(24 days)
No
The device description and other sections do not mention AI, ML, or related terms, and the described functionalities are typical for traditional ultrasound systems.
No
Explanation: The device is described as "Diagnostic ultrasound imaging or fluid flow analysis," indicating its purpose is for diagnosis, not treatment. While it can guide biopsy and puncture needles, this is a diagnostic aid, not a therapeutic action performed by the device itself.
Yes
The "Intended Use / Indications for Use" section explicitly states "Diagnostic ultrasound imaging or fluid flow analysis of the human body". The "Device Description" also mentions performing calculations in various medical areas and guiding biopsy/puncture needles, which are indicative of a diagnostic purpose.
No
The device description clearly outlines hardware components and functionalities typical of an ultrasound system, such as scanning modes (B-mode, M-mode, PWD, CFM), an optional ECG signal input, geometric measurements, calculations, biopsy/puncture needle guidance, and an optional 3-D unit for image reconstruction. These are not solely software functions.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "Diagnostic ultrasound imaging or fluid flow analysis of the human body". This describes a device that is used to visualize structures and processes within the body, not to perform tests on samples taken from the body.
- Device Description: The description details the scanning modes (B-mode, M-mode, PWD, CFM), measurement capabilities, and optional features like ECG and 3D reconstruction. These are all characteristic of an ultrasound imaging system used for in-vivo diagnosis.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in-vitro diagnostic testing.
In-vitro diagnostics are tests performed on samples taken from the body to detect diseases, conditions, or infections. This device is used for imaging the body directly.
N/A
Intended Use / Indications for Use
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation |
|---|---|
| Abdominal | B, M, PWD,CW, CFM 1) and combinations. Tissue and contrast harmonic imaging |
| Cardiac | B, M, PWD,CW, CFM 1) and combinations. Tissue and contrast harmonic imaging |
| Fetal (incl Obstetrics) | B, M, PWD,CW, CFM 1) and combinations. Tissue and contrast harmonic imaging |
| Intraoperative | B, M, PWD,CW, CFM 1) and combinations. Tissue and contrast harmonic imaging |
| Neurosurgery | B, M, PWD,CW, CFM 1) and combinations. Tissue and contrast harmonic imaging |
| Pediatrics | B, M, PWD,CW, CFM 1) and combinations. Tissue and contrast harmonic imaging |
| Transrectal | B, M, PWD,CW, CFM 1) and combinations. Tissue and contrast harmonic imaging |
| Small Parts (organs) | B, M, PWD,CW, CFM 1) and combinations. Tissue and contrast harmonic imaging |
| Transvaginal | B, M, PWD,CW, CFM 1) and combinations. Tissue and contrast harmonic imaging |
| Peripheral vascular | B, M, PWD,CW, CFM 1) and combinations. Tissue and contrast harmonic imaging |
| Musculo-skeletal | B, M, PWD,CW, CFM 1) and combinations. Tissue and contrast harmonic imaging |
Additional Details for Transducers:
Transducer 1850:
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Specific Clinical Applications: Intra-operative (Specify), Trans-rectal, Trans-vaginal, Musculo-skel. (Conventional), Musculo-skel. (Superficial), Other (Specify) - Intraoperative: Rectum, Urethra, Urinary bladder.
Mode of Operation: B
Transducer 8661:
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Specific Clinical Applications: Ophthalmic, Trans-vaginal
Mode of Operation: B, M, PWD, Color Doppler, Combined (B+M, B+D, B+C, B+D+C), Amplitude Doppler
Transducer 8662:
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Specific Clinical Applications: Intra-operative (Specify 2), Intra-operative (Neuro), Pediatric
Mode of Operation: B, M, PWD, Color Doppler, Combined (B+M, B+D, B+C, B+D+C), Amplitude Doppler
Additional Comments: Intraoperative: Gall bladder
Transducer 8803:
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Specific Clinical Applications: Fetal, Abdominal, Pediatric, Cardiac Adult, Cardiac Pediatric
Mode of Operation: B, M, PWD, Harmonic imaging, Color Doppler, Combined (B+M, B+D, B+C, B+D+C), Amplitude Doppler
Transducer 8811:
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Specific Clinical Applications: Intra-operative (Specify 2), Pediatric, Small Organ (Specify 3), Musculo-skel. (Conventional), Musculo-skel. (Superficial), Peripheral vessel
Mode of Operation: B, M, PWD, Color Doppler, Combined (B, B+M, B+D, B+C, B+D+C), Amplitude Doppler
Additional Comments: Intraoperative: Breast, liver, pancreas, biliary system; Small Organ: Breast, testis, penis, thyroid, parathyroid, salivary glands, lymph nodes
Product codes (comma separated list FDA assigned to the subject device)
90 IYN, IYO, and ITX
Device Description
Pro Focus 2202 supports the following scanning modes and combinations thereof: B-mode, M-mode, PWD mode, CFM mode.
An optional ECG signal can be superimposed the ultrasound information in all modes and mode combinations.
The system can perform simple geometric measurements, and perform calculations in the areas of Vascular, Urology, Cardiology and OB/GYN applications.
The system can guide biopsy- and puncture needles.
An optional 3-D unit can reconstruct a series of 2-D images into a single 3-D volume and display this on the screen.
Transducers
Transducers are linear and convex arrays and mechanical sector. The patient contact materials are biocompatible.
All transducers used together with Pro Focus 2202 are Track 3 transducers.
Acoustic output
The system controlling the Acoustic Output in Pro Focus 2202 is the same as the system in 2400. The system will assure that the acoustic output always will stay below the pre-amendments upper limits i.e. Ispta ≤ 720 mW/cm² and MI ≤ 1.9 (Track 3, non ophthalmic). The Thermal Index values are maximum 6.0, i.e. TI ≤ 6.0
Clinical measurement accuracy.
Clinical measurements and calculations are described and accuracies are provided in the User Guide.
Thermal, mechanical and electrical safety.
The scanner Pro Focus 2202 has been tested by a recognized, Certified Body.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Abdominal, Cardiac, Fetal, Intraoperative, Neurosurgery, Pediatrics, Transrectal, Small Parts (organs), Transvaginal, Peripheral vascular, Musculo-skeletal.
Specific transducer indications include: Ophthalmic, Gall bladder, Breast, liver, pancreas, biliary system, testis, penis, thyroid, parathyroid, salivary glands, lymph nodes, Rectum, Urethra, Urinary bladder.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
510(k) Summary:
JAN 1 3 2005
K043524
Page of
This summary is provided as part of this Premarket Notification in compliance with 21CRF, Section 807.92.
Submitters name: B-K Medical Address: Mileparken 34, DK2730 Herlev, Denmark Phone: +45 44528100 Fax: +45 44528199 Contact person: Villy Braender, Regulatory Manager Date prepared: 17 December, 2004
Trade name: Ultrasound Scanner Pro Focus 2202 Common name: Diagnostic Ultrasound System Classification names: Ultrasonic Pulsed Echo Imaging System (90 IYO, CFR 892.1560) Ultrasonic Pulsed Doppler Imaging System (90 IYN, CFR 892.1560) (90 ITX, CFR 892.1570) Diagnostic Ultrasonic Transducer
Identification of predicate, legally marketed device: B-K Medical Ultrasound Scanner Type 2400, K024236 (JAN17 2003)
Device description:
Pro Focus 2202 supports the following scanning modes and combinations thereof: B-mode, M-mode, PWD mode, CFM mode.
An optional ECG signal can be superimposed the ultrasound information in all modes and mode combinations.
The system can perform simple geometric measurements, and perform calculations in the areas of Vascular, Urology, Cardiology and OB/GYN applications.
The system can guide biopsy- and puncture needles.
An optional 3-D unit can reconstruct a series of 2-D images into a single 3-D volume and display this on the screen.
Transducers
Transducers are linear and convex arrays and mechanical sector. The patient contact materials are biocompatible.
All transducers used together with Pro Focus 2202 are Track 3 transducers.
Acoustic output
The system controlling the Acoustic Output in Pro Focus 2202 is the same as the system in 2400. The system will assure that the acoustic output always will stay below the pre-amendments upper limits i.e. Ispta ≤ 720 mW/cm² and MI ≤ 1.9 (Track 3, non ophthalmic). The Thermal Index values are maximum 6.0, i.e. TI ≤ 6.0
Clinical measurement accuracy.
Clinical measurements and calculations are described and accuracies are provided in the User Guide.
Thermal, mechanical and electrical safety.
The scanner Pro Focus 2202 has been tested by a recognized, Certified Body.
1
K8 43524
Page 2 of 2
Acoustic Output Reporting
The Acoustic Output Reporting is made according to the standards required by "Information for Manufacturers Seeking Clearance of Diagnostic Ultrasound Systems and Transducers, FDA, CDRH, September 30, 1997"
Intended use.
| Predicate device: | Submitted device: | |
|---|---|---|
| Ultrasound scanner Type 2400 | Ultrasound scanner Pro | |
| K024236 (JAN17 2003) | Focus 2202 | |
| Modes of operation | B, M, PWD, CFM 1) and combinations. | |
| Tissue harmonic imaging | B, M, PWD,CW, CFM 1) and combinations. Tissue | |
| and contrast harmonic | ||
| imaging | ||
| Intended use(clinical | ||
| application) | Abdominal | |
| Cardiac | ||
| Fetal (incl Obstetrics) | ||
| Intraoperative | ||
| Neurosurgery | ||
| Pediatrics | ||
| Transrectal | ||
| Small Parts (organs) | ||
| Transvaginal | ||
| Peripheral vascular | ||
| Musculo-skeletal | Abdominal | |
| Cardiac | ||
| Fetal (incl Obstetrics) | ||
| Intraoperative | ||
| Neurosurgery | ||
| Pediatrics | ||
| Transrectal | ||
| Small Parts (organs) | ||
| Transvaginal | ||
| Peripheral vascular | ||
| Musculo-skeletal | ||
| Features | ECG (not monitoring) | ECG (not monitoring) |
| 3D |
2202 intended uses are contained within 2400-intended uses:
- CFM= Color Flow Mapping=Color Doppler and Amplitude Doppler.
Technological characteristics compared to the predicate device.
The predicate device has the same major technological characteristics as the subject device described above.
Minor differences consist: Modified processor and operating system, modified mechanical outline and 3D imaging.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 3 2005
Mr. Villy Brænder Regulatory Manager B-K Medical A/S Mileparken 34 Herlev 34, DK 2730 DENMARK
Re: K043524
Trade Name: Ultrasonic Scanner Pro Focus 2202 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: 90 IYN, IYO, and ITX Dated: December 17, 2004 Received: December 31, 2004
Dear Mr. Brænder:
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 Ultrasonic Scanner Pro Focus 2202, as described in your premarket notification:
Transducer Model Number
| 1850 |
|---|
| 8661 |
| 8662 |
3
Page 2 - Mr. Brænder
8803 8811
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 (OS) 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 determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.
The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:
Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850
This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
4
Page 3 - Mr. Brænder
If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at (301) 594-1212.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
5
Diagnostic Ultrasound Indications for Use Form
System: 2202
Fill out one form for each ultrasound system and each transducer.
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | Tissue- | |||||
| and | ||||||||||
| contrast | ||||||||||
| harmonic | ||||||||||
| imaging | Color | |||||||||
| Doppl | ||||||||||
| er | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify 1) | Continous | |||||||||
| Wave) | ||||||||||
| Ophthalmic | ||||||||||
| Fetal | P | P | P | P | P | P | P | |||
| Abdominal | P | P | P | P | P | P | P | |||
| Intraoperative (specify) | P | P | P | P | P | P | P | |||
| Intraoperative Neurological | P | P | P | P | P | P | P | |||
| Pediatric | P | P | P | P | P | P | P | |||
| Small Organ (specify) | P | P | P | P | P | P | P | |||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | P | P | P | P | P | P | P | |||
| Transesophageal | ||||||||||
| Transrectal | P | P | P | P | P | P | P | |||
| Transvaginal | P | P | P | P | P | P | P | |||
| Transurethral | P | P | P | P | P | P | P | |||
| Intravascular | ||||||||||
| Peripheral Vascular | P | P | P | P | P | P | P | |||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | P | P | P | P | P | P | P | |||
| Musculo-skeletal Superficial | P | P | P | P | P | P | P | |||
| Other (specify) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:__________________________________________________________________________________________________________________________________________________________ D is PWD, C is Color Doppler. Fetal is often called Obstetrics
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Yancy C. Hoydon
(Division Sign-Off)
Division of Reproductive, Andominal and Radiological Devices
510(k) Number K093524
6
2202 System: Transducer: 1850_(with interchangeable probes_8539,6004,6005)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track I Only) | Specific | |||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | |||
| Doppler | Combined | |||||||
| (Specify) | Other* | |||||||
| (Specify) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging | ||||||||
| & Other | Fetal | |||||||
| Abdominal | ||||||||
| Intra-operative (Specify) | P | |||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Specify) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | P | |||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Conventional) | ||||||||
| Musculo-skel. (Superficial) | ||||||||
| Intra-luminal | ||||||||
| Other (Specify) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esoph. (Cardiac) | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (Specify) |
N = new indication; P = previously cleared by FDA(K002085); E = added under Appendix E *Examples may include: A-mode, Amplitude Doppler, 3-D Imaging, Harmonic Imaging, Tissue Motion Doppler, Color Velocity Imaging
Additional Comments: Intraoperative: Rectum, Urethra, Urinary bladder, ---------------
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health, Office of Device Evaluation
Y. James I. Swalen
(Division Sign-Off) // Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
7
| System: | 2202 |
|---|---|
| Transducer: | 8661 |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track I Only) | Specific | |||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | |||
| Doppler | Combined | |||||||
| (Specify) | Amplitude | |||||||
| e Doppler | ||||||||
| Ophthalmic | Ophthalmic | P | P | P | P | P 1) | P | |
| Fetal | ||||||||
| Abdominal | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Fetal Imaging | ||||||||
| & Other | Pediatric | |||||||
| Small Organ (Specify) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | P | P | P | P | P 1) | P | ||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Conventional) | ||||||||
| Musculo-skel. (Superficial) | ||||||||
| Intra-luminal | ||||||||
| Other (Specify) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
*Examples may include: A-mode, Amplitude Doppler, 3-D Imaging, Harmonic Imaging, Tissue Motion Doppler, Color Velocity Imaging
Additional Comments: l))Mode combinations: B+M, B+D, B+C, B+D+C. (D is PWD, C is Color Flow mapping Doppler including Amplitude(power)Doppler) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
PLEASE DO NOT WRITE BELOW THIS LINE & CONTINUE ON ANOTHER PAGE IF NEEDED]
Concurrence of Center for Devices and Radiological Health, Office of Device Evaluation
Vlaric. boagton
Division f Reproductive, Abdominal, and Radiological Devic
510(k) Number K043524
8
| System: | 2202 |
|---|---|
| Transducer: | 8662 |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General | |||||||||
| (Track I Only) | Specific | ||||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | ||||
| Doppler | Combined | ||||||||
| (Specify 1) | Amplitude | ||||||||
| e Doppler | |||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Abdominal | |||||||||
| Intra-operative (Specify 2) | P | P | P | P | P | P | |||
| Intra-operative (Neuro) | P | P | P | P | P | P | |||
| Laparoscopic | |||||||||
| Fetal Imaging | |||||||||
| & Other | Pediatric | P | P | P | P | P | P | ||
| Small Organ (Specify) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skel. (Conventional) | |||||||||
| Musculo-skel. (Superficial) | |||||||||
| Intra-luminal | |||||||||
| Other (Specify) | |||||||||
| Cardiac Adult | |||||||||
| Cardiac | Cardiac Pediatric | ||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Other (Specify) | |||||||||
| Peripheral | |||||||||
| Vessel | Peripheral vessel | ||||||||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
- Examples may include: A-mode, Amplitude Doppler, 3-D Imaging, Harmonic Imaging, Tissue Motion Doppler, Color Velocity Imaging
Additional Comments: 1) Mode combinations: B+M, B+D, B+C, B+D+C. (D is PWD, C is Color Flow mapping Doppler including Amplitude(power)Doppler)_ 2)Intraoperative: Gall bladder
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health, Office of Device Evaluation
Nancy C. Roydon
Division Sign-Off
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Radiological Devices
(k) Number X042524
9
| System: | 2202 |
|---|---|
| Transducer: | 8803 |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track I Only) | Specific | |||||||
| (Tracks I & III) | B | M | PWD | Harmonic | ||||
| imaging | Color | |||||||
| Doppler | Combined | |||||||
| (Specify) | Amplitude | |||||||
| Doppler | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging | ||||||||
| & Other | Fetal | P | P | P | P | P | P 1) | P |
| Abdominal | P | P | P | P | P | P 1) | P | |
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | P | P | P 1) | P | |
| Small Organ (Specify) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Conventional) | ||||||||
| Musculo-skel. (Superficial) | ||||||||
| Intra-luminal | ||||||||
| Other (Specify) | ||||||||
| Cardiac | Cardiac Adult | P | P | P | P | P | P 1) | P |
| Cardiac Pediatric | P | P | P | P | P | P 1) | P | |
| Trans-esoph. (Cardiac) | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under Appendix E * Examples may include: A-mode, Amplitude Doppler, 3-D Imaging, Harmonic Imaging, Tissue Motion Doppler, Color Velocity Imaging
Additional Comments: l))Mode combinations: B+M, B+D, B+C, B+D+C. (D is PWD, C is Color Flow mapping Doppler including Amplitude(power)Doppler) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health, Office of Device Evaluation
Ylvia C. hogdon
(Division Sign-Off)
Division of Reproductive, Abdominal, ind Radiological Devices
510(k) Number
10
| System: | 2202 |
|---|---|
| Transducer: | 8811 |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track I Only) | Specific | |||||||
| (Tracks I & III) | B | M | PWD | Harm | ||||
| onic | ||||||||
| imagin | ||||||||
| g | Color | |||||||
| Doppler | Combined | |||||||
| (Specify 1) | Amplitude | |||||||
| e Doppler | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Abdominal | ||||||||
| Fetal Imaging | ||||||||
| & Other | Intra-operative (Specify 2) | P | P | P | P | P | P | |
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | P | P | P | ||
| Small Organ (Specify 3) | P | P | P | P | P | P | ||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Conventional) | P | P | P | P | P | P | ||
| Musculo-skel. (Superficial) | P | P | P | P | P | P | ||
| Intra-luminal | ||||||||
| Other (Specify) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | P | P | P | P | P | P | |
| Other (Specify) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
- Examples may include: A-mode, Amplitude Doppler, 3-D Imaging, Harmonic Imaging, Tissue Motion Doppler, Color Velocity Imaging
Additional Comments: 2)Intraoperative: Breast, liver, pancreas, biliary system
3)Small Organ: Breast, testis, penis, thyroid, parathyroid, salivary glands, lymph nodes l ) mode combinations: B, B+M, B+D, B+C, B+D+C. (D is PWD, C is Color Flow mapping Doppler including Amplitude(power)Doppler)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health, Office of Device Evaluation
Prescription Use (Per 21 CFR 801.109)
Nancy Ogden
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devic
510(k) Number