(23 days)
The device is intended for use by a qualified physician for ultrasound evaluation of Small Parts, Abdominal, Cardiac, Peripheral Vascular, Fetal, Intra-operative, Trans-vaginal , Trans-rectal, Gynecological, Musculo-sketal and Neonatal Cephalic applications. The device is not indicated for Ophthalmic applications.
The Prosound F75 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.
The provided document is a 510(k) summary for the Aloka Prosound F75 Diagnostic Ultrasound System. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a clinical study for a novel device. Therefore, many of the requested categories for acceptance criteria and clinical study details are not applicable in this context.
Here's a breakdown based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance
For a traditional medical device like an ultrasound system undergoing 510(k) clearance, the "acceptance criteria" are generally established through engineering and performance testing against recognized standards to demonstrate that the device performs as intended and is safe and effective. The "reported device performance" is then the outcome of these non-clinical tests. The key acceptance criterion for a 510(k) is substantial equivalence to a predicate device.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device | The Aloka Prosound F75 is deemed technically comparable and substantially equivalent to the Aloka Alpha 10 (K043196). It possesses the same technological characteristics, key safety and effectiveness features, intended uses, and basic operating modes. |
| Compliance with Applicable Medical Device Safety Standards | The device and its transducers (listed: UST-567, UST-675P, ASU-1010, UST-2265-2, UST-2266-5, UST-5293-5, UST-5411, UST-5415, UST-9118, UST-9130, UST-9133, UST-9146I, UST-9146T, UST-9147, UST-52105, UST-52119S, UST-52121S, UST-52124) have been evaluated for: - Acoustic output - Biocompatibility - Cleaning & disinfection effectiveness - Electromagnetic compatibility - Electrical and mechanical safety. They were found to conform with applicable medical device safety standards. |
| Quality System Compliance | The design, development, and quality process conforms with 21 CFR 820, ISO 9001:2000, and ISO 13485 quality systems. |
| Intended Use Alignment with Traditional Clinical Practices | Intended uses and other key features are consistent with traditional clinical practices and FDA guidelines. |
Study Details:
For this 510(k) submission, the primary "study" is the demonstration of substantial equivalence through non-clinical testing and comparison to a legally marketed predicate device.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable for this type of submission. This 510(k) does not involve a clinical test set in the way a novel AI device might. The review is based on internal technical evaluations, compliance with standards, and comparison to a predicate device.
- Data Provenance: Not applicable. The "data" are primarily technical specifications, test reports for acoustic output, biocompatibility, etc., and a comparison matrix to the predicate device. These are internal company documents and safety standard compliance reports.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Number of Experts & Qualifications: Not applicable. Ground truth, in the context of clinical studies with expert consensus, is not part of this 510(k) pathway for an ultrasound system. The "ground truth" here is adherence to engineering specifications and safety standards, and functional equivalence to the predicate device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable. This concept pertains to resolving discrepancies in expert labeling or diagnoses in clinical studies, which were not conducted for this submission.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC Comparative Effectiveness Study: No. This device is a diagnostic ultrasound system, not an AI-powered image analysis tool designed to assist human readers, or a novel therapy. Therefore, an MRMC study is not relevant to its clearance.
6. If a standalone (i.e. algorithm only, without human-in-the loop performance) was done
- Standalone Performance Study: No. This device is an imaging system operated by a human physician, not an algorithm, and the concept of "standalone performance" for an algorithm is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: The "ground truth" in this context is the established safety and effectiveness of the predicate device (Aloka Alpha 10), and the objective measurements demonstrating that the new device meets recognized safety and performance standards (e.g., acoustic output limits, electrical safety, biocompatibility, cleaning efficacy).
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
- Ground Truth for Training Set Establishment: Not applicable. As this is not an AI/machine learning device, there is no training set or associated ground truth for it.
In summary: The Aloka Prosound F75 Diagnostic Ultrasound System obtained 510(k) clearance by demonstrating substantial equivalence to a predicate device (Aloka Alpha 10) through technical comparisons and compliance with recognized safety and performance standards. It did not involve clinical trials, expert consensus studies, or AI algorithm performance evaluations as typically seen for novel software or AI/ML devices.
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י
.
"
Model Prosound F75
510(K)
1026 KI FEB 1 7 2011
510(k) Summary of Safety and Effectiveness ・ Prepared in accordance with 21 CFR Part 807.92
| 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: | 11/24/2010 |
| 2. Device Name: | Aloka Prosound F75 Diagnostic Ultrasound SystemUltrasonic Pulsed Doppler Imaging System, 21 CFR 892.1550 , 90 IYNDiagnostic Ultrasound Transducer, 21 CFR 892.1570, 90 ITXUltrasonic Pulsed Echo Imaging System, 21 CFR 892.1560, 90 IYO |
| 3. Marketed Device: | Aloka Alpha 10 Diagnostic Ultrasound System, K043196, (90-IYN, ITX, IYO)( A device currently in commercial distribution) |
| 4. Device Description: | The Prosound F75 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, Trans-vaginal , Trans-rectal, Gynecological, Musculo-sketal and Neonatal Cephalic applications. The device is not indicated for Ophthalmic applications. |
| 6. Comparison w/ Predicate Device: | The Aloka Prosound F75 is technically comparable and substantially equivalent to the current Aloka Alpha 10-(K043196). 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 Prosound F75 Diagnostic Ultrasound System and its transducers are substantially equivalent with respect to safety and effectiveness to its predicate and other currently cleared Aloka systems. |
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New Indications for Use: There are no new indications for use. 1.3.2
Previously Cleared Indications for Use: 1.3.3
The Prosound F75 diagnostic ultrasound system and its transducers are intended for use in diagnostic ultrasound examinations. These ultrasound applications for use include: Small Parts, Intraoperative, Abdominal, Gynecological, Cardiac, Musculo-skeletal, Transvaginal, Neonatal: Cephalic, Fetal & Peripheral Vascular.
The Prosound F75 has the same indications for use as its predicate - Aloka Alpha 10- (K043196) and other market cleared systems and transducers manufactured by Aloka.
Promotional information for the Prosound F75 is provided in Appendix D of this submission.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES.USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with outstretched wings.
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
FEB 1 7 2011
Re: K110207
Trade/Device Name: Aloka Prosound F75 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: January 14, 2011 Received: January 25, 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 Prosound F75, as described in your premarket notification: ··
Transducer Model Number
| UST-567 | UST-5411 | UST-9146T |
|---|---|---|
| UST-675P | UST-5415 | UST-9147 |
| ASU-1010 | UST-9118 | UST-52105 |
| UST-2265-2 | UST-9130 | UST-52119S |
| UST-2266-5 | UST-9133 | UST-52121S |
| UST-5293-5 | UST-9146I | UST-52124 |
{3}------------------------------------------------
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 Lauren Hefner at (301) 796-6881.
Sincerely Yours.
han DOK for
Mary Pastel, ScD. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure(s)
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Indications for Use
510(K) Number (if known): Device Name:
Indications For Use:
Aloka Prosound F75
The device is intended for use by a qualified physician for ultrasound evaluation of Small Parts, Abdominal, Cardiac, Peripheral Vascular, Fetal, Intra-operative, Trans-vaginal, Trans-rectal, Musculo-skeletal, Gynecological and Neonatal Cephalic applications.
The device is not indicated for Ophthalmic applications.
Prescription Use_ P (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)
Aushad D.K.
(Division Sign-Off) Division of Radiological Devices Office of In Vitro Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K K110207
Page 1 of 1
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1.3.1
Diagnostic Ultrasound Indications for Use Form Prosound F75 .
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 | ColorDoppler(CD) | AmplitudeDoppler | ColorVelocityImaging | Combined(specify) | Other(specify) |
| Opthalmic | ||||||||||
| Fetal | N | N | N | N | See Note 1 | |||||
| Abdominal | N | N | N | N | See Note 1 | |||||
| Intra-operative (specify) | N | N | N | N | See Note 1 | |||||
| Intra-operative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | N | N | N | N | See Note 1 | |||||
| Neonatal Cephalic | N | N | N | N | See Note 1 | |||||
| Adult Cephalic | ||||||||||
| Cardiac | N | N | N | N | N | See Note 1, 2 | ||||
| Transesophageal | ||||||||||
| Transrectal | N | N | N | N | See Note 1 | |||||
| Transvaginal | N | N | N | N | See Note 1 | |||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | N | N | N | N | See Note 1 | |||||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | N | N | N | N | ||||||
| Musculo-skeletal Superficial | ||||||||||
| Other: Gynecological | N | N | N | N | See Note 1 |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Mixed mode operation includes: Note I- B/M, B/PWD, M/CD, B/CWD, B/CD/CWD 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)
510K K110207
{6}------------------------------------------------
Diagnostic Ultrasound Indications for Use Form UST-567 (K041916)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler(CD) | AmplitudeDoppler | ColorVelocityImaging | Combined(specify) | Other (specify) |
|---|---|---|---|---|---|---|---|---|---|---|
| Opthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | N | N | N | N | See Note 1 | |||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | N | N | N | N | See Note 1 | |||||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | N | N | N | N | See Note 1 | |||||
| Musculo-skeletal Superficial | ||||||||||
| Other: |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Combined includes Note 1: B/M, B/WD, M/CD, B/CD/PWD
Applications: Small Parts: ( breasts, 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)
510K K110207
{7}------------------------------------------------
Diagnostic Ultrasound Indications for Use Form UST-675P (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 | ColorDoppler(CD) | AmplitudeDoppler | ColorVelocityImaging | Combined(specify) | Other(specify) |
| Opthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | P | P | P | P | See Note 1 | |||||
| Transvaginal | P | P | P | P | See Note 1 | |||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other: Gynecological |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Combined includes Note 1: 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)
Mihail D. O'Brien
(Division Sign-Off)
510K K110207
{8}------------------------------------------------
Diagnostic Ultrasound Indications for Use Form ASU-1010 (K043196)
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 | ColorDoppler(CD) | AmplitudeVelocity | ColorVelocityImaging | Combined(specify) | Other(specify) |
| Opthalmic | ||||||||||
| Fetal | P | P | P | P | See Note 1 | |||||
| Abdominal | P | P | P | P | See Note 1 | |||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal- | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other: Gynecological | P | P | P | P | See Note 1 |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Combined includes Note 1: 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)
No br. 10 Prescription Use (Per 21 CFR 801.109)
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K Kilox22
{9}------------------------------------------------
Diagnostic Ultrasound Indications for Use Form UST-2265-2 (K012080)
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 | ColorDoppler | AmplitudeVelocity | ColorVelocityImaging | Combined(specify) | Other(specify) | |
| Opthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intraoperative (specify) | |||||||||||
| Intraoperative Neurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ (specify) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | P | ||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletalConventional | |||||||||||
| Musculo-skeletal Superficial | |||||||||||
| Other: |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
(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 Division of Alakological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K. K110267
45
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Diagnostic Ultrasound Indications for Use Form UST-2266-5 (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 | ColorDoppler | AmplitudeVelocity | ColorVelocityImaging | Combined(specify) | Other(specify) | |
| Opthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intraoperative (specify) | |||||||||||
| Intraoperative Neurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ (specify) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | N | ||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletalConventional | |||||||||||
| Musculo-skeletal Superficial | |||||||||||
| Other: |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
(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 K110267
{11}------------------------------------------------
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 | ColorDoppler(CD) | AmplitudeVelocity | ColorVelocityImaging | Combined(specify) | Other(specify) |
| Opthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | P | P | P | P | P | See Note 1, 2 | ||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other: |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Combined includes Note 1: BM, BPWD, MCD, B/CD/PWD, Note 2: B/CWD, B/CD/CWD
(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)
510K. K110207
{12}------------------------------------------------
Diagnostic Ultrasound Indications for Use Form UST-5411 (K043196)
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 | ColorDoppler(CD) | AmplitudeVelocity | ColorVelocityImaging | Combined(specify) | Other(specify) | |
| Opthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intraoperative (specify) | |||||||||||
| Intraoperative Neurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ (specify) | P | P | P | P | See Note 1 | ||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | P | P | P | P | See Note 1 | ||||||
| Laparoscopic | |||||||||||
| Musculo-skeletalConventional | P | P | P | P | See Note 1 | ||||||
| Musculo-skeletal Superficial | |||||||||||
| Other: |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Combined includes Note 1: B/M, B/PWD, M/CD, B/CD/PWD
Applications: Small Parts: (breasts, testes, thyroid ... )
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Preseription Use (Per 21 CFR 801.109)
48
(Division Sign-Off)
510K K110207
{13}------------------------------------------------
.
510(K)
Diagnostic Ultrasound Indications for Use Form UST-5415 (K043196)
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 | ColorDoppler(CD) | AmplitudeVelocity | ColorVelocityImaging | Combined(specify) | Other(specify) | |
| Opthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intraoperative (specify) | |||||||||||
| Intraoperative Neurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ (specify) | N | N | N | N | See Note 1 | ||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | N | N | N | N | See Note 1 | ||||||
| Laparoscopic | |||||||||||
| Musculo-skeletal Conventional | N | N | N | N | See Note 1 | ||||||
| Musculo-skeletal Superficial | |||||||||||
| Other: |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Combined includes Note 1: BM, BIPWD, MICD, BICD/PWD
Applications: Small Parts: (breasts, testes, thyroid....)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
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510K K110207
{14}------------------------------------------------
Diagnostic Ultrasound Indications for Use Form UST-9118 (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 | ColorDoppler(CD) | AmplitudeVelocity | ColorVelocityImaging | Combined(specify) | Other(specify) |
| Opthalmic | ||||||||||
| Fetal | P | P | P | P | See Note 1 | |||||
| Abdominal | ||||||||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | P | P | P | P | See Note 1 | |||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other: Gynecological | P | P | P | P | See Note 1 |
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)
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510K K110267
50
{15}------------------------------------------------
Diagnostic Ultrasound Indications for Use Form UST-9130 (K043196)
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 | ColorDoppler(CD) | AmplitudeVelocity | ColorVelocityImaging | Combined(specify) | Other(specify) | |
| Opthalmic | ||||||||||
| Fetal | P | P | P | P | See Note 1 | |||||
| Abdominal | P | P | P | P | See Note 1 | |||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other: Gynecological | P | P | P | P | See Note 1 |
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)
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510K K110207
{16}------------------------------------------------
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 | ColorDoppler(CD) | AmplitudeVelocity | ColorVelocityImaging | Combined(specify) | Other(specify) | |
| Opthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intraoperative (specify) | P | P | P | P | See Note 1 | ||||||
| Intraoperative Neurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ (specify) | |||||||||||
| Neonatal Cephalic | P | P | P | P | See Note 1 | ||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transuretbral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletalConventional | |||||||||||
| Musculo-skeletal Superficial | |||||||||||
| Other: |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Combined includes-Note 1: 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)
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510K: K110207
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{17}------------------------------------------------
Diagnostic Ultrasound Indications for Use Form UST-91461 (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 | ColorDoppler(CD) | AmplitudeVelocity | ColorVelocityImaging | Combined(specify) | Other(specify) |
| Opthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | N | N | N | N | See Note 1 | |||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other: |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Combined includes-Note 1: 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
510K. K115207
{18}------------------------------------------------
ﺍ
Diagnostic Ultrasound Indications for Use Form UST-9146T (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 | ColorDoppler(CD) | AmplitudeVelocity | ColorVelocityImaging | Combined(specify) | Other(specify) | |
| Opthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intraoperative (specify) | N | N | N | N | See Note 1 | ||||||
| Intraoperative Neurological | |||||||||||
| Pediatric | |||||||||||
| 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 Note 1: 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)
Mh Dork
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510K K110207
{19}------------------------------------------------
Diagnostic Ultrasound Indications for Use Form UST-9147 (K043196)
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 | ColorDoppler(CD) | AmplitudeVelocity | ColorVelocityImaging | Combined(specify) | Other(specify) |
| Opthalmic | ||||||||||
| Fetal | N | N | N | N | See Note 1 | |||||
| Abdominal | N | N | N | N | See Note 1 | |||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other: Gynecological | N | N | N | N | See Note 1 |
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)
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510K. K110207
{20}------------------------------------------------
Diagnostic Ultrasound Indications for Use Form UST-52105 (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 | ColorDoppler(CD) | AmplitudeVelocity | ColorVelocityImaging | Combined(specify) | Other(specify) |
| Opthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | N | N | N | N | N | See Note 1, 2 | ||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other: |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Combined includes Note 1: B/M, B/PWD, M/CD, B/CD/PWD & Note 2: B/CWD, B/CD/CWD.
(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)
510K K110207 56
56
{21}------------------------------------------------
Diagnostic Ultrasound Indications for Use Form UST-52119S (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 | ColorDoppler(CD) | AmplitudeVelocity | ColorVelocityImaging | Combined(specify) | Other(specify) | |
| Opthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intraoperative (specify) | |||||||||||
| Intraoperative Neurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ (specify) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac, Pediatric | N | N | N | N | N | N | See Note 1, 2 | ||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletalConventional | |||||||||||
| Musculo-skeletal Superficial | |||||||||||
| Other: |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Combined includes Note 1: BM, BPWD, MCD, B/CDPWD, & Note 2: B/CWD, B/CD/CWD
(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 K110207
57
{22}------------------------------------------------
Diagnostic Ultrasound Indications for Use Form UST-521218 (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 | ColorDoppler(CD) | AmplitudeVelocity | ColorVelocityImaging | Combined(specify) | Other(specify) |
| Opthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac (Pediatric) | N | N | N | N | N | N | See Note 1, 2 | |||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other: |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Combined includes Note 1: BM, B/PWD, MCD, B/CD/PWD & Note 2: B/CWD, B/CD/CWD
(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)
h.D.O'K
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510K. K110207
દક
{23}------------------------------------------------
1
Diagnostic Ultrasound Indications for Use Form UST-52124 (K032875)
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 | ColorDoppler(CD) | AmplitudeVelocity | ColorVelocityImaging | Combined(specify) | Other(specify) | |
| Opthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | N | N | N | N | N | Note 1, 2 | ||||
| Adult Cephalic | ||||||||||
| Cardiac (Neonatal) | N | N | N | N | N | Note 1, 2 | ||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other: |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Combined includes Note 1: BM, BPWD, MCD, B/CDPWD, Note 2: B/CWD, B/CD/CWD
(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)
59 ·
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ica of In Vitro Diagnostic Device
510K K110207
§ 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.