | | (card.) | | | | | |…