(67 days)
Not Found
No
The summary does not mention AI, ML, or any related terms, and the device description focuses on hardware and basic signal processing.
No
The 'Intended Use / Indications for Use' section clearly states the device is for "ultrasound evaluation," indicating it is a diagnostic tool, not therapeutic.
Yes
The "Device Description" explicitly states, "The z.one Ultra is a general purpose diagnostic ultrasound system." The "Intended Use / Indications for Use" section further details its application for "ultrasound evaluation" across various anatomical sites, which is a diagnostic purpose.
No
The device description explicitly states it consists of a combination of portable scanners, a docking station, and transducer modules, which are all hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health.
- Device Function: The description clearly states this is a diagnostic ultrasound system. Ultrasound works by transmitting sound waves into the body and receiving the echoes to create images of internal structures. It does not involve the analysis of specimens taken from the body.
- Intended Use: The intended use lists various anatomical sites for ultrasound evaluation within the body (Ophthalmic, Fetal/obstetric, gynecological, Abdominal, etc.).
- Device Description: The description details the components of an ultrasound system (scanner, transducers, docking station) and how it interacts with the patient (transducer comes into contact with the patient).
Therefore, this device is a diagnostic imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The device is intended for use by a qualified physician for ultrasound evaluation of Ophthalmic; Fetal/obstetric, gynecological; Abdominal (renal, GYN/Pelvic; Intra-operative (abdominal, thoracic, and vascular). Intra-operative neurological; Pediatric; Small organ (thyroid, breast, testes, etc), Adult & Neonatal Cephalic; Trans-rectal, Trans-cranial, Trans-esophageal (non-cardiac); Musculoskeletal (conventional & superficial); 3D/4D; Cardiac - Adult/Pediatric/Fetal; Intra-Cardiac; Pelvio; Peripheral vascular; harmonic tissue and contrast imaging and Tissue elasticity.
Product codes (comma separated list FDA assigned to the subject device)
90-IYN, 90-IYO, 90-ITX
Device Description
The z.one Ultra is a general purpose diagnostic ultrasound system which consists of a combination of portable scanner(s) less than 10 inches wide and 3 inches high, embedded in the cart, or that can be held by the user in one hand. They include buttons for controlling the system and may have a screen that display ultrasound mages and user interface or be without the screen (monitor) and user interface. The portable scanner can be held by the user in one hand accommodates a removable transducer module. Signals received from the transducer module are digitized and preprocessed. The transducer module comes into contact with the patient and both transmit and receive ultrasound energy.
The docking station (aka carts) provides holders for the portable scanner, and transducer modules, as well as battery chargers and other accessories. The modification for this submission includes new indication for use and off the shelf transducers.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Ophthalmic; Fetal/obstetric, gynecological; Abdominal (renal, GYN/Pelvic); Intra-operative (abdominal, thoracic, and vascular), Intra-operative neurological; Pediatric; Small organ (thyroid, breast, testes, etc), Adult & Neonatal Cephalic; Trans-vaginal, Trans-esophageal (non-cardiac and cardiac); Musculoskeletal (conventional & superficial); Cardiac (Adult/Pediatric/Fetal); Intra-Cardiac; Peripheral vascular; Pelvio;
For specific transducers, additional anatomical sites include:
Fetal, Abdominal, Intraoperative, Pediatric, Ophthalmic, Small organ/parts (breast/estest thyroid, ecc), Transvaginal, Transrectal, Transcranial, Trans-esoph, Trans-urethral, OB/GYN, Cardiac, Pelvic, Neonatal/Adult cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, Peripheral Vessel.
Indicated Patient Age Range
Adult & Neonatal/Pediatric
Intended User / Care Setting
Qualified physician
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)
Non-clinical tests: The device has been evaluated according to the applicable medical device quality systems, safety standards for acoustic output, biocompatibility, verification, cleaning, and disinfection effectiveness as well as for thermal, electrical, and mechanical safety, those applicable to ZONARE's ultrasound product are:
ISO 14971 Medical Devices – applications of risk management to medical devices
IEC/UL 60601-1 Medical Electrical Equipment (MEE) – General Requirements for Safety
IEC 60601-1-1 Medical Electrical Equipment for Systems
IEC 60601-1-2 EMC
IEC 60601-1-4 MEE – Programmable electrical medical systems
IEC 60601-2-37 Safety of ultrasonic medical diagnostic and monitoring equipment
IEC 62304 Medical Device software – software life cycle processes
ISO 10993 Biological evaluation of medical devices
AIUM Medical Ultrasound Safety, American Institute of Ultrasound in Medicine (2002)
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.
K022858, K082326, K031066, K073709, K062247, K053069
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
| 510(k) Summary of Safety & Effectiveness |
|---|
| ----------------------------------------------------- |
Prepared in accordance with 21 CFR Part 807.92(c)
| The assigned 510(k) number is: | K101091 |
|---|---|
| -------------------------------- | --------- |
Applicant Information:
| Date Prepared: | June 14, 2010 |
|---|---|
| Name: | ZONARE Medical Systems, Inc. |
| 420 North Bernardo Avenue | |
| Mountain View, CA 94043 | |
| Contact Persons: | Linda J. Moore |
| Director, Regulatory Affairs & Quality Assurance | |
| Telephone Numbers: | 650-230-2724 |
| Fax Number: | 650-967-9036 |
| lmoore@zonare.com |
Device Information:
| Trade Name: | ZONARE z.one Ultra Ultrasound System |
|---|---|
| ------------- | -------------------------------------- |
JUN 2 5 2010Device Name: ZONARE Diagnostic Ultrasound System
| 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 |
Marketed Device(s): The ZONARE z.one Ultra Ultrasound System (K022858), (K082326), EPMed Systems (St. Jude. K031066) (K073709), Philips HD11 (K062247), and Sonosite, Inc. (K053069) devices currently in commercial distribution.
Device Description: The z.one Ultra is a general purpose diagnostic ultrasound system which consists of a combination of portable scanner(s) less than 10 inches wide and 3 inches high, embedded in the cart, or that can be held by the user in one hand. They include buttons for controlling the system and may have a screen that display ultrasound mages and user interface or be without the screen (monitor) and user interface. The portable scanner can be held by the user in one hand accommodates a removable transducer module. Signals received from the transducer module are digitized and preprocessed. The transducer module comes into contact with the patient and both transmit and receive ultrasound energy.
The docking station (aka carts) provides holders for the portable scanner, and transducer modules, as well as battery chargers and other accessories. The modification for this submission includes new indication for use and off the shelf transducers.
1
Indications for Use: The device is intended for use by a qualified physician for ultrasound evaluation of Ophthalmic; Fetal/obstetric, gynecological; Abdominal (renal, GYN/Pelvic; Intra-operative (abdominal, thoracic, and vascular). Intra-operative neurological; Pediatric; Small organ (thyroid, breast, testes, etc), Adult & Neonatal Cephalic; Trans-rectal, Trans-cranial, Trans-cranial, Trans-esophageal (non-cardiac); Musculoskeletal (conventional & superficial); 3D/4D; Cardiac - Adult/Pediatric/Fetal; Intra-Cardiac; Pelvio; Peripheral vascular; harmonic tissue and contrast imaging and Tissue elasticity.
Comparison with Predicate Device: With respect to features and applications, the ZONARE z.one Ultra with the new ophthalmic indication for use and the off the shelf intra-cardiac echo catheter (View-Flex) is comparable and substantially equivalent to the currently marketed ZONARE z.one and the predicate devices listed in predicate devices section in terms of portability, features and functionality, they have the same important safety and effectiveness features, as well as design, materials, and construction.
Non-clinical tests: The device has been evaluated according to the applicable medical device quality systems, safety standards for acoustic output, biocompatibility, verification, cleaning, and disinfection effectiveness as well as for thermal, electrical, and mechanical safety, those applicable to ZONARE's ultrasound product are:
| ISO 14971 | Medical Devices – applications of risk management to medical devices |
|---|---|
| IEC/UL 60601-1 | Medical Electrical Equipment (MEE) – General Requirements for Safety |
| IEC 60601-1-1 | Medical Electrical Equipment for Systems |
| IEC 60601-1-2 | EMC |
| IEC 60601-1-4 | MEE – Programmable electrical medical systems |
| IEC 60601-2-37 | Safety of ultrasonic medical diagnostic and monitoring equipment |
| IEC 62304 | Medical Device software – software life cycle processes |
| ISO 10993 | Biological evaluation of medical devices |
| AIUM | Medical Ultrasound Safety, American Institute of Ultrasound in Medicine (2002) |
Clinical Tests: Non Required
Conclusion: The device conforms to applicable medical device safety standards and compliance for safety and effectiveness is verified through defined evaluation and market surveillance. The ZONARE z.one Ultra Diagnostic Ultrasound System is substantially equivalent with respect to safety and effectiveness to devices current cleared for market.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUN 2 5 2010
ZONARE Medical Systems, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
Re: K101091
Trade/Device Name: The z.one Ultra Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: TYN, IYO, and ITX Dated: June 9, 2010 Received: June 10, 2010
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 z.one Ultra Ultrasound System, as described in your premarket notification:
Transducer Model Number
Curvilinear Transducer C4-1 Curvilinear Transducer C5-2 Curvilinear Transducer C6-2 Curvilinear Transducer C9-3 Curvilinear Transducer C8-3 (3D/4D) Curvilinear Transducer C9-4t Phase (Sector) Array Transducer P4-1 Phase (Sector) Array Transducer P4-1c Phased (Sector) Array Transducer P10-4 Endo-Cavity Transducer E9-4 Endo-Cavity Transducer E9-4 (3D) Linear Transducer L10-5
Image /page/2/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
3
Linear Transducer L8-3 Linear Transducer L12-4v Linear Transducer L14-5sp Linear Transducer L14-5w Tran-Esophageal Transducer P8-3T St. Jude EP ViewFlex PLUS ICE Catheter model # VF-PM Part #09-2005 A2CW (Common name Pencil Probe) A5CW (Common name Pencil Probe)
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 895. 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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
If you have any questions regarding the content of this letter, please contact Shahram Vaezy at (301) 796-6242.
Sincerely vours.
Robert Becker (for)
Donald St. Pierre
Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure(s)
4
Image /page/4/Picture/0 description: The image shows a logo with a stylized letter 'Z' inside a black square. The letter 'Z' is white and appears to be made of thick, overlapping lines. Below the square, the word 'ZONARE' is written in a simple, blocky font. The logo has a slightly pixelated or grainy appearance, suggesting it may be a low-resolution image or a scan of an older print.
Indications for Use Statement
510(K) Number (if known): K101091
Device Name: The z.one Ultra Ultrasound system
Indications for Use: The device is intended for use by a qualified physician for ultrasound evaluation of Ophthalmic; Fetal/obstetric, gynecological; Abdominal (renal, GYN/Pelvic ; Intra-operative (abdominal, thoracic, and vascular), Intra-operative neurological; Pediatric; Small organ (thyroid, breast, testes, etc), Adult & Neonatal Cephalic; Trans-vaginal, Trans-vaginal, Trans-esophageal (non-cardiac and cardiac); Musculoskeletal (conventional & superficial); 3D/4D; Cardiac -Adult/Pediatric/Fetal; Intra-Cardiac; Peripheral vascular; harmonic tissue and contrast imaging and Tissue elasticity. .
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Robert P. Becker
Division Sign-Off.
Division Sign-Off Office of In Vitro Diagnostic Devices Evaluation and Safety
510(K) K101091
Page 1 of
5
Diagnostic Ultrasound Indications for use 1.3.
510(K) Number (if known):
System Name: ZONARE z.one Ultra Ultrasound Diagnostic System Device Name: Union of all Transducer Types
Indications for Use: This device is intended for use by a qualified physician for ultrasound evaluation of the following: Feal, Abdominal, Intraoperative, Pediatric, Ophthalmic, Small organ/parts (breast/estest thyroid, ecc), Transvaginal, Transrectal, Transcranial, Trans-esoph, Trans-urethral, OB/GYN, Cardiac, Pelvic, Neonatal/Adult cephalic, Vascular, 3D/4D, Tissue elasticity, Musculoskeletal, cardiac, Superficial Musculoskeletal, and Peripheral Vascular applications and others as shown below.
| Clinical Application | Specific | B | M | PWD2 | CWD
CWD
Aux | Color
Doppler3 | Combined
Modes4 | Other5, 8 |
|----------------------|------------------------------------------------|----|---|------|-------------------|-------------------|--------------------|-----------|
| Ophthalmic | Ophthalmic | N | | N | | N | | |
| | Fetal | P | P | P | P | P | P | p5 |
| | Abdominal | P | P | P | P | P | P | p5 |
| | Intra-operative
(Specify)6 | P | P | P | | P | P | p5 |
| | Intra-operative (Neuro) | P | | P | | P | P | p5 |
| | Laparoscopic | | | | | | | |
| | Pediatric | P | P | P | P | P | P | p5 |
| | Pediatric Aux | | | | P | | | |
| | Small Organ (Thyroid,
Breast, Testes, etc.) | P | P | P | | P | P | p5 |
| | Neonatal Cephalic | P | P | P | P | P | P | p5 |
| General | Adult Cephalic | P | P | P | P | P | P | p5 |
| Application | Trans-rectal | P | P | P | | P | P | p5 |
| | Trans-vaginal | P | P | P | | P | P | p5 |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-
Card.) | P | P | P | P | P | P | p5 |
| | Musculo-skel.
(Conventional) | P | P | P | | P | P | p5, 8 |
| | Musculo-skel.
(Superficial) | P | P | P | | P | P | p5, 8 |
| | Intra-luminal | | | | | | | |
| | Other (Specify)
(3D/4D) | P | P | P | | P | P | |
| | Cardiac Adult | P1 | P | P | P | P | P | p5 |
| | Cardia Adult Aux | | | | P | | | |
| | Cardiac Pediatric | P | P | P | P | P | P | p5 |
| Cardiac | Cardiac Pediatric Aux | | | | P | | | |
| | Trans-esoph. (Cardiac) | P | P | P | P | P | P | p5 |
| | Other (Specify)
(3D/4D) | P | P | P | P | P | P | |
| | Other (Intra-Cardiac)* | P | P | P | | P | P | p5 |
| Peripheral vascular | Peripheral Vessel | P | P | P | P | P | P | p5 |
| | Peripheral Vessel Aux | | | | P | | | |
| | Other (Specify)
(3D/4D) | P | P | P | | P | P | |
N = new indication; P = previously cleared by FDA 510(k) K022858 & K082326, *ST. Jude # 073709 E=Added under Appendix E Includes B-Mode and Harmonic (contrast) imaging (HI)
2 Includes PWD-Mode imaging and High Pulse Repetition Rate PWD-Mode (HPRF)
Includes Color Doppler (CD), Directional Power Doppler (DPD), and Power Doppler (PD)
Includes B+M, B+M+CM, M+CM, B+CD+M+CM, B+CD+PWD where CD could represent (CD, DPD, PD, or BD)
3 Color M-Mode (CM)
Abdominal includes renal, GYN/Pelvic Intra operative include abdominal, thoracic (cardiac) and vascular (PV)
Freehand tissue elasticity
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off
Office of In Vitro Diagnostic Devices Evaluation and Safety 510(K)
Page 1 of
510k Submittal ZONARE Medical Systems, Inc.
l
6
System Name: ZONARE z.one Ultra Ultrasound Diagnostic System Device Name: Curvilinear Transducer C4-1
Indications for Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | ||||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track I Only) | Specific | |||||||
| (Track I & III) | B | M | PWD² | CWD | Color | |||
| Doppler³ | Combined | |||||||
| Modes⁴ | Other | |||||||
| ⁸ | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | E | E | E | E | E | |||
| Abdominal | E | E | E | E | E | |||
| Intra-operative | ||||||||
| (Specify) | ||||||||
| Intra-operative | ||||||||
| (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | E | E | E | E | E | |||
| Small Organ | ||||||||
| (Thyroid, Breast, | ||||||||
| Testes, etc.) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non- | ||||||||
| Card.) | ||||||||
| Musculo-skel. | ||||||||
| (Conventional) | E | E | E | E | ||||
| Musculo-skel. | ||||||||
| (Superficial) | ||||||||
| Intra-luminal | ||||||||
| Other (Specify) | ||||||||
| (3D/4D) | ||||||||
| contrast | E | E | E | E | E | |||
| Cardiac Adult | E | E | E | E | E | |||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esoph. | ||||||||
| (Cardiac) | ||||||||
| Other (Specify) | ||||||||
| Peripheral | Peripheral vascular | |||||||
| vascular | Other (Specify) |
N = new indication; P=previously cleared by FDA 510(k), E=Added under Appendix E
1 Includes B-Mode and Harmonic (contrast) imaging (HI)
2 Includes PWD-Mode imaging and High Pulse Repetition Rate PWD-Mode (HPRF)
3 Includes Color Doppler (CD), Directional Power Doppler (DPD), and Power Doppler (PD)
4 Includes B+M, B+M+CM, M+CM, B+CD+M+CM, B+CD+PWD where CD could represent (CD, DPD, PD, or BD)
S Color M-Mode (CM)
6 Abdominal includes renal, GYN/Pelvic
7 Intra operative include abdominal, thoracic (cardiac) and vascular (PV)
8 Freehand tissue elasticity
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Concurre
Division Sign Off
Office of In Vitro Diagnostic Devices Evaluation and Safety
510(K) K101091
Page 1 of
7
System Name: ZONARE z.one Ultra Ultrasound Diagnostic System Device Name: Curvilinear Transducer C5-2
Indications for Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | Specific | |||||||
| (Track I & III) | B | M | PWD2 | CWD | Color | |||
| Doppler3 | Combined | |||||||
| Modes4 | Other8 | |||||||
| Ophthalmic | Ophthalmic | |||||||
| General | ||||||||
| applications | Fetal | P | P | P | P | P | P5 | |
| Abdominal6 | P | P | P | P | P | P5 | ||
| Intra-operative | ||||||||
| (Specify) | ||||||||
| Intra-operative | ||||||||
| (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | P | P | P5 | ||
| Small Organ | ||||||||
| (Thyroid, Breast, | ||||||||
| Testes, etc.) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non- | ||||||||
| Card.) | ||||||||
| Musculo-skel. | ||||||||
| (Conventional) | ||||||||
| Musculo-skel. | ||||||||
| (Superficial) | ||||||||
| Intra-luminal | ||||||||
| Other (Specify) | ||||||||
| (3D/4D) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac Pediatric | ||||||||
| Cardiac | Trans-esoph. | |||||||
| (Cardiac) | ||||||||
| Other (Specify) | ||||||||
| Peripheral Vascular | P | P | P | P | P | P5 | ||
| Peripheral | Other (Specify) |
N = new indication; P=previously cleared by FDA 510(k) K022858 & K082326, E=Added under Appendix E
1 Includes B-Mode and Harmonic (contrast) imaging (HI)
2 Includes PWD-Mode imaging and High Pulse Repetition Rate PWD-Mode (HPRF)
3 Includes Color Doppler (CD), Directional Power Doppler (DPD), and Power Doppler (PD)
4 Includes B+M, B+M+CM, B+CD+M+CM, B+CD+PWD where CD could represent (CD, DPD, PD, or BD) 5 Color M-Mode (CM)
- Color M-Mode (CM)
6 Abdominal includes renal, GYN/Pelvic
Intra operative include abdominal, thoracic (cardiac) and vascular (PV)
8 Freehand tissue elasticity
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Robert A. Becklof
Division Sign-Off
Office of In Vitro Diagnostic Devices Evaluation and Safety
510(K) 101091
8
System Name: ZONARE z.one Ultra Ultrasound Diagnostic System Device Name: Curvilinear Transducer C6-2
Indications for Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | Specific | |||||||
| (Track I & III) | B | M | PWD2 | CWD | Color | |||
| Doppler3 | Combined | |||||||
| Modes4 | Other8 | |||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | P | P | P | P | P | P5 | ||
| Abdominal6 | P | P | P | P | P | P5 | ||
| Intra-operative | ||||||||
| (Specify) | ||||||||
| Intra-operative | ||||||||
| (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | P | P | P5 | ||
| Small Organ | ||||||||
| (Thyroid, Breast, | ||||||||
| Testes, etc.) | ||||||||
| Neonatal Cephalic | ||||||||
| General | ||||||||
| applications | Adult Cephalic | |||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non- | ||||||||
| Card.) | ||||||||
| Musculo-skel. | ||||||||
| (Conventional) | ||||||||
| Musculo-skel. | ||||||||
| (Superficial) | ||||||||
| Intra-luminal | ||||||||
| Other (Specify) | ||||||||
| (3D/4D) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esoph. | ||||||||
| (Cardiac) | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vascular | Peripheral Vascular | P | P | P | P | P | P5 | |
| Other (Specify) |
N = new indication; P=previously cleared by FDA 510(k) K022858 & K082326, E=Added under Appendix E
1 Includes B-Mode and Harmonic (contrast) imaging (HI)
2 Includes PWD-Mode imaging and High Pulse Repetition Rate PWD-Mode (HPRF)
3 Includes Color Doppler (CD), Directional Power Doppler (DPD), and Power Doppler (PD)
4 Includes B+M, B+M+CM, M+CM, B+CD+M+CM, B+CD+PWD where CD could represent (CD, DPD, PD, or BD)
5 Color M-Mode (CM)
6 Abdominal includes renal, GYN/Pelvic
7 Intra operative include abdominal, thoracic (cardiac) and vascular (PV)
8 Freehand tissue elasticity
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
RolaRBeeted
Division Sign-Off
Office of In Vitro Diagnostic Devices Evaluation and Safety
510(K) K101091
9
System Name: ZONARE z.one Ultra Ultrasound Diagnostic System
Device Name: Curvilinear Transducer C9-3
Indications for Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | Specific | |||||||
| (Track I & III) | B | M | PWD2 | CWD | Color | |||
| Doppler3 | Combined | |||||||
| Modes4 | Other8 | |||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | P | P | P | P | P | P5 | ||
| Abdominal6 | P | P | P | P | P | P5 | ||
| Intra-operative | ||||||||
| (Abdominal) | P | P | P | P | P | P | P5 | |
| Intra-operative | ||||||||
| (Vascular) | P | P | P | P | P | P | P5 | |
| Laparoscopic | ||||||||
| Pediatric | P | P | P | P | P | P5 | ||
| Small Organ | ||||||||
| (Thyroid, Breast, | ||||||||
| Testes, etc.) | ||||||||
| Neonatal Cephalic | ||||||||
| General | Adult Cephalic | |||||||
| applications | Trans-rectal | |||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non- | ||||||||
| Card.) | ||||||||
| Musculo-skel. | ||||||||
| (Conventional) | P | P | P | P | P | P | P5 | |
| Musculo-skel. | ||||||||
| (Superficial) | P | P | P | P | P | P | P5 | |
| Intra-luminal | ||||||||
| Other (Specify) | ||||||||
| (3D/4D) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac Pediatric | ||||||||
| Cardiac | Trans-esoph. | |||||||
| (Cardiac) | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vascular | Peripheral Vascular | P | P | P | P | P | P5 | |
| Other (Specify) |
N = new indication: P=previously cleared by FDA 510(k) K082326, E=Added under Appendix E
Includes B-Mode and Harmonic (contrast) imaging (HI)
2 Includes PWD-Mode imaging and High Pulse Repetition Rate PWD-Mode (HPRF)
3 Includes Color Doppler (CD), Directional Power Doppler (DPD), and Power Doppler (PD)
4 Includes B+M, B+M+CM, M+CM, B+CD+M+CM, B+CD+PWD where CD could represent (CD, DPD, PD, or BD)
5 Color M-Mode (CM)
6 Abdominal includes renal, GYN/Pelvic
7 Intra operative include abdominal, thoracic (cardiac) and vascular (PV)
8 Freehand tissue elasticity
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Robert Beckerf
Division Sign-Off
Office of In Vitro Diagnostic Devices Evaluation and Safety
510(K) K101091
10
System Name: ZONARE z.one Ultra Ultrasound Diagnostic System
Device Name: Curvilinear Transducer C8-3 (3D/4D)
Indications for Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | Specific | |||||||
| (Track I & III) | B | M | PWD2 | CWD | Color | |||
| Doppler3 | Combined | |||||||
| Modes4 | Other5 | |||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | P | P | P | P | P | P5 | ||
| Abdominal6 | P | P | P | P | P | P5 | ||
| General | ||||||||
| applications | Intra-operative | |||||||
| (Specify) | ||||||||
| Intra-operative | ||||||||
| (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | P | P | P5 | ||
| Small Organ | ||||||||
| (Thyroid, Breast, | ||||||||
| Testes, etc.) | ||||||||
| Peonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non- | ||||||||
| Card.) | ||||||||
| Musculo-skel. | ||||||||
| (Conventional) | ||||||||
| Musculo-skel. | ||||||||
| (Superficial) | ||||||||
| Intra-luminal | ||||||||
| Other (Specify) | ||||||||
| (3D/4D) | P | P | P | P | P | P5 | ||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esoph. | ||||||||
| (Cardiac) | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vascular | Peripheral Vascular | P | P | P | P | P | P5 |
N = new indication; P=previously cleared by FDA 510(k) K082326, E=Added under Appendix E
1 Includes B-Mode and Harmonic (contrast) imaging (HI)
2 Includes PWD-Mode imaging and High Pulse Repetition Rate PWD-Mode (HPRF)
3 Includes Color Doppler (CD), Directional Power Doppler (DPD), and Power Doppler (PD)
4 Includes B+M, B+M+CM, M+CM, B+CD+M+CM, B+CD+PWD where CD could represent (CD, DPD, PD, or BD)
5 Color M-Mode (CM)
6 Abdominal includes renal, GYN/Pelvic
7 Intra operative include abdominal, thoracic (cardiac) and vascular (PV)
8 Freehand tissue elasticity
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Zolul Beckuf
Division Sign-Off
Office of In Vitro Diagnostic Devices Evaluation and Safety
510(K) K101091
11
System Name: ZONARE z.one Ultra Ultrasound Diagnostic System Device Name: Curvilinear Transducer C9-4t
Indications for Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General | |||||||||
| (Track I Only) | Specific | ||||||||
| (Track I & III) | B | M | PWD2 | CWD | Color | ||||
| Doppler3 | Combined | ||||||||
| Modes4 | Other8 | ||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Abdominal | E | E | E | E | E | ||||
| Intra-operative | |||||||||
| (Specify)7 | |||||||||
| Intra-operative | |||||||||
| (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | E | E | E | E | E | ||||
| Small Organ | |||||||||
| (Thyroid, Breast, | |||||||||
| Testes, etc.) | |||||||||
| Neonatal Cephalic | E | E | E | E | E | ||||
| General | |||||||||
| application | Adult Cephalic | ||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non- | |||||||||
| Card.) | |||||||||
| Musculo-skel. | |||||||||
| (Conventional) | E | E | E | E | E | ||||
| Musculo-skel. | |||||||||
| (Superficial) | E | E | E | E | E | ||||
| Intra-luminal | |||||||||
| Other (Specify) | |||||||||
| (3D/4D) | E | E | E | E | E | ||||
| Vet abdominal | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | E | E | E | E | E | ||||
| Cardiac | Trans-esoph. | ||||||||
| (Cardiac) | |||||||||
| Other (Specify) vet | |||||||||
| cardiac | E | E | E | E | E | ||||
| Peripheral | |||||||||
| vascular | Peripheral vascular | ||||||||
| Other (Specify) |
N = new indication; P=previously cleared by FDA E=Added under Appendix E
1 Includes B-Mode and Harmonic (contrast) imaging (HI)
2 Includes PWD-Mode imaging and High Pulse Repetition Rate PWD-Mode (HPRF)
3 Includes Color Doppler (CD), Directional Power Doppler (DPD), and Power Doppler (PD)
4 Includes B+M, B+M+CM, M+CM, B+CD+M+CM, B+CD+PWD where CD could represent (CD, DPD, PD, or BD)
5 Color M-Mode (CM)
6 Abdominal includes renal, GYN/Pelvic
7 Intra operative include abdominal, thoracic (cardiac) and vascular (PV)
8 Freehand tissue elasticity
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Concur
Division Sign-Off
Office of In Vitro Diagnostic Devices Evaluation and Safety
510(K) K101091
12
System Name: ZONARE z.one Ultra Ultrasound Diagnostic System
Device Name: Phase (Sector) Array Transducer P4-1
Indications for Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General | Specific | ||||||||
| (Track I & III) | B | M | PWD2 | CWD | Color | ||||
| Doppler3 | Combined | ||||||||
| Modes4 | Other8 | ||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | P | P | P | P | P | P | P5 | ||
| Abdominal6 | P | P | P | P | P | P | p5 | ||
| Intra-operative | |||||||||
| (Specify)7 | |||||||||
| Intra-operative | |||||||||
| (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | P | P | P | P | P | P | p5 | ||
| Small Organ | |||||||||
| (Thyroid, Breast, | |||||||||
| Testes, etc.) | |||||||||
| Neonatal Cephalic | P | P | P | P | P | P | p5 | ||
| General | |||||||||
| application | Adult Cephalic/ trans | ||||||||
| cranial | P | P | P | P | P | P | p5 | ||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non- | |||||||||
| Card.) | |||||||||
| Musculo-skel. | |||||||||
| (Conventional) | |||||||||
| Musculo-skel. | |||||||||
| (Superficial) | |||||||||
| Intra-luminal | |||||||||
| Other (Specify) | |||||||||
| Cardiac | Cardiac Adult | P | P | P | P | P | P | p5 | |
| Cardiac Pediatric | P | P | P | P | P | P | p5 | ||
| Trans-esoph. | |||||||||
| (Cardiac) | |||||||||
| Other (Specify) | |||||||||
| (3D/4D) | |||||||||
| Peripheral | |||||||||
| vascular | Peripheral Vascular | P | P | P | P | P | P | p5 | |
| Other (Specify) |
N = new indication; P=previously cleared by the FDA 510(k) K082326, E=Added under Appendix E
1 Includes B-Mode and Harmonic (contrast) imaging (HI)
2 Includes PWD-Mode imaging and High Pulse Repetition Rate PWD-Mode (HPRF)
3 Includes Color Doppler (CD), Directional Power Doppler (DPD), and Power Doppler (PD)
4 Includes B+M, B+M+CM, M+CM, B+CD+M+CM, B+CD+PWD where CD could represent (CD, DPD, PD, or BD)
5 Color M-Mode (CM)
6 Abdominal includes renal, GYN/Pelvic
7 Intra operative include abdominal, thoracic (cardiac) and vascular (PV)
8 Freehand tissue elasticity
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrer
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
ivision Sign-Off Office of In Vitro Diagnostic Devices Evaluation and Safety
510(K) K101091
13
System Name: ZONARE z.one Ultra Ultrasound Diagnostic System
Device Name: Phase (Sector) Array Transducer P4-1c
Indications for Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | Specific | |||||||
| (Track I & III) | B | M | PWD2 | CWD | Color | |||
| Doppler3 | Combined | |||||||
| Modes4 | Other8 | |||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | P | P | P | P | P | P | P5 | |
| Abdominal6 | P | P | P | P | P | P | P5 | |
| Intra-operative | ||||||||
| (Specify)7 | ||||||||
| Intra-operative | ||||||||
| (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | P | P | P | P5 | |
| Small Organ | ||||||||
| (Thyroid, Breast, | ||||||||
| Testes, etc.) | ||||||||
| Neonatal Cephalic | P | P | P | P | P | P | P5 | |
| General | ||||||||
| application | Adult Cephalic/ trans | |||||||
| cranial | P | P | P | P | P | P | P5 | |
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non- | ||||||||
| Card.) | ||||||||
| Musculo-skel. | ||||||||
| (Conventional) | ||||||||
| Musculo-skel.: | ||||||||
| (Superficial) | ||||||||
| Intra-luminal | ||||||||
| Other (Specify) | ||||||||
| Cardiac Adult | P1 | P | P | P | P | P | P5 | |
| Cardiac Pediatric | P | P | P | P | P | P | P5 | |
| Cardiac | Trans-esoph. | |||||||
| (Cardiac) | ||||||||
| Other (Specify) | ||||||||
| (3D/4D)contrast | E | E | E | E | E | E | E5 | |
| Peripheral | Peripheral Vascular | P | P | P | P | P | P | P5 |
| vascular | Other (Specify) |
N = new indication; P=previously cleared by the FDA 510(k) K082326, E=Added under Appendix E
Includes B-Mode and Harmonic (contrast) imaging (HI)
2 Includes PWD-Mode imaging and High Pulse Repetition Rate PWD-Mode (HPRF)
3 Includes Color Doppler (CD), Directional Power Doppler (DPD), and Power Doppler (PD)
4 Includes B+M, B+M+CM, B+CD+M+CM, B+CD+PWD where CD could represent (CD, DPD, PD, or BD)
5 Color M-Mode (CM)
6 Abdominal includes renal, GYN/Pelvic
Intra operative include abdominal, thoracic (cardiac) and vascular (PV)
8 Freehand tissue elasticity
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off Office of In Vitro Diagnostic Devices Evaluation and Safety
510(K) K101091
14
System Name: ZONARE z.one Ultra Ultrasound Diagnostic System Device Name: Phased (Sector) Array Transducer P10-4
Indications for Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | Specific | |||||||
| (Track I & III) | B | M | PWD2 | CWD | Color | |||
| Doppler3 | Combined | |||||||
| Modes4 | Other8 | |||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | P | P | P | P | P | P | P5 | |
| Abdominal6 | P | P | P | P | P | P | P5 | |
| Intra-operative | ||||||||
| (Specify)7 | P | P | P | P | P | P5 | ||
| Intra-operative | ||||||||
| (Peuro) | P | P | P | P | P | P5 | ||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | P | P | P | P5 | |
| Small Organ | ||||||||
| (Thyroid, Breast, | ||||||||
| Testes, etc.) | ||||||||
| Neonatal Cephalic | P | P | P | P | P | P | P5 | |
| General | ||||||||
| application | Adult Cephalic/ trans | |||||||
| cranial | P | P | P | P | P | P | P5 | |
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non- | ||||||||
| Card.) | ||||||||
| Musculo-skel. | ||||||||
| (Conventional) | ||||||||
| Musculo-skel. | ||||||||
| (Superficial) | ||||||||
| Intra-luminal | ||||||||
| Other (Specify) | ||||||||
| Cardiac Adult | P | P | P | P | P | P | P5 | |
| Cardiac Pediatric | P | P | P | P | P | P | P5 | |
| Cardiac | Trans-esoph. | |||||||
| (Cardiac) | ||||||||
| Other (Specify) | ||||||||
| (3D/4D) | ||||||||
| Peripheral | ||||||||
| vascular | Peripheral Vascular | P | P | P | P | P | P | P5 |
| Other (Specify) |
N = new indication; P=previously cleared by the FDA 510(k) K082326, E=Added under Appendix E
1 Includes B-Mode and Harmonic (contrast) imaging (HI)
2 Includes PWD-Mode imaging and High Pulse Repetition Rate PWD-Mode (HPRF)
3 Includes Color Doppler (CD), Directional Power Doppler (DPD), and Power Doppler (PD)
4 Includes B+M, B+M+CM, M+CM, B+CD+M+CM, B+CD+PWD where CD could represent (CD, DPD, PD, or BD)
5 Color M-Mode (CM)
Abdominal includes renal, GYN/Pelvic
7 Intra operative include abdominal, thoracic (cardiac) and vascular (PV)
8 Freehand tissue elasticity
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Robert T. Becker
Division Sign-Off Office of In Vitro Diagnostic Devices Evaluation and Safety
510(K) 101091
15
System Name: ZONARE z.one Ultra Ultrasound Diagnostic System Device Name: Endo-Cavity Transducer E9-4
Indications for Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track I Only) | Specific | |||||||
| (Track I & III) | B | M | PWD2 | CWD | Color | |||
| Doppler3 | Combined | |||||||
| Modes4 | Other5 | |||||||
| 8 | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | P | P | P | P | P | P5 | ||
| Abdominal | ||||||||
| Intra-operative | ||||||||
| (Specify)7 | ||||||||
| Intra-operative | ||||||||
| (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ | ||||||||
| (Thyroid, Breast, | ||||||||
| Testes, etc.) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| General | ||||||||
| application | Trans-rectal | P | P | P | P | P | P5 | |
| Trans-vaginal | P | P | P | P | P | P5 | ||
| Trans-urethral | ||||||||
| Trans-esoph. (non- | ||||||||
| Card.) | ||||||||
| Musculo-skel. | ||||||||
| (Conventional) | ||||||||
| Musculo-skel. | ||||||||
| (Superficial) | ||||||||
| Intra-luminal | ||||||||
| Other (Specify) | ||||||||
| (3D/4D) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac Pediatric | ||||||||
| Cardiac | Trans-esoph. | |||||||
| (Cardiac) | ||||||||
| Other (Specify) | ||||||||
| Peripheral | Peripheral vascular | |||||||
| vascular | Other (Specify) |
N = new indication; P=previously cleared by FDA 510(k) K022858 & K082326, E=Added under Appendix E
1 Includes B-Mode and Harmonic (contrast) imaging (HI)
2 Includes PWD-Mode imaging and High Pulse Repetition Rate PWD-Mode (HPRF)
3 Includes Color Doppler (CD), Directional Power Doppler (DPD), and Power Doppler (PD)
4 Includes B+M, B+M+CM, M+CM, B+CD+M+CM, B+CD+PWD where CD could represent (CD, DPD, PD, or BD)
5 Color M-Mode (CM)
్ Abdominal includes renal, GYN/Pelvic
7 Intra operative include abdominal, thoracic (cardiac) and vascular (PV)
8 Freehand tissue elasticity
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Concurre
Division Sign-Off
Office of In Vitro Diagnostic Devices Evaluation and Safety
510(K) 10101091
16
System Name: ZONARE Z.one Ultra Ultrasound Diagnostic System Device Name: Endo-Cavity Transducer E9-4 (3D)
Indications for Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track I Only) | Specific | |||||||
| (Track I & III) | B | M | PWD2 | CWD | Color | |||
| Doppler3 | Combined | |||||||
| Modes4 | Other8 | |||||||
| Ophthalmic | Ophthalmic | |||||||
| General | ||||||||
| application | Fetal | P | P | P | P | P | P5 | |
| Abdominal | ||||||||
| Intra-operative | ||||||||
| (Specify)7 | ||||||||
| Intra-operative | ||||||||
| (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ | ||||||||
| (Thyroid, Breast, | ||||||||
| Testes, etc.) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | P | P | P | P | P | P5 | ||
| Trans-vaginal | P | P | P | P | P | P5 | ||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. | ||||||||
| (Conventional) | ||||||||
| Musculo-skel. | ||||||||
| (Superficial) | ||||||||
| Intra-luminal | ||||||||
| Other (Specify) | ||||||||
| (3D/4D) | P | P | P | P | P | P5 | ||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esoph. | ||||||||
| (Cardiac) | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| vascular | Peripheral vascular | |||||||
| Other (Specify) |
N = new indication; P=previously cleared by FDA 510(k) K082326, E=Added under Appendix E
1 Includes B-Mode and Harmonic (contrast) imaging (HI)
2 Includes PWD-Mode imaging and High Pulse Repetition Rate PWD-Mode (HPRF)
3 Includes Color Doppler (CD), Directional Power Doppler (DPD), and Power Doppler (PD)
4 Includes B+M, B+M+CM, M+CM, B+CD+M+CM, B+CD+PWD where CD could represent (CD, DPD, PD, or BD)
S Color M-Mode (CM)
6 Abdominal includes renal, GYN/Pelvic
7 Intra operative include abdominal, thoracic (cardiac) and vascular (PV)
8 Freehand tissue elasticity
.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Darn Becked
Division Sign-Off
Office of In Vitro Diagnostic Devices Evaluation and Safety
510(K) K101091
17
System Name: ZONARE z.one Ultra Ultrasound Diagnostic System Device Name: Linear Transducer L10-5
Indications for Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track I Only) | Specific | |||||||
| (Track I & III) | B | M | PWD2 | CWD | Color | |||
| Doppler3 | Combined | |||||||
| Modes4 | Other5 | |||||||
| Ophthalmic | Ophthalmic | N | N | N | ||||
| General | ||||||||
| application | Fetal | P | P | P | P | P | P5 | |
| Abdominal6 | P | P | P | P | P | P5 | ||
| Intra-operative | ||||||||
| (Specify)7 | P | P | P | P | P | P5 | ||
| Intra-operative | ||||||||
| (Neuro) | P | P | P | P5 | ||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | P | P | P5 | ||
| Small Organ | ||||||||
| (Thyroid, Breast, | ||||||||
| Testes, etc.) | P | P | P | P | P | P5 | ||
| P8 | ||||||||
| Neonatal Cephalic | P | P | P | P | P | P5 | ||
| General | ||||||||
| application | Adult Cephalic | |||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non- | ||||||||
| Card.) | ||||||||
| Musculo-skel. | ||||||||
| (Conventional) | P | P | P | P | P | P5,8 | ||
| Musculo-skel. | ||||||||
| (Superficial) | P | P | P | P | P | P5,8 | ||
| Intra-luminal | ||||||||
| Other (Specify)8 | ||||||||
| (3D/4D) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac Pediatric | ||||||||
| Cardiac | Trans-esoph. | |||||||
| (Cardiac) | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vascular | Peripheral Vascular | P | P | P | P | P | P5 | |
| P8 | ||||||||
| Other (Specify) |
N = new indication; P=previously cleared by the FDA 510(k) K022858 & K082326, E=Added under Appendix E
1 Includes B-Mode and Harmonic (contrast) imaging (HI)
2 Includes PWD-Mode imaging and High Pulse Repetition Rate PWD-Mode (HPRF)
3 Includes Color Doppler (CD), Directional Power Doppler (DPD), and Power Doppler (PD)
4 Includes B+M, B+M+CM, B+CD+M+CM, B+CD+PWD where CD could represent (CD, DPD, PD, or BD)
5 Color M-Mode (CM)
6 Abdominal includes renal, GYN/Pelvic
7 Intra operative include abdominal, thoracic (cardiac) and vascular (PV)
8 Freehand tissue elasticity
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
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18
System Name: ZONARE z.one Ultra Ultrasound Diagnostic System
Device Name: Linear Transducer L8-3
Indications for Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track I Only) | Specific | |||||||
| (Track I & III) | B | M | PWD2 | CWD | Color | |||
| Doppler3 | Combined | |||||||
| Modes4 | Other8 | |||||||
| Ophthalmic | Ophthalmic | |||||||
| General | ||||||||
| application | Fetal | P | P | P | P | P | P5 | |
| Abdominal6 | P | P | P | P | P | P5 | ||
| Intra-operative | ||||||||
| (Specify)7 | P | P | P | P | P | P5 | ||
| Intra-operative | ||||||||
| (Neuro) | P | P | P | P | P5 | |||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | P | P | P5 | ||
| Small Organ | ||||||||
| (Thyroid, Breast, | ||||||||
| Testes, etc.) | P | P | P | P | P | P5 | ||
| P8 | ||||||||
| Neonatal Cephalic | P | P | P | P | P | P5 | ||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non- | ||||||||
| Card.) | ||||||||
| Musculo-skel. | ||||||||
| (Conventional) | P | P | P | P | P | P5,8 | ||
| Musculo-skel. | ||||||||
| (Superficial) | P | P | P | P | P | P5,8 | ||
| Intra-luminal | ||||||||
| Other (Specify)8 | ||||||||
| 3D/4D | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esoph. | ||||||||
| (Cardiac) | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vascular | Peripheral Vascular | P | P | P | P | P | P5 | |
| P8 | ||||||||
| Other (Specify) |
N = new indication; P=previously cleared by the FDA 510(k) K082326, E=Added under Appendix E
I Includes B-Mode and Harmonic (contrast) imaging (HI)
2 Includes PWD-Mode imaging and High Pulse Repetition Rate PWD-Mode (HPRF)
3 Includes Color Doppler (CD), Directional Power Doppler (DPD), and Power Doppler (PD)
4 Includes B+M, B+M+CM, M+CM, B+CD+M+CM, B+CD+PWD where CD could represent (CD, DPD, PD, or BD)
్ Color M-Mode (CM)
6 Abdominal includes renal, GYN/Pelvic
7 Intra operative include abdominal, thoracic (cardiac) and vascular (PV)
8 Freehand tissue elasticity
Examples may include A-mode, Amplitude Doppler, 3-D insging, Tissue Motion Doppler, Color velocity imaging
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
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510(K) Kiona I
19
System Name: ZONARE z.one Ultra Ultrasound Diagnostic System Device Name: Linear Transducer L12-4v
Indications for Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track I Only) | Specific | |||||||
| (Track I & III) | B | M | PWD2 | CWD | Color | |||
| Doppler3 | Combined | |||||||
| Modes4 | Other5 | |||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Abdominal | ||||||||
| Intra-operative | ||||||||
| (Specify)7 | ||||||||
| Intra-operative | ||||||||
| (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | E | E | E | E | E | |||
| Small Organ | ||||||||
| (Thyroid, Breast, | ||||||||
| Testes, etc.) | E | E | E | E | E | |||
| Neonatal Cephalic | ||||||||
| General | ||||||||
| application | Adult Cephalic | |||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non- | ||||||||
| Card.) | ||||||||
| Musculo-skel. | ||||||||
| (Conventional) | E | E | E | E | E | E | ||
| Musculo-skel. | ||||||||
| (Superficial) | E | E | E | E | E | E | ||
| Intra-luminal | ||||||||
| Other (Specify) | ||||||||
| (3D/4D) | ||||||||
| (vet use too) | E | E | E | E | E | E | ||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esoph. | ||||||||
| (Cardiac) | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| vascular | Peripheral vascular | E | E | E | E | E | E | |
| Other (Specify) |
N = new indication; P=previously cleared by FDA, E=Added under appendix E,
I Includes B-Mode and Harmonic (contrast) imaging (HI)
4 Includes PWD-Mode imaging and High Pulse Repetition Rate PWD-Mode (HPRF)
3 Includes Color Doppler (CD), Directional Power Doppler (DPD), and Power Doppler (PD)
4 Includes BHM, B+M+CM, B+CD+M+CM, B+CD+M+CM, B+CD+PWD where CD could represent (CD, DPD, PD, or BD)
5 C. Lock Late M+CM, M+CM, B+CD+M+CM, B+CD+PWD where CD could represent (
5 Color M-Mode (CM)
6 Abdominal includes renal, GYN/Pelvic
7 Intra operative include abdominal, thoracic (cardiac) and vascular (PV)
8 Freehand tissue elasticity
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
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Concur
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510(K) K101091
20
510(K) Number (if known): System Name: ZONARE z.one Ultra Ultrasound Diagnostic System Device Name: Linear Transducer L14-5sp
Indications for Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track I Only) | Specific | |||||||
| (Track I & III) | B | M | PWD2 | CWD | Color | |||
| Doppler3 | Combined | |||||||
| Modes4 | Other8 | |||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | P | P | P | P | P | P5 | ||
| Abdominal6 | P | P | P | P | P | P5 | ||
| Intra-operative | ||||||||
| (Specify)7 | P | P | P | P | P | P5 | ||
| Intra-operative | ||||||||
| (Neuro) | P | P | P | P | P5 | |||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | P | P | P5 | ||
| Small Organ | ||||||||
| (Thyroid, Breast, | ||||||||
| Testes, etc.) | P | P | P | P | P | P5 | ||
| P8 | ||||||||
| General | ||||||||
| application | Neonatal Cephalic | P | P | P | P | P | P5 | |
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non- | ||||||||
| Card.) | ||||||||
| Musculo-skel. | ||||||||
| (Conventional) | P | P | P | P | P | P5,8 | ||
| Musculo-skel. | ||||||||
| (Superficial) | P | P | P | P | P | P5,8 | ||
| Intra-luminal | ||||||||
| Other (Specify)8 | ||||||||
| 3D/4D | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esoph. | ||||||||
| (Cardiac) | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vascular | Peripheral Vascular | P | P | P | P | P | P5 | |
| P8 | ||||||||
| Other (Specify) | ||||||||
| 3D/4D |
N = new indication; P=previously cleared by the FDA 510(k) K082326, E=Added under Appendix E
1 Includes B-Mode and Harmonic (contrast) imaging (HI)
2 Includes PWD-Mode imaging and High Pulse Repetition Rate PWD-Mode (HPRF)
3 Includes Color Doppler (CD), Directional Power Doppler (DPD), and Power Doppler (PD)
4 Includes B+M, B+M+CM, M+CM, B+CD+M+CM, B+CD+PWD where CD could represent (CD, DPD, PD, or BD)
5 Color M-Mode (CM)
6 Abdominal includes renal, GYN/Pelvic
7 Intra operative include abdominal, thoracic (cardiac) and vascular (PV)
8 Freehand tissue elasticity
. Examples may include A-mode, Amplitude Doppler, 3-D imaging, Tissue Motion Doppler, Color velocity imaging
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Congurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
on Sign-Off Office of In Vitro Diagnostic Devices Evaluation and Safety
510(K) K101091
21
System Name ZONARE Z.one Ultra Ultrasound Diagnostic System Device Name: Linear Transducer L14-5w
Indications for Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track I Only) | Specific | |||||||
| (Track I & III) | B | M | PWD2 | CWD | Color | |||
| Doppler3 | Combined | |||||||
| Modes4 | Other8 | |||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | P | P | P | P | P | P5 | ||
| Abdominal6 | P | P | P | P | P | P5 | ||
| Intra-operative | ||||||||
| (Specify)7 | P | P | P | P | P | P5 | ||
| Intra-operative | ||||||||
| (Neuro) | P | P | P | P | P5 | |||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | P | P | P5 | ||
| Small Organ | ||||||||
| (Thyroid, Breast, | ||||||||
| Testes, etc.) | P | P | P | P | P | P5 | ||
| P8 | ||||||||
| Neonatal Cephalic | P | P | P | P | P | P5 | ||
| General | Adult Cephalic | |||||||
| application | Trans-rectal | |||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non- | ||||||||
| Card.) | ||||||||
| Musculo-skel. | ||||||||
| (Conventional) | P | P | P | P | P | P5,8 | ||
| Musculo-skel. | ||||||||
| (Superficial) | P | P | P | P | P | P5,8 | ||
| Intra-luminal | ||||||||
| Other (Specify)8 | ||||||||
| 3D/4D | ||||||||
| Cardiac Adult | ||||||||
| Cardiac Pediatric | ||||||||
| Cardiac | Trans-esoph. | |||||||
| (Cardiac) | ||||||||
| Other (Specify) | ||||||||
| Peripheral | Peripheral Vascular | P | P | P | P | P | P5 | |
| P8 | ||||||||
| Vascular | Other (Specify) | |||||||
| 3D/4D |
N = new indication; P=previously cleared by the FDA 510(k) K082326, E=Added under Appendix E
1 Includes B-Mode and Harmonic (contrast) imaging (HI)
2 Includes PWD-Mode imaging and High Pulse Repetition Rate PWD-Mode (HPRF)
3 Includes Color Doppler (CD), Directional Power Doppler (DPD), and Power Doppler (PD)
4 Includes B+M, B+M+CM, B+CD+M+CM, B+CD+PWD where CD could represent (CD, DPD, PD, or BD)
3 Color M-Mode (CM)
6 Abdominal includes renal, GYN/Pelvic
7 Intra operative include abdominal, thoracic (cardiac) and vascular (PV)
8 Freehand tissue elasticity
Examples may include A-mode, Amplinde Doppler, 3-D imaging, Tissue Motion Doppler, Color velocity imaging
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
oncurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
NarARedds
Division Sign Off
Concurrence
Division Sign-Off Office of In Vitro Diagnostic Devices Evaluation and Safety
510(K) K101091
Page 1 of
22
System Name: ZONARE z.one Ultra Ultrasound Diagnostic System
Device Name: Tran-Esophageal Transducer: P8-3T
Indications for Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track I Only) | Specific | |||||||
| (Track I & III) | B | M | PWD2 | CWD | Color | |||
| Doppler3 | Combined | |||||||
| Modes4 | Other5 | |||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Abdominal | ||||||||
| Intra-operative | ||||||||
| (Specify)7 | ||||||||
| Intra-operative | ||||||||
| (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ | ||||||||
| (Thyroid, Breast, | ||||||||
| Testes, etc.) | ||||||||
| Neonatal Cephalic | ||||||||
| General | ||||||||
| applications | Adult Cephalic | |||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non- | ||||||||
| Card.) | P | P | P | P | P | P | P5 | |
| Musculo-skel. | ||||||||
| (Conventional) | ||||||||
| Musculo-skel. | ||||||||
| (Superficial) | ||||||||
| Intra-luminal | ||||||||
| Other (Specify) | ||||||||
| (3D/4D) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esoph. | ||||||||
| (Cardiac) | P | P | P | P | P | P | P5 | |
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral Vessel | |||||||
| Other (Specify) |
N = new indication; P=previously cleared by FDA 510(k) K082326, E=Appendix E
1 Includes B-Mode and Harmonic (contrast) imaging (HI)
2 Includes PWD-Mode imaging and High Pulse Repetition Rate PWD-Mode (HPRF)
3 Includes Color Doppler (CD), Directional Power Doppler (DPD), and Power Doppler (PD)
4 Includes B+M, B+M+CM, M+CM, B+CD+M+CM, B+CD+PWD where CD could represent (CD, DPD, PD, or BD)
5 Color M-Mode (CM)
6 Abdominal includes renal, GYN/Pelvic
7 Intra operative include abdominal, thoracic (cardiac) and vascular (PV)
8 Freehand tissue elasticity
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Peter Becker
ision Sign Office of In Vitro Diagnostic Devices Evaluation and Safety
510(K) K161091
23
System Name: ZONARE z.one Ultra Ultrasound Diagnostic System
Device Name: St. Jude EP ViewFlex PLUS ICE Catheter model # VF-PM Part #09-2005 Indications for Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track I Only) | Specific | |||||||
| (Track I & III) | B | M | PWD2 | CWD | Color | |||
| Doppler | Combined | |||||||
| Modes4 | Other8 | |||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Abdominal | ||||||||
| Intra-operative | ||||||||
| (Specify)7 | ||||||||
| Intra-operative | ||||||||
| (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ | ||||||||
| (Thyroid, Breast, | ||||||||
| Testes, etc.) | ||||||||
| Neonatal Cephalic | ||||||||
| General | ||||||||
| application | Adult Cephalic | |||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non- | ||||||||
| Card.) | ||||||||
| Musculo-skel. | ||||||||
| (Conventional) | ||||||||
| Musculo-skel. | ||||||||
| (Superficial) | ||||||||
| Intra-luminal | ||||||||
| Other (Specify) | ||||||||
| (3D/4D) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac Pediatric | ||||||||
| Cardiac | Trans-esoph. | |||||||
| (Cardiac) | ||||||||
| Other (Intra-Cardiac) | P | P | P | P | ||||
| Peripheral vascular | ||||||||
| Peripheral | ||||||||
| vascular | Other (Specify) | |||||||
N = new indication; P=previously cleared by FDA 510(k) K031066 & K073709, E=Added under Appendix E
1 Includes B-Mode and Harmonic (contrast) imaging (HI)
2 Includes PWD-Mode imaging and High Pulse Repetition Rate PWD-Mode (HPRF)
3 Includes Color Doppler (CD), Directional Power Doppler (DPD), and Power Doppler (PD)
4 Includes B+M, B+M+CM, M+CM, B+CD+M+CM, B+CD+PWD where CD could represent (CD, DPD, PD, or BD) 5 Color M-Mode (CM)
Color M-Mode (CM)
6. Additional help
6 Abdominal includes renal, GYN/Pelvic
7 Intra operative include abdominal, thoracic (cardiac) and vascular (PV)
8 Freehand tissue elasticity
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Concurren
Robert Beck
Division Sign Off
Division Sign-Off Office of In Vitro Diagnostic Devices Evaluation and Safety
510(K) K101091
24
System Name: ZONARE z.one Ultra Ultrasound Diagnostic System
Device Name: A2CW (Common name Pencil Probe)
Indications for Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track I Only) | Specific | |||||||
| (Track I & III) | B | M | PWD2 | CWD | Color | |||
| Doppler3 | Combined | |||||||
| Modes4 | Other5 | |||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Abdominal | ||||||||
| Intra-operative | ||||||||
| (Specify)7 | ||||||||
| Intra-operative | ||||||||
| (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | |||||||
| Small Organ | ||||||||
| (Thyroid, Breast, | ||||||||
| Testes, etc.) | ||||||||
| Neonatal Cephalic | ||||||||
| General | ||||||||
| application | Adult Cephalic | |||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non- | ||||||||
| Card.) | ||||||||
| Musculo-skel. | ||||||||
| (Conventional) | ||||||||
| Musculo-skel. | ||||||||
| (Superficial) | ||||||||
| Intra-luminal | ||||||||
| Other (Specify) | ||||||||
| (3D/4D) | ||||||||
| Cardiac Adult | P | |||||||
| Cardiac Pediatric | P | |||||||
| Cardiac | Trans-esoph. | |||||||
| (Cardiac) | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| vascular | Peripheral vascular | |||||||
| vascular | Other (Specify) |
N = new indication; P=previously cleared by FDA 510(k) K082326, E=Appendix E
I Includes B-Mode and Harmonic (contrast) imaging (HI)
2 Includes PWD-Mode imaging and High Pulse Repetition Rate PWD-Mode (HPRF)
3 Includes Color Doppler (CD), Directional Power Doppler (DPD), and Power Doppler (PD)
4 Includes B+M, B+M+CM, M+CM, B+CD+M+CM, B+CD+PWD where CD could represent (CD, DPD, PD, or BD)
5 Color M-Mode (CM)
Abdominal includes renal, GYN/Pelvic
7 Intra operative include abdominal, thoracic (cardiac) and vascular (PV)
8 Freehand tissue elasticity
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
N. Becker
Division Sign-Off
Office of In Vitro Diagnostic Devices Evaluation and Safety
510(K) K101091'
25
System Name: ZONARE z.one Ultra Ultrasound Diagnostic System
Device Name: A5CW (Common name Pencil Probe)
Indications for Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track I Only) | Specific | |||||||
| (Track I & III) | B | M | PWD2 | CWD | Color | |||
| Doppler3 | Combined | |||||||
| Modes4 | Other8 | |||||||
| Ophthalmic | Ophthalmic | |||||||
| General | ||||||||
| application | Fetal | |||||||
| Abdominal | ||||||||
| Intra-operative | ||||||||
| (Specify)7 | ||||||||
| Intra-operative | ||||||||
| (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ | ||||||||
| (Thyroid, Breast, | ||||||||
| Testes, etc.) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non- | ||||||||
| Card.) | ||||||||
| Musculo-skel. | ||||||||
| (Conventional) | ||||||||
| Musculo-skel. | ||||||||
| (Superficial) | ||||||||
| Intra-luminal | ||||||||
| Other (Specify) | ||||||||
| (3D/4D) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esoph. | ||||||||
| (Cardiac) | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| vascular | Peripheral vascular | P | ||||||
| Other (Specify) |
N = new indication; P=previously cleared by FDA 510(k) K082326, E=Appendix E
Includes B-Mode and Harmonic (contrast) imaging (HI)
2 Includes PWD-Mode imaging and High Pulse Repetition Rate PWD-Mode (HPRF)
1 Includes Color Doppler (CD), Directional Power Doppler (DPD), and Power Doppler (PD)
1 Includes Color Doppler (CD), Directional Power Doppler (DPD), and Power Doppler (PD)
- Entinces B+M, B+M+CM, B+CD+M+CM, B+CD+DWF(DPD), and Power Doppler (PD)
- Includes B+M, B+M+CM, B+CD+M+CM, B+CD+PWD where CD could represent (CD, DPD, PD, or BD)
- Color M-M
5 Color M-Mode (CM)
6 Abdominal includes renal, GYN/Pelvic
1 Intra operative include abdominal, thoracic (cardiac) and vascular (PV)
8 Freehand tissue elasticity
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Dorret Becker
Division Sign-Off
Office of In Vitro Diagnostic Devices Evaluation and Safety
510(K) K101091