(45 days)
No
The document describes a standard ultrasound system with image processing capabilities, but there is no mention of AI, ML, or related concepts like training or test sets for algorithms.
No
The device is described as an "imaging and analysis system" for "ultrasound evaluation" and its intended use focuses on diagnostic applications to visualize anatomical structures, rather than to treat conditions.
Yes
The device is described as a "Diagnostic Ultrasound System" and is used for "ultrasound evaluation" in various medical applications.
No
The device description explicitly states it is a "full-digital portable imaging and analysis system" consisting of a monitor, keyboard, controls, and display, indicating it is a hardware system with integrated software, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states the device is a "Diagnostic Ultrasound System." Ultrasound is an imaging modality that uses sound waves to create images of internal body structures. It does not involve testing samples taken from the body.
- Intended Use: The intended uses listed are all related to imaging and evaluating internal anatomical structures (Gyneological, Fetal, Peripheral Vascular, Cardiac, etc.). This is consistent with an imaging device, not an IVD.
Therefore, the Aloka Prosound 2 Diagnostic Ultrasound System is a medical imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The device is intended for use by a qualified physician for ultrasound evaluation of Gyneological, Fetal, Peripheral Vascular, Cardiac, Neonatal Cephalic, Small Parts, Intra-operative, Transrectal and Abdominal applications. The device is not indicated for Ophthalmic applications. Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal, Abdominal, Intraoperative (specify), Small Organ (specify), Neonatal Cephalic, Cardiac, Transrectal, Transvaginal, Peripheral Vascular, Gynecological. Mixed mode operation includes: BM. Applications: Small Parts-(breast, testes & thyroid), abdominal, gynecological-fetal, neonatal cephalic, transrectal, transvaginal, cardiac, intra-operative-(liver, pancreas, gall bladder, etc.), peripheral vascular.
For transducers:
UST-5561-7.5: Intrartoperative (specify): Intra-Operative- (Liver, pancreas, gall Bladder); Small Organ (specify): Small Parts- (breasts, tests, thyroid, etc.)
UST-556T-7.5: Intraoperative (specify): Intra-Operative- (Liver, pancreas, gall Bladder); Small Organ (specify): Small Parts- (breasts, tests, thyroid, etc.)
UST-556TU-7.5: Intraoperative (specify): Intra-Operative- (Liver, pancreas, gall Bladder); Small Organ (specify): Small Parts- (breasts, tests, thyroid, etc.)
UST-586-5: Small Organ (specify): Small Parts- (breasts, tests, thyroid, etc.)
UST-5871-5: Intraoperative (specify): Intra-Operative- (Liver, pancreas, gall Bladder); Small Organ (specify): Small Parts- (breasts, tests, thyroid, etc.)
UST-660-7.5: Transrectal
UST-934N-3.5: Fetal, Abdominal, Other: Gynecological
UST-935N-5: Fetal, Abdominal, Other: Gynecological
UST-944B-3.5: Abdominal, Cardiac
UST-945B-5: Fetal, Transvaginal, Gynecological
UST-974-5: Neonatal Cephalic
UST-981-5: Fetal, Transvaginal, Gynecological
UST-5512U-7.5: Small Organ (specify): Small Parts- (breasts, tests, thyroid, etc.); Peripheral Vascular
UST-5551: Small Organ (specify): Small Parts- (breasts, tests, thyroid, etc.)
UST-5711: Small Organ (specify): Small Parts- (breasts, tests, thyroid, etc.); Peripheral Vascular
UST-5820-5: Intraoperative (specify): Intra-Operative- (Liver, pancreas, gall Bladder); Small Organ (specify): Small Parts- (breasts, tests, thyroid, etc.)
UST-9111-5: Intraoperative (specify): Intra-Operative- (Liver, pancreas, gall Bladder); Neonatal Cephalic
UST-9137: Fetal, Abdominal, Gynecological
Product codes (comma separated list FDA assigned to the subject device)
IYN, ITX, IYO
Device Description
The Aloka Prosound 2 Diagnostic Ultrasound System is a light weight, full-digital portable imaging and analysis system. It consist of a high resolution LCD flat panel monitor that provides excellent image quality and processing. 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
Gyneological, Fetal, Peripheral Vascular, Cardiac, Neonatal Cephalic, Small Parts (breast, testes & thyroid), Intraoperative (liver, pancreas, gall bladder, etc.), Transrectal, Abdominal, Transvaginal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Qualified physician/Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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. 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.
K840540, K870916, K861538, K910153
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
510(K)
KCJ3254
DEC 1 9 2008
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 Richard J. Cehovsky, RA/QA Coordinator, Contact Person: Tel: (203)269-5088 Ext. 346, Fax: 203-269-6075 Date Prepared: 9/18/08 2. Device Name: Aloka Prosound 2 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 Aloka SSD-500 Diagnostic Ultrasound System K900805, (90-IYN, ITX, IYO) 3. Marketed Device: ( A device currently in commercial distribution) 4. Device Description: The Aloka Prosound 2 Diagnostic Ultrasound System is a light weight, full-digital portable imaging and analysis system. It consist of a high resolution LCD flat panel monitor that provides excellent image quality and processing . The user interface includes a computer type keyboard. specialized controls and a display. Indications for Use: The device is intended for use by a qualified physician for ultrasound evaluation of 5. Gyneological, Fetal, Peripheral Vascular, Cardiac, Neonatal Cephalic, Small Parts, Intraoperative, Transrectal and Abdominal applications. The device is not indicated for Ophthalmic applications. 6.Comparison w/ Predicate Device: The Aloka Prosound 2 is technically comparable and substantially equivalent to the current Aloka SSD-500-(K900805). 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 2 Diagnostic Ultrasound System and its transducers are substantially equivalent with respect
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 Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
000 2 2 2009
Aloka Co., Ltd. % Mr. Tamas Borsai Division Manager, Medical Division TÜV Rheinland of North America 12 Commerce Road NEWTOWN CT 06470
Re: K083254
Trade/Device Name: Aloka Prosound 2 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: December 2, 2008 Received: December 4, 2008
Dear Mr. Borsai:
J
This letter corrects our substantially equivalent letter of December 19, 2008.
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 2, as described in your premarket notification:
Transducer Model Number
| UST-5561-7.5 | UST-660-7.5 |
|---|---|
| UST-556T-7.5 | UST-934N-3.5 |
| UST-556TU-7.5 | UST-935N-5 |
| UST-586-5 | UST-944B-3.5 |
| UST587I-5 | UST-945B-5 |
2
| UST-974-5 | UST-5711 |
|---|---|
| UST-981-5 | UST-5820-5 |
| UST-5512U-7.5 | UST-9111-5 |
| UST-5551 | UST-9137 |
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 898. 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 contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
If you have any questions regarding the content of this letter, please contact Lauren Hefner at (240) 276-3666.
Sincerely yours,
Harald Lemke
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
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Section 1.3 Indications for Use
Section 1.3.1
510(k) Indications for Use Statement/Forms
( Immediately follows this page)
4
Indications for Use
510(K) Number (if known):
Device Name:
Aloka Prosound 2
Indications For Use:
The device is intended for use by a qualified physician for ultrasound evaluation of Gyneological, Fetal, Peripheral Vascular, Cardiac, Neonatal Cephalic, Small Parts, Intra-operative, Transrectal and Abdominal 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)
IPLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hertenn
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 8355 510(k) Number
Page 1 of 1
5
1.3.1
Diagnostic Ultrasound Indications for Use Form Prosound 2
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 | N | N | See Below | |||||||
| Abdominal | N | N | See Below | |||||||
| Intraoperative (specify) | N | N | See Below | |||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | N | N | See Below | |||||||
| Neonatal Cephalic | N | N | See Below | |||||||
| Adult Cephalic | ||||||||||
| Cardiac | N | N | See Below | |||||||
| Transesophageal | ||||||||||
| Transrectal | N | N | See Below | |||||||
| Transvaginal | N | N | See Below | |||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | N | N | See Below | |||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other: Gynecological | N | N | See Below |
N= new indication; P= previously cleared by FDA; E= added under Appendix A
Additional Comments: Mixed mode operation includes- BM
Applications: Small Parts-(breast, testes & thyroid), abdominal, gynecological-fetal, neonatal cephalic,
transrectal, transvaginal, cardiac, intra-operative-(liver, pancreas, gall bladder, etc.), peripheral vascular.
(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 Reproductive, Abdominal and Radiological Devices 510(k) Number
6
.
・
Diagnostic Ultrasound Indications for Use Form UST-5561-7.5 (K840540)
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 | See Below | |||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | P | P | See Below | |||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Mixed mode operation includes- B/M
Applications: Small Parts- (breasts, tests, thyroid, etc.), Intra-Operative- (Liver, pancreas, gall Bladder)
IE 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 Reproductive, Abdominal and Radiological Devices Radiological Devices 2018 3 255
AAA
00
・
. .
7
Diagnostic Ultrasound Indications for Use Form UST-556T-7.5 (K840540)
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 | See Below | |||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | P | P | See Below | |||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other: |
Ne new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Mixed mode operation includes- B/M
Applications: Small Parts- (breasts, tests, thyroid, etc.), Intra-Operative- (Liver, pancreas, gall Bladder)
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 Reproductive, Abdominal and
Radiological Devices
510(k) Number
8
Diagnostic Ultrasound Indications for Use Form UST-556TU-7.5
(K870916)
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 | See Below | ||||||||
| Intraoperative Neurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ (specify) | P | P | See Below | ||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletal | |||||||||||
| Conventional | |||||||||||
| Musculo-skeletal Superficial | |||||||||||
| Other |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Mixed mode operation includes- B/M
Applications: Small Parts- (breasts, tests, thyroid, etc.), Intra-Operative- (Liver, pancreas, gall Bladder)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANQTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)
Herl Rem
(Division Sigh-Off) Division of Reproductive, Abdominal and Radiological Devices 083254 510(k) Number _
9
Diagnostic Ultrasound Indications for Use Form UST-586-5 (K861538)
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) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | N | N | 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: Mixed mode operation includes- B/M
Applications: Small Parts- (breasts, tests, thyroid, etc.)
(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 Reproductive, Abdominal and Radiological Devices 510(k) Number
10
Diagnostic Ultrasound Indications for Use Form UST-5871-5 (K840540)
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 | See Below | ||||||||
| Intraoperative Neurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ (specify) | P | P | See Below | ||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletal | |||||||||||
| Conventional | |||||||||||
| Musculo-skeletal Superficial | |||||||||||
| Other |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Mixed mode operation includes- B/M
Applications: Small Parts- (breasts, tests, thyroid, etc.), 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 Reproductive, Abdominal and Radiological Devices 510(k) Number
43
11
Diagnostic Ultrasound Indications for Use Form UST-660-7.5 (K870916)
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) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | 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: Mixed mode operation includes- B/M
(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 Reproductive, Abdominal and Radiological Devices 510(k) Number _
. .
ann
44
i 27
12
Diagnostic Ultrasound Indications for Use Form UST-934N-3.5 (K900805)
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 | P | P | See Below | |||||||
| Abdominal | P | P | See Below | |||||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other: Gynecological | 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
un
(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 Reproductive, Abdominal and
Radiological Devices 510(k) Number
13
Diagnostic Ultrasound Indications for Use Form UST-935N-5 (K900805)
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 | P | P | See Below | |||||||
| Abdominal | P | P | See Below | |||||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other: Gynecological | 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
(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 Reproductive, Abdominal and
Radiological Devices
510(k) Number
14
Diagnostic Ultrasound Indications for Use Form UST-944B-3.5 (K870916)
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 | See Below | |||||||||
| Intraoperative (specify) | ||||||||||||
| Intraoperative Neurological | ||||||||||||
| Pediatric | ||||||||||||
| Small Organ (specify) | ||||||||||||
| Neonatal Cephalic | ||||||||||||
| Adult Cephalic | ||||||||||||
| Cardiac | 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: Mixed mode operation includes- B/M
(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)
Ted Kens
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
.
15
Diagnostic Ultrasound Indications for Use Form UST-945B-5 (K900805)
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 | P | P | See Below | |||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | P | P | See Below | |||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other: Gynecological | 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
(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 Reproductive, Abdominal and
Radiological Devices
510(k) Number K083254
16
Diagnostic Ultrasound Indications for Use Form UST-974-5 (K910153)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (specify) | Other (specify) |
|---|---|---|---|---|---|---|---|---|---|---|
| Opthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | 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: Mixed mode operation includes- B/M
(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)
Heubolem
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
17
. . .
: ·
Diagnostic Ultrasound Indications for Use Form UST-981-5 (K900805)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Modes of operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| A | B | M | PWD | CWD | Color | ||||||
| Doppler | Amplitude | ||||||||||
| Doppler | Color | ||||||||||
| Velocity | |||||||||||
| Imaging | Combined | ||||||||||
| (specify) | Other | ||||||||||
| (specify) | |||||||||||
| Opthalmic | |||||||||||
| Fetal | N | N | See Below | ||||||||
| Abdominal | |||||||||||
| Intraoperative (specify) | |||||||||||
| Intraoperative Neurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ (specify) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | N | N | See Below | ||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletal | |||||||||||
| Conventional | |||||||||||
| Musculo-skeletal Superficial | |||||||||||
| Other: Gynecological | N | N | See Below |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Mixed mode operation includes- B/M
(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)
Prescripti
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 083254 510(k) Number
.
・
50
18
Diagnostic Ultrasound Indications for Use Form UST-5512U-7.5 (K861538)
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) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | P | P | See Below | |||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | P | P | See Below | |||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other: |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Mixed mode operation includes- B/M
Applications: Small Parts- (breasts, tests, thyroid, etc.)
(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 Reproductive, Abdominal and Radiological Devices 510(k) Number
. . . .
ર્સ્વ
19
1 35
Diagnostic Ultrasound Indications for Use Form UST-5551 (K861538)
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) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | N | N | 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; Mixed mode operation includes- B/M
Applications: Small Parts- (breasts, tests, thyroid, etc.)
(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)
Hetlew
(Division Sign-Off)
Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
20
. .
Diagnostic Ultrasound Indications for Use Form UST-5711 (K861538)
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) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | N | N | See Below | |||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | N | N | See Below | |||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal Conventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other: |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Mixed mode operation includes- B/M
Applications: Small Parts- (breasts, tests, thyroid, etc.)
(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 Reproductive, Abdominal and Radiological Devices 510(k) Number
.
21
Diagnostic Ultrasound Indications for Use Form UST-5820-5 (K840540)
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) | N | N | See Below | |||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | N | N | 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: Mixed mode operation includes- B/M
Applications: Small Parts- (breasts, tests, thyroid, etc.)
(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 Reproductive, Abdominal and
Radiological Devices
510(k) Number K083254
. . .
રત
22
Diagnostic Ultrasound Indications for Use Form UST-9111-5 (K910153)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Modes of operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| A | B | M | PWD | CWD | Color | ||||||
| Doppler | Amplitude | ||||||||||
| Doppler | Color | ||||||||||
| Velocity | |||||||||||
| Imaging | Combined | ||||||||||
| (specify) | Other | ||||||||||
| (specify) | |||||||||||
| Opthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intraoperative (specify) | N | N | See Below | ||||||||
| Intraoperative Neurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ (specify) | |||||||||||
| Neonatal Cephalic | N | N | 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: Mixed mode operation includes- B/M
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 Reproductive, Abdominal and
Radiological Devices,
510(k) Number K083254
રેસ
23
Diagnostic Ultrasound Indications for Use Form UST-9137 (K900805)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Modes of operation | | | | | | | | | | Other
(specify) |
|----------------------------------|--------------------|---|---|-----|-----|------------------|----------------------|-------------------------------|-----------------------|--|--------------------|
| | A | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Color.
Velocity
Imaging | Combined
(specify) | | |
| Opthalmic | | | | | | | | | | | |
| Fetal | | N | N | | | | | | See Below | | |
| Abdominal | | N | N | | | | | | See Below | | |
| Intraoperative (specify) | | | | | | | | | | | |
| 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: Gynecological | | N | N | | | | | | See Below | | |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Mixed mode operation includes- B/M
(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)
Heleum
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number _
24
ાપ્ય છે
1.3.2 New Indications for Use: There are no new indications for use.
1.3.3 Previously Cleared Indications for Use:
The Prosound 2 diagnostic ultrasound system and its transducers are intended for use in diagnostic ultrasound examinations. These ultrasound applications for use include: Gyneological, Fetal, Peripheral Vascular, Cardiac, Neonatal Cephalic, Small Parts, Intra-operative, Transrectal and Abdominal applications.
The Prosound 2 has the same indications for use as its predicate - Aloka SSD-500 (K910153) and other market cleared systems and transducers manufactured by Aloka.
Promotional information for the Prosound 2 is provided in Appendix D of this submission.