ASPEN ULTRASOUND WITH FREESTYLE IMAGING OPTION
Device Facts
| Record ID | K991805 |
|---|---|
| Device Name | ASPEN ULTRASOUND WITH FREESTYLE IMAGING OPTION |
| Applicant | Acuson Corp. |
| Product Code | IYN · Radiology |
| Decision Date | Aug 2, 1999 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
Intended Use
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 Story
The Aspen Ultrasound System with FreeStyle is a modification of the previously cleared Aspen Ultrasound System (K934915/S1). It adds a PC-based option for extended field-of-view imaging. The system collects real-time B-mode or Color Doppler image frames, which are stored and processed to form a larger composite image. The PC (Pentium II/III, Windows NT) performs 2D motion analysis to calculate frame-to-frame translation and rotation vectors, then uses graphics library functions to stitch frames into a composite image. The output is displayed on the ultrasound console or stored in DICOM format for PACS review. The system includes a caliper measurement tool for B-mode images; Color Doppler extended images are for qualitative flow detection only. Used in clinical settings by trained sonographers or physicians. The feature aids visualization of anatomy beyond standard field-of-view limits, potentially assisting in diagnostic assessment, provided the user verifies image quality and avoids measurements on poorly reconstructed images.
Clinical Evidence
Clinical data was obtained to demonstrate the efficacy of FreeStyle images. The data was included in the 510(k) submission and reviewed by the FDA. No specific performance metrics (e.g., sensitivity, specificity) are provided in the summary document.
Technological Characteristics
System consists of an ultrasound console modified with a Pentium II/III PC running Windows NT. Connectivity via DICOM. Software performs 2D motion analysis and image composition. Transducers are previously cleared models. No changes to patient-contact materials.
Indications for Use
Indicated for fetal, small organ (thyroid, breast, testicle), peripheral vessel, abdominal, gynecologic, transrectal, intraoperative, and musculoskeletal imaging. Contraindicated for cardiac, ophthalmic, and transcranial uses.
Regulatory Classification
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.
Predicate Devices
- Aspen Ultrasound System (Model 2001) (K934915/S1)
Related Devices
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- K023255 — TECHNOS MP, MODEL AU6 · Biosound Esaote, Inc. · Feb 11, 2003
- K121076 — ULTRAEXTEND FX, ULTRASOUND WORKSTATION PACKAGE · Toshiba America Medical Systems, In.C · Oct 9, 2012
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- K980308 — ECHOTECH 3D FREESCAN · Echotech 3D Imaging Systems GmbH · May 6, 1998
Submission Summary (Full Text)
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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
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.
#### III. 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, 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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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.
#### 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
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#### 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
.
| Clinical<br>Applications | A | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Ampl.)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
|----------------------------------------------------|---|---|---|-----|-----|------------------|-----------------------------|------------------------------|-----------------------|--------------------|
| Ophthalmic | | | | | | | | | * | |
| Fetal | P | P | P | P | | P | P | | * | |
| Abdominal | P | P | P | P | | P | P | | * | |
| Intra-operative<br>(Specify) | P | P | P | P | | P | P | | * | |
| Intra-operative<br>Neurological | P | P | P | P | | P | P | | * | |
| Pediatric | P | P | P | P | | P | P | | * | |
| Small Organ<br>- Thyroid<br>- Breast<br>- Testicle | P | P | P | P | | P | P | | * | |
| Neonatal<br>Cephalic | 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 | | | | | | | | | | |
| Peripheral<br>Vascular | P | P | P | P | | P | P | | * | |
| Laparoscopic | P | P | P | P | | P | P | | * | |
| Musculo-Skeletal<br>Conventional | P | P | P | P | | P | P | | * | |
| Musculo-Skeletal<br>Superficial | 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
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### העפופה א
### DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM
#### Ultrasound System: Aspen
Transducer: 4V2
| Clinical<br>Applications | A | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Ampl.)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
|----------------------------------------------------|---|---|---|-----|-----|------------------|-----------------------------|------------------------------|-----------------------|--------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | E | E | E | | E | E | | * | |
| Abdominal | | E | E | E | | E | E | | * | |
| Intra-operative<br>(Specify) | | | | | | | | | | |
| Intra-operative<br>Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ<br>- Thyroid<br>- Breast<br>- Testicle | | | | | | | | | | |
| Neonatal | | | | | | | | | | |
| Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Trans-Rectal | | | | | | | | | | |
| Trans-Vaginal | | | | | | | | | | |
| Trans-Urethral | | | | | | | | | | |
| Intra-Luminal | | | | | | | | | | |
| Peripheral<br>Vascular | | E | E | E | | E | E | | * | |
| Laparoscopic | | | | | | | | | | |
| Musculo-Skeletal<br>Conventional | | | | | | | | | | |
| Musculo-Skeletal<br>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)
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
{7}------------------------------------------------
## 991805
### DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM
#### Ultrasound System: Aspen
Transducer: C3
| Clinical<br>Applications | A | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Ampl.)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
|----------------------------------------------------|---|---|---|-----|-----|------------------|-----------------------------|------------------------------|-----------------------|--------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | E | E | E | | E | E | | * | |
| Abdominal | | E | E | E | | E | E | | * | |
| Intra-operative<br>(Specify) | | | | | | | | | | |
| Intra-operative<br>Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ<br>- Thyroid<br>- Breast<br>- Testicle | | | | | | | | | | |
| Neonatal | | | | | | | | | | |
| Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Trans-Rectal | | | | | | | | | | |
| Trans-Vaginal | | | | | | | | | | |
| Trans-Urethral | | | | | | | | | | |
| Intra-Luminal | | | | | | | | | | |
| Peripheral<br>Vascular | | E | E | E | | E | E | | * | |
| Laparoscopic | | | | | | | | | | |
| Musculo-Skeletal<br>Conventional | | | | | | | | | | |
| Musculo-Skeletal<br>Superficial | | | | | | | | | | |
| 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
| Clinical<br>Applications | A | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Ampl.)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
|----------------------------------------------------|---|---|---|-----|-----|------------------|-----------------------------|------------------------------|-----------------------|--------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | E | E | E | E | | E | E | | * | |
| Abdominal | E | E | E | | E | E | E | | * | |
| Intra-operative<br>(Specify) | | | | | | | | | | |
| Intra-operative<br>Neurological | | | | | | | | | | |
| Pediatric | E | E | E | | E | E | E | | * | |
| Small Organ<br>- Thyroid<br>- Breast<br>- Testicle | | | | | | | | | | |
| Neonatal | | | | | | | | | | |
| Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Trans-Rectal | | | | | | | | | | |
| Trans-Vaginal | | | | | | | | | | |
| Trans-Urethral | | | | | | | | | | |
| Intra-Luminal | | | | | | | | | | |
| Peripheral<br>Vascular | E | E | E | | E | E | E | | * | |
| Laparoscopic | | | | | | | | | | |
| Musculo-Skeletal<br>Conventional | | | | | | | | | | |
| Musculo-Skeletal<br>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)
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
| Clinical<br>Applications | A | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Ampl.)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
|----------------------------------------------------|---|---|---|-----|-----|------------------|-----------------------------|------------------------------|-----------------------|--------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | E | E | E | | E | E | | * | |
| Abdominal | | | | | | | | | | |
| Intra-operative<br>(Specify) | | | | | | | | | | |
| Intra-operative<br>Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ<br>- Thyroid<br>- Breast<br>- 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-Skeletal<br>Conventional | | | | | | | | | | |
| Musculo-Skeletal<br>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)
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
| Clinical<br>Applications | A | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Ampl.)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) | |
|----------------------------------------------------|---|---|---|-----|-----|------------------|-----------------------------|------------------------------|-----------------------|--------------------|--|
| Ophthalmic | | | | | | | | | | | |
| Fetal | P | P | P | P | | P | P | | * | | |
| Abdominal | P | P | P | P | | P | P | | * | | |
| Intra-operative<br>(Specify) | | | | | | | | | | | |
| Intra-operative<br>Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ<br>- Thyroid<br>- Breast<br>- Testicle | | | | | | | | | | | |
| Neonatal | | | | | | | | | | | |
| Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | | |
| Trans-Rectal | | | | | | | | | | | |
| Trans-Vaginal | | | | | | | | | | | |
| Trans-Urethral | | | | | | | | | | | |
| Intra-Luminal | | | | | | | | | | | |
| Peripheral<br>Vascular | P | P | P | P | | P | P | | * | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-Skeletal<br>Conventional | | | | | | | | | | | |
| Musculo-Skeletal<br>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)
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
| Clinical<br>Applications | A | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Ampl.)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
|----------------------------------------------------|---|---|---|-----|-----|------------------|-----------------------------|------------------------------|-----------------------|--------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | P | P | P | P | | P | P | | * | |
| Abdominal | P | P | P | P | | P | P | | * | |
| Intra-operative<br>(Specify) | | | | | | | | | | |
| Intra-operative<br>Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ<br>- Thyroid<br>- Breast<br>- Testicle | | | | | | | | | | |
| Neonatal | | | | | | | | | | |
| Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Trans-Rectal | | | | | | | | | | |
| Trans-Vaginal | | | | | | | | | | |
| Trans-Urethral | | | | | | | | | | |
| Intra-Luminal | | | | | | | | | | |
| Peripheral | | | | | | | | | | |
| Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-Skeletal<br>Conventional | | | | | | | | | | |
| Musculo-Skeletal<br>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. 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 | A | B | M | PWD | CWD | Color Doppler | Power (Ampl.) Doppler | Color Velocity Imaging | Combined (Specify) | Other (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)<br>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
| Clinical<br>Applications | A | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Ampl.)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
|----------------------------------------------------|---|---|---|-----|-----|------------------|-----------------------------|------------------------------|-----------------------|--------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | E | E | E | | E | E | | * | | |
| Abdominal | E | E | E | | E | E | | * | | |
| Intra-operative<br>(Specify) | | | | | | | | | | |
| Intra-operative<br>Neurological | | | | | | | | | | |
| Pediatric | E | E | E | | E | E | | * | | |
| Small Organ<br>- Thyroid<br>- Breast<br>- Testicle | | | | | | | | | | |
| Neonatal | | | | | | | | | | |
| Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Trans-Rectal | | | | | | | | | | |
| Trans-Vaginal | | | | | | | | | | |
| Trans-Urethral | | | | | | | | | | |
| Intra-Luminal | | | | | | | | | | |
| Peripheral<br>Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-Skeletal | | | | | | | | | | |
| Conventional | | | | | | | | | | |
| Musculo-Skeletal<br>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 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
| Clinical<br>Applications | A | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Ampl.)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) | |
|----------------------------------------------------|---|---|---|-----|-----|------------------|-----------------------------|------------------------------|-----------------------|--------------------|--|
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | P | P | P | | P | P | | * | | |
| Intra-operative<br>(Specify) | | | | | | | | | | | |
| Intra-operative<br>Neurological | | | | | | | | | | | |
| Pediatric | | P | P | P | | P | P | | * | | |
| Small Organ<br>- Thyroid<br>- Breast<br>- Testicle | | | | | | | | | | | |
| Neonatal | | | | | | | | | | | |
| Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | | |
| Trans-Rectal | | | | | | | | | | | |
| Trans-Vaginal | | | | | | | | | | | |
| Trans-Urethral | | | | | | | | | | | |
| Intra-Luminal | | | | | | | | | | | |
| Peripheral | | | | | | | | | | | |
| Vascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-Skeletal<br>Conventional | | | | | | | | | | | |
| Musculo-Skeletal<br>Superficial | | | | | | | | | | | |
| 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
| Clinical<br>Applications | A | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Ampl.)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
|----------------------------------------------------|---|---|---|-----|-----|------------------|-----------------------------|------------------------------|-----------------------|--------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | E | E | E | E | | E | E | | * | |
| Abdominal | E | E | E | E | | E | E | | * | |
| Intra-operative<br>(Specify) | | | | | | | | | | |
| Intra-operative<br>Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ<br>- Thyroid<br>- Breast<br>- Testicle | | | | | | | | | | |
| Neonatal | | | | | | | | | | |
| Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Trans-Rectal | | | | | | | | | | |
| Trans-Vaginal | | | | | | | | | | |
| Trans-Urethral | | | | | | | | | | |
| Intra-Luminal | | | | | | | | | | |
| Peripheral<br>Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-Skeletal<br>Conventional | | | | | | | | | | |
| Musculo-Skeletal<br>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. 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 | PWD | CWD | Color Doppler | Power (Ampl.) Doppler | Color Velocity Imaging | Combined (Specify) | Other (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
| Clinical<br>Applications | A | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Ampl.)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
|-----------------------------------------------------------------------------------|---|---|---|-----|-----|------------------|-----------------------------|------------------------------|-----------------------|--------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intra-operative<br>(Specify) | | | | | | | | | | |
| Intra-operative<br>Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ<br>- Thyroid<br>- Breast<br>- Testicle | | E | E | E | | E | E | | * | |
| Neonatal | | | | | | | | | | |
| Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Trans-Rectal | | | | | | | | | | |
| Trans-Vaginal…
