The Aspen Ultrasound System with the FreeStyle option provides B-mode images of anatomy in a field of view that extends well beyond a conventional B-mode region of interest. The FreeStyle option can also provide qualitative Color flow information in this extended field of view. The indications for use for each transducer operating with the FreeStyle feature are unchanged and include fetal, small organ, peripheral vessel, abdominal, gynecologic, transrectal, intraoperative, and musculoskeletal uses.

Device Description

The Aspen Ultrasound System with the FreeStyle feature is a modification of the Aspen Ultrasound System previously cleared as Model 2001, K934915/S1. The FreeStyle feature allows visualization of anatomy over a wider field of view that surrounds a particular region of interest. The feature operates in B-mode and Color Doppler modes for transducers that have been previously cleared by FDA for all indications for use except cardiac, opthalmic, and transcranial uses.

The FreeStyle feature operates by collecting a series of B-mode or Color Doppler image frames in real time, storing them, and then forming a larger composite image for display. The composite image can be displayed within seconds of the real time image frame captures or can be stored and displayed at a later time, perhaps at a Picture Archiving and Communications (PACS) review station. The frames can be captured over a 70cm linear distance or less.

The process is executed by a Pentium II or III based PC running Windows NT that is cabled to the ultrasound system and which resides on a shelf in the ultrasound system console. The hardware and software of the ultrasound system itself has not been modified except to add keyboard strokes the enables the Freestyle option and transfers control between the PC and ultrasound system. The PC has been programmed to store the B mode and Color Doppler image frames captured by the ultrasound system in DICOM format, to perform 2 dimensional motion analysis to determine frame to frame translation and rotation vectors, and to form the composite extended image using a graphics library function, and to transfer the extended image back to the ultrasound system for display or storage.

There is also a caliper measurement capability in the PC software that can be used on the B mode extended images to perform distance and length measurements. The Color Doppler extended images are used to detect the presence or absence of blood flow and are not for quantification.

AI/ML Overview

The provided text is a 510(k) summary for the Acuson Aspen™ Ultrasound System with FreeStyle™ Imaging Option. This document describes the device, its intended use, warnings, and precautions, but it does not contain explicit acceptance criteria or a detailed study section that directly proves the device meets specific performance criteria with reported metrics.

Instead, the document states, "Clinical data was obtained to show the efficacy of FreeStyle images. They are contained in the 510k and were reviewed by FDA." This suggests that a separate document within the 510(k) submission provided the detailed performance data, but this information is not included in the provided text.

Based on the available information, I can only provide general acceptance criteria inferred from the "Warnings and Precautions" and the fact that the device received 510(k) clearance, implying it met the FDA's requirements for substantial equivalence.

Here's an attempt to structure the information, with caveats due to the lack of explicit performance data:

Acceptance Criteria and Device Performance (Inferred)

Since specific numerical acceptance criteria and reported performance metrics are not provided in the summary, the table below is based on the implied performance expectations and warnings outlined in the document. The "Reported Device Performance" column reflects that the device was cleared by the FDA, suggesting these general criteria were met.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Acceptance Criteria (Inferred from Warnings/Precautions)	Reported Device Performance
Image Quality	Image quality should be sufficient for diagnostic purposes and free from significant artifacts.	The device provides "B-mode images of anatomy in a field of view that extends well beyond a conventional B-mode region of interest" and "qualitative Color flow information." The 510(k) clearance implies that the imaging performance for its indications of use was found acceptable by the FDA, under the condition that users are aware of potential artifacts and their impact on image quality as outlined in the warnings.
Artifact Management	User must be able to identify and determine if artifactual characteristics (obvious linear discontinuity, excess shadowing, ill-defined anatomy, jagged skin line) exist. If present, quality is suspect and reacquisition may be required.	The device's labeling includes warnings to guide users in identifying artifacts (e.g., obvious linear discontinuity, excess shadowing, ill-defined anatomy, jagged skin line) that could compromise image quality. The system is designed to allow clinical interpretation, and the responsibility for determining image quality and potential reacquisition rests with the trained sonographer or physician.
Measurement Accuracy	Caliper measurements on B-mode extended images should be reliable and accurate for diagnosis when the reconstructed image is free from acquisition-related artifacts.	The device offers caliper measurement capability on B-mode extended images for distance and length measurements. The labeling provides warnings about potential sources of error (e.g., wrong B-mode slice, non-planar acquisition) and emphasizes that measurements should only be made on well-reconstructed images. The FDA clearance suggests that, when used as instructed and with clinical judgment, the measurement capability is deemed acceptable for qualitative assessments (for Color Doppler) and quantitative (for B-mode) within its intended use. "When it is possible to make a measurement on a single acquired image frame, then that is preferable."
Safety	Minimization of misdiagnosis caused by inaccurate measurements and calculations on poorly reconstructed images.	The primary potential adverse effect is misdiagnosis due to poorly reconstructed images or inaccurate measurements. This risk is mitigated through comprehensive warnings in the labeling and implied requirement for adequate user training, as accepted by the FDA for market clearance.
Functionality	The FreeStyle option should provide extended field of view images in B-mode and Color Doppler modes as described.	The FreeStyle option collects and composites real-time B-mode or Color Doppler image frames to form a larger composite image for display, extending the field of view up to 70cm linear distance. This core functionality is central to the device's design and was cleared by the FDA for various transducers and clinical applications (fetal, small organ, peripheral vessel, abdominal, gynecologic, transrectal, intraoperative, musculoskeletal).

2. Sample Size Used for the Test Set and Data Provenance

The document states: "Clinical data was obtained to show the efficacy of FreeStyle images. They are contained in the 510k and were reviewed by FDA."

Sample Size: Not specified in the provided text.
Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This information is not provided in the summary. The "Warnings and Precautions" section heavily relies on the "trained sonographer or physician's judgment" for determining image quality and the presence of artifacts, suggesting that clinical expertise is paramount in the operational use of the device.

4. Adjudication Method for the Test Set

The adjudication method is not specified in the provided text.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

Not explicitly stated. The document focuses on demonstrating the efficacy of the FreeStyle images themselves rather than comparing performance with and without AI assistance (the FreeStyle option is described as a feature of the ultrasound system, not explicitly as an AI system in the modern sense, though it involves image processing). Therefore, no effect size of human readers improving with AI vs. without AI assistance is mentioned.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not explicitly stated, but given the nature of the device (an ultrasound system with an imaging option) and the emphasis on user judgment for image interpretation and measurements, it is highly probable that performance was evaluated in the context of human use. The "Warnings and Precautions" explicitly highlight the user's role in assessing image quality and measurement reliability.

7. The Type of Ground Truth Used

The type of ground truth used is not specified in the provided text beyond "Clinical data was obtained to show the efficacy of FreeStyle images." Given the context of a diagnostic ultrasound system, ground truth would typically be established through clinical findings, patient outcomes, or comparison with other established imaging modalities, interpreted by clinicians.

8. The Sample Size for the Training Set

The document does not describe the development or training of an algorithm in the contemporary sense of machine learning, so a "training set" is not applicable in this context. The FreeStyle feature is described as collecting, storing, processing frames "to perform 2 dimensional motion analysis to determine frame to frame translation and rotation vectors, to form the composite extended image," which implies a more classical image processing approach rather than machine learning requiring a training set.

9. How the Ground Truth for the Training Set was Established

As a training set is not applicable (see point 8), this question is not relevant to the provided text.

Summary

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SUMMARY OF SAFETY AND EFFECTIVENESS

I. GENERAL INFORMATION

Device Generic Name : Ultrasonic pulsed echo imaging system and ultrasonic transducers Ultrasonic pulsed Doppler imaging system

Device Trade Name : Aspen™ Ultrasound System with FreeStyle™ Imaging Option

510k No : Unknown at this time

Date of 510k Submission : May 24,1999

II. INDICATIONS FOR USE

III. DEVICE DESCRIPTION

The process is executed by a Pentium II or III based PC running Windows NT that is cabled to the ultrasound system and which resides on a shelf in the ultrasound system console. The hardware and software of the ultrasound system itself has not been modified except to add keyboard strokes the enables the Freestyle option and transfers control between the PC and ultrasound system. The PC has been programmed to store the B mode and Color Doppler image frames captured by the ultrasound system in DICOM format, to perform 2 dimensional motion analysis to determine frame to frame translation and rotation vectors, to form the composite extended image using a graphics library function, and to transfer the extended image back to the ultrasound system for display or storage.

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IV. WARNINGS AND PRECAUTIONS

The addition of the FreeStyle feature resulted in modifying our labeling to include the following warnings and cautions:

Caution: Your judgement as a trained sonographer or physician is required to determine if the following artifactual characteristics exist. The presence of these artifacts make the quality of an image suspect and may require reacquisition.

Obvious linear discontinuity is normally related to a jerky motion during acquisition or . moving out of plane. Discontinuity related lines are usually perpendicular to the transducer face.
Excess shadowing will make the motion estimation process unreliable. .
Ill defined anatomy or evidence of distorted anatomical representation. .
Jagged skin line. .

Warning: An unreliable caliper measurement can be caused by the following sources of error:

Wrong B-mode Slice When attempting to measure the maximum length within a 3D organ ● remember that you are only measuring from a 2D slice within that organ. Repeat the scan until you are certain that you have the slice most relevant to a possible diagnosis.
Non planar acquisition FreeStyle imaging ( like similar ultrasound image composition . products) assumes that the acquisition lies in a single flat plane. If acquisition follows a curve, then an unwrapped image is formed.

Warning: In the case of a poorly reconstructed FreeStyle image, as determined by the above criteria or by the user's clinical experience and training, dimensional measurements should not be made. If for any reason measurements are made using a poorly reconstructed image, these measurements should not be used for making diagnostic decisions.

The user must satisfy themselves of the accuracy of image representations and measurements. FreeStyle image scans should be repeated if there is the slightest doubt as to the accuracy of images and measurements.

Important: When it is possible to make a measurement on a single acquired image frame, then that is preferable. Only make measurements when you are satisfied that the reconstructed image is free from acquisition related artifacts.

V. POTENTIAL ADVERSE EFFECTS

Misdiagnosis caused by inaccurate measurements and calculations made on poorly reconstructed FreeStyle images is a potential adverse effect introduced by the FreeStyle feature.

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K991805 page 3 of 3

Since this a user dependent effect the risk of this adverse effect occurring can only be mitigated by warnings in the labeling and adequate training.

VI. BIOCOMPATIBILITY

No changes to materials that could possibly contact patients and users have been made. A matrix of biocompatibility data for existing patient contact materials is on file.

VII. IMAGING PERFORMANCE

Clinical data was obtained to show the efficacy of FreeStyle images. They are contained in the 510k and were reviewed by FDA.

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Image /page/3/Picture/2 description: The image is a black and white circular seal. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is an abstract image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 2 1999 AUG --------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Mr. William Welch Manager, Regulatory Affairs Acuson Corporation 1220 Charleston Road P.O. Box 17393 Mountain View, California 94043-7393

Re: K991805

Trade Name: Aspen™ Ultrasound System with FreeStyle™ Imaging Option Regulatory Class: II 21 CFR 892.1550/Procode: 90-IYN, Ultrasonic Pulsed Doppler Imaging System Product Code: 21 CFR 892.1560/Procode: 90-IYO, Ultrasonic Pulsed Echo Imaging System 21 CFR 892.1570/Procode: 90-ITX, Diagnostic Ultrasound

Dated: May 24, 1999 Received: May 26, 1999

Dear Mr. Welch:

We have reviewed your Section 510(k) 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 Aspen"14 Ultrasound System with FreeStyle"16 Imaging Option, as described in your premarket notification:

Transducer Model Number

4V2, C3, C7, EVC8, L582, V328, V4, V5, V7, 4V1, 5C2, L10, EC7, ER7B, EV7, L5, L7, L7L, L7T, S219R

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) 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. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice requirement, as set forth in the

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

Page 2 - Mr. William Welch

Quality System Regulation (OS) for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic QS inspections, the FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification does not affect any obligation you may have under sections 531 and 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

Please be advised that the determination above is based on the fact that no medical devices have been demonstrated to be safe and effective for in vitro fertilization or percutaneous umbilical blood sampling. nor have any devices been marketed for these uses in interstate commerce prior to May 28, 1976, or reclassified into class I (General Controls) or class II (Special Controls). FDA considers devices specifically intended for in vitro fertilization and percutaneous umbilical blood sampling to be investigational, and subject to the provision of the investigational device exemptions (IDE) regulations, 21 CFR, Part 812. Therefore, your product labeling must be consistent with FDA's position on this use.

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, and additionally 809.10 for in vitro diagnostic devices), 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807..97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 Paul M. Gammell, Ph. D. at (301) 594-1212.

Sincerely vours.

Jasint G. Ligman

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive. Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

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Aspen Ultrasound System

ClinicalApplications	A	B	M	PWD	ColorDoppler	Power(Ampl.)Doppler	Combined(Specify)
Ophthalmic							*
Fetal	P	P	P	P	P	P	*
Abdominal	P	P	P	P	P	P	*
Intra-operative(Specify)	P	P	P	P	P	P	*
Intra-operativeNeurological	P	P	P	P	P	P	*
Pediatric	P	P	P	P	P	P	*
Small Organ- Thyroid- Breast- Testicle	P	P	P	P	P	P	*
NeonatalCephalic	P	P	P	P	P	P	*
Adult Cephalic	P	P	P	P	P	P	*
Cardiac	P	P	P	P	P	P	*
Trans-esophageal	P	P	P	P	P	P	*
Trans-Rectal	P	P	P	P	P	P	*
Trans-Vaginal	P	P	P	P	P	P	*
Trans-Urethral
Intra-Luminal
PeripheralVascular	P	P	P	P	P	P	*
Laparoscopic	P	P	P	P	P	P	*
Musculo-SkeletalConventional	P	P	P	P	P	P	*
Musculo-SkeletalSuperficial	P	P	P	P	P	P	*
Other (Specify)

N = New Indication

P = Previously cleared by FDA

E = Added under Appendix E

Additional Comments:

Combinations: B+M, B+PWD, B+Color Doppler, B+PWD+Color Doppler, B+Power Doppler, B+PWD+Power Doppler

Concurrence of CDRH, Office of Device Evaluation (ODE)

Clifford A. Syver
Division Size Off.

Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number

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

העפופה א

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

Ultrasound System: Aspen

Transducer: 4V2

ClinicalApplications	B	M	PWD	ColorDoppler	Power(Ampl.)Doppler	Combined(Specify)
Ophthalmic
Fetal	E	E	E	E	E	*
Abdominal	E	E	E	E	E	*
Intra-operative(Specify)
Intra-operativeNeurological
Pediatric
Small Organ- Thyroid- Breast- Testicle
Neonatal
Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Trans-Rectal
Trans-Vaginal
Trans-Urethral
Intra-Luminal
PeripheralVascular	E	E	E	E	E	*
Laparoscopic
Musculo-SkeletalConventional
Musculo-SkeletalSuperficial
Other (Specify)

Additional Comments:

Combinations: B+M, B+PWD, B+Color Doppler, B+PWD+Color Doppler, B+Power Doppler, B+PWD+Power Doppler

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Deason

(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices ાવવાયું છે.
આ ગામના લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપા 510(k) Number

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991805

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

Ultrasound System: Aspen

Transducer: C3

ClinicalApplications	B	M	PWD	ColorDoppler	Power(Ampl.)Doppler	Combined(Specify)
Ophthalmic
Fetal	E	E	E	E	E	*
Abdominal	E	E	E	E	E	*
Intra-operative(Specify)
Intra-operativeNeurological
Pediatric
Small Organ- Thyroid- Breast- Testicle
Neonatal
Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Trans-Rectal
Trans-Vaginal
Trans-Urethral
Intra-Luminal
PeripheralVascular	E	E	E	E	E	*
Laparoscopic
Musculo-SkeletalConventional
Musculo-SkeletalSuperficial
Other (Specify)

N = New Indication

P = Previously cleared by FDA

E = Added under Appendix E

Additional Comments:

Combinations: 8+M, B+PWD, B+Color Doppler, B+PWD+Color Doppler, B+Power Doppler, B+PWD+Power Doppler

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Eygner

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

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

DIAGNOSTIC ULTRASOUND INDICATIONS FOR FORM

Ultrasound System: Aspen

Transducer: C7

ClinicalApplications	A	B	M	PWD	CWD	ColorDoppler	Power(Ampl.)Doppler	Combined(Specify)
Ophthalmic
Fetal	E	E	E	E		E	E	*
Abdominal	E	E	E		E	E	E	*
Intra-operative(Specify)
Intra-operativeNeurological
Pediatric	E	E	E		E	E	E	*
Small Organ- Thyroid- Breast- Testicle
Neonatal
Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Trans-Rectal
Trans-Vaginal
Trans-Urethral
Intra-Luminal
PeripheralVascular	E	E	E		E	E	E	*
Laparoscopic
Musculo-SkeletalConventional
Musculo-SkeletalSuperficial
Other (Specify)

N = New Indication

P = Previously cleared by FDA

E = Added under Appendix E

Additional Comments:

Combinations: B+M, B+PWD, B+Color Doppler, B+PWD+Color Doppler, B+Power Doppler, B+PWD+Power Doppler

Concurrence of CDRH, Office of Device Evaluation (ODE)

Chnist A. Stegmann
(Division Sign-Off)

( Division of Reproductive, Abdominal, ENT, and Radiological Devic 510(k) Number .

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

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

Ultrasound System: Aspen

Transducer: EVC8

ClinicalApplications	B	M	PWD	ColorDoppler	Power(Ampl.)Doppler	Combined(Specify)
Ophthalmic
Fetal	E	E	E	E	E	*
Abdominal
Intra-operative(Specify)
Intra-operativeNeurological
Pediatric
Small Organ- Thyroid- Breast- Testicle
Neonatal
Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Trans-Rectal
Trans-Vaginal	E	E	E	E	E	*
Trans-Urethral
Intra-Luminal
Peripheral
Vascular
Laparoscopic
Musculo-SkeletalConventional
Musculo-SkeletalSuperficial
Other (Specify)

Additional Comments:

Combinations: B+M, B+PWD, B+Color Doppler, B+PWD+Color Doppler, B+Power Doppler, B+PWD+Power Doppler

Concurrence of CDRH, Office of Device Evaluation (ODE)

Elvin A. Hegeman

(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Device

510(k) Number K991605

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

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

Ultrasound System: Aspen

Transducer: L582

ClinicalApplications	A	B	M	PWD	ColorDoppler	Power(Ampl.)Doppler	Combined(Specify)
Ophthalmic
Fetal	P	P	P	P	P	P	*
Abdominal	P	P	P	P	P	P	*
Intra-operative(Specify)
Intra-operativeNeurological
Pediatric
Small Organ- Thyroid- Breast- Testicle
Neonatal
Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Trans-Rectal
Trans-Vaginal
Trans-Urethral
Intra-Luminal
PeripheralVascular	P	P	P	P	P	P	*
Laparoscopic
Musculo-SkeletalConventional
Musculo-SkeletalSuperficial
Other (Specify)

N = New Indication

P = Previously cleared by FDA

E = Added under Appendix E

Additional Comments:

Combinations: B+M, B+PWD, B+Color Doppler, B+PWD+Color Doppler, B+Power Doppler, B+PWD+Power Doppler

Concurrence of CDRH, Office of Device Evaluation (ODE)

Thind h. beyson
(Division Sign-Off)

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

{11}------------------------------------------------

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

Ultrasound System: Aspen

Transducer: V328

ClinicalApplications	A	B	M	PWD	ColorDoppler	Power(Ampl.)Doppler	Combined(Specify)
Ophthalmic
Fetal	P	P	P	P	P	P	*
Abdominal	P	P	P	P	P	P	*
Intra-operative(Specify)
Intra-operativeNeurological
Pediatric
Small Organ- Thyroid- Breast- Testicle
Neonatal
Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Trans-Rectal
Trans-Vaginal
Trans-Urethral
Intra-Luminal
Peripheral
Vascular
Laparoscopic
Musculo-SkeletalConventional
Musculo-SkeletalSuperficial
Other (Specify)

N = New Indication

P = Previously cleared by FDA

E = Added under Appendix E

Additional Comments:

Combinations: B+M, B+PWD, B+Color Doppler, B+PWD+Color Doppler, B+Power Doppler, B+PWD+Power Doppler

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. bogen

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number _

{12}------------------------------------------------

14 991805

DIAGNOSTIC ULTRAS OUND INDICATIONS FOR USE FORM

Ultrasound System: Aspen

Transducer: V4

Clinical Applications	B	M	PWD	Color Doppler	Power (Ampl.) Doppler	Combined (Specify)
Ophthalmic
Fetal	E	E	E	E	E	*
Abdominal	E	E	E	E	E	*
Intra-operative (Specify)
Intra-operative Neurological
Pediatric
Small Organ - Thyroid - Breast - Testicle
Neonatal
Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Trans-Rectal
Trans-Vaginal
Trans-Urethral
Intra-Luminal
Peripheral Vascular
Laparoscopic
Musculo-Skeletal Conventional
Musculo-Skeletal Superficial
Other (Specify)N = New Indication

P = Previously cleared by FDA

E = Added under Appendix E

Additional Comments:

Combinations: B+M, B+PWD, B+Color Doppler, B+PWD+Color Doppler, B+Power Doppler, B+PWD+Power Doppler

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Hegemann

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number

{13}------------------------------------------------

14991805

Ultrasound System: Aspen

Transducer: V5

ClinicalApplications	A	B	M	CWD	ColorDoppler	ColorVelocityImaging
Ophthalmic
Fetal	E	E	E	E	E	*
Abdominal	E	E	E	E	E	*
Intra-operative(Specify)
Intra-operativeNeurological
Pediatric	E	E	E	E	E	*
Small Organ- Thyroid- Breast- Testicle
Neonatal
Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Trans-Rectal
Trans-Vaginal
Trans-Urethral
Intra-Luminal
PeripheralVascular
Laparoscopic
Musculo-Skeletal
Conventional
Musculo-SkeletalSuperficial
Other (Specify)

N = New Indication

P = Previously cleared by FDA

E = Added under Appendix E

Additional Comments:

Combinations: B+M, B+PWD, B+Color Doppler, B+PWD+Color Doppler, B+Power Doppler, B+PWD+Power Doppler

Concurrence of CDRH, Office of Device Evaluation (ODE)

David G. Syverson
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT and Radiological Device 510(k) Number .

{14}------------------------------------------------

DIAGNOSTTIC ULTRASOUND INDICATIONS FOR USE FORM

Ultrasound System: Aspen

Transducer: V7

ClinicalApplications	B	M	PWD	ColorDoppler	Power(Ampl.)Doppler	Combined(Specify)
Ophthalmic
Fetal
Abdominal	P	P	P	P	P	*
Intra-operative(Specify)
Intra-operativeNeurological
Pediatric	P	P	P	P	P	*
Small Organ- Thyroid- Breast- Testicle
Neonatal
Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Trans-Rectal
Trans-Vaginal
Trans-Urethral
Intra-Luminal
Peripheral
Vascular
Laparoscopic
Musculo-SkeletalConventional
Musculo-SkeletalSuperficial
Other (Specify)

N = New Indication
N = New Indication P = Previously cleared by FDA E = Added under Appendix E

Additional Comments:

Combinations: 8+M, B+PWD, B+Color Doppler, B+PWD+Color Doppler, B+Power Doppler, B+PWD+Power Doppler

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

( Division of Reproductive, Abdominal, ENT, and Radiological Device

510(k) Number K991805

{15}------------------------------------------------

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

Ultrasound System: Aspen

Transducer: 4V1

ClinicalApplications	A	B	M	PWD	ColorDoppler	Power(Ampl.)Doppler	Combined(Specify)
Ophthalmic
Fetal	E	E	E	E	E	E	*
Abdominal	E	E	E	E	E	E	*
Intra-operative(Specify)
Intra-operativeNeurological
Pediatric
Small Organ- Thyroid- Breast- Testicle
Neonatal
Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Trans-Rectal
Trans-Vaginal
Trans-Urethral
Intra-Luminal
PeripheralVascular
Laparoscopic
Musculo-SkeletalConventional
Musculo-SkeletalSuperficial
Other (Specify)

N = New Indication

P = Previously cleared by FDA

E = Added under Appendix E

Additional Comments:

Combinations: B+M, B+PWD, B+Color Doppler, B+PWD+Color Doppler, B+Power Doppler, B+PWD+Power Doppler

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Sigmon
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devi 510(k) Number

{16}------------------------------------------------

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

Ultrasound System: Aspen

Transducer: 5C2

Clinical Applications	A	B	M	CWD	Power (Ampl.) Doppler	Combined (Specify)
Ophthalmic
Fetal	E	E	E	E	E	*
Abdominal	E	E	E	E	E	*
Intra-operative (Specify)
Intra-operative Neurological
Pediatric
Small Organ
- Thyroid
- Breast
- Testicle
Neonatal
Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Trans-Rectal
Trans-Vaginal
Trans-Urethral
Intra-Luminal
Peripheral Vascular	E	E	E	E	E	*
Laparoscopic
Musculo-Skeletal Conventional
Musculo-Skeletal Superficial
Other (Specify)

Additional Comments:

Combinations: B+M, B+PWD, B+Color Doppler, B+PWD+Color Doppler, B+Power Doppler, B+PWD+Power Doppler

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ehrich A. Stegmann

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devic 510(k) Number _

{17}------------------------------------------------

ીર તેને છે તે જ દિવેલા તાલુકામાં આવેલું એક ગામનાં લોક

DIAGNOSTIC INDICATIONS FOR USE FORM

Ultrasound System: Aspen

Transducer: L10

ClinicalApplications	B	M	PWD	ColorDoppler	Power(Ampl.)Doppler	Combined(Specify)
Ophthalmic
Fetal
Abdominal
Intra-operative(Specify)
Intra-operativeNeurological
Pediatric
Small Organ- Thyroid- Breast- Testicle	E	E	E	E	E	*
Neonatal
Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Trans-Rectal
Trans-Vaginal
Trans-Urethral
Intra-Luminal
PeripheralVascular
Laparoscopic
Musculo-SkeletalConventional	E	E	E	E	E	*
Musculo-SkeletalSuperficial	E	E	E	E	E	*
Other (Specify)
N = New IndicationP = Previously cleared by FDAE = Added under Appendix E

Additional Comments:

*Combinations: B+M, B+PWD, B+Color Doppler, B+PWD+Color Doppler, B+Power Doppler, B+PWD+Power Doppler

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Steppan
Division Sign Off

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Device

510(k) Number _

{18}------------------------------------------------

DIAGNOSTIC ULTRASQUND INDICATIONS FOR USE FORM

Ultrasound System: Aspen

Transducer: EC7

ClinicalApplications	A	B	M	PWD	ColorDoppler	Power(Ampl.)Doppler	Combined(Specify)
Ophthalmic
Fetal	E	E	E	E	E	E	*
Abdominal
Intra-operative(Specify)
Intra-operativeNeurological
Pediatric
Small Organ- Thyroid- Breast- Testicle
Neonatal
Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Trans-Rectal	E	E	E	E	E	E	*
Trans-Vaginal	E	E	E	E	E	E	*
Trans-Urethral
Intra-Luminal
PeripheralVascular
Laparoscopic
Musculo-SkeletalConventional
Musculo-SkeletalSuperficial
Other (Specify)

N = New Indication

P = Previously cleared by FDA

E = Added under Appendix E

Additional Comments:

Combinations: B+M, B+PWD, B+Color Doppler, B+PWD+Color Doppler, B+Power Doppler, B+PWD+Power Doppler

Concurrence of CDRH, Office of Device Evaluation (ODE)

David La. Symons
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devic 510(k) Number .

{19}------------------------------------------------

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

Ultrasound System: Aspen

Transducer: ER7B

ClinicalApplications	B	M	PWD	ColorDoppler	Power(Ampl.)Doppler	Combined(Specify)
Ophthalmic
Fetal
Abdominal
Intra-operative(Specify)
Intra-operativeNeurological
Pediatric
Small Organ
- Thyroid
- Breast
- Testicle
Neonatal
Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Trans-Rectal	E	E	E	E	E	*
Trans-Vaginal
Trans-Urethral
Intra-Luminal
Peripheral
Vascular
Laparoscopic
Musculo-SkeletalConventional
Musculo-SkeletalSuperficial
Other (Specify)

N = New Indication

P = Previously cleared by FDA

E = Added under Appendix E

Additional Comments:

Combinations: B+M, B+PWD, B+Color Doppler, B+PWD+Color Doppler, B+Power Doppler, B+PWD+Power Doppler

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Siegmann
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Device 510(k) Number

{20}------------------------------------------------

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

Ultrasound System: Aspen

Transducer: EV7

ClinicalApplications	B	M	PWD	ColorDoppler	Power(Ampl.)Doppler	Combined(Specify)
Ophthalmic
Fetal	E	E	E	E	E	*
Abdominal
Intra-operative(Specify)
Intra-operativeNeurological
Pediatric
Small Organ- Thyroid- Breast
- Testicle
Neonatal
Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Trans-Rectal
Trans-Vaginal	E	E	E	E	E	*
Trans-Urethral
Intra-Luminal
Peripheral
Vascular
Laparoscopic
Musculo-SkeletalConventional
Musculo-SkeletalSuperficial
Other (Specify)

N = New Indication

P = Previously cleared by FDA

E = Added under Appendix E

Additional Comments:

Combinations: B+M, B+PWD, B+Color Doppler, B+PWD+Color Doppler, B+Power Doppler, B+PWD+Power Doppler

Concurrence of CDRH, Office of Device Evaluation (ODE)

David L. Wyman
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number .

{21}------------------------------------------------

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

Ultrasound System: Aspen

Transducer: L5

ClinicalApplications	A	B	M	PWD	ColorDoppler	Power(Ampl.)Doppler	Combined(Specify)
Ophthalmic							*
Fetal	P	P	P	P	P	P	*
Abdominal	P	P	P	P	P	P	*
Intra-operative(Specify)
Intra-operativeNeurological
Pediatric
Small Organ
- Thyroid
- Breast
- Testicle
Neonatal
Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Trans-Rectal
Trans-Vaginal
Trans-Urethral
Intra-Luminal
PeripheralVascular	P	P	P	P	P	P	*
Laparoscopic
Musculo-SkeletalConventional
Musculo-SkeletalSuperficial
Other (Specify)

N = New Indication

P = Previously cleared by FDA

E = Added under Appendix E

Additional Comments:

Combinations: B+M, B+PWD, B+Color Doppler, B+PWD+Color Doppler, B+Power Doppler, B+PWD+Power Doppler

Concurrence of CDRH, Office of Device Evaluation (ODE)

Thind le degrom
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number K991805

{22}------------------------------------------------

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

Ultrasound System: - Aspen

Transducer: L7

ClinicalApplications	A	B	M	PWD	CWD	Power(Ampl.)Doppler	Combined(Specify)
Ophthalmic
Fetal
Abdominal	P	P	P	P	P	P	*
Intra-operative- abdominal- cardiac	P	P	P		P	P	*
Intra-operativeNeurological
Pediatric
Small Organ- Thyroid- Breast- Testicle	P	P	P		P	P	*
NeonatalCephalic	P	P	P		P	P	*
Adult Cephalic
Cardiac	P	P	P		P	P	*
Trans-esophageal
Trans-Rectal
Trans-Vaginal
Trans-Urethral
Intra-Luminal
PeripheralVascular	P	P	P		P	P	*
Laparoscopic
Musculo-SkeletalConventional	P	P	P		P	P	*
Musculo-SkeletalSuperficial	P	P	P		P	P	*
Other (Specify)

N = New Indication

P = Previously cleared by FDA

E = Added under Appendix E

Additional Comments:

Combinations: B+M, B+PWD, B+Color Doppler, B+PWD+Color Doppler, B+Power Doppler, B+PWD+Power Doppler

Concurrence of CDRH, Office of Device Evaluation (ODE)

Emind G. Agnim
(Division Sign-Off)

( = Choir Gigil-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices and Radiological Device 510(k) Number -

{23}------------------------------------------------

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

Ultrasound System: Aspen

Transducer: L7L

ClinicalApplications	B	M	PWD	ColorDoppler	Power(Ampl.)Doppler	Combined(Specify)
Ophthalmic
Fetal
Abdominal
Intra-operative(Specify)
Intra-operativeNeurological
Pediatric
Small Organ
- Thyroid
- Breast
- Testicle
NeonatalCephalic
Adult Cephalic
Cardiac
Trans-esophageal
Trans-Rectal
Trans-Vaginal
Trans-Urethral
Intra-Luminal
PeripheralVascular
Laparoscopic	E	E	E	E	E	*
Musculo-SkeletalConventional
Musculo-SkeletalSuperficial
Other (Specify)

N = New Indication

P = Previously cleared by FDA

E = Added under Appendix E

Additional Comments:

Combinations: B+M, B+PWD, B+Color Doppler, B+PWD+Color Doppler, B+Power Doppler, B+PWD+Power Doppler

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Peterson

(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Device

Digital Devices,
510(k) Number K991805

{24}------------------------------------------------

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

Ultrasound System: Aspen

Transducer: L7T

ClinicalApplications	B	M	PWD	ColorDoppler	Power(Ampl.)Doppler	Combined(Specify)
Ophthalmic
Fetal
Abdominal
Intra-operative(Specify)	E	E	E	E	E	*
Intra-operativeNeurological
Pediatric
Small Organ- Thyroid- Breast- Testicle
Neonatal
Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Trans-Rectal
Trans-Vaginal
Trans-Urethral
Intra-Luminal
Peripheral
Vascular
Laparoscopic
Musculo-Skeletal
Conventional
Musculo-Skeletal ·
Superficial
Other (Specify)

N = New Indication

P = Previously cleared by FDA

E = Added under Appendix E

Additional Comments:

Combinations: B+M, B+PWD, B+Color Doppler, B+PWD+Color Doppler, B+Power Doppler, B+PWD+Power Doppler

Concurrence of CDRH, Office of Device Evaluation (ODE)

Gmilh. dyson
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number K991805

{25}------------------------------------------------

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

Ultrasound System: Aspen

Transducer: S219R

ClinicalApplications	B	M	PWD	ColorDoppler	Power(Ampl.)Doppler	Combined(Specify)
Ophthalmic
Fetal
Abdominal	E	E	E	E	E	*
Intra-operative(Specify)
Intra-operativeNeurological
Pediatric
Small Organ- Thyroid- Breast- Testicle
Neonatal
Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Trans-Rectal
Trans-Vaginal
Trans-Urethral
Intra-Luminal
PeripheralVascular
Laparoscopic
Musculo-SkeletalConventional
Musculo-SkeletalSuperficial
Other (Specify)

N = New Indication

P = Previously cleared by FDA

E = Added under Appendix E

Additional Comments:

Combinations: B+M, B+PWD, B+Color Doppler, B+PWD+Color Doppler, B+Power Doppler, B+PWD+Power Doppler

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Flynn
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K991805

Prescription Use
(Per 21 CFR 801.109)

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.