(57 days)
Not Found
No
The device description explicitly states "makes no changes to... signal processing technologies" and "no new system functions, significant new clinical information provided or significant claims of added effectiveness." There is no mention of AI, ML, or related concepts.
No.
The device is clearly stated as a "Diagnostic Ultrasound System" for "diagnostic ultrasound imaging" and makes no mention of treatment or therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that "The SSD-5000 Diagnostic Ultrasound System and Transducers be used for diagnostic ultrasound imaging".
No
The device description explicitly states it is an "Ultrasound System" and mentions hardware components like the "ultrasound generator" and "transducer(s)".
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "diagnostic ultrasound imaging" for various anatomical sites and applications. This describes a device used to create images of internal structures, which is the core function of an ultrasound system.
- Device Description: The description focuses on the system's components and lack of significant changes from a predicate ultrasound device. It mentions "signal processing technologies," which is typical for image processing in ultrasound, not for analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing biological samples (like blood, urine, tissue, etc.) or performing tests on these samples outside of the body. IVD devices are specifically designed for such in vitro analysis.
Therefore, the SSD-5000 Diagnostic Ultrasound System is a medical imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The SSD-5000 Diagnostic Ultrasound System and Transducers be used for diagnostic ultrasound imaging in Cardiac, Gynecological, Neurological, Obstetrical, Neonatal, Pediatric, Perinatal, Radiological, Vascular, Urological, Abdominal, Gastrointestinal, Trauma, Surgical and Endoscopic applications. The Aloka SSD-5500 is not indicated for ophthalmic applications.
Product codes (comma separated list FDA assigned to the subject device)
90 ITX, 90 IYN, 90 IYO
Device Description
The SSD-5000 makes no changes to the indications for use, the ultrasound generator, transducer(s), controls, or signal processing technologies. There are no new system functions, significant new clinical information provided or significant claims of added effectiveness. In addition, clinical applications/modes of operation provide no new significant interpretation of the predicate device, the SSD-5500.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Cardiac, Gynecological, Neurological, Obstetrical, Neonatal, Pediatric, Perinatal, Radiological, Vascular, Urological, Abdominal, Gastrointestinal, Trauma, Surgical, Fetal, Intraoperative (specify), Intraoperative Neurological, Small Organ (specify), Adult Cephalic, Transesophageal, Transrectal, Transvaginal, Transurethral, Intravascular, Peripheral Vascular, Laparoscopic, Musculo-skeletal Conventional, Musculo-skeletal Superficial
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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.
K992663, K002784, K011315, K011457
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
§ 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.
0
510(k) Summary
This summary statement complies with 21 CFR, section 807.92 as amended March 14, 1995.
| Submitter's Name and Address | Aloka Co., Ltd.
10 Fairfield Boulevard
Wallingford, CT 06492 |
|-----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact's Name, Title, Address and Telephone Number | Kelvin Burroughs
Regulatory Affairs/Quality Assurance Coordinator
Aloka Co., Ltd.
10 Fairfield Boulevard
Wallingford, CT 06492
(203) 269-5088 |
| Device Proprietary Name | SSD-5000 Diagnostic Ultrasound System |
| Device Common Name | Diagnostic ultrasound system |
| Classification | The charts below list the Regulatory Class and Device Codes. |
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Book Company
LENNER BE REE
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|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
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.
E L C S M L L S
Commender of the control of the control of the production of each and
FILE IN ROLL I DOLL I BOR MARK BOOK BOOK BOOK BOOK BOOK BOOK BOOK BOOK BOOK BOOK BOOK BOOK BOOK BOOK BOOK BOOK BOOK BOOK BOOK BOOK BOOK BOOK BOOM BOOK BOOM BOOK BOOK BOOK BOO
and the characterial consideration to the collection of the collection of the collection of the collection of the complex of the complex of the complex of the complex of the
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| Code | Description | Regulation |
|---|---|---|
| 90 ITX | Transducer, Ultrasonic, Diagnostic | 892.1570 |
| 90 IYN | Ultrasonic, Pulsed Doppler Imaging System | 892.1550 |
| 90 IYO | Ultrasonic, Pulsed Echo Imaging System and | |
| Accessories | 892.1560 |
Continued on next page
Aloka Company, Ltd.
Page 8 of 64
1
510(k) Summary, Continued
| Identification of
predicate
devices | The SSD-5000 is substantially equivalent to the SSD-5500, which is subject
of the following submitted and cleared 510(k)s: K992663, K002784,
K011315 and K011457. |
|-------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device
Description | The SSD-5000 makes no changes to the indications for use, the ultrasound
generator, transducer(s), controls, or signal processing technologies. There are
no new system functions, significant new clinical information provided or
significant claims of added effectiveness. In addition, clinical
applications/modes of operation provide no new significant interpretation of
the predicate device, the SSD-5500. |
| Probes | Probe that are the subject of a submitted and cleared 510(k) for the SSD-5500
have already been added to the SSD-5000. New probes and additional
probes for used with the SSD-5000 are the subjects of this submission. |
| Intended Use | The SSD-5000 Diagnostic Ultrasound System and Transducers be used for
diagnostic ultrasound imaging in Cardiac, Gynecological, Neurological,
Obstetrical, Neonatal, Pediatric, Perinatal, Radiological, Vascular, Urological,
Abdominal, Gastrointestinal, Trauma, Surgical and Endoscopic applications.
The Aloka SSD-5500 is not indicated for ophthalmic applications. |
:
Aloka Company, Ltd.
・ :
... ...
:
Page 9 of 64
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle with three stylized wing segments.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 9 2001
Mr. Kelvin Burroughs Coordinator, Regulatory Affairs & Quality Assurance ALOKA Co., Ltd. 10 Fairfield Boulevard WALLINGFORD CT 06492-7502
Re: K012080
Trade Name: Aloka SSD-5000 Diagnostic Ultrasound System Regulatory Class: II/21 CFR 892.1550 Product Code: 90 IYN Regulatory Class: II/21 CFR 892.1560 Product code: 90 IYO Dated: June 29, 2001 Received: July 3, 2001
Dear Mr. Burroughs:
We have reviewed your Section 510(k) notification of intent to market the device referenced we have reviewed four becally be is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce stated in the energiale, to regary inn date of the Medical Device Amendments, or to devices that prior to may 20, 1978, and ance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls Costical Fet (110). I The general controls provisions of the Act include requirements for provisions of the rea- rea- reas good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
This determination of substantial equivalence applies to the following transducers intended for 1 ms determination of bacement Ultrasound System, as described in your premarket notification:
Transducer Model Number
ASU-67 ASU-1000C-3.5 ASU-1002 UST-2265-2 UST-52718-5
3
UST-5281-5
UST-5284-2.5
UST-5285-3.5
UST-5293-5
UST-5294-5
UST-5296
UST-5297
UST-5524-5
UST-5524-7.5
UST-5531
UST-5534T-7.5
UST-5543
UST-5545
UST-5712
UST-9101-7.5
UST-9104-5
UST-9114-3.5
UST-9115-5
If your device is classified (see above) into either class II (Special Controls) or class III If your device is classified (sec above) this uch additional (x) { = { (Premarket Approval) it may be subject to back as a legulations, Title 21, Parts 800 to affecting your device can be round the equivalent determination assumes compliance with the Good 895. A substantially Cquirement, as set forth in the Quality System Regulation (OS) for Manufacturing Fractice requirement, as set read man and that, through periodic QS
Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, the CMB verylation Medical Devices: General (GMT) regulation (21 - 2 Reilure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may may result in regulatory action: in adultion, are device in the Federal Register. Please note: this publish further anilouncements concerning your affect any obligation you may have under response to your premarket notification active 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 a I his detenmination of Substantial oquiralers special report. This report should contain complete the first device, you submit a postoleatures special in production line devices, requested information, menuding acousul of the Center's September 30, 1997 "Information for Manufacturers" In Appellulx U, (enclosed) of the Oct.er violente of Systems and Transducers'. If the special Seeking Marketing Clearance of Diagnound Of Lines (e.g., acoustic output greater than approved report is incomplete of comailis unaccepably furted (orgi, as the production units which as a result may be considered adulterated or misbranded.
4
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, International and Consumer Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at (301) 594-1212.
Sincerely vours.
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)
5
| System/Transducer | A LIES & LANDRIA LA BE CO
Veter
|
|------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| -1000 | -000 |
|
Annual A L Children
510/k) Number | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
AND AND AN |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Modes of operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| A | B | M | PWD | CWD | Color | |||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Opthalmic | ||||||||||
| Fetal | E | E | E | E | E | E | See Below | |||
| Abdominal | E | E | E | E | E | See Below | ||||
| Intraoperative (specify) | E | E | E | E | E | See Below | ||||
| Intraoperative Neurological | E | E | E | E | E | E | See Below | |||
| Pediatric | E | E | E | E | E | See Below | ||||
| Small Organ (specify) | E | E | E | E | E | See Below | ||||
| Neonatal Cephalic | E | E | E | E | E | See Below | ||||
| Adult Cephalic | ||||||||||
| Cardiac | E | E | E | E | E | E | See Below | |||
| Transesophageal | E | E | E | E | E | E | See Below | |||
| Transrectal | E | E | E | E | E | See Below | ||||
| Transvaginal | E | E | E | E | E | See Below | ||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | E | E | E | E | E | See Below | ||||
| Laparoscopic | E | E | E | E | E | E | See Below | |||
| Musculo-skeletal Conventional | E | E | E | E | E | See Below | ||||
| Musculo-skeletal Superficial | E | E | E | E | E | See Below | ||||
| Other |
N= new indication; P= previously cleared by FDA; E= added under Appendix E;
Additional Comments: BIA-SMA.
Mixed mode operation includes B/M, B/PWD, B/CD, M/CD, B/CD/PWD,
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Nancy Brogdon
and Radiological Devic 510(k) Number
Page 1 1 of 64
Aloka Company, Ltd.
6
| A
Svstem/Transducer | would and annual and the processor of the arts of the only of the only of the can the comments
ransqucer |
|------------------------|-------------------------------------------------------------------------------------------------------------|
| N 0.510 | |
| 510/k) Number
| |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Modes of operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| A | B | M | PWD | CWD | Color | |||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Opthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | E | E | E | E | E | See Below | ||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal Conventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other |
indication; P= previously cleared by FDA; E= added under Appendix E;
Additional Comments: B/A-SMA.
Mixed mode operation includes B/M, B/PWD, B/CD, M/CD, B/CD/PWD,
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Nancy C bogdon
(Division Sign-Off)
Division of Reproducti ve. Abdom and Radiological Devices 510(k) Number
Aloka Company, Ltd.
Page 12 of 64
7
| System/Transducer | Transducer |
|---|---|
| Model | ASU-1000C-3.5 |
| 510(k) Number | Appendix E |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | Combined
(specify) | Other
(specify) |
|-------------------------------|---|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Opthalmic | | | | | | | | | | |
| Fetal | | E | E | E | | E | E | | See Below | |
| Abdominal | | E | E | E | | E | E | | See Below | |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | E | E | E | | E | E | | See Below | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Other | | | | | | | | | | |
N= new indication: P= previously cleared by FDA: E= added under Appendix E
Additional Comments: Mixed mode operation includes B/M, B/PWD, B/CD, M/CD, B/CD/PWD, BIA-SMA.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Nancy C. hogdon
(Division Sign-Off) Division of Reproductive, Abdom and Radiological Devices 510(k) Number _
Aloka Company, Ltd.
SSD-5000 Abbreviated 510(k) Submission
Page 1 3 of 64
F
8
| System/Transducer |
ransducer |
|-------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Mone | 1000 |
| 510(k) Number | אותו
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Modes of operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| A | B | M | PWD | CWD | Color | |||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Opthalmic | ||||||||||
| Fetal | E | E | E | E | E | See Below | ||||
| Abdominal | ||||||||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | E | E | E | E | E | See Below | ||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal Conventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other |
N= new indication; P= previously cleared by FDA; E= added under Appendix E;
Additional Comments: BIA-SMA
Mixed mode operation includes B/M, B/PWD, B/CD, M/CD, B/CD/PWD,
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Nancy C. hogdon
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Device 510(k) Number
Aloka Company, Ltd.
Page 14 of 64
9
| ----------
Transancer | I assessment 1 a new an
ransdicer
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| |
|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
10/7 |
11 11 100000 Boom L Book L
A contra come of
| Call of Call of Children a |
|---|
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Modes of operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| A | B | M | PWD | CWD | Color | |||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Opthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | P | |||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal Conventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other |
N= new indication; P= previously cleared by FDA; E= added under Appendix E;
Mixed mode operation includes B/M, B/PWD, B/CD, M/CD, B/CD/PWD, Additional Comments: BIA-SMA.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Nancy C. hogdon
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number _
Aloka Company, Ltd.
Page 1 5 of 64
10
| System/Transducer | ransducer |
|---|---|
| Model | 1000000 |
| 1 1 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 | |
| 510/k) Number | Annendix 1 |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Modes of operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| A | B | M | PWD | CWD | Color | |||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Opthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | E | E | E | E | E | See Below | ||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | E | E | E | E | E | See Below | ||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal Conventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other |
new indication; P= previously cleared by FDA; E= added under Appendix E;
Additional Comments: BIA-SMA.
Mixed mode operation includes B/M, B/PWD, B/CD, M/CD, B/CD/PWD,
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Nancy C. hodson
(Division Sign-Off)
Division of Reproduct ve. Abdor and Radiological Devices 510(k) Number
Aloka Company, Ltd.
Page 1 6 of 64
I
11
| System/Transducer | ransducer |
|---|---|
| vindel | . |
| 510(k) Number | endix |
| . |
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Modes of operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| A | B | M | PWD | CWD | Color | |||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Opthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | E | E | E | E | E | E | See Below | |||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | E | E | E | E | E | E | See Below | |||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal Conventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other |
indication; P= previously cleared by FDA; E= added under Appendix E;
Additional Comments: BIA-SMA
Mixed mode operation includes B/M, B/PWD, B/CD, M/CD, B/CD/PWD,
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Nancy C. hogdon
(Division Sign-Off) Division of Reproductive and Radiological Devices 51(Yk) Number
Page 1 7 of 64
Aloka Company, Ltd.
12
| System/Transducer | Transducer |
|---|---|
| Model | UST-5284-2.5 |
| 510(k) Number |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Modes of operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| A | B | M | PWD | CWD | Color | |||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Opthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | N | N | N | N | N | N | See Below | |||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal Conventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other |
N= new indication; P= previously cleared by FDA; E= added under Appendix E;
Mixed mode operation includes B/M, B/PWD, B/CD, M/CD, B/CD/PWD, Additional Comments: BIA-SMA.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Nancy C. brondom
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
and Radiological Devices 510(k) Number
Aloka Company, Ltd.
Page 1 8 of 64
13
| ------------
Sustem/Transducer |
August Chicago
Property of Children or successful and any
LINE CONS LE RIGE
| ransducer |
|---|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| Mon |
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
| 510/k) Number |
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Modes of operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| A | B | M | PWD | CWD | Color | |||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Opthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | N | N | N | N | N | N | See Below | |||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal Conventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other |
N= new indication; P= previously cleared by FDA; E= added under Appendix E;
Additional Comments: BIA-SMA.
Mixed mode operation includes B/M, B/PWD, B/CD, M/CD, B/CD/PWD,
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Nancy C. hogdon
(Division Sign-Off) Division of Reproduc and Radiological Device 18:13
Page 1 9 of 64
Aloka Company, Ltd.
Page 19 of 64
14
| System/Transducer | Transducer |
|---|---|
| Model | UST-5293-5 |
| 510(k) Number | K003739 |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Modes of operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| A | B | M | PWD | CWD | Color | |||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Opthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | P | P | P | P | P | P | See Below | |||
| Transesophageal | P | P | P | P | P | P | See Below | |||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal Conventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other |
new indication; P= previously cleared by FDA; E= added under Appendix E;
Additional Comments: BIA-SMA.
Mixed mode operation includes B/M, B/PWD, B/CD, M/CD, B/CD/PWD,
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Nancy C. Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices K012080
510(k) Number
Aloka Company, Ltd.
Page 20 of 64
15
| System/Transducer | Transducer |
|---|---|
| Model | UST-5294-5 |
| 510(k) Number | Appendix E |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows. | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | Modes of operation | ||||||||||
| A | B | M | PWD | CWD | Color | ||||||
| Doppler | Amplitude | ||||||||||
| Doppler | Color | ||||||||||
| Velocity | |||||||||||
| Imaging | Combined | ||||||||||
| (specify) | Other | ||||||||||
| (specify) | |||||||||||
| Opthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intraoperative (specify) | |||||||||||
| Intraoperative Neurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ (specify) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | E | E | E | E | E | E | E | See Below | |||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletal Conventional | |||||||||||
| Musculo-skeletal Superficial | |||||||||||
| Other |
ew indication; P= previously cleared by FDA; E= added under Appendix E;
Additional Comments:
Mixed mode operation includes B/M, B/CD, M/CD, B/A-SMA.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Nancy C. hogdon
(Division Sign-Off)
Division of Reproduc ve, At and Radiological Devices 510(k) Number _
Aloka Company, Ltd.
Page 2 1 of 64
16
| System/Transducer | Transducer |
|---|---|
| Model | UST-5296 |
| 510(k) Number | Appendix E |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Modes of operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| A | B | M | PWD | CWD | Color | |||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Opthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | E | E | E | E | E | See Below | ||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | E | E | E | E | E | See Below | ||||
| Adult Cephalic | ||||||||||
| Cardiac | E | E | E | E | E | E | See Below | |||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal Conventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other |
N= new indication; P= previously cleared by FDA; E= added under Appendix E;
Additional Comments:
Mixed mode operation includes B/M, B/CD, M/CD, B/CD/PWD,
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Nancy C. hogdon
(Division Sign-Off) Division of Reproductiv , Abdomi and Radiological Devices 510(k) Number
Aloka Company, Ltd.
Page 22 of 64
17
| System/Transducer | Transducer |
|---|---|
| Model | UST-5297 |
| 510(k) Number |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Modes of operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| A | B | M | PWD | CWD | Color | |||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Opthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | N | N | N | N | N | N | See Below | |||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal Conventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other |
N= new indication; P= previously cleared by FDA; E= added under Appendix E;
Additional Comments: Mixed mode operation includes B/M, B/CD, M/CD, B/CD/PWD, B/A-SMA.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Nancy C. hogdon
(Division Sign-Off)
Division of Reproductive and Radiological Devices
Aloka Company, Ltd.
Page 23 of 64
18
| System/Transducer | Transducer |
|---|---|
| Model | UST-5524-5 |
| 510(k) Number | K983879 |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Modes of operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| A | B | M | PWD | CWD | Color | |||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Opthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | P | P | P | P | P | P | See Below | |||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | P | P | P | P | P | P | See Below | |||
| Laparoscopic | ||||||||||
| Musculo-skeletal Conventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other |
N= new indication; P= previously cleared by FDA; E= added under Appendix E;
Additional Comments:
Mixed mode operation includes B/M, B/CD, M/CD,
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Nancy C. hogdon
(Division Sign-Off) Division of Reproductive, and Radiological Devices - 1 - ki Number
Aloka Company, Ltd.
SSD-5000 Abbreviated 510(k) Submission
Page 24 of 64
19
| -------------------
m/ I ransdricer
| VCTA. | ransducer |
|---|---|
| 10000 | Ann Address of the |
| 510(k) Number | |
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | |
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Modes of operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| A | B | M | PWD | CWD | Color | |||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Opthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | E | E | E | E | E | See Below | ||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | E | E | E | E | E | See Below | ||||
| Laparoscopic | ||||||||||
| Musculo-skeletal Conventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other |
N= new indication; P= previously cleared by FDA; E= added under Appendix E;
Additional Comments:
Mixed mode operation includes B/M, B/CD, M/CD.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Nancy C. Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
4012080
Aloka Company, Ltd.
Page 25 of 64
SSD-5000 Abbreviated 510(k) Submission
510(k) Number
20
| /Transducer
| System/ | schicer |
|---|---|
| No. of Anticle State an it a come of each | |
| . |