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K Number
K122574
Device Name
DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM, MODEL D3 AND D6
Manufacturer
EDAN INSTRUMENTS, INC.
Date Cleared
2012-10-12

(50 days)

Product Code
IYOITX
Regulation Number
892.1560
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The D3 and D6 Digital Ultrasonic Diagnostic Imaging System are applicable for adult or children ultrasound evaluation in hospitals, clinics, gynecology rooms, obstetrics rooms, examination rooms, intensive care units, and emergency rooms The D3 and D6 are intended for use by or on the order of a physician or similarly qualified health care professional for ultrasound evaluation of Fetus; Abdomen; Pediatrics; Small Organ; Neonatal head; Cardiology; Peripheral Vessel; Musculo-skeleton (both Conventional and Superficial); Urology (including prostate); Transrecta and Transvagina.
Device Description
D3 and D6 Digital Ultrasound Diagnostic Imaging System is a portable digital ultrasonic diagnostic system applied in ultrasound diagnostic examination of abdominal, obstetrical, small parts, gynecological, orthopedic, cardiac, and urological applications. It is designed to produce ultrasound waves into body tissue and to present the returned echo information on the monitor, the resulting information is displayed in five display modes: B-Mode, 2B-Mode, 4B-Mode, M-Mode, B+M Mode. This system controlled by software is a Track 1 device that employs an array of probes that include linear array, convex linear array, microconvex linear array, transrectal and transvaginal with a frequency range of approximately 2.0MHz-10.0MHz. The system consists of a main unit, transducers and other accessories.
More Information

K091680

Not Found

No
The document does not mention AI, ML, or related terms, and the device description focuses on standard ultrasound technology and display modes.

No
The device is described as a "Digital Ultrasonic Diagnostic Imaging System" intended for "ultrasound diagnostic examination," which indicates it is used for diagnosis, not therapy.

Yes
The "Intended Use / Indications for Use" section explicitly states that the system is an "Ultrasonic Diagnostic Imaging System."

No

The device description explicitly states that the system consists of a "main unit, transducers and other accessories," indicating the presence of hardware components beyond just software.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
  • Device Function: The D3 and D6 Digital Ultrasonic Diagnostic Imaging System uses ultrasound waves to create images of internal body structures. It does not analyze specimens taken from the body.
  • Intended Use: The intended use clearly states it's for "ultrasound evaluation" of various anatomical sites within the body.
  • Device Description: The description details how it produces and processes ultrasound echoes from body tissue.

Therefore, this device falls under the category of diagnostic imaging systems, not In Vitro Diagnostics.

N/A

Intended Use / Indications for Use

The D3 and D6 Digital Ultrasonic Diagnostic Imaging System are applicable for adult or children ultrasound evaluation in hospitals, clinics, gynecology rooms, obstetrics rooms, examination rooms, intensive care units, and emergency rooms The D3 and D6 are intended for use by or on the order of a physician or similarly qualified health care professional for ultrasound evaluation of Fetus; Abdomen; Pediatrics; Small Organ; Neonatal head; Cardiology; Peripheral Vessel; Musculo-skeleton (both Conventional and Superficial); Urology (including prostate); Transrecta and Transvagina.

Product codes (comma separated list FDA assigned to the subject device)

IYO, ITX

Device Description

D3 and D6 Digital Ultrasound Diagnostic Imaging System is a portable digital ultrasonic diagnostic system applied in ultrasound diagnostic examination of abdominal, obstetrical, small parts, gynecological, orthopedic, cardiac, and urological applications.

It is designed to produce ultrasound waves into body tissue and to present the returned echo information on the monitor, the resulting information is displayed in five display modes: B-Mode, 2B-Mode, 4B-Mode, M-Mode, B+M Mode. This system controlled by software is a Track 1 device that employs an array of probes that include linear array, convex linear array, microconvex linear array, transrectal and transvaginal with a frequency range of approximately 2.0MHz-10.0MHz.

The system consists of a main unit, transducers and other accessories.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Fetus; Abdomen; Pediatrics; Small Organ; Neonatal head; Cardiology; Peripheral Vessel; Musculo-skeleton (both Conventional and Superficial); Urology (including prostate); Transrecta and Transvagina.

Indicated Patient Age Range

Adult or children

Intended User / Care Setting

Intended for use by or on the order of a physician or similarly qualified health care professional for ultrasound evaluation in hospitals, clinics, gynecology rooms, obstetrics rooms, examination rooms, intensive care units, and emergency rooms.

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)

Clinical testing is not required.
Non-clinical test:
The following safety standards are conducted on the subject device:

    1. IEC 60601-1 Electrical Safety
    1. IEC 60601-1-2 Electromagnetic Compatibility
    1. Acoustic output testing as per the guideline "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" dated September 9, 2008.
    1. UD-2, IEC 60601-2-37
    1. ISO 10993-1, ISO 10993-5 and ISO 10993-10
      Verification and validation testing was conducted on the subject device. This premarket notification submission demonstrates that D3 and D6 Digital Ultrasonic Diagnostic Imaging System is substantially equivalent to the predicate device.

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.

K091680

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

§ 892.1560 Ultrasonic pulsed echo imaging system.

(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

0

Digital Ultrasonic Diagnostic Imaging System
510K Submission

OCT 12 2012

Section 5- 510(k) Summary of Safety and Effectiveness

Prepared in accordance with the requirements of 21 CFR Part 807.92

  1. Submitter:

Edan Instruments, Inc.

3/F-B, Nanshan Medical Equipments Park, Nanhai Rd 1019#, Shekou, Nanshan Shenzhen, 518067 P.R. China

Telephone: 0086-755-6856469

Fax: 0086-755-26882223

Contact Person: Randy Jiang Prepare date: Feb 21, 2012

  1. Device name and Device name: Digital Ultrasonic Diagnostic Imaging System classification:

Models D3 and D6

Classification: 892.1560 System, Imaging, Pulsed echo, Ultrasonic

Product code: IYO

892.1570 Transducer, Ultrasonic, Diagnostic

Product code: ITX

Regulatory Class: Class II

  1. Predicate Device:

Digital Ultrasonic Diagnostic Imaging System. K091680 Manufacturer: Edan Instruments, Inc.

  1. Device Description: D3 and D6 Digital Ultrasound Diagnostic Imaging System is a portable digital ultrasonic diagnostic system applied in ultrasound diagnostic examination of abdominal, obstetrical, small parts, gynecological, orthopedic, cardiac, and urological applications.

It is designed to produce ultrasound waves into body tissue and to present the returned echo information on the monitor, the resulting information is displayed in five display modes: B-Mode, 2B-Mode, 4B-Mode, M-Mode, B+M Mode. This system controlled by software is a Track 1 device that employs an array of probes that include linear array, convex linear array, microconvex linear array, transrectal and transvaginal with a frequency range of approximately 2.0MHz-10.0MHz.

The system consists of a main unit, transducers and other accessories.

1

5. Intended Use:

The D3 and D6 Digital Ultrasonic Diagnostic Imaging System are applicable for adult or children ultrasound evaluation in hospitals, clinics, gynecology rooms, obstetrics rooms, examination rooms, intensive care units, and emergency rooms The D3 and D6 are intended for use by or on the order of a physician or similarly qualified health care professional for ultrasound evaluation of Fetus; Abdomen; Pediatrics; Small Organ; Neonatal head; Cardiology; Peripheral Vessel; Musculo-skeleton (both Conventional and Superficial); Urology (including prostate); Transrecta and Transvagina.

6. Effectiveness and Safety Considerations:

Clinical test:

Clinical testing is not required.

Non-clinical test:

The following safety standards are conducted on the subject device:

    1. IEC 60601-1 Electrical Safety
    1. IEC 60601-1-2 Electromagnetic Compatibility
    1. Acoustic output testing as per the guideline "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" dated September 9, 2008.
    1. UD-2, IEC 60601-2-37
    1. ISO 10993-1, ISO 10993-5 and ISO 10993-10

7.Comparison to the predicate device

Comparison to the predicate device, the subject device has the similar technology characteristics and has the same intended use, same design principle, same electrical classification and same accuracy. The different between the subject device and predicate device primarily includes physical specifications, display type and display mode, all the above differences do not affect the usage, safety and effectiveness, and no new question is raised regarding the safety and effectiveness.

8. Substantially Equivalent Determination

Verification and validation testing was conducted on the subject device. This premarket notification submission demonstrates that D3 and D6 Digital Ultrasonic Diagnostic Imaging System is substantially equivalent to the predicate device.

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 stylized eagle with three tail feathers, representing the department's commitment to health, human services, and well-being. The eagle is surrounded by a circular inscription that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

OCT 12 2012

Edan Instruments, Inc. % Mr. Ned Devine Senior Staff Engineer/FDA Office Coordinator Underwriters Laboratories, Inc. 333 Pfingsten Road NORTHBROOK IL 60062

. Re: K122574

Trade/Device Name: Digital Ultrasonic Diagnostic Imaging System, Models D3 and D6 Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO and ITX Dated: September 21, 2012 Received: September 26, 2012

Dear Mr. Devine:

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 Digital Ultrasonic Diagnostic Imaging System, Models D3 and D6, as described in your premarket notification:

Transducer Model Number

D3D6
C361-1/C341C363-1
C321-1C362
L741C343-1
E741C321
E611-1L743
E743
E613

3

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This 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 Yours,

Zumhof D O'Hern Lier

Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure(s)

4

Section 6- Indications for Use

510(k) Number (if known):

Device Name: Digital Ultrasonic Diagnostic Imaging System Models D3 and D6

The D3 and D6 Digital Ultrasonic Diagnostic Imaging System are applicable for adult or children ultrasound evaluation in hospitals, clinics, gynecology rooms, obstetrics rooms, examination rooms, intensive care units, and emergency rooms The D3 and D6 are intended for use by or on the order of a physician or similarly qualified health care professional for ultrasound evaluation of Fetus; Abdomen; Pediatrics; Small Organ; Neonatal head; Cardiology; Peripheral Vessel; Musculo-skeleton (both Conventional and Superficial); Urology (including prostate); Transrecta and Transvagina.

Prescription Use (21 CFR Part 801 Subpart D)

Or Over the Counter Use

(21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IFNEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

(Division Sign-Off)

Division of Radiotogical Devices Office of In Vitro Diagnostic Device Evaluation and Safety

Ki22574
510K.

5

Diagnostic Ultrasound Indications for Use Form

D3 Digital Ultrasonic Diagnostic Imaging System

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical ApplicationMode of Operation
BMPWDCWDColor DopplerCombined (Specify)Other* (Specify)
Ophthalmic
Fetal / ObstetricsNNNNote 1,Noter2
AbdominalNNNNote 1,Noter2
Intra-operative (Specify)
Intra-operative (Neurological)
Laparoscopic
PediatricNNNNote 1,Noter2
Small Organ (Specify)NNNNote 1,Noter2
Neonatal CephalicNNNNote 1,Noter2
Adult Cephalic
TransrectalNNNNote 1,Noter2
TransvaginalNNNNote 1,Noter2
Transurethral
Musculo-skeletal (Conventional)NNNNote 1,Noter2
Musculo-skeletal (Superficial)NNNNote 1,Noter2
Intravascular
Other (Gynecology)NNN
CardiacNNNNote 1,Noter2
Intravascular
Peripheral vascularNNNNote 1,Noter2
Other (Urology)NNNNote 1,Noter2

N = new indication; P = previously cleared by FDA; E = added under this appendix

Additional comments: Combined mode: B+M

Note 1: This feature does not use contrast agent.

Note 2: Needle guide bracket kit

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mull D'the
(Division Sign-Off)

Division of Radiological Devices
Office In Vitro Diagnostic Device Evaluation and Safety

510K K122574/

6

Diagnostic Ultrasound Indications for Use Form

D3 with C361-1 / C341 Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Mode of Operation
Clinical ApplicationBMPWDCWDColor DopplerCombined (Specify)Other*
(Specify)
Ophthalmic
Fetal / ObstetricsPPPNote 1,Noter2
AbdominalPPPNote 1,Noter2
Intra-operative (Specify)
Intra-operative (Neurological)
Laparoscopic
PediatricPPP
Small Organ (Specify)
Neonatal Cephalic
Adult Cephalic
Transrectal
Transvaginal
Transurethral
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Gynecology)PPPNote 1,Noter2
Cardiac
Intravascular
Peripheral vascular
Other (Urology)PPPNote 1,Noter2

N = new indication; P = previously cleared by FDA; E = added under this appendix

Additional comments: Combined mode: B+M

Note 1: This feature does not use contrast agent.

Note 2: Needle guide bracket kit

(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 Radiological Devices Office of In Vitro Diagnostic Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

510K K122574

7

Diagnostic Ultrasound Indications for Use Form

D3 with C321-1 Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical ApplicationMode of Operation
BMPWDCWDColor
DopplerCombined
(Specify)Other*
(Specify)
Ophthalmic
Fetal / ObstetricsPPPNote 1,Noter2
AbdominalPPPNote 1,Noter2
Intra-operative (Specify)
Intra-operative (Neurological)
Laparoscopic
PediatricPPPNote 1,Noter2
Small Organ (Specify)
Neonatal Cephalic
Adult Cephalic
Transrectal
Transvaginal
Transurethral
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Gynecology)PPPNote 1,Noter2
CardiacPPPNote 1,Noter2
Intravascular
Peripheral vascular
Other (Urology)PPPNote 1,Noter2

N = new indication; P = previously cleared by FDA; E = added under this appendix

Additional comments: Combined mode: B+M

Note 1: This feature does not use contrast agent.

Note 2: Needle guide bracket kit

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

510K -

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Office of In Vitro Diagnostic Device Evaluation and Safety
Division of Radiological Devices
(Division Sign-Off)

6-4

8

Diagnostic Ultrasound Indications for Use Form

D3 with L741 Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

| Clinical Application | | Mode of Operation | | | | | | Other*
(Specify) |
|---------------------------------|--|-------------------|---|-----|-----|------------------|-----------------------|---------------------|
| | | B | M | PWD | CWD | Color
Doppler | Combined
(Specify) | |
| Ophthalmic | | | | | | | | |
| Fetal / Obstetrics | | | | | | | | |
| Abdominal | | | | | | | | |
| Intra-operative (Specify) | | | | | | | | |
| Intra-operative (Neurological) | | | | | | | | |
| Laparoscopic | | | | | | | | |
| Pediatric | | | | | | | | |
| Small Organ (Specify) | | P | P | | | | P | Note 1,Noter2 |
| Neonatal Cephalic | | P | P | | | | P | Note 1,Noter2 |
| Adult Cephalic | | | | | | | | |
| Transrectal | | | | | | | | |
| Transvaginal | | | | | | | | |
| Transurethral | | | | | | | | |
| Musculo-skeletal (Conventional) | | P | P | | | | P | Note 1,Noter2 |
| Musculo-skeletal (Superficial) | | P | P | | | | P | Note 1,Noter2 |
| Intravascular | | | | | | | | |
| Other (Gynecology) | | | | | | | | |
| Cardiac | | | | | | | | |
| Intravascular | | | | | | | | |
| Peripheral vascular | | P | P | | | | P | Note 1,Noter2 |
| Other (Urology) | | P | P | | | | P | Note 1,Noter2 |

N = new indication; P = previously cleared by FDA; E = added under this appendix Additional comments: Combined mode: B+M

Note 1: This feature does not use contrast agent.

Note 2: Needle guide bracket kit

Small organ includes galactophore, thyroid gland, prostate

(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 Radiological Devices Office of In Vitro Diagnostic Devices
Office of In Vitro Diagnostic Devices
Office of In Vitro Diagnostic Devices

510k K122574

9

Diagnostic Ultrasound Indications for Use Form

D3 with E741 Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical ApplicationMode of Operation
BMPWDCWDColor
DopplerCombined
(Specify)Other*
(Specify)
Ophthalmic
Fetal / Obstetrics
Abdominal
Intra-operative (Specify)
Intra-operative (Neurological)
Laparoscopic
Pediatric
Small Organ (Specify)
Neonatal Cephalic
Adult Cephalic
TransrectalPPPNote 1,Noter2
Transvaginal
Transurethral
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Gynecology)
Cardiac
Intravascular
Peripheral vascular
Other (Urology)PPPNote 1,Noter2

N = new indication; P = previously cleared by FDA; E = added under this appendix

Additional comments: Combined mode: B+M

Note 1: This feature does not use contrast agent.

Note 2: Needle guide bracket kit

(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 Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510K K12257X/

ર-ઉ

10

Diagnostic Ultrasound Indications for Use Form

D3 with E611-1 Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical ApplicationBMPWDCWDColor DopplerCombined (Specify)Other* (Specify)
Ophthalmic
Fetal / ObstetricsPPPNote 1,Noter2
Abdominal
Intra-operative (Specify)
Intra-operative (Neurological)
Laparoscopic
Pediatric
Small Organ (Specify)
Neonatal Cephalic
Adult Cephalic
Transrectal
TransvaginalPPPNote 1,Noter2
Transurethral
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Gynecology)PPPNote 1,Noter2
Cardiac
Intravascular
Peripheral vascular
Other (Urology)PPPNote 1,Noter2

N = new indication; P = previously cleared by FDA; E = added under this appendix

Additional comments: Combined mode: B+M

Note 1: This feature does not use contrast agent.

Note 2: Needle guide bracket kit.

(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 Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510K K122574/

11

Diagnostic Ultrasound Indications for Use Form

D6 Digital Ultrasonic Diagnostic Imaging System

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical ApplicationMode of Operation
BMPWDCWDColor
DopplerCombined
(Specify)Other*
(Specify)
Ophthalmic
Fetal / ObstetricsNNNNote 1,Note2
AbdominalNNNNote 1,Note2
Intra-operative (Specify)
Intra-operative (Neurological)
Laparoscopic
PediatricNNNNote 1,Note2
Small Organ (Specify)NNNNote 1,Note2
Neonatal CephalicNNNNote 1,Note2
Adult Cephalic
TransrectalNNNNote 1,Note2
TransvaginalNNNNote 1,Note2
Transurethral
Musculo-skeletal
(Conventional)NNNNote 1,Note2
Musculo-skeletal (Superficial)NNNNote 1,Note2
Intravascular
Other (Gynecology)
CardiacNNNNote 1,Note2
Intravascular
Peripheral vascularNNNNote 1,Note2
Other (Urology)NNNNote 1,Note2

N = new indication; P = previously cleared by FDA; E = added under this appendix

Additional comments: Combined mode: B+M

Note 1: This feature does not use contrast agent.

Note 2: Needle guide bracket kit

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Radiological Devices Office of In Vitro Diagnostic Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

510K K122574/

12

Diagnostic Ultrasound Indications for Use Form

D6 with C363-1 Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical ApplicationMode of OperationOther* (Specify)
BMPWDCWDColor DopplerCombined (Specify).
Ophthalmic
Fetal / ObstetricsPPPNote 1,Noter2
AbdominalPPPNote 1,Noter2
Intra-operative (Specify)
Intra-operative (Neurological)
Laparoscopic
PediatricPPPNote 1,Noter2
Small Organ (Specify)
Neonatal Cephalic
Adult Cephalic
Transrectal
Transvaginal
Transurethral
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Gynecology)PPPNote 1,Noter2
Cardiac
Intravascular
Peripheral vascular
Other (Urology)PPPNote 1,Noter2

N = new indication; P = previously cleared by FDA; E = added under this appendix Additional comments: Combined mode: B+M

Note 1: This feature does not use contrast agent.

Note 2: Needle guide bracket kit

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

510K.

Prescription Use (Per 21 CFR 801.109)

Mmhnd DK
(Division Sign-Off)

Division of Radiological Devices
Vitro Diagnostic Devices Devices
Vitro Diagnostic Devices Custom Custom Office of In Vitro Diagnostic Devices
Office of In Vitro Diagnostic Devices
Constitution Diagnostic Devices Evelulation and Safety
Constitution of One Commend Safety

6-9

13

Diagnostic Ultrasound Indications for Use Form

D6 with C362 Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

| Clinical Application | Mode of Operation | | | | | | Other*
(Specify) |
|---------------------------------|-------------------|---|-----|-----|---------------|-----------------------|---------------------|
| | B | M | PWD | CWD | Color Doppler | Combined
(Specify) | |
| Ophthalmic | | | | | | | |
| Fetal / Obstetrics | P | P | | | | P | Note 1,Note2 |
| Abdominal | P | P | | | | P | Note 1,Note2 |
| Intra-operative (Specify) | | | | | | | |
| Intra-operative (Neurological) | | | | | | | |
| Laparoscopic | | | | | | | |
| Pediatric | P | P | | | | P | Note 1,Note2 |
| Small Organ (Specify) | | | | | | | |
| Neonatal Cephalic | | | | | | | |
| Adult Cephalic | | | | | | | |
| Transrectal | | | | | | | |
| Transvaginal | | | | | | | |
| Transurethral | | | | | | | |
| Musculo-skeletal (Conventional) | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | |
| Intravascular | | | | | | | |
| Other (Gynecology) | P | P | | | | P | Note 1,Note2 |
| Cardiac | | | | | | | |
| Intravascular | | | | | | | |
| Peripheral vascular | | | | | | | |
| Other (Urology) | P | P | | | | P | Note 1,Note2 |

N = new indication; P = previously cleared by FDA; E = added under this appendix

Additional comments: Combined mode: B+M

Note 1: This feature does not use contrast agent.

Note 2: Needle guide bracket kit

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

510K K122574

14

Diagnostic Ultrasound Indications for Use Form

D6 withC343-1 Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical ApplicationMode of Operation
BMPWDCWDColor
DopplerCombined
(Specify)Other*
(Specify)
Ophthalmic
Fetal / ObstetricsPPPNote 1,Noter2
AbdominalPPPNote 1,Noter2
Intra-operative (Specify)
Intra-operative (Neurological)
Laparoscopic
PediatricPPPNote 1,Noter2
Small Organ (Specify)
Neonatal Cephalic
Adult Cephalic
Transrectal
Transvaginal
Transurethral
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Gynecology)PPPNote 1,Noter2
Cardiac
Intravascular
Peripheral vascular
Other (Urology)PPPNote 1,Noter2

N = new indication; P = previously cleared by FDA; E = added under this appendix

Additional comments: Combined mode: B+M

Note 1: This feature does not use contrast agent.

Note 2: Needle guide bracket kit

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

510K. K.122574/

15

Diagnostic Ultrasound Indications for Use Form

D6 with C321 Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical ApplicationMode of Operation
BMPWDCWDColor DopplerCombined (Specify)Other* (Specify)
Ophthalmic
Fetal / ObstetricsPPPNote 1,Noter2
AbdominalPPPNote 1,Noter2
Intra-operative (Specify)
Intra-operative (Neurological)
Laparoscopic
PediatricPPPNote 1,Noter2
Small Organ (Specify)
Neonatal Cephalic
Adult Cephalic
Transrectal
Transvaginal
Transurethral
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Gynecology)PPPNote 1,Noter2
CardiacPPPNote 1,Noter2
Intravascular
Peripheral vascular
Other (Urology)PPPNote 1,Noter2

N = new indication; P = previously cleared by FDA; E = added under this appendix

Additional comments: Combined mode: B+M

Note 1: This feature does not use contrast agent.

Note 2: Needle guide bracket kit

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

510K

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

(Division Sign-Off)

Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

16

Diagnostic Ultrasound Indications for Use Form

D6 with L743 Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical ApplicationMode of Operation
BMPWDCWDColor
DopplerCombined
(Specify)Other*
(Specify)
Ophthalmic
Fetal / Obstetrics
Abdominal
Intra-operative (Specify)
Intra-operative (Neurological)
Laparoscopic
Pediatric
Small Organ (Specify)PPPNote 1,Noter2
Neonatal CephalicPPPNote 1,Noter2
Adult Cephalic
Transrectal
Transvaginal
Transurethral
Musculo-skeletal (Conventional)PPPNote 1,Noter2
Musculo-skeletal (Superficial)PPPNote 1,Noter2
Intravascular
Other (Gynecology)
Cardiac
Intravascular
Peripheral vascularPPPNote 1,Noter2
Other (Urology)PPPNote 1,Noter2

N = new indication; P = previously cleared by FDA; E = added under this appendix

Additional comments: Combined mode: B+M

Note 1: This feature does not use contrast agent.

Note 2: Needle guide bracket kit

Small Organ includes galactophore, thyroid gland, prostate

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

510K.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

MundlADR
(Division Sign-Off)

Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

K122574

17

Diagnostic Ultrasound Indications for Use Form

D6 with E743 Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical ApplicationMode of Operation
BMPWDCWDColor
DopplerCombined
(Specify)Other*
(Specify)
Ophthalmic
Fetal / Obstetrics
Abdominal
Intra-operative (Specify)
Intra-operative (Neurological)
Laparoscopic
Pediatric
Small Organ (Specify)
Neonatal Cephalic
Adult Cephalic
TransrectalPPPNote 1,Noter2
Transvaginal
Transurethral
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Gynecology)
Cardiac
Intravascular
Peripheral vascular
Other (Urology)PPPNote 1,Noter2

N = new indication; P = previously cleared by FDA; E = added under this appendix

Additional comments: Combined mode: B+M

Note 1: This feature does not use contrast agent.

Note 2: Needle guide bracket kit

(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 Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510K K12252/

18

Diagnostic Ultrasound Indications for Use Form

D6 with E613 Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical ApplicationMode of Operation
BMPWDCWDColor DopplerCombined (Specify)Other* (Specify)
Ophthalmic
Fetal / ObstetricsPPPNote 1,Noter2
Abdominal
Intra-operative (Specify)
Intra-operative (Neurological)
Laparoscopic
Pediatric
Small Organ (Specify)
Neonatal Cephalic
Adult Cephalic
Transrectal
TransvaginalPPPNote 1,Noter2
Transurethral
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Gynecology)PPPNote 1,Noter2
Cardiac
Intravascular
Peripheral vascular
Other (Urology)PPPNote 1,Noter2

N = new indication; P = previously cleared by FDA; E = added under this appendix

Additional comments: Combined mode: B+M

Note 1: This feature does not use contrast agent ..

Note 2: Needle guide bracket kit.

(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)

Michael D. O'Brien
(Division Sign-Off)

Division of Radiological Devices Office of In Vitre Diagnostic Devices
Office of In Vitce Diagnostic Device Evaluation and Safety

510K K122574