(43 days)
No
The document explicitly states "no new system functions added" and makes no mention of AI, ML, or related technologies in the device description or any other section. The focus is on signal processing, which is a standard ultrasound technology.
No
The device is described as a "Diagnostic Ultrasound System" used for "diagnostic ultrasound imaging," which means it is used to identify or diagnose medical conditions, not to treat them.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "used for diagnostic ultrasound imaging."
No
The device description explicitly states it is a "Diagnostic Ultrasound System and Transducers," which are hardware components. The submission focuses on modifications to an existing ultrasound system, not a standalone software application.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Definition of IVD: 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 description clearly states that the SSD-1000 is a Diagnostic Ultrasound System. Ultrasound imaging is a non-invasive technique that uses sound waves to create images of internal body structures. It does not involve testing samples taken from the body.
- Intended Use: The intended use describes imaging various anatomical sites within the human body, which is consistent with an ultrasound system, not an IVD.
Therefore, the SSD-1000 is a medical imaging device, specifically an ultrasound system, and not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The SSD-1000 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-1400 is not indicated for ophthalmic applications.
Product codes
90 ITX, 90 IYN, 90 IYO
Device Description
The SSD-1000 makes no changes to the indications for use, the ultrasound generator, transducer(s), controls, and signal processing technologies. There are no new system functions added, significant new clinical information provided or significant claims of added effectiveness. In addition, clinical applications/modes of operation provide no new significant interpretation of predicate device; the SSD-1400. Only those probe that are the subject of the submitted and cleared 510(k) for the SSD-1400 have been added to the SSD-1000. Probes that have been added to the SSD-1400 using Appendix E and are intended to be used with the SSD-1000 are the subjects of this submission. A list of added probes has been provided.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Diagnostic ultrasound imaging
Anatomical Site
Cardiac, Gynecological, Neurological, Obstetrical, Neonatal, Pediatric, Perinatal, Radiological, Vascular, Urological, Abdominal, Gastrointestinal, Trauma, Surgical
Indicated Patient Age Range
Neonatal, Pediatric, Fetal, Adult
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)
Reference Device(s)
K983879, K009793, K985879, K003739
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
AUG 3 0 2001
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-1000 Diagnostic Ultrasound System |
| Device Common Name | Diagnostic ultrasound system |
| Classification | The charts below list the Regulatory Class and Device Codes. |
|---|---|
| ---------------- | -------------------------------------------------------------- |
| Subject | Description |
|---|---|
| Regulatory Class | Class II |
| Review Category | Tier II |
| 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 | 892.1560 |
Continued on next page
Aloka Company, Ltd.
Accessories
1
510(k) Summary, Continued
- :
| Identification of predicate devices | The SSD-1000 (Appendix E) is substantially equivalent to the SSD-1400, which is subject of a submitted and cleared 510(k): K972465. |
|---|---|
| Device Description | The SSD-1000 makes no changes to the indications for use, the ultrasound generator, transducer(s), controls, and signal processing technologies. There are no new system functions added, significant new clinical information provided or significant claims of added effectiveness. In addition, clinical applications/modes of operation provide no new significant interpretation of predicate device; the SSD-1400. |
| Probes | Only those probe that are the subject of the submitted and cleared 510(k) for the SSD-1400 have been added to the SSD-1000. Probes that have been added to the SSD-1400 using Appendix E and are intended to be used with the SSD-1000 are the subjects of this submission. A list of added probes has been provided. |
| Intended Use | The SSD-1000 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-1400 is not indicated for ophthalmic applications. |
Aloka Company, Ltd.
:
.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 3 0 2001
Mr. Kelvin Burroughs Coordinator, Regulatory Affairs/Quality Assurance ALOKA Co., Ltd. Fairfield Boulevard WALLINGFORD CT 06492-7502
Re: K012253
Trade Name: Aloka SSD-1000 Diagnostic Ultrasound System Regulatory Class: II/21 CFR 892.1560 Product Code: 90 IYO Regulatory Class: II/21 CFR 892.1570 Product Code: 90 ITX Dated: July 16, 2001 Received: July 18, 2001
Dear Mr. Burroughs:
We have reviewed your Section 510(k) notification of intent to market the device referenced we have teviewed your became in the device is substantially equivalent (for the indications for use above and we nave acteriment to legally marketed predicate devices marketed in interstate commerce stated in the energister) to regarry int date of the Medical Device Amendments, or to devices that prove to may 20, 177, 0, 1978, accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls Cosinede Act (11ct). Tourise), provisions of the Act include requirements for provisions of the Freat First of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
This determination of substantial equivalence applies to the following transducers intended for r ins detenminded or backling of the Ultrasound System, as described in your premarket notification:
Transducer Model Number
ASU-35-5 ASU-35B-5 ASU-67 ASU-1000C-3.5 UST-978-3.5 UST-984P-5 UST-990-5
3
UST-5524-5
UST-5534T-7.5
UST-5710-7.5
UST-5818-5
UST-5819T-5
UST-9101-7.5
UST-9102-3.5
UST-9103-5
UST-9104-5
UST-9112-5
UST-9116P-5
If your device is classified (see above) into either class II (Special Controls) or class III) If your device is classified (SC above) this onch additional controls. Existing major regulations (Premarket Approval) it may be subject to back as a little 21, Parts 800 to
affecting your device can be found in the Code of Federal Regulations with the Good allecting your device can be round emmination assumes compliance with the Good 895. A substantially equirement, as set forth in the Quality System Regulation (QS) for Manufacturing Practice requirement, as set read mixed of the through periodic QS
Medical Devices: General (GMP) regulation (21 CFR Part 820) and that the GMP regulation Medical Devices: Gelleral (GMT) regulation (2) - 1. Failure to comply with the GMP regulation (FDA) may inspections, the FDA Will verliy such assamplier of and Drug Administration (FDA) may
may result in regulatory action. In addition, the Food well Register Register and may result in regulatory action. In adultion, and rovice in the Federal Register. Please note: this
publish further announcements concerning your device in the Federal por publish further allinouncements concerning your affect any obligation you may have under
response to your premarket notification does not affect any obligation Control response to your premarket nothrouten acts and more and and on the Electronic Product Radiation Control sections 551 - other Federal laws or regulations.
This determination of substantial equivalence is granted on the condition that print to shipping to I his determination of Substance special report. This report should contain complete the first device, you submit a postered and species is based on production line devices, requested
information, including acoustic output measurements based on production fo information, including acoustic output measurements on 1997 "Information for Manufacturers" in Appendix O, (enclosed) of the Center 3 September 3 3, stems and Transducers." If the special Seeking Marketing Clearance of Diagnostic Craias and 1944
report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved report is incomplete of contails unacceptation varies (engy more of 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 The special report should referent iE'' 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 This letter will anow you to ocgin marketing your alence of your device to a legally marketed
4
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 If you desire of Compliance at (301) 594-4591. Additionally, for questions on the contact the Office or compilance at (vice, please contact the Office of Compliance at (301) 594promotion and advertubility or youlation entitled, "Misbranding by reference to premarket 40.5% Also, prouse note are roganal information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer inay be obtained from and 217.2017 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 Rodgrio 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)
5
| System/Transducer | System |
|---|---|
| Model | SSD-1000 |
| 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) | ||||||||||
| Ophthalmic | ||||||||||
| Fetal | E | E | See Below | |||||||
| Abdominal | E | E | See Below | |||||||
| Intraoperative (specify) | E | E | See Below | |||||||
| Intraoperative Neurological | E | E | See Below | |||||||
| Pediatric | E | E | See Below | |||||||
| Small Organ (specify) | E | E | See Below | |||||||
| Neonatal Cephalic | E | E | See Below | |||||||
| Adult Cephalic | E | E | See Below | |||||||
| Cardiac | E | E | See Below | |||||||
| Transesophageal | See Below | |||||||||
| Transrectal | E | E | See Below | |||||||
| Transvaginal | E | E | See Below | |||||||
| Transurethral | ||||||||||
| Intravascular | See Below | |||||||||
| Peripheral Vascular | E | E | See Below | |||||||
| Laparoscopic | E | E | See Below | |||||||
| Musculo-skeletal Conventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other |
N= new indication; P= previously cleared by FDA; E= added under Appendix E;
Additional Comments: B/M-Mode
(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
| K012253 | |
|---|---|
| Member |
Aloka Company, Ltd.
Page 1 1 of 43
6
| System/Transducer | Transducer |
|---|---|
| Model | ASU-35-5 |
| 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) | ||||||||||
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | P | P | ||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | P | 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;
Additional Comments:
(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. Brogdom
Division Sign-Off)
ivision of Reproductive, Abdominal,
and Radiological Devices
10kl Numbe K012253
Aloka Company, Ltd.
Page 12 of 43
7
| System/Transducer | Transducer |
|---|---|
| Model | ASU-35B-5 |
| 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) | ||||||||||
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | E | E | ||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | E | E | ||||||||
| 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:
(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
(División Sign-om)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number
Aloka Company, Ltd.
Page 13 of 43
8
| System/Transducer | ransducer |
|---|---|
| Model | A LA BALL BALL BE A BELLER AND A BELLER AND A BELLER AND A BELLER AND A BELLER AND A BELLER AND A BELLER AND A BELLER AND A BELLER AND A BELLER AND A BELLER AND A BELLER AND |
| 510(k) Number | Annendix |
| A Book Company |
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) | ||||||||||
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | E | E | ||||||||
| 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:
(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.
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices K012253
510(k) Number.
Aloka Company, Ltd.
Page 1 4 of 43
9
| 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 | Modes of operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| A | B | M | PWD | CWD | Color | |||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Ophthalmic | ||||||||||
| Fetal | E | E | See Below | |||||||
| Abdominal | E | E | See Below | |||||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | 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: B/M-Mode
(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
Division of Reproductive, Abdominal,
and Radiological Devices K012253
510(k) Number.
Aloka Company, Ltd.
Page 15 of 43
10
| System/Transducer | Transducer |
|---|---|
| Model | UST-978-3.5 |
| 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) | ||||||||||
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | E | E | See Below | |||||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | E | E | See Below | |||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| 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: B/M-Mode
(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. H012253
Aloka Company, Ltd.
Page 16 of 43
11
| System/Transducer | Transducer |
|---|---|
| Model | UST-984P-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) | ||||||||||
| Ophthalmic | ||||||||||
| Fetal | E | E | See Below | |||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | 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: B/M-Mode
(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. boyden
(Division Si Division of Reprod and Radiological Devices 510(k) Number
Aloka Company, Ltd.
Page 17 of 43
12
| System/Transducer | Transducer |
|---|---|
| Model | UST-990-5 |
| 510(k) Number | K009793 |
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) | ||||||||||
| Ophthalmic | ||||||||||
| Fetal | P | P | See Below | |||||||
| Abdominal | P | P | See Below | |||||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | P | P | 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: B/M-Mode
(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 Reproduct and Radiological Devices 510(k) Number
Aloka Company, Ltd.
Page 18 of 43
13
| System/Transducer | Transducer |
|---|---|
| Model | UST-5524-5 |
| 510(k) Number | K985879 |
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) | ||||||||||
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | P | P | See Below | |||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | 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: B/M-Mode
(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 and Radiological Devices 510(k) Number
Aloka Company, Ltd.
Page 19 of 43
14
| System/Transducer | l ransducer |
|---|---|
| Model | UST-5534T-7.5 |
| Superior of Children Company of American Comments of the First of the First of the First of the First of the First of the research of the research of the research of the rese | |
| 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) | ||||||||||
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | P | P | See Below | |||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | P | P | See Below | |||||||
| Neonatal Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | 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: B/M-Mode
ال
(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. Braden | |
|---|---|
| (Division Sign-Off) | |
| Division of Reproductive, Abdominal, | |
| and Radiological Devices | |
| 510(k) Number | K012253 |
Aloka Company, Ltd.
Page 20 of 43
15
| System/Transducer | Transducer |
|---|---|
| Model | UST-5710-7.5 |
| 510(k) Number | K00379 |
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) | ||||||||||
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | P | P | See Below | |||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| 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: B/M-Mode
(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-Division of Reprodu and Radiological Devic 510(k) Number
Aloka Company, Ltd.
Page 21 of 43
16
| System/Transducer | ransducer |
|---|---|
| Inde | |