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K Number
K123503
Device Name
DC-N3/DC-NS3 DIAGNOSTIC ULTRASOUND SYSTEM
Manufacturer
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
Date Cleared
2012-12-13

(30 days)

Product Code
IYNITXIYO
Regulation Number
892.1550
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DC-N3/DC-N3S Diagnostic Ultrasound System is applicable for adult, pregnant woman, pediatric and neonate. It is intended for use in fetal, abdominal, pediatric, small organ(breast, thyroid, testes.), cephalic(neonatal and adult), trans-rectal, trans-vaginal, musculo-skeletal(conventional, superficial), cardiac(Adult and Pediatric), Peripheral Vascular and urology exams.
Device Description
DC-N3/DC-N3S is a mobile, software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound data in B, M, PW, CW, Color, Power, HPRF, TVI, TEI,TVD, Free Xros M/ Free Xros CM, Smart 3D, 4D, iScape, or the combined mode (i.e. B/M-Mode, B/PW-mode, B/PW/Color).This system is a Track 3 device that employs an array of probes that include linear array, convex array and phased array with a frequency range of approximately 2.5 MHz to 10.0 MHz.
More Information

K103583, K120699, K113647, K122010

Not Found

No
The document does not mention AI, DNN, or ML, and the device description focuses on standard ultrasound imaging modes and probes.

No
The device is described as a "Diagnostic Ultrasound System" intended for acquiring and displaying ultrasound data for various exams. Its purpose is diagnosis, not therapy.

Yes

The "Intended Use / Indications for Use" section explicitly states "The DC-N3/DC-N3S Diagnostic Ultrasound System is applicable..." and the "Device Description" section refers to it as an "ultrasonic diagnostic system."

No

The device description explicitly states it is a "mobile, software controlled, ultrasonic diagnostic system" and mentions employing "an array of probes," which are hardware components essential for acquiring ultrasound data.

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

Here's why:

  • IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to examine these samples outside of the body.
  • Device Description: The DC-N3/DC-N3S is described as a "Diagnostic Ultrasound System." Ultrasound is an imaging modality that uses sound waves to create images of internal body structures within the body.
  • Intended Use: The intended uses listed are all related to imaging various anatomical sites within the body (fetal, abdominal, cardiac, etc.). There is no mention of analyzing samples taken from the body.

Therefore, the DC-N3/DC-N3S is an in-vivo diagnostic imaging device, not an in-vitro diagnostic device.

N/A

Intended Use / Indications for Use

The DC-N3/ DC-N3S Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatric, small organ (breast, thyroid, testes), cephalic (neonatal and adult), trans-rectal, trans-vaginal, musculo-skeletal (conventional and superficial), cardiac (adult and pediatric), peripheral vascular and urology exams.

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

IYN, IYO, ITX

Device Description

DC-N3/DC-N3S is a mobile, software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound data in B, M, PW, CW, Color, Power, HPRF, TVI, TEI, TVD, Free Xros M/ Free Xros CM, Smart 3D, 4D, iScape, or the combined mode (i.e. B/M-Mode, B/PW-mode, B/PW/Color).This system is a Track 3 device that employs an array of probes that include linear array, convex array and phased array with a frequency range of approximately 2.5 MHz to 10.0 MHz.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Fetal, abdominal, pediatric, small organ (breast, thyroid, testes), cephalic (neonatal and adult), trans-rectal, trans-vaginal, musculo-skeletal (conventional and superficial), cardiac (adult and pediatric), peripheral vascular and urology. Specific transducers also indicate use for intraoperative (including Neuro, Laparoscopic), trans-urethral, trans-esophageal (non-cardiac and cardiac), intravascular (including cardiac), and intra-cardiac applications.

Indicated Patient Age Range

adult, pregnant woman, pediatric and neonate.

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

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.

K103583, K120699, K113647, K122010

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 892.1550 Ultrasonic pulsed doppler imaging system.

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

0

K123503

510(K) SUMMARY

DEC 1 3 2012

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92(c).

The assigned 510(k) number is:

1. Submitter:

Shenzhen Mindray Bio-medical Electronics Co., LTD Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan, Shenzhen, 518057, P. R. China

Tel: +86 755 8188 5635 Fax: +86 755 2658 2680

Contact Person:

Bai Yanhong Shenzhen Mindray Bio-medical Electronics Co., LTD Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan, Shenzhen, 518057, P. R. China

Date Prepared: September 7, 2012

2. Device Name: DC-N3/DC-N3S Diagnostic Ultrasound System

Classification

Regulatory Class: II

Review Category: Tier II

21 CFR 892.1550 Ultrasonic Pulsed Doppler Imaging System (90-IYN)

21 CFR 892.1560 Ultrasonic Pulsed Echo Imaging System (90-IYO)

21 CFR 892.1570 Diagnostic Ultrasound Transducer (90-ITX)

3. Device Description:

DC-N3/DC-N3S is a mobile, software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound data in B, M, PW, CW, Color, Power, HPRF, TVI, TEI,TVD, Free Xros M/ Free Xros CM, Smart 3D, 4D, iScape, or the combined mode (i.e. B/M-Mode, B/PW-mode, B/PW/Color).This system is a Track 3 device that employs an array of probes that include linear array, convex array and phased

Image /page/0/Figure/20 description: The image shows the number 05-1 in bold black font. The number 05 is followed by a hyphen and then the number 1. The background is white.

1

array with a frequency range of approximately 2.5 MHz to 10.0 MHz.

4. Intended Use:

DC-N3/DC-N3S Diagnostic Ultrasound System is applicable for adult, pregnant woman, pediatric and neonate. It is intended for use in fetal, abdominal, pediatric, small organ(breast, thyroid, testes.), cephalic(neonatal and adult), trans-rectal, trans-vaginal, musculo-skeletal(conventional, superficial), cardiac(Adult and Pediatric), Peripheral Vascular and urology exams.

5. Comparison with Predicate Devices:

| Predicate

DeviceManufacturerModel510(k) Control Number
1MindrayDC-7K103583
2MindrayDC-T6K120699
3MindrayDC-8K113647
4MindrayZ6K122010

DC-N3/DC-N3S Diagnostic Ultrasound System is comparable with and substantially equivalent to these predicate devices:

They have the same technological characteristics, are comparable in key safety and effectiveness features, and have the same intended uses and basic operating modes as the predicate devices.

6. Non-clinical Tests:

DC-N3/DC-N3S Diagnostic Ultrasound System has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical and mechanical safety, and has been found to conform with applicable medical safety standards. This device has been designed to meet the following standards: UD 2. UD 3. IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-1-4, IEC 60601-2-37,UL 60601-1, ISO14971 and ISO 10993-1.

Conclusion:

Intended uses and other key features are consistent with traditional clinical practices, FDA guidelines and established methods of patient examination. The design, development and quality process of the manufacturer confirms with 21 CFR 820, ISO 9001 and ISO 13485 quality systems. The device conforms to applicable medical device safety standards. Therefore, the DC-N3/DC-N3S Diagnostic Ultrasound System is

Image /page/1/Figure/11 description: The image shows the number "05-2" in a bold, sans-serif font. The numbers and hyphen are all in black. The background is white.

2

substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.

.

:

.

.

.

05-3

:

:

3

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of a human figure embracing a globe.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

December 13, 2012

Shenzhen Mindray Bio-Medical Electronics., Ltd. . % Mr. Jeff D. Rongero Senior Project Engineer Underwriters Laboratories, Inc. 12 Laboratory Drive Research Triangle Park, NC 27709

3C5A 6C2 V10-4 V10-4B 7L4A L12-4

Re: K123503

Trade/Device Name: The DC-N3/DC-N3S Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: October 31, 2012 Received: November 13, 2012

Dear Mr. Rongero:

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 The DC-N3/DC-N3S Diagnostic Ultrasound System as described in your premarket notification:

Transducer Model Number

L14-6
2P2
D6-2
D6-2A
6CV1

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

4

can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part . 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/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 Lauren Hefner at (301) 796-6881.

Sincerely Yours.

Janine M. Morris -S

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

Enclosure(s)

5

Indications for Use

510(k) Number (if known):

Device Name: The DC-N3/ DC-N3S Diagnostic Ultrasound System

Indications for Use:

The DC-N3/ DC-N3S Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatric, small organ (breast, thyroid, testes), cephalic (neonatal and adult), trans-rectal, trans-vaginal, musculo-skeletal (conventional and superficial), cardiac (adult and pediatric), peripheral vascular and urology exams.

Over – The – Counter Use AND/OR Prescription Use X (21 CFR Part 807 Subpart C) (21 CFR Part 801 Subpart D)

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

Concurrence of CDRH, Office of In Vitro Diagnostic and Radiological Health (OIR)

ivision of Rediolor

Office of In Vitro Diagnostics

510(k) K123503

OS-1

6

Transducer

and the same of the same of the states of the states of the states of the states of the states of the states of the states of the states of the states of the states of the st

System Model:

DC-N3

×

.

510(k) Number(s)

Mode of Operation
Clinical ApplicationBMPWDCWDColor
DopplerAmplitude
e DopplerCombined
(specify)Other (specify)
Ophthalmic
FetalNNNNNNNNote1,2, 3, 4,6,7
AbdominalNNNNNNNNote1,2, 3, 4,5,6,7
Intraoperative (specify)*
Intraoperative (Neuro)
Laparoscopic
PediatricNNNNNNNNote 1, 2, 4,5,6,7
Small organ(specify)**NNNNNNNNote1, 2, 4,6,7
Neonatal CephalicNNNNNNNNote1, 2, 4,5,6,7
Adult CephalicNNNNNNNNote1, 2, 4,5,6,7
Trans-rectalNNNNNNNNote 1,2,4,6,7
Trans-vaginalNNNNNNNNote 1,2,4,6,7
Trans-urethral
Trans-esoph.(non-Card.)
Musculo-skeletalNNNNNNNNote 1,2,4,6,7
Musculo-skeletal SuperficialNNNNNNNNote 1,2,4,6,7
Intravascular
Cardiac AdultNNNNNNNNote 1,2,5,6,7
Cardiac PediatricNNNNNNNNote 1,2,5,6,7
Intravascular (Cardiac)
Trans-esoph.(Cardiac)
Intra-Cardiac
Peripheral VascularNNNNNNNNote 1,2,4,6,7
Other (specify)***NNNNNNNNote 1,2,4,6,7
N=new indication; P=previously cleared by FDA; E=added under Appendix E
Additional comments:Combined modes: B+M, PW+B, Color + B, Power + B, PW +Color+ B, Power + PW +B.
*Intraoperative includes abdominal, thoracic, and vascular etc.
**Small organ-breast, thyroid, testes, etc.
***Other use includes Urology.
Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
Note 2: Smart3D
Note 3:4D(Real-time 3D)
Note 4: iScape
Note5: TDI
Note6: Color M
Note7: Biopsy Guidance
(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)

Biriston of Radiolog

510(k)

08-2

7

SystemTransducerX
Model:3C5A
510(k) Number(s)
Mode of Operation
Clinical ApplicationBMPWDCWDColor
DopplerAmplitud
e DopplerCombined
(specify)Other (specify)
Ophthalmic
FetalNNNNNNNote 1, 2, 4,6,7
AbdominalNNNNNNNote 1, 2, 4,6,7
Intraoperative (specify)*
Intraoperative (Neuro)
Laparoscopic
PediatricNNNNNNNote 1, 2, 4,6,7
Small organ(specify)**
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph (non-Card.)
Musculo-skeletalNNNNNNNote 1, 2, 4,6,7
Musculo-skeletal Superficial
Intravascular
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph.(Cardiac)
Intra-Cardiac
Peripheral VascularNNNNNNNote 1, 2, 4,6,7
Other (specify) ***
N=new indication; P=previously cleared by FDA; E=added under Appendix E
Additional comments: Combined modes: B+M, PW+B, Color + B, Power + B, PW +Color+B, Power + PW +B.
*Intraoperative includes abdominal, thoracic, and vascular etc.
** Small organ-breast, thyroid, testes, etc.
** * Other use includes Urology.
Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
Note 2: Smart3D
Note 3:4D(Real-time 3D)
Note 4: iScape
Note5: TDI
Note6: Color M
Note7: Biopsy Guidance
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Division of Radiological Health

Office of In Vitro Diagnostics and Radiological Health

ID+

Prescription USE (Per 21 CFR 801.109)

ン... ・

510(k) K123503

08-3

8

6C2

×

System Model:

510(k) Number(s)

Mode of Operation
Clinical ApplicationBMPWDCWDColor
DopplerAmplitude
e DopplerCombined
(specify)Other (specify)
Ophthalmic
Fetal
AbdominalNNNNNNNNote 1, 2, 4,6,7
Intraoperative (specify)*
Intraoperative (Neuro)
Laparoscopic
PediatricNNNNNNNNote 1, 2, 4,6,7
Small organ(specify)**
Neonatal CephalicNNNNNNNNote 1, 2, 4,6,7
Adult CephalicNNNNNNNNote 1, 2, 4,6,7
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph.(non-Card.)
Musculo-skeletalNNNNNNNNote 1, 2, 4,6,7
Musculo-skeletal SuperficialNNNNNNNNote 1, 2, 4,6,7
Intravascular
Cardiac AdultNNNNNNNNote 1, 2, 4,6,7
Cardiac PediatricNNNNNNNNote 1, 2, 4,6,7
Intravascular (Cardiac)
Trans-esoph.(Cardiac)
Intra-Cardiac
Peripheral VascularNNNNNNNNote 1, 2, 4,6,7
Other (specify) ***
N=new indication; P=previously cleared by FDA; E=added under Appendix E
Additional comments: Combined modes: B+M, PW+B, Color + B, Power + B, PW +Color+B, PW +Color+B, Power + PW+B.
*Intraoperative includes abdominal, thoracic, and vascular etc.
** Small organ-breast, thyroid, testes, etc.
*** Other use includes Urology.
Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
Note 2: Smart3D
Note 3:4D(Real-time 3D)
Note 4: iScape
Note5: TDI
Note6: Color M
Note7: Biopsy Guidance
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Mode of Operation
Clinical ApplicationBMPWDCWDColor
DopplerAmplitude
DopplerCombined
(specify)Other (specify)
Ophthalmic
FetalNNNNNNNNote 1, 2, 4,6,7
Abdominal
Intraoperative (specify)*
Intraoperative (Neuro)
Laparoscopic
Pediatric
Small organ(specify)**
Neonatal Cephalic
Adult Cephalic
Trans-rectalNNNNNNNNote 1, 2, 4,6,7
Trans-vaginalNNNNNNNNote 1, 2, 4,6,7
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal
Musculo-skeletal Superficial
Intravascular
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-Cardiac
Peripheral Vascular
Other (specify)***NNNNNNNNote 1, 2, 4,6,7
N=new indication; P=previously cleared by FDA; E=added under Appendix E
Additional comments:Combined modes: B+M, PW+B, Color + B, Power + B, PW +Color+ B, Power + PW +B.
* Intraoperative includes abdominal, thoracic, and vascular etc.
** Small organ-breast, thyroid, testes, etc.
*** Other use includes Urology.
Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
Note 2: Smart3D
Note 3:4D(Real-time 3D)
Note 4: iScape
Note5: TDI
Note6: Color M
Note7: Biopsy Guidance
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation(QDE)

Prescription USE (Per 21 CFR 801.109)

(Division Sign Off)

Division of Radiological Health

510(k)

08-4

9

V 10-4

Transducer

×

System Mođel:

510(k) Number(s)

Concurrence of CDRH, Office of Device Evaluation(ODE)

Prescription USE (Per 21 CFR 80 1000

CFR 801(f)(9)
(Division Sign Off)

Division of Radiological Health

510(k) K123503

10

SystemTransducerX
Model:V10-4B
510(k) Number(s)
Clinical ApplicationBMPWDCWDColor DopplerAmplitude DopplerCombined (specify)Other (specify)
Ophthalmic
FetalNNNNNNNote 1, 2, 4,6,7
Abdominal
Intraoperative (specify)*
Intraoperative (Neuro)
Laparoscopic
Pediatric
Small organ(specify)**
Neonatal Cephalic
Adult Cephalic
Trans-rectalNNNNNNNote 1, 2, 4,6,7
Trans-vaginalNNNNNNNote 1, 2, 4,6,7
Trans-urethral
Trans-esoph.(non-Card.)
Musculo-skeletal
Musculo-skeletal Superficial
Intravascular
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph.(Cardiac)
Intra-Cardiac
Peripheral Vascular
Other (specify) ***NNNNNNNote 1, 2, 4,6,7

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

Additional comments:Combined modes: B+M, PW+B, Color + B, Power + B, PW +Color+ B, Power + PW +B.

  • Intraoperative includes abdominal, thoracic, and vascular etc.

** Small organ-breast, thyroid, testes, etc.

*** Other use includes Urology.

Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.

Note 2: Smart3D

Note 3:4D(Real-time 3D)

Note 4: iScape

Note5: TDI

Note6: Color M

Note7: Biopsy Guidance

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

Concurrence of CDRH, Office of Device Evaluation(QDE)

Prescription USE (Per 21 CFR 801.189)

.

・

(Division Sign Off)

Division of Radiological Health

510(k) K123503

08-6

11

Model:7L4A
510(k) Number(s)
Mode of Operation
Clinical ApplicationBMPWDCWDColor
DopplerAmplitude
DopplerCombined
(specify)Other (specify)
Ophthalmic
Fetal
AbdominalNNNNNNNote 1,2, 4,6,7
Intraoperative (specify)*
Intraoperative (Neuro)
Laparoscopic
PediatricNNNNNNNote 1,2, 4,6,7
Small organ(specify)**NNNNNNNote 1,2, 4,6,7
Neonatal CephalicNNNNNNNote 1,2, 4,6,7
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletalNNNNNNNote 1,2, 4,6,7
Musculo-skeletal SuperficialNNNNNNNote 1,2, 4,6,7
Intravascular
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-Cardiac
Peripheral VascularNNNNNNNote 1,2, 4,6,7
Other (specify)***
N=new indication; P=previously cleared by FDA; E=added under Appendix E
Additional comments: Combined modes: B+M, PW+B, Color + B, Power + B, PW +Color+ B, Power + PW+B.
* Intraoperative includes abdominal, thoracic, and vascular etc.
** Small organ-breast, thyroid, testes, etc.
*** Other use includes Urology.
Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
Note 2: Smart3D
Note 3:4D(Real-time 3D)
Note 4: iScape
NoteS: TDI
Note6: Color M
Note7: Biopsy Guidance
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Transducer

×

System

(Division Sign Off)

Prescription USE (Per 21 CFR 801.109)

Division of Rastiblogical Health

afte

Office of In Vitro Diagnostics and Radiological Health

510(k) K123503

1

12

L12-4

x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x

System Model:

·

510(k) Number(s)

Mode of Operation
Clinical ApplicationBMPWDCWDColor
DopplerAmplitude
DopplerCombined
(specify)Other (specify)
Ophthalmic
Fetal
AbdominalNNNNNNNNote 1,2, 4,6,7
Intraoperative (specify)*
Intraoperative (Neuro)
Laparoscopic
PediatricNNNNNNNNote 1,2, 4,6,7
Small organ(specify)**NNNNNNNNote 1,2, 4,6,7
Neonatal CephalicNNNNNNNNote 1,2, 4,6,7
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph.(non-Card.)
Musculo-skeletalNNNNNNNNote 1,2, 4,6,7
Musculo-skeletal SuperficialNNNNNNNNote 1,2, 4,6,7
Intravascular
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-Cardiac
Peripheral VascularNNNNNNNNote 1,2, 4,6,7
Other (specify)***

(Division Sign Off) Division of Radiological Health

510(k) K123503

08-8

13

L 14-6

Transducer

.

×

System Model:

510(k) Number(s)

Mode of Operation
Clinical ApplicationBMPWDCWDColor
DopplerAmplitude
e DopplerCombined
(specify)Other (specify)
Ophthalmic
Fetal
AbdominalNNNNNNNNote 1,2, 4,6,7
Intraoperative (specify)*
Intraoperative (Neuro)
Laparoscopic
PediatricNNNNNNNNote 1,2, 4,6,7
Small organ(specify)**NNNNNNNNote 1,2, 4,6,7
Neonatal CephalicNNNNNNNNote 1,2, 4,6,7
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletalNNNNNNNNote 1,2, 4,6,7
Musculo-skeletal SuperficialNNNNNNNNote 1,2, 4,6,7
Intravascular
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph.(Cardiac)
Intra-Cardiac
Peripheral VascularNNNNNNNNote 1,2, 4,6,7
Other (specify)***
N=new indication; P=previously cleared by FDA; E=added under Appendix E
Additional comments: Combined modes: B+M, PW+B, Color + B, Power + B, PW +Color+B, PW +Color+B, Power + PW +B.
*Intraoperative includes abdominal, thoracic, and vascular etc.
** Small organ-breast, thyroid, testes, etc.
*** Other use includes Urology.
Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
Note 2: Smart3D
Note 3:4D(Real-time 3D)
Note 4: iScape
Note5: TDI
Note6: Color M
Note7: Biopsy Guidance
(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)
Mode of Operation
Clinical ApplicationBMPWDCWDColor
DopplerAmplitude
e DopplerCombined
(specify)Other (specify)
Ophthalmic
Fetal
AbdominalNNNNNNNNote 1, 2,4,5,6,7
Intraoperative (specify)*
Intraoperative (Neuro)
Laparoscopic
PediatricNNNNNNNNote 1, 2,4,5,6,7
Small organ(specify) **
Neonatal CephalicNNNNNNNNote 1, 2, 4,6,7
Adult CephalicNNNNNNNNote 1, 2,4,5,6,7
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph.(non-Card.)
Musculo-skeletal
Musculo-skeletal Superficial
Intravascular
Cardiac AdultNNNNNNNNote 1, 2,4,5,6,7
Cardiac PediatricNNNNNNNNote 1, 2,4,5,6,7
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-Cardiac
Peripheral Vascular
Other (specify) ***
N=new indication; P=previously cleared by FDA; E=added under Appendix E
Additional comments:Combined modes: B+M, PW+B, Color + B, Power + B, PW+Color+ B, Power + PW +B
* Intraoperative includes abdominal, thoracic, and vascular etc.
** Small organ-breast, thyroid, testes, etc.
*** Other use includes Urology.
Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
Note 2: Smart3D
Note 3:4D(Real-time 3D)
Note 4: iScape
Note5: TDI
Note6: Color M
Note7: Biopsy Guidance
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Division of Radlological Health

510(k) K123503

14

2P2

×

System Model:

510(k) Number(s)

Prescription USE (Per 21 CFR 801.109)

(.109)
(Division Sign Off)

Division of Radiological Health

510(k) K123503

08-10

15

SystemTransducerX
Model:D6-2
510(k) Number(s)

Mode of Operation

Clinical ApplicationBMPWDCWDColor DopplerAmplitude DopplerCombined (specify)Other (specify)
Ophthalmic
FetalNNNNNNNNote 1,2, 3, 4,6
AbdominalNNNNNNNNote 1,2, 3, 4,6
Intraoperative (specify)*
Intraoperative (Neuro)
Laparoscopic
Pediatric
Small organ(specify)**
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal
Musculo-skeletal Superficial
Intravascular
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph.(Cardiac)
Intra-Cardiac
Peripheral Vascular
Other (specify)***

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

Additional comments: Combined modes: B+M, PW+B, Color + B, Power + B, PW +Color+ B, Power + PW +B.

*Intraoperative includes abdominal, thoracic, and vascular etc.

**Small organ-breast, thyroid, testes, etc.

***Other use includes Urology.

Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.

Note 2: Smart3D

Note 3:4D(Real-time 3D)

Note 4: iScape

Note5: TDI

Note6: Color M

Note7: Biopsy Guidance

(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 Health

510(k) 123503

08-11

16

Clinical ApplicationMode of Operation
BMPWDCWDColor
DopplerAmplitude
DopplerCombined
(specify)Other (specify)
Ophthalmic
FetalNNNNNNNote1,2, 3, 4,
AbdominalNNNNNNNote1,2, 3, 4,
Intraoperative (specify)*
Intraoperative (Neuro)
Laparoscopic
Pediatric
Small organ(specify)**
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal
Musculo-skeletal Superficial
Intravascular
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph.(Cardiac)
Intra-Cardiac
Peripheral Vascular
Other (specify) ***
N=new indication; P=previously cleared by FDA; E=added under Appendix E
Additional comments:Combined modes: B+M, PW+B, Color + B, Power + B, PW +Color+B, Power + PW +B.
* Intraoperative includes abdominal, thoracic, and vascular etc.
** Small organ-breast, thyroid, testes, etc.
*** Other use includes Urology.
Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
Note 2: Smart3D
Note 3:4D(Real-time 3D)
Note 4: iScape
Note5: TDI
Note6: Color M

System

Transducer

×

Bivision of Aadiological Health

Prescription USE (Per 21 CFR 801.109)

Office of In Vitro Diagnostics and Radiological Health

(Division Sign Off),

in

510(k) K123503

08-12

17

System
Model:6CV1
TransducerX
510(k) Number(s)
Clinical ApplicationBMPWDCWDColor DopplerAmplitude DopplerCombined (specify)Other (specify)
Ophthalmic
FetalNNNNNNNote 1,2, 4,6,7
Abdominal
Intraoperative (specify)*
Intraoperative (Neuro)
Laparoscopic
Pediatric
Small organ(specify)**
Neonatal Cephalic
Adult Cephalic
Trans-rectalNNNNNNNote1,2, 4,6,7
Trans-vaginalNNNNNNNote1,2, 4,6,7
Trans-urethral
Trans-esoph.(non-Card.)
Musculo-skeletal
Musculo-skeletal Superficial
Intravascular
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph.(Cardiac)
Intra-Cardiac
Peripheral Vascular
Other (specify)***NNNNNNNote1,2, 4,6,7

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

Additional comments: Combined modes: B+M, PW+B, Color + B, Power + B, PW +Color+ B, Power + PW +B.

*Intraoperative includes abdominal, thoracic, and vascular etc.

**Small organ-breast, thyroid, testes, etc.

***Other use includes Urology.

Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.

Note 2: Smart3D

Note 3:4D(Real-time 3D)

Note 4: iScape

Note5: TDI

Note6: Color M

Note7: Biopsy Guidance

(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 Health

1

  1. 1

Office of In Vitro Diagnostics and Radiological Health

510(k) K123503 08-13

Diagnostic Ultrasound Indications for Use Form