K Number

Device Name

SA8000 SE DIAGNOSTIC ULTRASOUND SYSTEM

Manufacturer

MEDISON CO., LTD.

Date Cleared

2004-12-21

(6 days)

Product Code

IYN ITX IYO

Regulation Number

892.1550

Intended Use

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: - Fetal (includes infertility monitoring of follicle development) - Abdominal - Pediatric - Small Organ - Neonatal Cephalic - Adult Cephalic - Cardiac (Adult, Pediatric) - Trans-Rectal - Trans-Vaginal - Peripheral-Vascular - Muscular-Skeletal (conventional, superficial) Typical examinations performed using the system are: - General abdominal and pelvic studies including organ surveys, assessment, and retroperitoneal cavity studies. - Study of small parts including breasts, shoulders, thyroid, and the abdominal wall. - Pediatric scans of organs and bony structures. - Peripheral vascular applications including carotid arteries, legs, arms, feet, and penile artery. - Monitoring procedures for infertility studies (other than in vitro fertilization). - First, second and third trimester pregnancy studies. - Prostate, prostate biopsy guidance, and rectal wall studies. - Neonatal head studies. - Trans-cranial studies of middle cerebral arteries, internal carotid artery, and vertebral arteries. - Cardiac studies in adults and children. - Biopsy guidance for tissue or fluid sampling. - Conventional podiatry scans.

Device Description

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K013627, K031552

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description focuses on standard ultrasound imaging modes, digital signal processing, and measurement tools. There is no mention of AI, ML, or any features that would typically be associated with these technologies for image analysis, interpretation, or workflow optimization.

Therapeutic

No
The device is described as a "diagnostic ultrasound system" used for "imaging or fluid flow analysis" and for "making a diagnosis," which indicates a diagnostic rather than a therapeutic purpose.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states "Diagnostic ultrasound imaging or fluid flow analysis of the human body". Furthermore, the "Device Description" section starts by identifying the device as "a general purpose, mobile, software controlled, diagnostic ultrasound system." The device is designed to provide information used by healthcare professionals to make a diagnosis.

SaMD (Software as a Medical Device)

The device description explicitly states it is a "software controlled, diagnostic ultrasound system" and mentions the availability of "Ten different models of transducers" and "Probes are supported in frequencies from 1.0 MHz to 20.0 MHz". This indicates the device includes hardware components (transducers/probes) essential for its function, making it a hardware and software system, not software-only.

IVD (In Vitro Diagnostic)

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

Here's why:

IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Device Function: The SA8000 SE system is a diagnostic ultrasound system. It uses sound waves to create images of internal body structures and analyze fluid flow. It does not analyze samples taken from the body.
Intended Use: The intended uses listed are all related to imaging and analysis within the human body.

Therefore, while it is a diagnostic device, it falls under the category of medical imaging devices, not In Vitro Diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

SA8000 SE intended uses as defined FDA guidance documents are:

Fetal (includes infertility monitoring of follicle development)
Abdominal
Pediatric
Small Organ
Neonatal Cephalic
Adult Cephalic
Cardiac (Adult, Pediatric)
Trans-Rectal
Trans-Vaginal
Peripheral-Vascular
Muscular-Skeletal (conventional, superficial)

Typical examinations performed using the system are:

General abdominal and pelvic studies including organ surveys, assessment, and retroperitoneal cavity studies.
Study of small parts including breasts, shoulders, thyroid, and the abdominal wall.
Pediatric scans of organs and bony structures.
Peripheral vascular applications including carotid arteries, legs, arms, feet, and penile artery.
Monitoring procedures for infertility studies (other than in vitro fertilization).
First, second and third trimester pregnancy studies.
Prostate, prostate biopsy guidance, and rectal wall studies.
Neonatal head studies.
Trans-cranial studies of middle cerebral arteries, internal carotid artery, and vertebral arteries.
Cardiac studies in adults and children.
Biopsy guidance for tissue or fluid sampling.
Conventional podiatry scans.
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Fetal (See Note 3)
Abdominal
Intra-operative (Abdominal, vascular)
Pediatric
Small Organ (See Note 5)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Musculo-skel. (Convent.)
Musculo-skel. (Superfic.)
Cardiac Adult
Cardiac Pediatric
Peripheral vessel
Note 1: B/M, B/PW Doppler, B/Color Doppler/PW Doppler/PW Doppler/PW Doppler/PW Doppler, B/Color Doppler/Color M
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging

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

90-IYC, 90-IYN, 90-ITX, IYO

Device Description

The SA8000 SE system is a general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as B-mode, M-mode, Color-Flow Doppler, Pulsed (PW) Doppler and Power Doppler, or as a combination of these modes. The SA8000 SE also gives the operator the ability to measure anatomical structures and offers analysis packages that provide information that is used to make a diagnosis by competent health care professionals. The SA8000 SE has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed. Ten different models of transducers are available and only one can be connected. In addition to the initial operational settings for each transducer preprogrammed in the system, user-customized parameter settings for each transducer may be inserted by the operator and stored for recall as needed via the system control panel. Customization includes transmit focusing, filtering, image enhancement processing, dynamic window curve selection. Controls are also provided to select display format (single and various combinations), to activate zoom features, and to utilize the cine loop function. More detailed explanations of these functions and controls are included in Chapter 2 of the Operator manual, and in the software/firmware documentation included in this 510(k) Notification. The SA8000 SE uses digital beamforming technology, and supports a variety of Linear, Convex, Phased Array and Static probes for a wide variety of applications. It is an ultrasound scanner, which provides high resolution, high penetration performance, and various measurement functions. Probes are supported in frequencies from 1.0 MHz to 20.0 MHz. These probes can be applied to a variety of clinical applications such as fetal, abdominal, pediatric, small organ, cardiac, trans-rectal, trans-vaginal, peripheral-vascular, and muscular-skeletal. The same clinical uses were cleared for the predicate devices, SA8000 (K013627) and mycolor202 (K031552). The system can be used to measure distances and calculate areas, circumferences and volumes, as well as calculate the expected date of delivery by using BPD (Biparietal Diameter), HC (Head Circumference), OFD (Occipital Frontal Diameter), FL (Femur Length), AC (Abdominal Circumference), FTA (Fetal Trunk Area), APTD (Anterior Posterior Thoracic Diameter), TTD (Transverse Thoracic Diameter), TAD (Transverse Abdominal Diameter), CRL (Crown Rump Length), GS (Gestational Sac), APD (Anterior-Posterior Abdominal Diameter), AFI (Amniotic Fluid Index), APD (Anterior-Posterior Abdominal Diameter), Cerebellum, CLAV(Clavicle), CM (Cisterna Magna), Ear, FIB (Fibular), Foot, HUM (Humerus), IOD (Inner Ocular Distance), LV (Lateral Ventricle), Mid Cerebral Artery, MP (Middle Phalanx), NF (Nuchal Fold), OOD (Outer Ocular Distance), RAD (Radius Length), TIB (Tibia), ULNA (Ulna Length), Umbilical Artery, YS- Yolk Sac, Cardiac Analysis (volume by area/length, Simpson biplane and single plane, M-mode analysis, Doppler: peak and mean gradients, pressure half time, E/A ratio and continuity equation) and Vascular Analysis (resistive index, pulsatility index, % stenosis, JCA/CCA ratio, Volume flow). Biopsy guidelines are provided on screen to assist in the collection of tissue samples, using biopsy guide adapters offered as an optional accessory. M-roode uses the scroll display method, which has its images flow from the right to the left on the monitor. The SA8000 SE supports the Cine function (capable of storing up to 256 sequential images) and real-time zoom function to the region-of-interest. The system provides the ability to perform remote viewing of images, without compression, via a DICOM 3.0 compatible output. Management of patient history is possible by image-filing function. High-resolution images are provided by utilizing a technology called digital dynamic receive focusing.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Fetal, Abdominal, Pediatric, Small Organ (e.g., breasts, shoulders, thyroid, abdominal wall, thyroid, parathyroid, breast, scrotum and penis), Neonatal Cephalic, Adult Cephalic, Cardiac (Adult, Pediatric), Trans-Rectal, Trans-Vaginal, Peripheral-Vascular (carotid arteries, legs, arms, feet, penile artery, peripheral vessel), Muscular-Skeletal (conventional, superficial), Prostate, Rectal wall, Trans-cranial (middle cerebral arteries, internal carotid artery, vertebral arteries).

Indicated Patient Age Range

Adult, Pediatric, Neonatal, Fetal.

Intended User / Care Setting

Competent health care professionals

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

Not Found

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

Not Found

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

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K013627, K031552

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

Not Found

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

Not Found

Regulation Number and Section

§ 892.1550 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.

Summary

Image /page/0/Picture/2 description: The image shows a handwritten string of characters that appear to be alphanumeric. The string reads 'K043455' and is written in a simple, slightly slanted style. The characters are bold and dark against a white background, making them easily readable.

DEC 2 1 2004

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

Prepared August 28, 2004

This summary of safety and effectiveness is provided as part of this Premarket Notification in compliance with 21 CFR, Part 807, Subpart E, Section 807.92.

Submitter's Information: 21 CFR 807.92(a)(1) 1)

Mr. Kyung-Am. Shim Regulatory Affairs Manager Medison Co. Ltd. Medison Venture Tower, 997-10 Daechi-dong, Kangnam-gu, Seoul 135-280, Korea 82.2.2194.1381 Telephone: Facsimile: 82.2.2194.1399 Email: kashim(amedison.com

2) Name of the device:

Common/Usual Name:

Diagnostic Ultrasound System and Accessories

Proprietary Name:

SA8000 SE Diagnostic Ultrasound System and Transducers

Classification Names:	FR Number	Product Code
Ultrasound Pulsed Echo Imaging System	892.1560	90-IYC
Ultrasonic Pulsed Doppler Imaging System	892.1550	90-IYN
Diagnostic Ultrasound Transducer	892.1570	90-ITX

3) Identification of the predicate or legally marketed device:

Medison Co., Ltd. believes that SA8000 SE ultrasound system is substantially equivalent to the currently marketed SA 8000 ultrasound system (K013627) and mycolor202 ultrasound system (K031552)

4) Device Description:

Ten different models of transducers are available and only one can be connected. In addition to the initial operational settings for each transducer preprogrammed in the system, user-customized parameter settings for each transducer may be inserted by the operator and stored for recall as needed via the system control panel. Customization includes transmit focusing, filtering, image enhancement processing, dynamic window curve selection. Controls are also provided to select display format (single and various combinations), to activate zoom features, and to utilize the cine loop function. More detailed explanations of these functions and controls are included in Chapter 2 of the Operator manual, and in the software/firmware documentation included in this 510(k) Notification.

The SA8000 SE uses digital beamforming technology, and supports a variety of Linear, Convex, Phased Array and Static probes for a wide variety of applications. It is an ultrasound scanner, which provides high resolution, high penetration performance, and various measurement functions. Probes are supported in frequencies from 1.0 MHz to 20.0 MHz. These probes can be applied to a variety of clinical applications such as fetal, abdominal, pediatric, small organ, cardiac, trans-rectal, trans-vaginal, peripheral-vascular, and muscular-skeletal. The same clinical uses were cleared for the predicate devices, SA8000 (K013627) and mycolor202 (K031552)

The system can be used to measure distances and calculate areas, circumferences and volumes, as well as calculate the expected date of delivery by using BPD (Biparietal Diameter), HC (Head Circumference), OFD (Occipital Frontal Diameter), FL (Femur Length), AC (Abdominal Circumference), FTA (Fetal Trunk Area), APTD (Anterior Posterior Thoracic Diameter), TTD (Transverse Thoracic Diameter), TAD (Transverse Abdominal Diameter), CRL (Crown Rump Length), GS (Gestational Sac), APD (Anterior-Posterior Abdominal Diameter), AFI (Amniotic Fluid Index), APD (Anterior-Posterior Abdominal Diameter), Cerebellum, CLAV(Clavicle), CM (Cisterna Magna), Ear, FIB (Fibular), Foot, HUM (Humerus), IOD (Inner Ocular Distance), LV (Lateral Ventricle), Mid Cerebral Artery, MP (Middle Phalanx), NF (Nuchal Fold), OOD (Outer Ocular Distance), RAD (Radius Length), TIB (Tibia), ULNA (Ulna Length), Umbilical Artery, YS- Yolk Sac, Cardiac Analysis (volume by area/length, Simpson biplane and single plane, M-mode analysis, Doppler: peak and mean gradients, pressure half time, E/A ratio and continuity equation) and Vascular Analysis (resistive index, pulsatility index, % stenosis, JCA/CCA ratio, Volume flow).

Biopsy guidelines are provided on screen to assist in the collection of tissue samples, using biopsy guide adapters offered as an optional accessory. M-roode uses the scroll display method, which has its images flow from the right to the left on the monitor. The SA8000 SE supports the Cine function (capable of storing up to 256 sequential images) and real-time zoom function to the

region-of-interest. The system provides the ability to perform remote viewing of images, without compression, via a DICOM 3.0 compatible output.

Management of patient history is possible by image-filing function. High-resolution images are provided by utilizing a technology called digital dynamic receive focusing.

The SA8000 SE has been designed to meet the following electromechanical safety standards:

( EN 60601-1 (IEC 601-1,) European Norm, Medical Electrical Equipment
( UL 2601-1, Underwriters Laboratories Standards, Medical Electrical Equipment
C22.2 No. 601.1, Canadian Standards Association, Medical Electrical ( Equipment
CEI/IEC 1157:1992, International Electrotechnical Commission, ( Requirements for the declaration of the acoustic output of medical diagnostic ultrasonic equipment
{ EN 60601-1-2 (IEC 60601-1-2.) European Norm, Collateral Standard: Electromagnetic Compatibility
EN 60601-2-37 (IEC 60601-2-37,) European Norm, Collateral Standard: ( Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment
Compliant with the European Medical Device Directive Certificate issued ( by TUV.

5) Intended Use:

SA8000 SE intended uses as defined FDA guidance documents are:

Fetal (includes infertility monitoring of follicle development) (
Abdominal
Pediatric (
Small Organ {
Neonatal Cephalic (
Adult Cephalic (
Cardiac (Adult, Pediatric) (
Trans-Rectal (
Trans-Vaginal
Peripheral-Vascular (
Muscular-Skeletal (conventional, superficial)

Typical examinations performed using the system are:

General abdominal and pelvic studies including organ surveys, assessment, { and retroperitoneal cavity studies.
Study of small parts including breasts, shoulders, thyroid, and the abdominal ( wall.
Pediatric scans of organs and bony structures. (

ﺴﻤ

( Peripheral vascular applications including carotid arteries, legs, arms, feet, and penile artery.
Monitoring procedures for infertility studies (other than in vitro fertilization). {
First, second and third trimester pregnancy studies. (
( Prostate, prostate biopsy guidance, and rectal wall studies.
( Neonatal head studies.
{ Trans-cranial studies of middle cerebral arteries, internal carotid artery, and vertebral arteries.
Cardiac studies in adults and children. (
Biopsy guidance for tissue or fluid sampling. (
Conventional podiatry scans.

6) Technological Characteristics:

This device operates identical to the predicate devices in that piezoelectric material in the transducer is used as an ultrasound source to transmit sound waves into the body. Sound waves are reflected back to the transducer and converted to electrical signals that are processed and displayed as 2D and M-mode, Spectral Doppler, Color Doppler, Power Doppler, or 3D images. Transducer patient contact materials are biocompatible.

The device's acoustic output limits are:

All Applications: (Maximum Range)

720 mW/cm2 ISPTA

MI 1.9

The limits are the same as predicate Track 3 devices.

7) Conclusion:

The SA8000 SE™ 510(k) Pre-Market Notification contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device.

SA8000 SE™ will be manufactured in accordance with the voluntary standards listed in the enclosed voluntary standard survey.

The submission contains the results of a hazard analysis and the "Level of Concern for potential hazards has been classified as "Moderate".

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized eagle with three stripes extending from its wing, representing health, services, and people.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 1 2004

Medison Co., Ltd. % Mr. N. E. Devine, Jr. Responsible Third Party Entela, Inc. 3033 Madison Ave. SE GRAND RAPIDS MI 49548

Re: K043455

Trade Name: SA8000 SE Diagnostic Ultrasound System 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 14, 2004 Received: December 15, 2004

Dear Mr. Devine:

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 SA8000 SE Diagnostic Ultrasound System, as described in your premarket notification:

Transducer Model Number

C2-5ET / 2-5MHz / 3.5 MHz / 40R Curved Linear Array C3-7ED / 3-7MHz / 5.0MHz / 50R Curved Linear Array

C3-7EP / 3-7MHz / 5.0MHz / 50R Curved Linear Array C4-9ED / 4-9MHz / 6.5MHz / 10R Curved Linear Array EC4-9/10ED / 4-9MHz / 6.5MHz / 10R Endocavity Curved Linear Array HL5-9ED / 5-9MHz / 7.5MHz / 40mm Linear Array L5-9EE / 5-9MHz / 7.5 MHz / 50 mm Linear Array P2-4AH / 2-4MHz / 3.0MHz 19.2mm Phased Array 2.0CW / 2MHz / Static CW 4.0CW / 4MHz / Static CW

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 (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Marc gacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

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

Sincerely yours,

Nancy C Brogdon

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

Enclosure(s)

4.3 INDICATIONS FOR USE

DIAGNOSTIC ULTRASOUND INDICATIONS STATEMENT

510(k) No.:

System: SA8000 SE Ultrasound System

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

	Clinical Application	Mode of Operation (*includes simultaneous B-mode)
General	Specific	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
(Track I only)	(Tracks I & III)
Ophthalmic	Ophthalmic
	Fetal (See Note 3)	N	N	N		N	Note 1	Note 2, 6, 7, 8
	Abdominal	N	N	N	N	N	Note 1	Note 2, 6, 7, 8
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging	Laparoscopic
& Other	Pediatric	N	N	N		N	Note 1	Note 2, 5,7, 8
	Small Organ (See Note 5)	N	N	N		N	Note 1	Note 2, 5, 8
	Neonatal Cephalic	N	N	N		N	Note 1	Note 2, 5, 8
	Adult Cephalic				N
	Trans-rectal	N	N	N		N	Note 1	Note 2, 8
	Trans-vaginal	N	N	N		N	Note 1	Note 2, 3, 8
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)	N	N	N		N	Note 1	Note 2, 5, 8
	Musculo-skel. (Superfic.)	N	N	N		N	Note 1	Note 2, 5, 8
	Intra-luminal
	Other (spec.)
	Cardiac Adult	N	N	N	N	N	Note 1	Note 4. 7
Cardiac	Cardiac Pediatric				N
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral	Peripheral vessel	N	N	N	N	N	Note 1	Note 2, 5, 8
Vessel	Other (spec.)				N

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

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B/M, B/PW Doppler, B/Color Doppler/PW Doppler/PW Doppler/PW Doppler/PW Doppler, B/Color Doppler/Color M

Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging

David A. hyrum

Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number KOH3455

510(k) No.:

SA8000 SE Ultrasound System System:

C2-5ET / 2-5MHz / 3.5 MHz / 40R Curved Linear Array Transducer:

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

Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
	Fetal (See Note 3)	N	N	N	N	N	Note 1	Note 2, 6, 7, 8
	Abdominal	N	N	N	N	N	Note 1	Note 2, 6, 7, 8
	Intra-operative (Abdominal,
vascular)
	Intra-operative (Neuro.)
Fetal Imaging
& Other	Laparoscopic
	Pediatric
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel
	Other (spec.)

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

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note I : B/M, B/PW Doppler, B/Color Doppler/PW Doppler/PW Doppler, B/Power Doppler/PW Doppler, B/Color Doppler/Color M

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Concurrence of CDRH, Office of Dev Prescription Use (Per 21 CFR 801.109)

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number
K043455

510(k) No .:

SA8000 SE Ultrasound System System : C3-7ED / 3-7MHz / 5.0 MHz / 50R Curved Linear Array

Transducer:

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Intended Use: Mode of Operation (includes simultaneous B-mode) Clinical Application Color Combined Other PWD CWD M B General Specific Doppler* (Spec.) (Spec.) (Tracks I & III) (Track I only) Ophthalmic Ophthalmic N N N Note 2, 6, 7, 8 N Note 1 Fetal (See Note 3) N Note 2, 6, 7, 8 N N N Note 1 Abdominal Intra-operative (Abdominal, vascular) Intra-operative (Neuro.) Laparoscopic Fetal Imaging N N N N Note 2, 6, 7, 8 Note l & Other Pediatric

& Other	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel
	Other (spec.)

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

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B/M, B/PW Doppler, B/Color Doppler, B/Color Doppler, B/Power Doppler/PW Doppler, B/Color Doppler/Color M
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode

Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging

Concurrence of CDRH, Office o Prescription Use (Per 21 CFR 801.109)

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number
K024/3455

510(k) No .:

SA8000 SE Ultrasound System System:

C3-7EP / 3-7MHz / 5.0 MHz / 50R Curved Linear Array Transducer:

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

Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
Fetal Imaging
& Other	Fetal (See Note 3)	N	N	N	N	N	Note 1	Note 2, 6, 7, 8
	Abdominal	N	N	N	N	N	Note 1	Note 2, 6, 7, 8
	Intra-operative (Abdominal, vascular)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric	N	N	N	N	N	Note 1	Note 2, 6, 7, 8
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel
	Other (spec.)

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

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B/M, B/PW Doppler, B/Color Doppler/PW Doppler/PW Doppler/PW Doppler/PW Doppler, B/Color Doppler/Color M

Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
David R. hegeman

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number
KD434/53

510(k) No .:

SA8000 SE Ultrasound System System:

C4-9ED / 4-9MHz / 6.5 MHz / 10R Curved Linear Array Transducer:

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

Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
	Fetal (See Note 3)	N	N	N	N	N	Note 1	Note 2, 6, 7, 8
	Abdominal
	Intra-operative
(Abdominal,
vascular)
	Intra-operative (Neuro.)
Fetal Imaging
& Other	Laparoscopic
	Pediatric
	Small Organ (See Note 5)	N	N	N	N	N	Note 1	Note 2, 5, 8
	Neonatal Cephalic	N	N	N	N	N	Note 1	Note 2, 5, 8
	Adult Cephalic
	Trans-rectal	N	N	N	N	N	Note 1	Note 2, 8
	Trans-vaginal	N	N	N	N	N	Note 1	Note 2, 3, 8
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel	N	N	N	N	N	Note 1	Note 2, 5, 8
	Other (spec.)

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

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B/M, B/PW Doppler, B/Color Doppler/PW Doppler/PW Doppler/PW Doppler/PW Doppler, B/Color Doppler/Color M

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging
Device Evaluation (ODE)

David A. Seymann

(Division Sign-Of Division of Reproductive, Abdo and Radiological Devices 510(k) Number

510(k) No .:

System:	SA8000 SE Ultrasound System
Transducer:	EC4-9/10ED / 4-9MHz / 6.5 MHz / 10R Endocavity Curved Linear Array
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General	Specific	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
(Track I only)	(Tracks I & III)
Ophthalmic	Ophthalmic
	Fetal (See Note 3)	N	N	N	N	N	Note 1	Note 2, 8
	Abdominal
	Intra-operative
(Abdominal,
vascular)
	Intra-operative (Neuro.)
Fetal Imaging
& Other	Laparoscopic
	Pediatric
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	N	N	N	N	N	Note 1	Note 2, 8
	Trans-vaginal	N	N	N	N	N	Note 1	Note 2, 3, 8
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel
	Other (spec.)

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

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B/M, B/PW Doppler, B/Color Doppler/PW Doppler/PW Doppler/PW Doppler/PW Doppler, B/Color Doppler/Color M

Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging
Concurrence of CDRH, Office of Device B Prescription Use (Per 21 CFR 801.109)

David A. Hagemann

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

510(k) No.:

SA8000 SE Ultrasound System System:

HL5-9ED / 5-9MHz / 7.5 MHz / 40mm Linear Array Transducer:

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

Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
	Fetal ( See Note 3 )
Abdominal
	Intra-operative (Abdominal, vascular)
	Intra-operative (Neuro.)
Fetal Imaging
& Other	Laparoscopic
	Pediatric	N	N	N	N	N	Note 1	Note 2, 5, 8
	Small Organ ( See Note 5 )	N	N	N	N	N	Note 1	Note 2, 5, 8
	Neonatal Cephalic	N	N	N	N	N	Note 1	Note 2, 5, 8
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)	N	N	N	N	N	Note 1	Note 2, 5, 8
	Musculo-skel. (Superfic.)	N	N	N	N	N	Note 1	Note 2, 5, 8
	Intra-luminal
	Other (spec.)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral	Peripheral vessel	N	N	N	N	N	Note 1	Note 2, 5, 8
Vessel	Other (spec.)

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

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B/M, B/PW Doppler, B/Color Doppler/PW Doppler/PW Doppler/PW Doppler/PW Doppler, B/Color Doppler/Color M

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, parathyroid, breast, scroturn and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
10(k) Number
073455

510(k) No.:

System:	SA8000 SE Ultrasound System
Transducer:	L5-9EE/ 5-9MHz/ 7.5 MHz/ 50mm Linear Array
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
	Fetal (See Note 3)
	Abdominal
	Intra-operative (Abdominal,
vascular)
	Intra-operative (Neuro.)
Fetal Imaging
& Other	Laparoscopic
	Pediatric	N	N	N	N	N	Note 1	Note 2, 5, 8
	Small Organ (See Note 5)	N	N	N	N	N	Note 1	Note 2, 5, 8
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)	N	N	N	N	N	Note 1	Note 2, 5, 8
	Musculo-skel. (Superfic.)	N	N	N	N	N	Note 1	Note 2, 5, 8
	Intra-luminal
	Other (spec.)
Cardiac	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel	N	N	N	N	N	Note 1	Note 2, 8
	Other (spec.)

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

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B/M, B/PW Doppler, B/Color Doppler/PW Doppler/PW Doppler, B/Power Doppler/PW Doppler, B/Color Doppler/Color M

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Daniel A. Lynn

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
155

510(k) No.:

SA8000 SE Ultrasound System System : P2-4AH / 2-4 MHz / 3.0 MHz / 19.2mm Phased Array Transducer:

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

Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
Fetal Imaging
& Other	Fetal (See Note 3)
	Abdominal	N	N	N	N	N	Note 1	Note 4, 7
	Intra-operative
(Abdominal,
vascular)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.)
Cardiac	Cardiac Adult	N	N	N	N	N	Note 1	Note 4, 7
	Cardiac Pediatric	N	N	N	N	N	Note 1	Note 4, 7
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel
	Other (spec.)

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

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B/M, B/PW Doppler, B/Color Doppler/PW Doppler/PW Doppler/PW Doppler/PW Doppler, B/Color Doppler/Color M
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode

Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging

David A. Lynn

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K043155

510(k) No .:

SA8000 SE Ultrasound System System:

2.0CW / 2MHz / Static CW Transducer:

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

Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
Fetal Imaging
& Other	Fetal (See Note 3)
	Abdominal
	Intra-operative (Abdominal,
vascular)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic				N
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel				N
	Other (spec.)				N

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

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B/M, B/PW Doppler, B/Color Doppler/PW Doppler/PW Doppler, B/Power Doppler/PW Doppler, B/Color Doppler/Color M

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging
David H. Hodgson

(Division Sign-Off)
Division of Reproductive, Abdominal/
and Radiological Devices
MOVEINumhor
KOHO
0

510(k) Premarket Notification

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No .:

SA8000 SE Ultrasound System System:

Transducer: 4.0CW / 4MHz / Static CW

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

Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
Fetal Imaging
& Other	Fetal (See Note 3)
	Abdominal
	Intra-operative (Abdominal,
vascular)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic				N
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.)
Cardiac	Cardiac Adult				N
	Cardiac Pediatric				N
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel				N
	Other (spec.)				N

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

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B/M, B/PW Doppler, B/Color Doppler, B/Color Doppler, B/Power Doppler/PW Doppler, B/Color Doppler/Color M

Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D Imaging
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)

Daniel A. Lippman

(Division Sign-Off) Division of Reproductive. A and Radiological Devices って(Wk) Number