(28 days)
No
The document describes standard ultrasound imaging modes, measurement tools, and image processing techniques common in diagnostic ultrasound systems. There is no mention of AI, ML, or any features that suggest the use of such technologies for image analysis, interpretation, or workflow optimization beyond conventional methods.
No
The device is described as a "diagnostic ultrasound imaging or fluid flow analysis" system, and its function is to acquire and display "diagnostic ultrasound" data, leading to a "diagnosis" by health care professionals. It measures anatomical structures and provides analysis packages, but does not claim to treat any conditions.
Yes
The "Intended Use / Indications for Use" states "Diagnostic ultrasound imaging or fluid flow analysis of the human body," and the "Device Description" explicitly calls the UM 400C/SA 6000C system a "general purpose, mobile, software controlled, diagnostic ultrasound system."
No
The device description explicitly states it is a "diagnostic ultrasound system" and mentions hardware components like transducers, probes, and a control panel, indicating it is not software-only.
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. They are used to examine these samples outside of the body.
- Device Function: The description clearly states that this device is a "diagnostic ultrasound system." Ultrasound imaging works by sending sound waves into the body and interpreting the echoes to create images of internal structures. This is an in vivo (within the living body) diagnostic method, not an in vitro method.
- Intended Use: The intended use describes imaging and fluid flow analysis of the human body. This further confirms its in vivo nature.
- Device Description: The description details the use of transducers, beamforming technology, and the display of images and measurements derived from the ultrasound signals within the body.
Therefore, while this is a diagnostic device, it falls under the category of medical imaging equipment used in vivo, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
Ultramark® 400C/ SonoAce 6000C intended uses as defined FDA guidance documents are:
- Fetal (includes infertility monitoring of follicle development)
- Abdominal
- Intra-operative (abdominal organs and peripheral vessel, neurological)
- Pediatric
- Small Organ
- Neonatal Cephalic
- Adult Cephalic
- Cardiac
- 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 retro-peritoneal 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.
- Transcranial 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.
- Intraoperative application including soft tissue structures.
Product codes (comma separated list FDA assigned to the subject device)
90-IYO, 90-IYN, 90-ITX
Device Description
The UM 400C/SA 6000C 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, Power Doppler, 3D, Tissue Harmonic Imaging or in a combination of these modes. M-mode uses the sweep display method which has its images flow from the left to the right on the monitor The UM 400C/SA 6000C 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 system has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.
Nine different models of transducers are available and any two may be connected at the same time. 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.
The UM 400C/SA 6000C system uses digital beamforming technology, and supports a variety of Linear and Convex probes for a wide variety of applications. It is a diagnostic ultrasound scanner, which provides high resolution, high penetration performance, and various measurement functions. Probes are supported in frequencies from 2.0 MHz to 9.0 MHz.
The system can be used to measure distances and calculate areas, circumferences and volumes, as well as calculate the date of delivery by using BPD (biparietal diameter), OFD (occipitofrontal diameter), HC (head circumference), AC (abdominal circumference), AD (abdominal diameter), FL (femur length), CRL (crown rump length), APTD (anteroposterior trunk diameter), TTD (transverse trunk diameter), GS (gestational sac), LMP (last menstural period.), Cardiac Analysis and Vascular Analysis.
Biopsy guidelines are provided on screen to assist in the collection of tissue samples, using biopsy guide adapters offered as an optional accessory. The UM 400C/SA 6000C supports the Cine function (capable of storing up to 64 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, Abdomen, Intra-operative (abdominal organs and peripheral vessel, neurological), Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Cardiac, Trans-Rectal, Trans-Vaginal, Peripheral-Vascular, Muscular-Skeletal (conventional, superficial)
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.
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.
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
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
UM 400C/ SA 6000C Ultrasound System
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
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 name, address, telephone number, contact person: Advanced Technology Laboratories, Inc. P.O. Box 3003 Bothell, WA 98031-3003 Vice President, Worldwide Quality & Regulatory Affairs Telephone: (425) 487-7602
Prepared: August 23, 1999
Name of the device, including the trade or proprietary name if applicable, the common or 2) usual name, and the classification name, if known:
Common/Usual Name: Diagnostic Ultrasound System and Accessories
Proprietary Name:
Ultramark® 400C Diagnostic Ultrasound System and Transducers.
Also called: SonoAce 6000C Diagnostic Ultrasound System and Transducers.
| Classification Names: | FR Number | Product Code |
|---|---|---|
| Ultrasound Pulsed Echo Imaging System | 892.1560 | 90-IYO |
| Ultrasonic Pulsed Doppler Imaging System | 892.1550 | 90-IYN |
| Diagnostic Ultrasound Transducer | 892.1570 | 90-ITX |
Identification of the predicate or legally marketed device: 3)
Advanced Technology Laboratories, Inc. believes that the UM 400C/ SA 6000C Ultrasound System is substantially equivalent to the currently marketed SA 8800/HDI® 1500 system (K974269).
1
510(k) Premarket Notification Tissue Harmonic Imaging
UM 400C/ SA 6000C Ultrasound System
Device Description: 4)
The UM 400C/SA 6000C 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, Power Doppler, 3D, Tissue Harmonic Imaging or in a combination of these modes. M-mode uses the sweep display method which has its images flow from the left to the right on the monitor The UM 400C/SA 6000C 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 system has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.
Nine different models of transducers are available and any two may be connected at the same time. 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.
The UM 400C/SA 6000C system uses digital beamforming technology, and supports a variety of Linear and Convex probes for a wide variety of applications. It is a diagnostic ultrasound scanner, which provides high resolution, high penetration performance, and various measurement functions. Probes are supported in frequencies from 2.0 MHz to 9.0 MHz.
The system can be used to measure distances and calculate areas, circumferences and volumes, as well as calculate the date of delivery by using BPD (biparietal diameter), OFD (occipitofrontal diameter), HC (head circumference), AC (abdominal circumference), AD (abdominal diameter), FL (femur length), CRL (crown rump length), APTD (anteroposterior trunk diameter), TTD (transverse trunk diameter), GS (gestational sac), LMP (last menstural period.), Cardiac Analysis and Vascular Analysis.
Biopsy guidelines are provided on screen to assist in the collection of tissue samples, using biopsy guide adapters offered as an optional accessory. The UM 400C/SA 6000C supports the Cine function (capable of storing up to 64 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
2
image-filing function. High-resolution images are provided by utilizing a technology called
digital dynamic receive focusing.
The UM 400C/SA 6000C has been designed to meet the following electromechanical safety standards:
- -UL 2601-1, Underwriters Laboratories Standards, Medical Electrical Equipment
- -C22.2 No. 601.1, Canadian Standards Association, Medical Electrical Equipment
- declaration of the acoustic output of medical diagnostic ultrasonic equipment
- EN 60601-1-2 (IEC 601-1-2,) European Norm, Collateral Standard: Electromagnetic -Compatibility
Intended Use: 5)
Ultramark 400C/ SonoAce 6000C intended uses as defined FDA guidance documents are:
- Fetal (includes infertility monitoring of follicle development) -
- Abdominal -
- Intra-operative (abdominal organs and peripheral vessel, neurological) -
- -Pediatric
- Small Organ -
- Neonatal Cephalic .
- Adult Cephalic -
- Cardiac -
- 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 retro-peritoneal 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.
- Transcranial 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. -
- Intraoperative application including soft tissue structures. .
3
K992470 p. 34,4
UM 400C/ SA 6000C Ultrasound System
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 a 2D and M-mode, Spectral Doppler, Color Doppler, Power Doppler, 3D, or Tissue Harmonic Imaging images. Transducer patient contact materials are biocompatible.
The device's acoustic output limits are:
All Applications:
| TIS/TIB/TIC | 0.0 - 5.0 | (Range) |
|---|---|---|
| ISPTA | 720 mW/cm2 | (Maximum) |
| MI | 1.9 | (Maximum) |
The limits are the same as predicate Track 3 devices.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines above it, representing the department's mission to protect and promote the health of all Americans. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is simple and recognizable, conveying the department's authority and purpose.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 7 3 1999
Mr. Terrence J. Sweeney
Vice President, Worldwide Quality and Regulatory Affairs
ATL Ultrasound
Post Office Box 3003
· Bothel, Washington 98041-3303
K992470 Re:
Trade Name: Ultramark® 400C/Sonoace 6000C Diagnostic Ultrasound System with Tissue Harmonic Imaging (THI) Regulatory Class: II 21 CFR §892.1560/Procode: 90 IYO Dated: July 23, 1999 Received: July 26, 1999
Dear Mr. Sweeney:
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 transducer intended for use with the Ultramark® 400C/Sonoace 6000C Diagnostic Ultrasound System with Tissue Harmonic Imaging (THI), as described in your premarket notification:
Transducer Model Number
C3-7 Curved Linear Array 4.5 MHz/60R/60D/128 elements
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
5
Page 2 - Mr. Terrence J. Sweeney
Practice requirement, as set forth in the Quality System Regulation (QS) 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.
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 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".
6
Page 3 - Mr. Terrence J. Sweeney
l :
If you have any questions regarding the content of this letter, please contact Paul M. Gammell, Ph.D. at (301) 594-1212.
Sincerely yours,
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)
7
4.3 INDICATIONS FOR USE
STIC ULTRASOUND INDICATIONS STATEMENT DIA
510(k) Number: Ultramark® 400C/SonoAce 6000C Ultrasound System
System: 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) | P | P | P | P | P | Note 1 | Notes 2, 5, 6 | |
| Abdominal | P | P | P | P | P | Note 1 | Notes 2, 5, 6 | |
| Intra-operative (Abdominal, | ||||||||
| vascular) | P | P | P | P | P | Note 1 | Notes 2, 5 | |
| Intra-operative (Neuro.) | P | P | P | P | Note 1 | Note 5 | ||
| Fetal Imaging | ||||||||
| & Other | Laparoscopic | |||||||
| Pediatric | P | P | P | P | P | Note 1 | Notes 2, 5, 6 | |
| Small Organ (See Note 4) | P | P | P | P | P | Note 1 | Notes 2, 5, 6 | |
| Neonatal Cephalic | P | P | P | P | Note 1 | Note 5 | ||
| Adult Cephalic | P | P | P | P | Note 1 | Note 5 | ||
| Trans-rectal | P | P | P | P | P | Note 1 | Notes 2, 5 | |
| Trans-vaginal | P | P | P | P | P | Note 1 | Notes 2, 5 | |
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Convent.) | P | P | P | P | Note 1 | Notes 2, 5 | ||
| Musculo-skel. (Superfic.) | P | P | P | P | Note 1 | Notes 2, 5 | ||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Other (spec.) | ||||||||
| Cardiac Adult | P | P | P | P | P | Note 1 | Note 5 | |
| Cardiac | Cardiac Pediatric | P | P | P | P | P | Note 1 | Note 5 |
| Trans-esophageal (card) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | P | P | P | P | Note 1 | Note 5 | |
| Other (spec.) |
N=new indication; P= previously cleared by FDA in K981510 & K990970; E= added under Appendix E Additional Comments:
Color Doppler includes Color Amplitude Doppler (P)
Note 1: PWD/Color Doppler, PWD/Power Doppler (P)
Note 2: Includes imaging for guidance of biopsy (P)
Note 3: Includes infertility monitoring of follicle development (P)
Note 4: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients (P)
Note 5: 3D Imaging (P)
Note 6: Tissue Harmonic Imaging (N)
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)
Vinil h. Kym
Division Sign-Off) Division of Reproductive, Abdominal, E and Radiological I 510(k) Number
8
DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT
:
510(k) Number:
System:
Ultramark® 400C/ SonoAce 6000C Ultrasound System
C3-7 Curved Linear Array 4.5 MHz/60R/60D/128 elements Scanhead:
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) | N | N | N | N | Note 1 | Notes 2, 5, | ||
| Abdominal | N | N | N | N | Note 1 | Notes 2, 5, | ||
| Intra-operative (Abdominal, | ||||||||
| vascular) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Fetal Imaging | ||||||||
| & Other | Laparoscopic | |||||||
| Pediatric | N | N | N | N | Note 1 | Notes 2, 5, | ||
| Small Organ (See Note 4) | N | N | N | N | Note 1 | Notes 2, 5, | ||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (card.) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (spec.) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
Color Doppler includes Color Amplitude Doppler
Note 1: PWD/Color Doppler, PWD/Power Doppler (N)
Note 2: Includes imaging for guidance of biopsy (N)
Note 3: Includes infertility monitoring of follicle development (N)
Note 4: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients (N)
Note 5: 3D Imaging (N)
Note 6: Tissue Harmonic Imaging (N)
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)
Chid A. Segmen
(Division Sign-Off)
Division of Reproductive, Abdominal, EN and Radiological Devi
510(k) Number K992470