(55 days)
No
The document does not mention AI, ML, or any related terms in the device description or performance studies. The description focuses on standard ultrasound technology and image preprocessing.
No
The device is described as a "general purpose diagnostic ultrasound system" and its intended use is for "ultrasound evaluation" and "diagnostic ultrasound imaging or fluid flow analysis," which are diagnostic rather than therapeutic purposes.
Yes
The 'Device Description' explicitly states: "The z.one Ultra is a general purpose diagnostic ultrasound system." The 'Intended Use / Indications for Use' section also mentions "Diagnostic ultrasound imaging".
No
The device description clearly states it consists of a portable scanner, transducer module, and docking station, which are hardware components. The software is part of a larger hardware system.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The description clearly states this device is a "general purpose diagnostic ultrasound system." It uses ultrasound energy applied externally to the body to create images and analyze fluid flow within the body.
- Intended Use: The intended uses listed are all related to imaging and evaluating internal structures and processes of the human body directly, not analyzing samples taken from the body.
- Device Description: The description of the portable scanner and transducer module interacting with the patient's body confirms it's an external imaging device.
Therefore, based on the provided information, this device falls under the category of 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 utrasound evaluation of Fetal/OB; Abdominal; Intra-operative (abdominal, thoracic, and vascular); Intra-operative Neuro; Pediatric; Small Organ (Thyroid, Breast, Testes, etc.); Neonatal Cephalic; Adult Cephalic; Trans-rectal; Trans-cranial, trans-esoph (cardiac/noncardiac), musculo-skel conventional & superficial 3D/4D. cardiac adult & pediatric and other applications as shown in section 4.3.
This device is intended for use by a qualified physician for ultrasound evaluation of the following: Fetal, Abdominal, Intraoperative, Pediatric, Small organ/parts (breasttestes, thyroid, etc), Transrectal, Transcranial, Trans-esoph, Trans-urethral, OB/GYM, Cardiac, Pelvic, Neonatio. Vascular, 3D/4D, Tissue elasticity, Musculoskeletal (cardias, Superficial Musculoskeletal, and Peripheral Vascular applications.
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Product codes
90-IYN, 90-IYO, 90-ITX
Device Description
The z.one Ultra is a general purpose diagnostic ultrasound system. It consists of a portable scanner approximately 8 inches wide and 3 inches high that can be held by the user in one hand and includes buttons for controlling the system and a screen that display ultrasound mages 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 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 include new features and functionality that will enhance user convenience and work flow as well as provide clinicians with new indications of use.
Mentions image processing
Not Found
The subject device is an imaging device and processes images.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Fetal, Abdominal, Intra-operative (abdominal, thoracic, and vascular), Intra-operative Neuro, Pediatric, Small Organ (Thyroid, Breast, Testes, etc.), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-cranial, Trans-esoph (cardiac/noncardiac), Musculo-skel conventional & superficial, Cardiac adult & pediatric, Pelvic, Trans-urethral, Peripheral Vascular.
Indicated Patient Age Range
Adult, Pediatric, Neonatal, Fetal
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 safety standards for acoustic output, biocompatibility, cleaning, and disinfection effectiveness as well as thermal, electrical, and mechanical safety.
Clinical Tests: Non Required
Conclusion: ZONARE designs and develops their products according to 21 CFR 820, ISO 13485:2003 quality systems. The device conforms to applicable medical device safety standards and compliance for safety and effectiveness is verified through defined evaluation and market surveillance. Conforming to the required worldwide ultrasound standards, enables ZONARE to state that the ZONARE z.one Ultra Diagnostic Ultrasound System is substantially equivalent with respect to safety and effectiveness to devices current cleared for market.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K022858, K053435, K042540, K072786
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K08 a326
OCT 0 8 2008
Summary of Safety and Effectiveness
Prepared in accordance with 21 CFR Part 807.92(c)
| The assigned 510(k) number is: | ____________________________ |
|---|---|
| -------------------------------- | ------------------------------ |
Applicant Information:
| Date Prepared: | July 14, 2008 |
|---|---|
| Name: | ZONARE Medical Systems, Inc. |
| 420 North Bernardo Ave. | |
| Mountain View, CA 94043 | |
| Contact Persons: | Linda J. Moore |
| Director, Regulatory Affairs & Quality Assurance | |
| Telephone Numbers: | 650-230-2724 |
| Fax Number: | 650-230-2818 |
| lmoore@zonare.com |
Device Information:
| Trade Name: | ZONARE z.one Ultra Ultrasound System |
|---|---|
| Device 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 Ultrasound System (K022858), GE Voluson i(K053435), Philips iU22 (K042540), and Siemens Acuson S2000 (K072786) devices currently in commercial distribution.
Device Description: The z.one Ultra is a general purpose diagnostic ultrasound system. It consists of a portable scanner approximately 8 inches wide and 3 inches high that can be held by the user in one hand and includes buttons for controlling the system and a screen that display ultrasound mages 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 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 include new features and functionality that will enhance user convenience and work flow as well as provide clinicians with new indications of use.
510k Submittal ZONARE Medical Systems
1
Indications For Use: The device is intended for use by a qualified physician for utrasound evaluation of Fetal/OB; Abdominal; Intra-operative (abdominal, thoracic, and vascular); Intra-operative Neuro; Pediatric; Small Organ (Thyroid, Breast, Testes, etc.); Neonatal Cephalic; Adult Cephalic; Trans-rectal; Trans-cranial, trans-esoph (cardiac/noncardiac), musculo-skel conventional & superficial 3D/4D. cardiac adult & pediatric and other applications as shown in section 4.3.
Comparison with Predicate Device: With respect to features and applications, the ZONARE z.one Ultra is comparable and substantially equivalent to the currently marketed ZONARE z.one and the Voluson i, Siemens Acuson S2000, and Philips iU22 in terms of portability, features and functionality. Additionally, 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 safety standards for acoustic output, biocompatibility, cleaning, and disinfection effectiveness as well as thermal, electrical, and mechanical safety.
Clinical Tests: Non Required
Conclusion: ZONARE designs and develops their products according to 21 CFR 820, ISO 13485:2003 quality systems. The device conforms to applicable medical device safety standards and compliance for safety and effectiveness is verified through defined evaluation and market surveillance. Conforming to the required worldwide ultrasound standards, enables ZONARE to state that 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
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with its wings spread.
OCT 0 8 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Zonare Medical Systems, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
Re: K082326
Trade/Device Name: ZONARE System with Doppler & Harmonic Imaging Modes Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: September 20, 2008 Received: September 22, 2008
Dear Mr. Job:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
This determination of substantial equivalence applies to the following transducers intended for use with the ZONARE System with Doppler & Harmonic Imaging Modes, as described in your premarket notification:
Transducer Model Number
C5-2 Curvilinear C6-2 Curvilinear C9-3 Curvilinear C8-3r (3D/4D) Curvilinear P4-1 Phased (Sector) Array P4-1c Phased (Sector) Array P10-4 Phased (Sector) Array E9-4 Endo-Cavity E9-4 3D Endo-Cavity L10-5 Linear
3
L8-3 Linear L14-5SP Linear L14-5W Linear E14-5 EndoScopic P8-3T Tran-Esophageal AUX CW2 AUX CW4 AUX CW5
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
If you have any questions regarding the content of this letter, please contact Lauren Hefner at (240) 276-3666.
Sincerely yours,
for Joyce M. Whang, Ph.D.
Acting Director, Division of Reproductive,
Abdominal, and Radiological Devices
Office of Device Evaluation
Center for Devices and Radiological Health
Enclosure(s)
4
4.3 Indications for use
This device is intended for use by a qualified physician for ultrasound evaluation of the following: Fetal, Abdominal, Intraoperative, Pediatric, Small organ/parts (breasttestes, thyroid, etc), Transrectal, Transcranial, Trans-esoph, Trans-urethral, OB/GYM, Cardiac, Pelvic, Neonatio. Vascular, 3D/4D, Tissue elasticity, Musculoskeletal (cardias, Superficial Musculoskeletal, and Peripheral Vascular applications.
Diagnostic Ultrasound Indication for Use
System: ZONARE System with Doppler & Harmonic Imaging Modes
Transducer: ZONARE System (Union of all Transducer Types)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | Specific | B¹ | M | PWD² | CWD | |||
| CWD Aux | Color | |||||||
| Doppler | Combined | |||||||
| Modes⁴ | Other⁵, ⁸ | |||||||
| Ophthalmic | Ophthalmic | |||||||
| 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 | N | |||||||
| Small Organ (Thyroid, | ||||||||
| Breast, Testes, etc.) | P | P | P | P | P | P⁵ | ||
| N⁸ | ||||||||
| Neonatal Cephalic | P | P | P | P | P | P | P⁵ | |
| General | ||||||||
| Application | Adult Cephalic | P | P | P | P | P | P | P⁵ |
| Trans-rectal | P | P | P | P | P | P⁵ | ||
| Trans-vaginal | P | P | P | P | P | P⁵ | ||
| Trans-urethral | ||||||||
| Trans-esoph. (non- | ||||||||
| Card.) | N | N | N | N | N | N | N⁵ | |
| Musculo-skel. | ||||||||
| (Conventional) | N | N | N | N | N | N⁵, ⁸ | ||
| Musculo-skel. | ||||||||
| (Superficial) | N | N | N | N | N | N⁵, ⁸ | ||
| Intra-luminal | ||||||||
| Other (Specify) | ||||||||
| (3D/4D) | N | N | N | N | N | |||
| Cardiac Adult | P | P | P | P | P | P | P⁵ | |
| Cardia Adult Aux | N | |||||||
| Cardiac | Cardiac Pediatric | P | P | P | P | P | P | P⁵ |
| Cardiac Pediatric Aux | N | |||||||
| Trans-esoph. (Cardiac) | N | N | N | N | N | N | N⁵ | |
| Other (Specify) | ||||||||
| (3D/4D) | N | N | N | N | N | N | ||
| Peripheral Vessel | P | P | P | N | P | P | P⁵ | |
| N⁸ | ||||||||
| Peripheral vascular | Peripheral Vessel Aux | N | ||||||
| Other (Specify) | ||||||||
| (3D/4D) | N | N | N | N | N |
N = new indication; P = previously cleared by FDA 510k # 022852
Includes B-Mode and Harmonic imaging (HI)
Includes PWD-Mode imaging and High Pulse Repetition Rate PWD-Mode (HPRF)
Includes Color Doppler (CD) Dina
) * new indication; P = previously cleared by FDA S 10k # (22858)
Taclides PWD-Mode imaging (10)
1 moludes WD-Mode imaging add Highe Reputition Rate PWD-M-Repler (PD)
1 sent (CD, DPD, PD, or BD)
Color M-Mode (CM)
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 Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K082326
5
Transducer: Curvilinear Transducers C5-2*
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Specific
(Track I & III) | B1 | M | PWD2 | CWD | Color
Doppler3 | Combined
Modes4 | Other7,8 |
|-------------------------|---------------------------------------------------|----|---|------|-----|-------------------|--------------------|----------|
| General | 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 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 510k # 022858 E added under Appendix E *market designation Includes B-Mode and Harmonic 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
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Hale Leem
ivision Sidn-Off) Division of Reproductive, Abdomin Radiologic 510(k) Number
6
Transducer: Curvilinear Transducers C6-2*
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | Specific | |||||||
| (Track I & III) | B1 | M | PWD2 | CWD | Color | |||
| Doppler3 | Combined | |||||||
| Modes4 | Other8 | |||||||
| Ophthalmic | Ophthalmic | |||||||
| General | ||||||||
| applications | Fetal | P | P | P | P | P | P7 | |
| Abdominal6 | P | P | P | P | P | P7 | ||
| Intra-operative | ||||||||
| (Specify) | ||||||||
| Intra-operative | ||||||||
| (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | P | P | P7 | ||
| Small Organ | ||||||||
| (Thyroid, Breast, | ||||||||
| Testes, etc.) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Cardiac | Trans-esoph. (non- | |||||||
| Card.) | ||||||||
| Musculo-skel. | ||||||||
| (Conventional) | ||||||||
| Musculo-skel. | ||||||||
| (Superficial) | ||||||||
| Intra-luminal | ||||||||
| Other (Specify) | ||||||||
| (3D/4D) | ||||||||
| 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 510k # 022858 E= added under Appendix E *market designation Includes B-Mode and Harmonic 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
(PLEASE DO NOT WRITEBELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Helmut Werner
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
7
Transducer: Curvilinear Transducers C9-3*
| Clinical Application | Specific
(Track I & III) | Mode of Operation | | | | | | |
|-------------------------|---------------------------------------------------|-------------------|---|------|-----|-------------------|--------------------|--------|
| General | | B1 | M | PWD2 | CWD | Color
Doppler3 | Combined
Modes4 | Other3 |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | E | E | E | | E | E | E3 |
| | Abdominal6 | E | E | E | | E | E | E3 |
| | Intra-operative
(Abdominal) | N | N | N | N | N | N | N5 |
| | Intra-operative
(Vascular) | N | N | N | N | N | N | N5 |
| | Laparoscopic | | | | | | | |
| | Pediatric | E | E | E | | E | E | E3 |
| | 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) | N | N | N | N | N | N | N5 |
| | Musculo-skel.
(Superficial) | N | N | N | N | N | N | N5 |
| | Intra-luminal | | | | | | | |
| | Other (Specify)
(3D/4D) | | | | | | | |
| | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| Cardiac | Trans-esoph.
(Cardiac) | | | | | | | |
| | Other (Specify) | | | | | | | |
| | Peripheral Vascular | E | E | E | | E | E | E3 |
| | Other (Specify) | | | | | | | |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = new indication; P=previously cleared by FDA 510k # 022858 E= added under Appendix E * market designation,
Includes B-Mode and Harmonic 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) 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 Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Helens
(Division Sign-Off) vision of Reproductive, Abdominal an Radiological De
510(k) Number
(k) Number K082346
8
Transducer: Curvilinear Transducers C8-3r* (3D/4D)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Specific
(Track I & III) | B¹ | M | PWD² | CWD | Color
Doppler³ | Combined
Modes⁴ | Other⁵ |
|-------------------------|---------------------------------------------------|----|---|------|-----|-------------------|--------------------|--------|
| General | Ophthalmic | | | | | | | |
| Ophthalmic | Fetal | N | N | N | | N | N | N⁵ |
| | Abdominal⁶ | N | N | N | | N | N | N⁵ |
| | Intra-operative
(Specify) | | | | | | | |
| | Intra-operative
(Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | N | N | N | | N | N | N⁵ |
| | 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) | N | N | N | | N | N | N⁵ |
| | Cardiac Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Trans-esoph.
(Cardiac) | | | | | | | |
| | Other (Specify) | | | | | | | |
| | | | | | | | | |
| Peripheral
Vascular | Peripheral Vascular | N | N | N | | N | N | N⁵ |
| | Other (Specify) | | | | | | | |
N = new indication; P=previously cleared by FDA 510k # 022858 E= added under Appendix E *market designation Includes B-Mode and Harmonic imaging (HI)
2 Includes PWD Mode imaging and High Pulse Repetition Rate PWD Mode (HPRF)
1 Includes Color Doopler (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)
' 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 WRITEBELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Halutleem
(Division Sign-Off) Division of Reproductive, Abdominal ar Radiologica 510(k) Number
9
Transducer: Phased (Sector) Array Transducers P4-1*
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | Specific | |||||||
| (Track I & III) | B1 | M | PWD2 | CWD | Color | |||
| Doppler3 | Combined | |||||||
| Modes4 | Other8 | |||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | P | P | P | P | P | P | P | |
| Abdominal | P | P | P | P | P | P | P | |
| Intra-operative | ||||||||
| (Specify)7 | ||||||||
| Intra-operative | ||||||||
| (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | P | P | P | P5 | |
| Small Organ | ||||||||
| (Thyroid, Breast, | ||||||||
| Testes, etc.) | ||||||||
| General | ||||||||
| application | Neonatal Cephalic | P | P | P | P | P | P | P5 |
| 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 | |
| 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 FDA510k # 022858 E=added under Appendix E *market designation
Includes B-Mode and Harmonic 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)
1 Includes B+M , B+CM+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)
· Freehand tissue elasticity
(PLEASE DO NOT WRITEBELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
uctive, Abdominal an
Radiological Devices
510(k) Number K082326
10
Transducer: Phased (Sector) Array Transducers P4-1c*
| Clinical Application | Specific
(Track I & III) | B1 | M | PWD2 | CWD | Color
Doppler3 | Combined
Modes4 | Other5,
8 |
|------------------------|---------------------------------------------------|---------------------|---|------|-----|-------------------|--------------------|--------------|
| 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 | 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 | Peripheral Vascular | P | P | P | P | P | P |
| vascular | Other (Specify) | | | | | | | |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = new indication; P=previously cleared by the FDA510k # 022858 E= added under Appendix E *market designation
Includes B-Mode and Harmonic 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
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 Device Evaluation (ODE)
Helene Reiner
livision Radiol 510/k) Number
11
Transducer: Phased (Sector) Array Transducers P10-4
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | Specific | |||||||
| (Track I & III) | B1 | M | PWD2 | CWD | Color | |||
| Doppler3 | Combined | |||||||
| Modes4 | Other5 | |||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | P | P | P | P | P | P | P5 | |
| Abdominal | P | P | P | P | P | P | P5 | |
| Intra-operative | ||||||||
| (Specify)7 | N | N | N | N | N | N | N5 | |
| Intra-operative | ||||||||
| (Neuro) | N | N | N | N | N | N5 | ||
| General | ||||||||
| application | Laparoscopic | |||||||
| Pediatric | P | P | P | P | P | P | P5 | |
| Small Organ | ||||||||
| (Thyroid, Breast, | ||||||||
| Testes, etc.) | ||||||||
| Neonatal Cephalic | P | P | P | P | P | P | P5 | |
| 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 FDA510k # 022858 E= added under Appendix E*market designation
Includes B-Mode and Harmonic 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)
S 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 Device Evaluation (ODE)
Helena Reuss
(Division Sign-Off)
oductive. Abdominal a Radio 510(k)
12
Transducer: Endo-Cavity Transducers E9-4*
... ... ... ..
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 | |||||||
| (Track I & III) | B1 | M | PWD2 | CWD | Color | |||
| Doppler3 | Combined | |||||||
| Modes4 | Other8 | |||||||
| 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 | ||||||||
| General | ||||||||
| application | 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) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac Pediatric | ||||||||
| Cardiac | Trans-esoph. | |||||||
| (Cardiac) | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| vascular | Peripheral vascular | |||||||
| Other (Specify) |
N = new indication; P=previously cleared by FDA 510k # 02258 E = added under Appendix E *market designation E9-4 Includes B-Mode and Harmonic 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
1 Intra operative include abdominal, thoracic (cardiac) and vascular (PV)
8 Freehand tissue elasticity
(PLEASE DO NOT WRITEBELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Herbert Hoover
(Division Sign-Off) oductive. Abdominal a Division of I Radiolo 510(k) Number
13
Transducer: Endo-Cavity Transducers* E9-4 3D
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 | |||||||
| (Track I & III) | B¹ | M | PWD² | CWD | Color | |||
| Doppler³ | Combined | |||||||
| Modes⁴ | Other⁸ | |||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | N | N | N | N | N | N⁵ | ||
| Abdominal | ||||||||
| Intra-operative | ||||||||
| (Specify)⁷ | ||||||||
| Intra-operative | ||||||||
| (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ | ||||||||
| (Thyroid, Breast, | ||||||||
| Testes, etc.) | ||||||||
| Neonatal Cephalic | ||||||||
| General | ||||||||
| application | Adult Cephalic | |||||||
| Trans-rectal | N | N | N | N | N | N⁵ | ||
| Trans-vaginal | N | N | N | N | N | N⁵ | ||
| Trans-urethral | ||||||||
| Trans-esoph. (non- | ||||||||
| Card.) | ||||||||
| Musculo-skel. | ||||||||
| (Conventional) | ||||||||
| Musculo-skel. | ||||||||
| (Superficial) | ||||||||
| Intra-luminal | ||||||||
| Other (Specify) | ||||||||
| (3D/4D) | N | N | N | N | N | N⁵ | ||
| Cardiac Adult | ||||||||
| Cardiac Pediatric | ||||||||
| Cardiac | Trans-esoph. | |||||||
| (Cardiac) | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| vascular | Peripheral vascular | |||||||
| Other (Specify) |
N = new indication; P=previously cleared by FDA 510k # 022858 E= added under Appendix E *market designation
1 Includes B-Mode and Harmonic 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+M+CM, B+CD+PWD where CD could represent (CD, DPD, 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 Device Evaluation (ODE)
Helene Newman
ion Sign-Off) productive. Abdomina Radiologica 510(k) Number
14
Transducer: Linear Transducers L10-5
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 | |||||||
| (Track I & III) | B1 | M | PWD2 | CWD | Color | |||
| Doppler3 | Combined | |||||||
| Modes4 | Other5, 8 | |||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | P | P | P | P | P | P5 | ||
| Abdominal | 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 | ||
| N8 | ||||||||
| 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) | N | N | N | N | N | N5, 8 | ||
| Musculo-skel. | ||||||||
| (Superficial) | N | N | N | N | N | N5, 8 | ||
| Intra-luminal | ||||||||
| Other (Specify)7 | ||||||||
| (3D/4D) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac Pediatric | ||||||||
| Cardiac | Trans-esoph. | |||||||
| (Cardiac) | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vascular | Peripheral Vascular | P | P | P | P | P | P5 | |
| N8 | ||||||||
| Other (Specify) | ||||||||
| 3D/4D |
N = new indication; P=previously cleared by the FDA 510k # (22858 E=added under Appendix E * market designation L10-5, 1 Includes B-Mode and Harmonic imaging (HI)
2 Includes PWDMode 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 Device Evaluation (ODE)
Hult Lewis
ductive, Abdominal ar Radiologi 510(k) Number
15
Transducer: Linear Transducers L8-3*
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 | |||||||
| (Track I & III) | B¹ | M | PWD² | CWD | Color | |||
| Doppler³ | Combined | |||||||
| Modes⁴ | Other'8 | |||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | E | E | E | E | E | E5 | ||
| Abdominal6 | E | E | E | E | P | E5 | ||
| Intra-operative | ||||||||
| (Specify)7 | E | E | E | E | E | E5 | ||
| Intra-operative | ||||||||
| (Neuro) | E | E | E | E | E5 | |||
| Laparoscopic | ||||||||
| Pediatric | E | E | E | E | E | E5 | ||
| General | ||||||||
| application | Small Organ | |||||||
| (Thyroid, Breast, | ||||||||
| Testes, etc.) | E | E | E | E | E | E5 | ||
| N8 | ||||||||
| Neonatal Cephalic | E | E | E | E | E | E5 | ||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non- | ||||||||
| Card.) | ||||||||
| Musculo-skel. | ||||||||
| (Conventional) | N | N | N | N | N | N5, 8 | ||
| Musculo-skel. | ||||||||
| (Superficial) | N | N | N | N | N | N5, 8 | ||
| Intra-luminal | ||||||||
| Other (Specify)7 | ||||||||
| 3D/4D | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esoph. | ||||||||
| (Cardiac) | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vascular | Peripheral Vascular | E | E | E | E | E | E5 | |
| N8 | ||||||||
| Other (Specify) | ||||||||
| 3D/4D |
N = new indication; P=previously cleared by the FDA 510k # 022858E= added under Appendix E *market designation Includes B-Mode and Harmonic 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)
S Color M-Mode (CM)
6 Abdominal includes renal, GYN/Pelvic
7 Intra operative include abdominal, thoracic (cardiac) and vascular (PV)
(Division Sign-Off)
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) Concurrence of CDRH, Office of Device Evaluation (ODE)
Helene Reuer
Division of Reproductive. Abdominal a
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K082326
16
Transducer: Linear Transducers L14-5SP*
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 | |||||||
| (Track I & III) | B¹ | M | PWD² | CWD | Color | |||
| Doppler³ | Combined | |||||||
| Modes⁴ | Other⁸ | |||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | E | E | E | E | E | E⁵ | ||
| Abdominal⁶ | E | E | E | E | E | E⁵ | ||
| Intra-operative | ||||||||
| (Specify)⁷ | E | E | E | E | E | E⁵ | ||
| Intra-operative | ||||||||
| (Neuro) | E | E | E | E | E⁵ | |||
| Laparoscopic | ||||||||
| Pediatric | E | E | E | E | E | E⁵ | ||
| Small Organ | ||||||||
| (Thyroid, Breast, | ||||||||
| Testes, etc.) | E | E | E | E | E | E⁵ | ||
| N⁸ | ||||||||
| General | ||||||||
| application | Neonatal Cephalic | E | E | E | E | E | E⁵ | |
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non- | ||||||||
| Card.) | ||||||||
| Musculo-skel. | ||||||||
| (Conventional) | N | N | N | N | N | N⁵, ⁸ | ||
| Musculo-skel. | ||||||||
| (Superficial) | N | N | N | N | N | N⁵, ⁸ | ||
| Intra-luminal | ||||||||
| Other (Specify)⁹ | ||||||||
| 3D/4D | ||||||||
| Cardiac Adult | ||||||||
| Cardiac Pediatric | ||||||||
| Cardiac | Trans-esoph. | |||||||
| (Cardiac) | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vascular | Peripheral Vascular | E | E | E | E | E | E⁵ | |
| N⁸ | ||||||||
| Other (Specify) | ||||||||
| 3D/4D |
N = new indication; P=previously cleared by the FDA 510k # 022858 E= added under Appendix E *market designation Includes B-Mode and Harmonic imaging (HI)
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))
And Posted Bridge (CD), Directional Power Doppler (DPD), and Power Doppler (PD)
1 meludes B+M, B+M+CM, B+CD+M+CM, B+CD+PWD where CD could represent (CD)
2 Colors B+M, B+M+CM, B+CD+M+CM, B+CD+PWD where CD could represent (CD, DPD, PD, or BD)
3 Color M Med
5 Color M-Mode (CM)
6 Abdominal includes renal, GYN/Pelvic
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)
Concurrence of CDRH, Office of Device Evaluation (ODE)Prescription Use (Per 21 CFR 801.109)
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
17
Transducer: Linear Transducers L14-5W*
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 | |||||||
| (Track I & III) | B1 | M | PWD2 | CWD | Color | |||
| Doppler3 | Combined | |||||||
| Modes4 | Other8 | |||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | E | E | E | E | E | E5 | ||
| Abdominal6 | E | E | E | E | E | E5 | ||
| Intra-operative | ||||||||
| (Specify)7 | E | E | E | E | E | E5 | ||
| Intra-operative | ||||||||
| (Neuro) | E | E | E | E | E | E5 | ||
| Laparoscopic | ||||||||
| Pediatric | E | E | E | E | E | E5 | ||
| Small Organ | ||||||||
| (Thyroid, Breast, | ||||||||
| Testes, etc.) | E | E | E | E | E | E5 | ||
| N8 | ||||||||
| General | ||||||||
| application | Neonatal Cephalic | E | E | E | E | E | E5 | |
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non- | ||||||||
| Card.) | ||||||||
| Musculo-skel. | ||||||||
| (Conventional) | N | N | N | N | N | N5, 8 | ||
| Musculo-skel. | ||||||||
| (Superficial) | N | N | N | N | N | N5, 8 | ||
| Intra-luminal | ||||||||
| Other (Specify)7 | ||||||||
| 3D/4D | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esoph. | ||||||||
| (Cardiac) | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vascular | Peripheral Vascular | E | E | E | E | E | E5 | |
| N8 | ||||||||
| Other (Specify) | ||||||||
| 3D/4D |
N = new indication; P=previously cleared by the FDA 510k # 022858 E=added under Appendix E *market designation
Includes B-Mode and Harmonic 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 couldrepresent (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, Amplitude Doppler, 3-D imaging, Tissue Motion Doppler, Color velocity imaging
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Principack GEE (P of E) SPR 03111
ductive, Abdominal a 510(k) Numbe
18
Transducer: EndoScopic Transducer Array E14-5*
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track I Only) | Specific | |||||||
| (Track I & III) | B¹ | M | PWD² | CWD | Color | |||
| Doppler³ | Combined | |||||||
| Modes⁴ | Other⁵ | |||||||
| ⁸ | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| General | ||||||||
| applications | Fetal | |||||||
| Abdominal | ||||||||
| Intra-operative | ||||||||
| (Specify)⁷ | ||||||||
| Intra-operative | ||||||||
| (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ | ||||||||
| (Thyroid, Breast, | ||||||||
| Testes, etc.) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | N | N | N | N | N | N⁵ | ||
| Trans-vaginal | N | N | N | N | N | N⁵ | ||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | N | N | N | N | N | N⁵ | ||
| Musculo-skel. | ||||||||
| (Conventional) | ||||||||
| Musculo-skel. | ||||||||
| (Superficial) | ||||||||
| Intra-luminal | ||||||||
| Other (Specify) | ||||||||
| (3D/4D) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esoph. | ||||||||
| (Cardiac) | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral Vessel | |||||||
| Other (Specify) |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = new indication; P=previously cleared by FDA 510k # 022858 *market designation E14-5
Includes B-Mode and Harmonic 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 WRITEBELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Helena
ision Sigh-Off) productive, Abdominal a Radiological 510(k) Number
19
Transducer: Tran-Esophageal P8-3T*
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 | ||||||||
| (Track I & III) | B1 | 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.) | |||||||||
| General | |||||||||
| applications | Neonatal Cephalic | ||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | N | N | N | N | N | N | N5 | ||
| Musculo-skel. | |||||||||
| (Conventional) | |||||||||
| Musculo-skel. | |||||||||
| (Superficial) | |||||||||
| Intra-luminal | |||||||||
| Other (Specify) | |||||||||
| (3D/4D) | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Cardiac | Trans-esoph. | ||||||||
| (Cardiac) | N | N | N | N | N | N | N5 | ||
| Other (Specify) | |||||||||
| Peripheral | |||||||||
| Vessel | Peripheral Vessel | ||||||||
| Other (Specify) |
N = new indication; P=previously cleared by FDA 510k # 022858 * market designation (TEE)
Includes B-Mode and Harmonic 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+M+CM, B+CD+PWD where CD could represent (CD, DPD, PD, PD, PD, PD, PD, PD, PD, PD, PD, PD, PD, PD, PD, PD, PD, PD, PD, PD, PD, PD, PD,
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 WRITEBELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Helene
vision Sid
Radiolo 510(k) Numbe
KD82326
20
Transducer: AUX CW2* (Common name pencil probe)
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 | ||||||||
| (Track I & III) | B¹ | M | PWD² | CWD | Color | ||||
| Doppler³ | Combined | ||||||||
| Modes⁴ | Other⁸ | ||||||||
| General | |||||||||
| application | Ophthalmic | Ophthalmic | |||||||
| Fetal | |||||||||
| Abdominal | |||||||||
| Intra-operative | |||||||||
| (Specify)¹ | |||||||||
| Intra-operative | |||||||||
| (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | N | ||||||||
| Small Organ | |||||||||
| (Thyroid, Breast, | |||||||||
| Testes, etc.) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| General | |||||||||
| application | 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 | N | |||||||
| Cardiac Pediatric | N | ||||||||
| Trans-esoph. | |||||||||
| (Cardiac) | |||||||||
| Other (Specify) | |||||||||
| Peripheral | |||||||||
| vascular | Peripheral vascular | ||||||||
| Other (Specify) |
N = new indication; P=previously cleared by FDA 510k # 022858 * market designation
1 Includes B-Mode and Harmonic imaging (HI)
2 Includes PWD Mode imaging and High Pulse Repettion 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)
S 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 Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Helena
(Division Sign-Off)
oductive. Abdominal
Radiological Devices
S2324
510(k) Number
21
Transducer: AUX CW4* (Common name pencil probe)
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 | |||||||
| (Track I & III) | B1 | M | PWD2 | CWD | Color | |||
| Doppler3 | Combined | |||||||
| Modes4 | Other5 | |||||||
| General | ||||||||
| application | Ophthalmic | |||||||
| Fetal | ||||||||
| Abdominal | ||||||||
| Intra-operative | ||||||||
| (Specify)7 | ||||||||
| Intra-operative | ||||||||
| (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | N | |||||||
| 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 | N | ||||||
| Other (Specify) |
N = new indication; P=previously cleared by FDA 510k # 022858 *market designation
Includes B-Mode and Harmonic imaging (HI)
4 Includes PWD Mode imaging and High Pulse Repetition Rate PWD Mode (HPRF)
3 Includes Color Dopler (CD), Directional Power Doppler (DPD), and Power Doppler (PDF)
1 Includes BJM, BAM (CD), Directional Power Doppler (DPD), and Power Doppler (PD)
" Lockudes B+M, B+M+CM, B+CD+M+CM, B+CD+D+D+D+D+D+D+D+D+D+D+D+D+D+D+C+D+D+C+C+C+C+C+C+C+C+C+C+C+C+C+C+C+C+C+C+C+C+C+C+C+C+C+C+C+C+C+C+C+C+C+C+C+C+C+C+C+C+C+C+C+C+C+C+C+C+C+C+
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 Device Evaluation (ODE)
Huls Verem
(Division Sign-Off)
ion of Reproductive. Abdominal and 510(k) Number
22
Transducer: AUX CW5* (Common name Pencil Probe)
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 | |||||||
| (Track I & III) | B1 | M | PWD2 | CWD | Color | |||
| Doppler3 | Combined | |||||||
| Modes4 | Other5 | |||||||
| Ophthalmic | Ophthalmic | |||||||
| General | ||||||||
| application | Fetal | |||||||
| Abdominal | ||||||||
| Intra-operative | ||||||||
| (Specify)7 | ||||||||
| Intra-operative | ||||||||
| (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | N | |||||||
| 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 | N | ||||||
| Other (Specify) |
N = new indication; P=previously cleared by FDA 510k # 022858 *market designation CW 2, CW4, CW5
Includes B-Mode and Harmonic 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)
" Includes B+M, B+M+CM, B+CD+M+CM, B+CD+PWD where CD could represent (CD)
" Includes B+M, B+M+CM, B+CD+M+CM, B+CD+PWD where CD could represent (CD, DPD, PD, or BD)
2 Color M
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 Device Evaluation (ODE)
uctive, Abdominal and