Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Abdominal, Cardiac, Fetal Doppler, Intraoperative, Neurosurgery, Obstetrics, Pediatrics, Transrectal, Small Parts (organ s), Transvaginal, Peripheral vascular, Musculo-skeletal.

Device Description

2400 supports the following scanning modes and combinations thereof: B-mode, M-mode, PWD mode and CFM mode. An optional ECG signal can be superimposed the ultrasound information in all modes and mode combinations. The system can perform simple geometric measurements, and perform calculations in the areas of Vascular, Urology, Cardiology and OB/GYN applications. The system can guide biopsy- and puncture needles. Transducers are linear and convex arrays and mechanical sector. The patient contact materials comply with ISO10993-1 All transducers used together with 2400 are Track 3 transducers.

AI/ML Overview

The provided 510(k) summary for the B-K Medical A/S Ultrasound Scanner Type 2400 (K024236) does not contain a typical clinical study with acceptance criteria and a detailed report of device performance against those criteria in the way a new diagnostic algorithm or AI system would.

Instead, this submission is for a traditional ultrasound system, and its "acceptance criteria" are related to established safety standards and demonstrating substantial equivalence to a predicate device for its intended uses. The "study" proving it meets these "criteria" primarily involves:

Engineering and Safety Testing: Compliance with recognized international standards for medical electrical equipment and acoustic output.
Comparison to a Predicate Device: Demonstrating that the new device's technological characteristics and intended uses are substantially equivalent to a previously cleared device.

Therefore, the requested information elements related to AI/algorithm performance (such as sample sizes for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth types) are not applicable or extractable from this document.

Here's an attempt to structure the available information per your request, with significant caveats that much of it either doesn't apply or can't be found in this specific document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion (Category)	Description	Reported Device Performance/Evidence
Acoustic Output Safety	Acoustic output (Ispta, MI, TI values) must stay below pre-amendment upper limits. Standards: "Information for Manufacturers Seeking Clearance of Diagnostic Ultrasound Systems and Transducers, FDA, CDRH, September 30, 1997" and "Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment" (NEMA 1997).	* Ispta: ≤ 720 mW/cm² (Track 3, non ophthalmic). The system in 2400 is the same as in 2102 and assures output stays below this limit.
		* MI: ≤ 1.9 (Track 3, non ophthalmic). The system in 2400 is the same as in 2102 and assures output stays below this limit.
		* TI (Thermal Index): maximum 6.0. The system in 2400 is the same as in 2102 and assures output stays below this limit.
Electrical & Mechanical Safety	Compliance with IEC 60601-1.	The scanner 2400 "has been tested by a recognized, certified body according to IEC 60601-1."
Biocompatibility	Patient contact materials comply with ISO10993-1.	"All transducers used together with 2400 are Track 3 transducers. The patient contact materials comply with ISO10993-1".
Clinical Measurement Accuracy	Measurements and calculations meet described accuracies (as stated in User Guide).	"Clinical measurements and calculations are described and accuracies are provided in the User Guide." (Specific accuracy values are not provided in this 510(k) summary.)
Substantial Equivalence (Intended Use)	The intended uses of the 2400 device must be contained within, or equivalent to, those of the predicate device (B-K Medical A/S 2102 Ultrasound Scanner K000567, K003986, K011417).	The provided tables show that the intended uses (clinical applications and modes of operation) for the 2400 system and its various transducers (1850, 8661, 8662, 8803, 8811) are either previously cleared (P) by FDA for the predicate device, or are new but within the scope of similar predicate devices/technologies (E - added under Appendix E for specific transducers for intraoperative, pediatric, small organ, musculo-skeletal, and peripheral vessel applications; N - new for tissue harmonic imaging mode for some applications). The overall intended uses are deemed substantially equivalent by the FDA letter.
Substantial Equivalence (Technology)	The technological characteristics of the 2400 device must be substantially equivalent to the predicate device (B-K Medical A/S 2102).	"The predicate device has the same major technological characteristics as the subject device described above. Minor differences consist: Digital beamformer, modified data acquisition technique, modified user interface and mechanical outline." These minor differences were deemed not to raise new questions of safety or effectiveness.

Regarding items specific to AI/algorithmic performance (which are NOT in this submission):

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. This is not an AI/algorithm submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. Performance is inherent to the physical device and its integrated software, not a separate algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of an AI/algorithm. Ground truth for a diagnostic ultrasound system refers to its ability to produce diagnostically useful images and accurate measurements, usually validated through engineering measurements, phantom studies, and comparison to established clinical standards and the predicate device's performance.
The sample size for the training set: Not applicable. (There might be internal software development and testing data, but it's not described as a "training set" in the AI sense for regulatory submission.)
How the ground truth for the training set was established: Not applicable.

Summary of the "study" proving the device meets acceptance criteria:

The "study" in this context is a combination of engineering testing, adherence to recognized standards, and a direct comparison to a legally marketed predicate device.

Acoustic Output, Electrical, and Biocompatibility Safety: Compliance was demonstrated through testing by a recognized, certified body (IEC 60601-1) and adherence to specific FDA guidance and NEMA standards for acoustic output and ISO standards for biocompatibility. The system's acoustic output control mechanism is stated to be identical to the predicate device, which had already been cleared.
Clinical Measurement Accuracy: The document states that accuracies are provided in the User Guide, implying that these have been established through internal validation and characterization of the device's measurement capabilities.
Substantial Equivalence: The core of the regulatory submission is demonstrating that the new Type 2400 Ultrasound Scanner is substantially equivalent to the predicate device (Type 2102). This involves showing that the intended uses and technological characteristics are either identical or that any differences do not raise new questions of safety or effectiveness. The detailed tables listing modes of operation and clinical applications for the system and its various transducers, marked as "previously cleared (P)" or "added under Appendix E (E)" or "new (N)", serve as the evidence for this comparison. The FDA's clearance letter confirms their agreement that the device is substantially equivalent for the stated indications for use. This means its performance is considered comparable to the predicate device, which is already accepted as safe and effective.

Summary

{0}------------------------------------------------

K.024236

510(k) Summary:

This summary is provided as part of this Premarket Notification in compliance with 21CRF, Section 807.92.

JAN 1 7 2003

Submitters name: B-K Medical A/S Address: Mileparken 34, DK2730 Gentofte, Denmark Phone: +45 44528100 Fax: +45 44528199 Contact person: Villy Braender, Quality Assurance Mnager Date prepared: 12 October, 2002

Trade name: Ultrasound Scanner Type 2400 Common name: Diagnostic Ultrasound System Classification names: Ultrasonic Pulsed Echo Imaging System (90 IYO, CFR 892.1560) Ultrasonic Pulsed Doppler Imaging System (90 IYN, CFR 892.1560) Diagnostic Ultrasonic Transducer (90 ITX, CFR 892.1570)

Identification of predicate, legally marketed device: B-K Medical A/S 2102 Ultrasound Scanner K000567(MAR9 2000), K003986 (AUG21 2001), K011417 (JUN8 2001)

Device description:

2400 supports the following scanning modes and combinations thereof:

B-mode M-mode PWD mode and CFM mode.

An optional ECG signal can be superimposed the ultrasound information in all modes and mode combinations.

The system can perform simple geometric measurements, and perform calculations in the areas of Vascular, Urology, Cardiology and OB/GYN applications.

The system can guide biopsy- and puncture needles.

Transducers

Transducers are linear and convex arrays and mechanical sector. The patient contact materials comply with ISO10993-1 All transducers used together with 2400 are Track 3 transducers.

Acoustic output

The system controlling the Acoustic Output in 2400 is the same as the system in 2102. The system will assure that the acoustic output always will stay below the pre-amendments upper limits i.e. Ispta ≤ 720 mW/cm² and MI ≤ 1.9 (Track 3, non ophthalmic). The Thermal Index values are maximum 6.0, i.e. TI ≤ 6.0

Clinical measurement accuracy.

Clinical measurements and calculations are described and accuracies are provided in the User Guide.

Thermal, mechanical and electrical safety.

The scanner 2400 has been tested by a recognized, certified body according to IEC 60601-1 .

{1}------------------------------------------------

The Acoustic Output Reporting is made according to the standards required by "Information for Manufacturers Seeking Clearance of Diagnostic Ultrasound Systems and Transducers, FDA, CDRH, September 30, 1997"

The acoustic output is measured and calculated according to: "Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment" (NEMA 1997).

Intended use.

2400 intended uses are contained within 2102-intended uses:

	Predicate device:	Submitted device:
	Ultrasound scanner Type 2102	Ultrasound scanner Type
	K000567(MAR9 2000), K003986 (AUG21	2400
	2001), K011417 (JUN8 2001)
Modes of operation	B, M, PWD, CFM 1) and combinations.Tissue harmonic imaging	B, M, PWD,CFM 1) andcombinations. Tissueharmonic imaging
Intended use(clinicalapplication)	AbdominalCardiacFetal DopplerIntraoperativeNeurosurgeryObstetricsPediatricsTransrectalSmall Parts (organs)TransvaginalPeripheral vascularMusculo-skeletal	AbdominalCardiacFetal DopplerIntraoperativeNeurosurgeryObstetricsPediatricsTransrectalSmall Parts (organs)TransvaginalPeripheral vascularMusculo-skeletal
Features	ECG (not monitoring)	ECG (not monitoring)

CFM= Color Flow Mapping=Color Doppler and Amplitude Doppler.

Technological characteristics compared to the predicate device.

The predicate device has the same major technological characteristics as the subject device described above.

Minor differences consist: Digital beamformer, modified data acquisition technique, modified user interface and mechanical outline.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem that resembles a stylized eagle or bird in flight, composed of three curved lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 7 2003

Mr. Villy Brænder Official Correspondent B-K Medical A/S Mileparken 34 DK-2730 Herlev DENMARK

Re: K024236

Trade Name: Ultrasound Scanner Type 2400 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: 90 IYN, IYO, and ITX Dated: December 19, 2002 Received: December 23, 2002

Dear Mr. Brænder:

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 Ultrasound Scanner Type 2400, as described in your premarket notification:

Transducer Model Number

1850
8661
ANALA ------------------------------------------------------------------------------------------------------------------------------------------------------------------------8662

{3}------------------------------------------------

8803 8811

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 (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 determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.

The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:

Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850

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 (301) 594-4591. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639.

{4}------------------------------------------------

Page 3 - Mr. Brænder

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at (301) 594-1212.

Sincerely yours,

Qurid d. Eignon

Nancy C. Brogdor Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

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K0242367p1

Diagnostic Ultrasound Indications for Use Form

System: 2400

Fill out one form for each ultrasound system and each transducer.

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

	Mode of Operation
Clinical Application	A	B	M	PWD	Tissueharmonicimaging	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify 1)	Other(specify)
Ophthalmic
Fetal		×	×	×	×	×	×		×
Abdominal		×	×	×	×	×	×		×
Intraoperative (specify)		×	×	×	×	×	×		×
Intraoperative Neurological		×	×	×	×	×	×		×
Pediatric		×	×	×	×	×	×		×
Small Organ (specify)		×	×	×	×	×	×		×
Neonatal Cephalic
Adult Cephalic
Cardiac		×	×	×	×	×	×		×
Transesophageal
Transrectal		×	×	×	×	×	×		×
Transvaginal		×	×	×	×	×	×		×
Transurethral		×	×	×	×	×	×		×
Intravascular
Peripheral Vascular		×	×	×	×	×	×		×
Laparoscopic
Musculo-skeletalConventional		×	×	×	×	×	×		×
Musculo-skeletal Superficial		×	×	×	×	×	×		×
Other (specify)

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

B+M, B+D, B+C, B+D+C. B mode includes Tissue Harmonic Imaging. Additional Comments:_ D is PWD, C is Color Doppler.

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

David A. Ingram
Division Sign Off

510(k)

{6}------------------------------------------------

K024i236

7 p.2

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

System: 2400 Transducer: 1850 (with interchangeable probes 8539,6004,6005)

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

Clinical Application		Mode of Operation
General(Track 1 Only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other*(Specify)
Ophthalmic	Ophthalmic
Fetal Imaging& Other	Fetal
	Abdominal
	Intra-operative (Specify)	P
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	P
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Conventional)
	Musculo-skel. (Superficial)
	Intra-luminal
	Other (Specify)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esoph. (Cardiac)
	Other (Specify)
PeripheralVessel	Peripheral vessel
	Other (Specify)

N= new indication; P= previously cleared by FDA(K002085); E= added under Appendix E *Examples may include: A-mode, Amplitude Doppler, 3-D Imaging, Harmonic Imaging, Tissue Motion Doppler, Color Velocity Imaging

Additional Comments: Intraoperative: Rectum, Urethra, Urinary bladder,

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

Concurrence of Center for Devices and Radiological Health, Office of Device Evaluation

David H. Stamm

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Device 510(k) Number .

{7}------------------------------------------------

K024236

System:	2400
Transducer:	8661

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(Tracks I & III)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Amplitudee Doppler
Ophthalmic	Ophthalmic
	Fetal	P		P		P	P 1)	P
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
Fetal Imaging& Other	Pediatric
	Small Organ (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	P		P		P	P 1)	P
	Trans-vaginal	P		P		P	P 1)	P
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Conventional)
	Musculo-skel. (Superficial)
	Intra-luminal
	Other (Specify)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esoph. (Cardiac)
	Other (Specify)
PeripheralVessel	Peripheral vessel
	Other (Specify)

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

Examples may include: A-mode, Amplitude Doppler, 3-D Imaging, Harmonic Imaging, Tissue Motion Doppler, Color Velocity Imaging

Additional Comments: l)}Mode combinations: B+M, B+D, B+C, B+D+C. (D is PWD, C is Color Flow mapping Doppler including Amplitude(power)Doppler) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of Center for Devices and Radiological Health, Office of Device Evaluation

David A. Bergman

(Division Sign-Division of Reproductive and Radiologica 510(k) Numbe

{8}------------------------------------------------

KO2H236

System:	2400
Transducer:	8662

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

Clinical Application		Mode of Operation
General(Track 1 Only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler	Combined(Specify 1)	Amplitudee Doppler
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative (Specify 2)	E	E	E		E	E	E
	Intra-operative (Neuro)	E	E	E		E	E	E
	Laparoscopic
Fetal Imaging& Other	Pediatric	E	E	E		E	E	E
	Small Organ (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Conventional)
	Musculo-skel. (Superficial)
	Intra-luminal
	Other (Specify)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esoph. (Cardiac)
	Other (Specify)
PeripheralVessel	Peripheral vessel	E	E	E		E	E	E
	Other (Specify)

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

Examples may include: A-mode, Amplitude Doppler, 3-D Imaging, Tissue Motion Doppler, Color Velocity Imaging

Mode combinations: B+M, B+D, B+C, B+D+C. (D is PWD, C is Color Flow Additional Comments: mapping Doppler including Amplitude(power)Doppler) 2)Intraoperative: Gall bladder

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

Concurrence of Center for Devices and Radiological Health, Office of Device Evaluation

David the hyrum
(Division Sign-Off)

Division of Reproductive, Al and Radiological Devic 510(k) Number

{9}------------------------------------------------

K024236

System:	2400
Transducer:	8803

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(Tracks I & III)	B	M	PWD	Tissueharmonicimaging	ColorDoppler	Combined(Specify)	AmplitudeDoppler
Ophthalmic	Ophthalmic
	Fetal	E		E	N	E	E 1)	E
	Abdominal	E		E	N	E	E 1)	E
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
Fetal Imaging& Other	Pediatric	E		E	N	E	E 1)	E
	Small Organ (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Conventional)
	Musculo-skel. (Superficial)
	Intra-luminal
	Other (Specify)
	Cardiac Adult	E		E	N	E	E 1)	E
Cardiac	Cardiac Pediatric	E		E	N	E	E 1)	E
	Trans-esoph. (Cardiac)
	Other (Specify)
PeripheralVessel	Peripheral vessel
	Other (Specify)

N= new indication; P= previously cleared by FDA; E= added under Appendix E * Examples may include: A-mode, Amplitude Doppler, 3-D Imaging, Harmonic Imaging, Tissue Motion Doppler, Color Velocity Imaging

Additional Comments: 1) ) Mode combinations: B+M, B+D, B+C, B+D+C. (D is PWD, C is Color Flow mapping Doppler including Amplitude(power)Doppler) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of Center for Devices and Radiological Health, Office of Device Evaluation

David A. Ingram

(Division Sign-Off) Division of Reproductive, Abdo and Radiological Devic 510(k) Number

{10}------------------------------------------------

K024236 "1

System:	2400
Transducer:	8811

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(Tracks I & III)	B	M	PWD	Tissueharmonicimaging	ColorDoppler	Combined(Specify 1)	AmplitudeDoppler
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative (Specify 2)	E	E	E	E	E	E	E
	Intra-operative (Neuro)
	Laparoscopic
Fetal Imaging& Other	Pediatric	E	E	E	E	E	E	E
	Small Organ (Specify 3)	E	E	E	E	E	E	E
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Conventional)	E	E	E	E	E	E	E
	Musculo-skel. (Superficial)	E	E	E	E	E	E	E
	Intra-luminal
	Other (Specify)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esoph. (Cardiac)
	Other (Specify)
PeripheralVessel	Peripheral vessel	E	E	E	E	E	E	E
	Other (Specify)

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

*Examples may include: A-mode, Amplitude Doppler, 3-D Imaging, Harmonic Imaging, Tissue Motion Doppler, Color Velocity Imaging

Additional Comments: 2)Intraoperative: Breast, liver, pancreas, biliary system

3)Small Organ: Breast, testis, penis, thyroid, parathyroid, salivary glands, lymph nodes 1 ) mode combinations: B, B+M, B+C, B+D+C. (D is PWD, C is Color Flow mapping Doppler including Amplitude(power)Doppler)

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

Concurrence of Center for Devices and Radiological Health, Office of Device Evaluation

David A. Bergman

Division of Renroductive. Abde and Radiological Device 510(k) Number

Regulation Number and Section

§ 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.