K Number

Device Name

DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM, CONVEX ARRAY TRANSDUCER, LINEAR ARRAY

Manufacturer

SHANTOU I NSTITUTE OF ULTRASONIC INSTRUMENTS (SIUI

Date Cleared

2010-06-08

(57 days)

Product Code

ITX IYN IYO

Regulation Number

892.1570

Intended Use

Diagnostic ultrasonic imaging for abdominal, pediatric, small organ, musculo-skeletal, cardiac, peripheral vascular applications in B, M, PWD, Color Doppler and 3D imaging modes.

Device Description

Apogee 1100 Digital Color Doppler Ultrasound Imaging System with Convex Array Transducer C3L60C, Linear Array Transducer L8L38C, Convex Array Transducer C5L40C, Phased Array Transducer P3F14C

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

Not Found

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary does not mention AI, ML, or related concepts, nor does it describe training or test sets typically associated with AI/ML development.

Therapeutic

No
The device is described as a diagnostic ultrasonic imaging system, indicating its purpose is to image and detect conditions, not to treat them.

Diagnostic

Yes.
The "Intended Use / Indications for Use" section explicitly states "Diagnostic ultrasonic imaging".

SaMD (Software as a Medical Device)

The device description explicitly lists hardware components: "Apogee 1100 Digital Color Doppler Ultrasound Imaging System with Convex Array Transducer C3L60C, Linear Array Transducer L8L38C, Convex Array Transducer C5L40C, Phased Array Transducer P3F14C". This indicates it is a hardware-based ultrasound system, not a software-only device.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use clearly states "Diagnostic ultrasonic imaging". This describes a device that uses ultrasound waves to create images of internal body structures for diagnostic purposes.
Device Description: The description details an "Ultrasound Imaging System" with various transducers. This aligns with the technology used for medical imaging, not for testing samples outside the body.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or performing tests on these samples in vitro (outside the living organism). IVDs are designed to provide information about a patient's health status by examining these types of samples.

Therefore, the Apogee 1100 Digital Color Doppler Ultrasound Imaging System is a medical imaging device, not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Diagnostic ultrasonic imaging for abdominal, pediatric, small organ, musculo-skeletal, cardiac, peripheral vascular applications in B, M, PWD, Color Doppler and 3D imaging modes.

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

IYO, ITX, IYN

Device Description

Apogee 1100 Digital Color Doppler Ultrasound Imaging System with Convex Array Transducer C3L60C, Linear Array Transducer L8L38C, Convex Array Transducer C5L40C, Phased Array Transducer P3F14C

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasonic

Anatomical Site

Abdominal, pediatric, small organ (Thyroid, Testes, Breast), musculo-skeletal, cardiac, peripheral vascular, Fetal, Prostate, Kidney, Uterus, Ovary

Indicated Patient Age Range

Not Found

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.

Not Found

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

Regulation Number and Section

§ 892.1570 Diagnostic ultrasonic transducer.

(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.

Summary

Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird-like figure with three stylized wing segments.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Shantou Institute if Ultrasonic Instruments Co., Ltd. (SIUI) % Mr. Bob Leiker ORS Representative Quality and Regulatory Services, Inc. 7263 Cronin Circle DUBLIN CA 95648

JUN = 8 2010

Re: K101008

Trade/Device Name: Apogee 1100 Digital Color Doppler Ultrasound Imaging System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYO, ITX, and IYN Dated: April 6, 2010 Received: April 12, 2010

Dear Mr. Leiker:

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 Apogee 1100 Digital Color Doppler Ultrasound Imaging System, as described in your premarket notification:

Transducer Model Number

Convex Array C3L60C Linear Array L8L38C Convex Array C5L40C Phased Array P3F14C

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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

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

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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

If you have any questions regarding the content of this letter, please contact Paul Hardy at (301) 796-6542.

Sincerely yours,

Donald Sabi

Donald St. Pierre Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure(s)

Indications for Use Statement

510(k) Number (if known):

Device Name:

Apogee 1100 Digital Color Doppler Ultrasound Imaging System with

Convex Array Transducer C3L60C

Linear Array Transducer L8L38C

Convex Array Transducer C5L40C

Phased Array Transducer P3F14C

Indications for Use:

Diagnostic ultrasonic imaging for abdominal, pediatric, small organ, musculo-skeletal, cardiac, peripheral vascular applications in B, M, PWD, Color Doppler and 3D imaging modes.

Prescription Use (Part 21 CFR 801 Subpart D)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

(Division Sign-Off)

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

510K K161008

Indications for Use Statement

3.1 System Indications for Use Form

System: Apogce 1100

Clinical Application			Mode of Operation
General
(Track 1 Only)	Specific
(Tracks 1 & 3)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)	Other*
(Specify)
Ophthalmic	Ophthalmic
	Fetal	N	N				N
	Abdominal	N	N	N		N	N
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
Fetal
Imaging
& Other	Pediatric	N	N	N		N
	Small Organ (Specify)	N	N	N		N
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)	N	N	N		N
	Musculo-skeletal
(Superficial)	N	N	N		N
	Intravascular
	Other (Specify)	N	N	N		N	N
	Cardiac Adult	N	N	N		N
Cardiac	Cardiac Pediatric	N	N	N		N
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral
Vessel	Peripheral vessel	N	N	N		N
	Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix * Other modes of operation include: 3-D Imaging;

Additional Comments: Other uses include: Prostate, Kidney, Uterus, Ovary Small organs include: Thyroid, Testes, Breast

Prescription Use (Per 21 CFR 801.109)

(Division Sign-Off)

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

510K K101008

TAB 3

Indications For Use

... ...

3.2 Transducer Indications for Use Form Transducer: Convex Array C3L60C

Clinical Application		Mode of Operation
General
(Track 1 Only)	Specific
(Tracks 1 & 3)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)	Other*
(Specify)
	Ophthalmic
	Fetal	N	N
	Abdominal	N	N	N		N
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
Fetal
Imaging
& Other	Pediatric
	Small Organ (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Intravascular
	Other (Specify)	N	N	N		N
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral
Vessel	Peripheral vessel
	Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Additional Comments: Other uses include: Prostate, Kidney, Uterus, Ovary

Prescription Use (Per 21 CFR 801.109)

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

510K K101008

TAB 3

3:3 Transducer Indications for Use Form Transducer: Linear Array L8L38C

Clinical Application			Mode of Operation
General
(Track 1 Only)	Specific
(Tracks 1 & 3)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)	Other*
(Specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
Fetal
Imaging
& Other	Pediatric	N	N	N		N
	Small Organ (Specify)	N	N	N		N
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)	N	N	N		N
	Musculo-skeletal
(Superficial)	N	N	N		N
	Intravascular
	Other (Specify)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral
Vessel	Peripheral vessel	N	N	N		N
	Other (Specify)

N = new indication: P = previously cleared by FDA: E = added under this appendix Additional Comments: Small organs include: Thyroid, Testes, Breast

510

Prescription Use (Per 21 CFR 801.109)

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

Indications For Use

3.4 Transducer Indications for Use Form Transducer: Convex Array C5L40C

Clinical Application		Mode of Operation
General
(Track 1 Only)	Specific
(Tracks 1 & 3)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)	Other*
(Specify)
Ophthalmic	Ophthalmic
	Fetal		N			N
	Abdominal		N			N
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
Fetal
Imaging
& Other	Pediatric
	Small Organ (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Intravascular
	Other (Specify)		N			N
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral
Vessel	Peripheral vessel
	Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix * Other modes include: 3-D Imaging;

Additional Comments: Other uses include: Prostate, Kidney, Uterus, Ovary

Prescription Use (Per 21 CFR 801.109)

801.109)

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

510K K101008

Indications For Use

3.5 Transducer Indications for Use Form Transducer: Phased Array P3F14C

Clinical Application		Mode of Operation
General
(Track 1 Only)	Specific
(Tracks 1 & 3)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)	Other*
(Specify)
Ophthalmic	Ophthalmic
Fetal
Imaging
& Other	Fetal
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Intravascular
	Other (Specify)
Cardiac	Cardiac Adult	N	N	N		N
	Cardiac Pediatric	N	N	N		N
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral
Vessel	Peripheral vessel
	Other (Specify)

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

Prescription Use (Per 21 CFR 801.109)

(Division Sign-Off)

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

510K K101608

Indications For Use