(11 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and provides no description of training or test sets, which are typical for AI/ML-based devices.
No
The device is a "Diagnostic Ultrasound System" intended for "ultrasound evaluation" and imaging, not for treating any medical condition.
Yes
The device description explicitly names the device as the "SSD-3500 Diagnostic Ultrasound System", indicating its primary diagnostic function.
No
The device description explicitly states it is a "full feature imaging and analysis system" consisting of a "mobile console" with a "computer type keyboard, specialized controls and a display," indicating it includes hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "ultrasound evaluation" of various anatomical sites. This involves imaging the internal structures of the body using ultrasound waves.
- Device Description: The description confirms it's a "Diagnostic Ultrasound System" that provides "acquisition, processing and display capability." This aligns with the function of an imaging device, not a device that analyzes samples taken from the body.
- Input Imaging Modality: The input modality is "Ultrasound," which is an imaging technique, not a method for analyzing biological samples.
- Anatomical Site: The device is used on various anatomical sites within the patient's body. IVDs typically analyze samples from the patient's body (like blood, urine, tissue).
IVD devices are designed to perform tests on samples taken from the human body to provide information about a physiological state, health, or disease. This ultrasound system is an imaging device used to visualize internal structures directly within the patient.
N/A
Intended Use / Indications for Use
The device is intended for use by a qualified physician for ultrasound evaluation of Small Parts, Abdominal, Cardiac, Peripheral Vascular, Fetal, Intra-operative, Intra-operative (Cardiac), Trans-vaginal, Trans-rectal, Gynecological, Pediatric, Laparoscopic, and Neonatal Cephalic applications.
The device is not indicated for Ophthalmic applications.
Product codes (comma separated list FDA assigned to the subject device)
IYN, IYO, and ITX
Device Description
The SSD-3500 Diagnostic Ultrasound System is a full feature imaging and analysis system. It consist of a mobile console that provides acquisition, processing and display capability. The user interface includes a computer type keyboard, specialized controls and a display.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Small Parts, Abdominal, Cardiac, Peripheral Vascular, Fetal, Intra-operative, Intra-operative (Cardiac), Trans-vaginal, Trans-rectal, Gynecological, Pediatric, Laparoscopic, Neonatal Cephalic
Indicated Patient Age Range
Pediatric, Neonatal, Adult
Intended User / Care Setting
Qualified physician
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)
The device and its transducers have been evaluated for acoustic output, biocompatibility, cleaning & disinfection effectiveness, electromagnetic compatibility, as well as electrical and mechanical safety, and have been found to conform with applicable medical device safety standards.
Clinical Tests: None Required.
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.
K032875, K042540, K003739, K963616, K954022, K992663, K023996, K972465, K020668, K012253, K043196
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
K 111227
510(K)
MAY 1 3 2011
510(k) Summary of Safety and Effectiveness Prepared in accordance with 21 CFR Part 807.92
Section a):
| Section a): | |
|---|---|
| 1. Submitter: | Aloka Co., Ltd., 10 Fairfield Boulevard, Wallingford, CT 06492 |
| Contact Person: | Richard J. Cehovsky, RA/QA Mngr., |
| Tel: (203)269-5088 Ext. 346, Fax: 203-269-6075 | |
| Date Prepared: | 2/17/11 |
| 2. Device Name: | Aloka SSD-3500 Ver. 7.8 Diagnostic Ultrasound System |
| Ultrasonic Pulsed Doppler Imaging System, 21 CFR 892.1550 , 90 IYN | |
| Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90 ITX | |
| Ultrasonic Pulsed Echo Imaging System., 21 CFR 892.1560, 90 IYO | |
| 3. Marketed Device: | Aloka SSD-3500 Ver. 7.0 Diagnostic Ultrasound System K060059, (90-IYN, ITX, IYO) |
| ( A device currently in commercial distribution) | |
| 4. Device Description: | The SSD-3500 Diagnostic Ultrasound System is a full feature imaging and analysis |
| system. It consist of a mobile console that provides acquisition, processing and display capability. | |
| The user interface includes a computer type keyboard, specialized controls and a display. | |
| 5. Indications for Use: | The device is intended for use by a qualified physician for ultrasound evaluation of |
| Small Parts, Abdominal, Cardiac, Peripheral Vascular, Fetal, Intra-operative, Intra-operative | |
| (Cardiac), Trans-vaginal, Trans-rectal, Gynecological, Pediatric, Laparoscopic, and Neonatal | |
| Cephalic applications. | |
| The device is not indicated for Ophthalmic applications. | |
| 6.Comparison w/ Predicate Device: | The Aloka SSD-3500 Ver. 7.8 is technically comparable and substantially equivalent to the |
| current Aloka SSD-3500 Ver. 7.0 -(K060059). It has the same technological characteristics, key | |
| safety and effectiveness features, and has the same intended uses and basic operating modes as | |
| the predicate device. | |
| Section b): | |
| 1. Non-clinical Tests: | The device and its transducers have been evaluated for acoustic output, biocompatibility, |
| cleaning & disinfection effectiveness, electromagnetic compatibility, as well as electrical and | |
| mechanical safety, and have been found to conform with applicable medical device safety | |
| standards. | |
| 2. Clinical Tests: | None Required. |
| 3. Conclusion: | Intended uses and other key features are consistent with traditional clinical practices, FDA |
| guidelines and established methods of patient examination. The design, development and | |
| quality process of the manufacturer confirms with 21 CFR 820, ISO 9001:2000 and ISO | |
| 13485 quality systems. The device conforms to applicable medical device safety standards | |
| and compliance is verified through independent evaluation with ongoing factory | |
| surveillance. Diagnostic ultrasound has accumulated a long history of safe and effectiveness | |
| performance. Therefore, it is the opinion of Aloka Co., Ltd. that the Aloka SSD-3500 Ver. 7.8 |
Ultrasound System and its transducers are substantially equivalent with respect ﻟﻠ lagino to safety and effectiveness to its predicate and other currently cleared Aloka systems.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle or other bird-like figure.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Aloka Co., Ltd. (ALOKA AMERICA) % Mr. Michael S. Ogunleye 510(k) Program Manager/Medical Lead Auditor TUV Rheinland of North America 12 Commerce Road NEWTOWN CT 06470
MAY 1 3 2011
Re: K111227
Trade/Device Name: Aloka SSD-3500 Ver. 7.8 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: April 24, 2011 Received: May 2, 2011
:
Dear Mr. Ogunleye:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments; or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
This determination of substantial equivalence applies to the following transducers intended for use with the Aloka SSD-3500 Ver. 7.8 Diagnostic Ultrasound System, as described in your premarket notification:
Transducer Model Number
| UST-533 | UST-676P | ASU-1003 | UST-5536-7.5 |
|---|---|---|---|
| UST-534 | UST-677P | ASU-1009 | UST-5542 |
| UST-535 | UST-978-3.5 | UST-5268P-5 | UST-5546 |
| UST-536 | UST-979-3.5 | UST-5293-5 | UST-5548 |
| UST-568 | UST-984-5 | UST-5298 | UST-5710-7.5 |
| UST-579T-7.5 | UST-987-7.5 | UST-5299 | UST-9101-7.5 |
| UST-670P-5 | UST-990-5 | UST-5413 | UST-9102-3.5 |
| UST-672-5/7.5 | UST-995-7.5 | UST-5524-7.5 | UST-9102U-3. |
2
| TITT 010 | 110T 0100 | 1100 0100 | 0 円 へ |
|---|---|---|---|
| T T CLETT | 105 010 | TOTT | |
| A 1 4 4 4 4 1 4 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 | |||
| 1 10 70 0 1 | |||
| 11 | |||
| --------------- | 700 000 | TTAT | |
| 019 |
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
If you have any questions regarding the content of this letter, please contact Shahram Vaezy at (301) 796-6242.
Sincerely Yours,
Michael D Ó hAnnracháin
Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure(s)
3
Indications for Use
510(K) Number (if known): {くししょえ 7
Device Name:
Aloka SSD-3500 Ver. 7.8
Indications For Use:
The device is intended for use by a qualified physician for ultrasound evaluation of Small Parts, Abdominal, Cardiac, Peripheral Vascular, Fetal, Intra-operative, Intraoperative (Cardiac), Trans-vaginal, Transrectal, Gynecological, Pediatric, Laparoscopic, and Neonatal Cephalic applications.
The device is not indicated for Ophthalmic applications.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Michael O'Hara
(Division Sign-Off)
Division of Radiological Devices Office of In Vitro Division of Hadlolugiour Dovice Evaluation and Safety
510K K11227
Page 1 of 1
4
1.3.1
Diagnostic Ultrasound Indications for Use Form SSD-3500 Ver. 7.8
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Modes of operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | |||||
| Doppler | Amplitude | ||||||||||
| Doppler | Color | ||||||||||
| Velocity | |||||||||||
| Imaging | Combined | ||||||||||
| (specify) | Other | ||||||||||
| (specify) | |||||||||||
| Opthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | P | P | P | See Below | |||||||
| Intra-operative (specify) | P | P | P | See Below | |||||||
| Intra-operative (cardiac) | N | N | N | See Below | |||||||
| Pediatric | P | P | P | See Below | |||||||
| Small Organ (specify) | P | P | P | See Below | |||||||
| Neonatal Cephalic | P | P | P | See Below | |||||||
| Adult Cephalic | |||||||||||
| Cardiac | P | P | P | See Below | |||||||
| Transesophageal | |||||||||||
| Transrectal | P | P | P | See Below | |||||||
| Transvaginal | P | P | P | See Below | |||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | P | P | P | See Below | |||||||
| Laparoscopic | P | P | P | See Below | |||||||
| Musculo-skeletal | |||||||||||
| Conventional | |||||||||||
| Musculo-skeletal Superficial | |||||||||||
| Other: Gynecological | P | P | P | See Below |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Mixed mode operation includes: B/M, B/PWD, M/CD, B/CD/PWD
Applications: Small Parts-(breast, testes & thyroid..), Intra-operative- (liver, pancreas, gall bladder, cardiac...)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
ncurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K. h 111227
5
Diagnostic Ultrasound Indications for Use Form
UST-533 (K032875)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Modes of operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | |||||
| Doppler | Amplitude | ||||||||||
| Doppler | Color | ||||||||||
| Velocity | |||||||||||
| Imaging | Combined | ||||||||||
| (specify) | Other (specify) | ||||||||||
| Opthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intraoperative (specify) | P | P | P | See Below | |||||||
| Pediatric | |||||||||||
| Small Organ (specify) | P | 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: Combined includes: B/M, B/PWD, M/CD, B/CD/PWD
Applications: Small Parts-(breast, testes & thyroid..), Intra-operative- (liver, pancreas, gall bladder ... )
(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)
///A.D.O.K
(Division Sign-Off)
Division of Radiological Devices Office of In Vitro Diagnostic Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K K111227
6
Diagnostic Ultrasound Indications for Use Form UST-534 (K032875)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Modes of operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | |||||
| Doppler | Amplitude | ||||||||||
| Doppler | Color | ||||||||||
| Velocity | |||||||||||
| Imaging | Combined | ||||||||||
| (specify) | Other | ||||||||||
| (specify) | |||||||||||
| Opthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intraoperative (specify) | E | E | E | See Below | |||||||
| Pediatric | |||||||||||
| Small Organ (specify) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletal | |||||||||||
| Conventional | |||||||||||
| Musculo-skeletal Superficial | |||||||||||
| Other: Gynecological |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Combined includes: B/M, B/PWD, M/CD, B/CD/PWD.
Applications: Intra-operative- (liver, pancreas, gall bladder, .... )
(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)
DÓK
(Division Sign-Off)
Division of Radiological Dev Office of In Vitro Dia
K11227
510K
7
Diagnostic Ultrasound Indications for Use Form UST- 535 (K042540, K032875))
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Modes of operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Velocity | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Opthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intra-operative (specify) | N | N | N | See Below | ||||||
| Intra-operative (cardiac) | N | N | N | See Below | ||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal- | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other: Gynecological |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Combined includes: B/M, B/PWD, M/CD, B/CD/PWD.
Applications: Intra-operative- (liver, pancreas, gall bladder ... & cardiac)
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)
(Division Sign-Off)
Office of In no unting and
510K KIIIAA¬
8
Diagnostic Ultrasound Indications for Use Form UST-536 (K060059)
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
Velocity | Color
Velocity
Imaging | Combined
(specify) | Other
(specify) |
|----------------------------------|---|---|---|-----|-----|------------------|-----------------------|------------------------------|-----------------------|--------------------|
| Opthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative (specify) | | P | P | P | | | | | See Below | |
| Pediatric | | | | | | | | | | |
| Small Organ (specify) | | P | 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: Combined includes: B/M, B/PWD, M/CD, B/CD/PWD.
Applications: Applications: Small Parts-(breast, testes & thyroid..), Intra-operative- (liver, pancreas, gall bladder ...)
(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)
Discian of Radionorica Office of In Vi
510K K111227
9
Diagnostic Ultrasound Indications for Use Form UST-568 (K003739)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Modes of operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Velocity | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Opthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | E | E | E | See Below | ||||||
| Pediatric | ||||||||||
| Small Organ (specify) | E | E | E | See Below | ||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | 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: Combined includes: B/M, B/PWD, M/CD, B/CD/PWD.
Applications: Applications: Small Parts-(breast, testes & thyroid..), Intra-operative- (liver, pancreas, gall bladder ... ) (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)
(Division Sign-Off)
on of Harmingical Device Office of In
510K K 11227
10
Diagnostic Ultrasound Indications for Use Form UST-579T-7.5 (K963616)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Modes of operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | |||||
| Doppler | Amplitude | ||||||||||
| Velocity | Color | ||||||||||
| Velocity | |||||||||||
| Imaging | Combined | ||||||||||
| (specify) | Other | ||||||||||
| (specify) | |||||||||||
| Opthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intraoperative (specify) | P | P | P | See Below | |||||||
| Pediatric | |||||||||||
| Small Organ (specify) | P | P | P | See Below | |||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| fransesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | 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: Combined includes: B/M, B/PWD, M/CD, B/CD/PWD.
Applications: Applications: Small Parts-(breast, testes & thyroid..), Intra-operative- (liver, pancreas, gall bladder ... )
(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)
(Division Sign-On)
Division of Radiological Dev Office of In Vitro Diagnostic Device Evaluation and Sc
510K KIIII227
11
Diagnostic Ultrasound Indications for Use Form UST-670P-5 (K954022)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Modes of operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Velocity | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Opthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | P | P | P | See Below | ||||||
| Transvaginal | P | 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: Combined includes- B/M, B/PWD, 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)
(Division Sign-Off)
Division of Radiok Office of In Vitro Diagn luation and Safat
510K K แวลา
12
Diagnostic Ultrasound Indications for Use Form UST-672-5/7.5 (K992663)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Modes of operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Velocity | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Opthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | P | P | P | See Below | ||||||
| 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: Combined includes: BM, B/PWD, 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)
(Division Sign-Off)
Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Sefety
510K KIIIO27
13
Diagnostic Ultrasound Indications for Use Form UST-676P (K023996)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Modes of operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Velocity | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Opthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | P | P | P | See Below | ||||||
| Transvaginal | P | P | P | See Below | ||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other: Gynecological |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Combined includes: BM, BPWD, 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)
(Division Sign-Off)
Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510K KIIIAA
14
Diagnostic Ultrasound Indications for Use Form UST-677P (K060059)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Modes of operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | |||||
| Doppler | Amplitude | ||||||||||
| Velocity | Color | ||||||||||
| Velocity | |||||||||||
| Imaging | Combined | ||||||||||
| (specify) | Other | ||||||||||
| (specify) | |||||||||||
| Opthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intraoperative (specify) | |||||||||||
| Pediatric | |||||||||||
| Small Organ (specify) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | P | P | P | See Below | |||||||
| Transvaginal | P | P | P | See Below | |||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletal | |||||||||||
| Conventional | |||||||||||
| Musculo-skeletal | |||||||||||
| Superficial | |||||||||||
| Other: Gynecological |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Combined includes: B/M, B/PWD, M/CD, B/CD/PW.
(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)
(Division Sign-On)
Division of Radiological Office of In Vitro Diagnostic
510K KII227
50
15
Diagnostic Ultrasound Indications for Use Form UST-978-3.5 (K963616)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Modes of operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Velocity | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Opthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | P | P | P | See Below | ||||||
| Intraoperative (specify) | ||||||||||
| Pediatric | P | P | P | 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: Combined includes: B/M, B/PWD, 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)
(Division Sign-Off)
Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510K K11222
16
Diagnostic Ultrasound Indications for Use Form UST-979-3.5 . (K963616)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Modes of operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Velocity | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Opthalmic | ||||||||||
| Fetal | P | P | P | |||||||
| Abdominal | P | P | P | See Below | ||||||
| Intraoperative (specify) | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other: Gynecological | P | P | P | See Below |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Combined includes: BM, BPWD, 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)
| (Division Sign-Off) |
|---|
Division of Radiological De Office of In Vitro Diagnostic De tion and Salan
510K K11227
17
Diagnostic Ultrasound Indications for Use Form UST-984-5 (K972465)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Modes of operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Velocity | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Opthalmic | ||||||||||
| Fetal | P | P | P | See Below | ||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | P | P | P | See Below | ||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other: Gynecological | P | P | P | See Below |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Combined includes: B/M, B/PWD, 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)
(Division Sign-Off)
Division of Radiological Devices Office of In Vitro Diagnostic Dev ice Evaluation and Safety
510K K11.227
18
Diagnostic Ultrasound Indications for Use Form UST-987-7.5 (K992663)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Modes of operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Velocity | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Opthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | P | P | P | See Below | ||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | P | P | P | See Below | ||||||
| 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: Combined includes: B/M, B/PWD, M/CD, B/CD/PWD.
Applications: Intra-operative- (liver, pancreas, gall bladder ... )
(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)
(Division Sign-Off)
Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
S10K KIIA27
19
Diagnostic Ultrasound Indications for Use Form UST-990-5 (K003739)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Modes of operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | |||||
| Doppler | Amplitude | ||||||||||
| Velocity | Color | ||||||||||
| Velocity | |||||||||||
| Imaging | Combined | ||||||||||
| (specify) | Other | ||||||||||
| (specify) | |||||||||||
| Opthalmic | |||||||||||
| Fetal | P | P | P | See Below | |||||||
| Abdominal | P | P | P | See Below | |||||||
| Intraoperative (specify) | |||||||||||
| Pediatric | |||||||||||
| Small Organ (specify) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac- Pediatric | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletal | |||||||||||
| Conventional | |||||||||||
| Musculo-skeletal Superficial | |||||||||||
| Other: Gynecological | P | P | P | See Below |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Combined includes: B/M, B/PWD, 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)
(Division Sign-Off)
Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Sefety
510K KIIIAA7
રક
20
Diagnostic Ultrasound Indications for Use Form UST-995-7.5 (K992663)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Modes of operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | |||||
| Doppler | Amplitude | ||||||||||
| Velocity | Color | ||||||||||
| Velocity | |||||||||||
| Imaging | Combined | ||||||||||
| (specify) | Other | ||||||||||
| (specify) | |||||||||||
| Opthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intraoperative (specify) | P | P | P | See Below | |||||||
| Pediatric | |||||||||||
| Small Organ (specify) | P | P | P | See Below | |||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | 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: Combined includes: BM, B/PWD, M/CD, B/CD/PWD.
Applications: Intra-operative- (liver, pancreas, gall bladder ... )
(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)
(Division Sign-Off)
Division of Radiologic Office of In Vitro Diagnostic Device Evaluation and Safety
510K
21
Diagnostic Ultrasound Indications for Use Form ASU-1003 (K020668)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Modes of operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Velocity | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Opthalmic | ||||||||||
| Fetal | P | P | P | See Below | ||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac (Pediatric) | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | P | P | P | See Below | ||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other: Gynecological | P | P | P | See Below |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Combined includes: BM, B/PWD, 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)
(Division Sign
Division of Radiological Devices Office of in Vitro Diagnostic Device Evaluation and Safety
510K Kuma?
22
Diagnostic Ultrasound Indications for Use Form ASU-1009 (K060059)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Modes of operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Velocity | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Opthalmic | ||||||||||
| Fetal | P | P | P | See Below | ||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac (Neonatal) | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | P | P | P | See Below | ||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other: Gynecological | P | P | P | See Below |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Combined includes: BM, B/PWD, 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)
Michael D. O'Hara
(Division Sign Off)
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K K11227
23
Diagnostic Ultrasound Indications for Use Form UST-5268P-5 (K992663)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Modes of operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | |||||
| Doppler | Amplitude | ||||||||||
| Velocity | Color | ||||||||||
| Velocity | |||||||||||
| Imaging | Combined | ||||||||||
| (specify) | Other | ||||||||||
| (specify) | |||||||||||
| Opthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intra-operative (specify) | P | P | P | See Below | |||||||
| Pediatric | |||||||||||
| Small Organ (specify) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac (Neonatal) | |||||||||||
| 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: Combined includes: BM, BPWD, M/CD, B/CD/PWD.
Intra-operative application: {liver, pancreas, gall bladder ... }
(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)
Michael D. O'Hern
(Division Sign-Off)
Office of Ir
510K KIIIAA
24
Diagnostic Ultrasound Indications for Use Form UST-5293-5 (K003739)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Modes of operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | |||||
| Doppler | Amplitude | ||||||||||
| Velocity | Color | ||||||||||
| Velocity | |||||||||||
| Imaging | Combined | ||||||||||
| (specify) | Other | ||||||||||
| (specify) | |||||||||||
| Opthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intraoperative (specify) | |||||||||||
| Pediatric | |||||||||||
| Small Organ (specify) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | P | P | P | 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: Combined includes: B/M, B/PWD, 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)
(Division Sign-Off)
Division of Radiological Devices
Office In Vitro Diagnostic Device Evaluation and Safety
510K K11227
25
Diagnostic Ultrasound Indications for Use Form UST-5298 (K003739)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Modes of operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | |||||
| Doppler | Amplitude | ||||||||||
| Velocity | Color | ||||||||||
| Velocity | |||||||||||
| Imaging | Combined | ||||||||||
| (specify) | Other | ||||||||||
| (specify) | |||||||||||
| Ophthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intraoperative (specify) | |||||||||||
| Pediatric | P | P | P | See Below | |||||||
| Small Organ (specify) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | P | P | P | 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: Combined includes: BM, B/PWD, 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)
(Division Sign-Off)
Division of Radlological Davices Office of In Vitro Diagnostic Device Evaluation and Safety
510K KIIIAA2
61
26
Diagnostic Ultrasound Indications for Use Form UST-5299 (K003739)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Modes of operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Velocity | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Opthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | P | P | P | P | 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: Combined includes: B/M, B/PWD, 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)
Michael D. D'Am
(Division Sign-Off)
Division of Ractionopical Dav Office of In ralyation and Safety
510K KII227
62
27
Diagnostic Ultrasound Indications for Use Form UST-5413 (K992663)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Modes of operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | |||||
| Doppler | Amplitude | ||||||||||
| Velocity | Color | ||||||||||
| Velocity | |||||||||||
| Imaging | Combined | ||||||||||
| (specify) | Other | ||||||||||
| (specify) | |||||||||||
| Opthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intraoperative (specify) | |||||||||||
| Pediatric | |||||||||||
| Small Organ (specify) | P | P | P | See Below | |||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac (Neonatal) | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | 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: Combined includes: BM, B/PWD, M/CD, B/CD/PWD.
Applications: Small Parts-(breast, testes & thyroid .. ),
(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)
Michael D. O'Hern
(Division Sign-Off)
Division of Radiological Devices Office of In Vit ice Evaluation and Safety
510K KIIUaA7
28
Diagnostic Ultrasound Indications for Use Form UST-5524-7.5 (K963616)
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 | |||||||||
| Velocity | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Opthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | P | P | P | See Below | ||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac (Neonatal) | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | 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: Combined includes: BM, B/PWD, M/CD, B/CD/PWD.
Applications: Small Parts-(breast, testes & thyroid..),
(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)
(Division Sign-Off)
Division of Radiological Devices Office of H aluation and Safety
Kแแวว
510K_
29
Diagnostic Ultrasound Indications for Use Form UST-5536-7.5 (K992663)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Modes of operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Velocity | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | P | P | P | See Below | ||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac (Neonatal) | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | P | P | P | See Below | ||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal | ||||||||||
| Superficial | ||||||||||
| Other: |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Combined includes: BM, B/PWD, M/CD, B/CD/PWD.
Applications: Intra-operative- (liver, pancreas, gall bladder ... )
(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)
Mhhal D. Oha
(Division Sign-Off)
Office of i
510K KII227
30
Diagnostic Ultrasound Indications for Use Form UST-5542 · (K003739)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Modes of operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Velocity | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Opthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | P | P | P | See Below | ||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac (Neonatal) | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | 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: Combined includes: BM, B/PWD, M/CD, B/CD/PWD.
Applications: Small Parts-(breast, testes & thyroid .. ),
(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)
Michael D. O'Hern
(Division Sign-Off)
n of Radiolon Office office of Evaluation and Sater
510K. KUUaaz
31
Diagnostic Ultrasound Indications for Use Form UST-5546 (K023996)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Modes of operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Velocity | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Opthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | P | P | P | See Below | ||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac (Neonatal) | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | 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: Combined includes: BM, B/PWD, M/CD, B/CD/PWD.
Applications: Small Parts-(breast, testes & thyroid..),
(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)
(Division Sign-Off)
on of Radiolonical Office of In ation and Safety
510K KIIIAA
32
Diagnostic Ultrasound Indications for Use Form UST-5548 (K032875)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Modes of operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | |||||
| Doppler | Amplitude | ||||||||||
| Velocity | Color | ||||||||||
| Velocity | |||||||||||
| Imaging | Combined | ||||||||||
| (specify) | Other | ||||||||||
| (specify) | |||||||||||
| Opthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intraoperative (specify) | |||||||||||
| Pediatric | |||||||||||
| Small Organ (specify) | P | P | P | See Below | |||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac (Neonatal) | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | 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: Combined includes: B/M, B/PWD, M/CD, B/CD/PWD.
Applications: Small Parts-(breast, testes & thyroid .. ),
(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)
Michael D'Hara
(Division Sign-Off)
Division of Badioloo Office of In ation and Safety
510K Kullaar
33
Diagnostic Ultrasound Indications for Use Form UST-5710-7.5 (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 | |||||||||
| Velocity | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Opthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | P | P | P | See Below | ||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac (Neonatal) | ||||||||||
| 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: Combined includes: B/M, B/PWD, M/CD, B/CD/PWD.
Applications: Small Parts-(breast, testes & thyroid .. ),
(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)
(Division Sign-Off)
Division of Radiologic Office of In
510K KIIววา
34
Diagnostic Ultrasound Indications for Use Form UST-9101-7.5 (K003739)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Modes of operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Velocity | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Opthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | P | P | P | See Below | ||||||
| Intraoperative (specify) | ||||||||||
| Pediatric | P | P | P | See Below | ||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac (Neonatal) | ||||||||||
| 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: Combined includes: BM, BPWD, 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)
Mukhlis D. Thahir
(Division Sign-Off)
Division of Radiological Devices thice of in Vitro Diagnostic Devices
thice of in Vitro Diagnostic Device Evaluation and Safety
:OK Kแลา
35
Diagnostic Ultrasound Indications for Use Form UST-9102-3.5 (K012253)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Modes of operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Velocity | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Opthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | P | P | P | See Below | ||||||
| Intraoperative (specify) | ||||||||||
| Pediatric | P | P | P | See Below | ||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac (Neonatal) | ||||||||||
| 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: Combined includes: BM, B/PWD, 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)
(Division Sign-Off)
(Division Sign-OH) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510K K111227
36
Diagnostic Ultrasound Indications for Use Form UST-9102U-3.5 (K012253)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Modes of operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Velocity | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Opthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | P | P | P | See Below | ||||||
| Intraoperative (specify) | ||||||||||
| Pediatric | P | P | P | See Below | ||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac (Neonatal) | ||||||||||
| fransesophageal | ||||||||||
| 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: Combined includes: B/M, B/PWD, 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)
(Division Sian-Off)
Division of Radiological Devices Office of In Vitro Diagnostic D ation and Safety
510K KII227
37
. Diagnostic Ultrasound Indications for Use Form UST-9104-5 (K003739)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Modes of operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Velocity | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Opthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | P | P | P | See Below | ||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | P | P | P | See Below | ||||||
| Adult Cephalic | ||||||||||
| Cardiac (Neonatal) | ||||||||||
| 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: Combined includes: BM, B/PWD, M/CD, B/CD/PWD.
Applications: Intra-operative- (liver, pancreas, gall bladder ... )
(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)
(Division Sign-Off)
Division of Radiological Office of in Vitro Diagnostic De
510K K11227
38
Diagnostic Ultrasound Indications for Use Form UST-9112-5 (K012253)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Modes of operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | |||||
| Doppler | Amplitude | ||||||||||
| Velocity | Color | ||||||||||
| Velocity | |||||||||||
| Imaging | Combined | ||||||||||
| (specify) | Other | ||||||||||
| (specify) | |||||||||||
| Opthalmic | |||||||||||
| Fetal | P | P | P | See Below | |||||||
| Abdominal | |||||||||||
| Intraoperative (specify) | |||||||||||
| Pediatric | |||||||||||
| Small Organ (specify) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac (Neonatal) | |||||||||||
| Fransesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | P | P | P | See Below | |||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletal | |||||||||||
| Conventional | |||||||||||
| Musculo-skeletal Superficial | |||||||||||
| Other: Gynecological | P | P | P | See Below |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Combined includes: B/M, B/PWD, 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)
Michael D. O'Hern
(Division Sign-Off)
Division of Badinlor Office of In Vitro Diagno aluation and Safety
510K. KIIaaA
39
Diagnostic Ultrasound Indications for Use Form UST-9121 (K003739)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Modes of operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Velocity | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Opthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | P | P | P | See Below | ||||||
| Intraoperative (specify) | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac (Neonatal) | ||||||||||
| 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: Combined includes: B/M, B/PWD, 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)
Muhul D'Ohm
(Division Sign-Off)
Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
610K K11227
40
Diagnostic Ultrasound Indications for Use Form UST-9123 (K003739)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Modes of operation | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||||
| Doppler | Amplitude | |||||||||||
| Velocity | Color | |||||||||||
| Velocity | ||||||||||||
| Imaging | Combined | |||||||||||
| (specify) | Other | |||||||||||
| (specify) | ||||||||||||
| Opthalmic | ||||||||||||
| Fetal | P | P | P | See Below | ||||||||
| Abdominal | P | P | P | See Below | ||||||||
| Intraoperative (specify) | ||||||||||||
| Pediatric | ||||||||||||
| Small Organ (specify) | ||||||||||||
| Neonatal Cephalic | ||||||||||||
| Adult Cephalic | ||||||||||||
| Cardiac (Neonatal) | ||||||||||||
| Transesophageal | ||||||||||||
| Transrectal | ||||||||||||
| Transvaginal | ||||||||||||
| Transurethral | ||||||||||||
| Intravascular | ||||||||||||
| Peripheral Vascular | ||||||||||||
| Laparoscopic | ||||||||||||
| Musculo-skeletal | ||||||||||||
| Conventional | ||||||||||||
| Musculo-skeletal Superficial | ||||||||||||
| Other: Gynecological | P | P | P | See Below |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Combined includes: BM, B/PWD, 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)
M.A.D. O'Hern
(Division Sign-Off)
Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510K. Kulla
41
Diagnostic Ultrasound Indications for Use Form UST-9124 (K003739)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Modes of operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Velocity | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Opthalmic | ||||||||||
| Fetal | P | P | P | See Below | ||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac (Neonatal) | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | P | P | P | See Below | ||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other: Gynecological | P | P | P | See Below |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Combined includes: BM, B/PWD, 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)
(Division Sign-Off)
Division of Radiological Devices Office of In Vitro Diagi ice Evaluation and Safety
510K KIIIAA7
42
t
Diagnostic Ultrasound Indications for Use Form UST-9127 (K060059)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Modes of operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Velocity | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Opthalmic | ||||||||||
| Fetal | P | P | P | See Below | ||||||
| Abdominal | P | P | P | See Below | ||||||
| Intraoperative (specify) | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac (Neonatal) | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other: Gynecological | P | P | P | See Below |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Combined includes: BM, BPWD, 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)
(Division Sign-Off
Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510K K 111227
43
Diagnostic Ultrasound Indications for Use Form UST-9128 (K032875)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Modes of operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Velocity | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Opthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | P | P | P | See Below | ||||||
| Intraoperative (specify) | ||||||||||
| Pediatric | P | P | P | See Below | ||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac (Neonatal) | ||||||||||
| 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: Combined includes: B/M, B/PWD, 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)
(Division
on of Radiological De Office of In
510K Kแววา
44
Diagnostic Ultrasound Indications for Use Form UST-9133 (K060059)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Modes of operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | |||||
| Doppler | Amplitude | ||||||||||
| Velocity | Color | ||||||||||
| Velocity | |||||||||||
| Imaging | Combined | ||||||||||
| (specify) | Other | ||||||||||
| (specify) | |||||||||||
| Opthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intraoperative (specify) | P | P | P | See Below | |||||||
| Pediatric | |||||||||||
| Small Organ (specify) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac (Neonatal) | |||||||||||
| 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: Combined includes: BM, B/PWD, M/CD, B/CD/PWD.
Applications: Intra-operative- (liver, pancreas, gall bladder ... )
(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)
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
KIIIA22
510K
45
Diagnostic Ultrasound Indications for Use Form UST-9136U (K043196)
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
Velocity | Color
Velocity
Imaging | Combined
(specify) | Other
(specify) |
|------------------------------------------------------------------|---|---|---|-----|-----|------------------|-----------------------|------------------------------|-----------------------|--------------------|
| Opthalmic | | | | | | | | | | |
| Fetal | | E | E | E | | | | | See Below | |
| Abdominal | | E | E | E | | | | | See Below | |
| Intraoperative (specify) | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac (Neonatal) | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal
Conventional
Musculo-skeletal Superficial | | | | | | | | | | |
| Other: Gynecological | | E | E | E | | | | | See Below | |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Combined includes: B/M, B/PWD, 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)
Mull O'thun
(Division Sign-Off)
on of Radiologic Office of In
510K KIIIAวา
46
Diagnostic Ultrasound Indications for Use Form UST-MC11-8731 (K032875)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Modes of operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Velocity | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Opthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | P | P | P | See Below | ||||||
| Pediatric | ||||||||||
| Small Organ (specify) | P | P | P | See Below | ||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac (Neonatal) | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | 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: Combined includes: B/M, B/PWD, M/CD, B/CD/PWD.
Applications: Small Parts-(breast, testes & thyroid..), Intra-operative- (liver, pancreas, gall bladder ... )
(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)
(Division Sign-Off)
Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510K K11227