(63 days)
Not Found
No
The document describes standard ultrasound technology and image processing techniques without mentioning AI or ML.
No
The device is described as a "diagnostic doppler ultrasound system" used for "clinical diagnostic imaging applications" and "evaluation," indicating its purpose is to diagnose conditions rather than treat them.
Yes
The "Device Description" explicitly states, "The UP600 diagnostic doppler ultrasound system is a compact and portable diagnostic ultrasound device..." and mentions it is used for "clinical diagnostic imaging applications."
No
The device description clearly outlines hardware components such as a control keyboard, LCD display, beam former, and ports, indicating it is a physical ultrasound system, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "evaluation of Abdomen, Cardiac, Small Organ...". This describes a diagnostic imaging procedure performed on a living patient, not a test performed on a sample taken from a patient (which is the hallmark of an IVD).
- Device Description: The description details an ultrasound system that produces images of internal structures. This aligns with in-vivo diagnostic imaging, not in-vitro testing.
- Input Imaging Modality: The input modality is Ultrasound, which is an imaging technique applied directly to the patient.
- Anatomical Site: The listed anatomical sites are all locations within the human body.
IVD devices are designed to perform tests on biological samples (like blood, urine, tissue) outside of the body to diagnose diseases or conditions. This device operates by sending and receiving ultrasound waves to create images of internal anatomy.
N/A
Intended Use / Indications for Use
The device is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Abdomen, Cardiac, Small Organ (breast, testes, thyroid), heart soft tissue, Peripheral Vascular, Musculo-skeletal (Conventional and Superficial), Pediatric, Fetal, Cephalic. Ob/Gyn.
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Ophthalmic, Fetal, Abdominal, Intra-operative Specify, Intra-operative Neuro, Laparoscopic, Pediatric, Small Organ (breast, thyroid, testes), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-urethral, Trans-esoph. (non-Card), Musculo-skeletal (Conventional), Musculo-skeletal (Superficial), Intravascular, Other (Ob/GYN), Cardiac Adult, Cardiac Pediatric, Intravascular (Cardiac), Trans-esoph. (Cardiac), Intra-cardiac, Other (specify), Peripheral vessel.
Product codes (comma separated list FDA assigned to the subject device)
IYN, IYO, ITX
Device Description
The UP600 diagnostic doppler ultrasound system is a compact and portable diagnostic ultrasound device, have integrated preprogrammed color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications. The user interface includes a specialized control keyboard and color 15-inch LCD display. The all digital architecture with progressive dynamic receive focusing allows the system to maximize the utility of all imaging transducers to enhance the diagnostic utility and confidence provided by the system. The exam dependent default setting allows the user to have minimum adjustment for imaging the patient, while the in depth soft-menu control allows the advanced user to set the system for different situations. The architecture allows cost-effective system integration to a variety of upgrade-able options and features.
The major features of the UP600:
- 128 Channel all digital beam former
- Progressive dynamic receive focusing
- Wide band all digital demodulation
- Native resolution digital scan converter
- Hand carried for portable use
- Remote access image management through LAN port
- USB2.0 flash drive for image transport and software upgrade
- Supports 2D B-mode, M-mode, Harmonic Image, Color, Power Doppler, Pulse wave Doppler, and CW.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasonic Pulsed Echo, Ultrasonic Pulsed Doppler, Diagnostic Ultrasound
Anatomical Site
Abdomen, Cardiac, Small Organ (breast, testes, thyroid), heart soft tissue, Peripheral Vascular, Musculo-skeletal (Conventional and Superficial), Pediatric, Fetal, Cephalic, Ob/Gyn.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Qualified physician / clinical diagnostic imaging applications
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
BenQ Medical Technology UP600 Diagnostic Doppler Ultrasound System 510(k) Submission
PREMARKET NOTIFICATION [510(k)] Summary
SEP 7 2012
Company Name: BenQ Medical Technology Corporation 7F., No. 46, Zhou-Z St., Nei-Hu, Taipei 114, Taiwan
Contact:
Bob Leiker Leiker Regulatory & Quality Consulting 7263 Cronin Circle Dublin, CA 94568 Telephone: (925) 556-1302 Fax: (866) 718-3819 E-mail: leiker-requlatory@comcast.net
Device Name:
UP600 Diagnostic Doppler Ultrasound System with C52 Curved Linear Array 2-5MHz. L115 Linear Array 5-11MHz, P42 Phase Array 80 elements 2-4MHz. :
Common Name: Diagnostic Ultrasound Imaging System
Classification Name: Regulatory Class: II Review Category: Tier II Classification Panel: Radiology
Ultrasonic Pulsed Echo Imaging System, 21 CFR 892.1560, 90-IYO Ultrasonic Pulsed Doppler Imaging System, 21 CFR 892.1550, 90-IYN Diagnostic Ultrasound Transducer 21 CFR 892.1570, Product Code 90-17X
Registration Number: 3003574554
Factory Location: Qisda Corporation 159 Shan-ying Road, Gueishan, Taoyuan 333, Taiwan
Reason for Submission:
This summary of safety and effectiveness is provided as part of this Premarket Notification in compliance with the Safe Medical Device Act of 1990 revisions to 21 CFR, Part 807.92, Content and Format of a 510(k) Summary.
Predicate Device Comparison:
The GE Voluson i (K053435) is of a comparable and substantially equivalent type. It has the same technological characteristics, key safety and effectiveness features, physical design, and has the same intended uses and basic operating modes as the predicate device.
General Device Description:
The UP600 diagnostic doppler ultrasound system is a compact and portable diagnostic
1
BenQ Medical Technology UP600 Diagnostic Doppler Uitrasound System 510(k) Submission ultrasound device, have integrated preprogrammed color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications. The user interface includes a specialized control keyboard and color 15-inch LCD display. The all digital architecture with progressive dynamic receive focusing allows the system to maximize the utility of all imaging transducers to enhance the diagnostic utility and confidence provided by the system. The exam dependent default setting allows the user to have minimum adjustment for imaging the patient, while the in depth soft-menu control allows the advanced user to set the system for different situations. The architecture allows cost-effective system integration to a variety of upgrade-able options and features.
The major features of the UP600:
- · 128 Channel all digital beam former
- Progressive dynamic receive focusing
- · Wide band all digital demodulation
- Native resolution digital scan converter
- . Hand carried for portable use
- Remote access image management through LAN port .
- USB2.0 flash drive for image transport and software upgrade
- Supports 2D B-mode, M-mode, Harmonic Image, Color, Power Doppler, Pulse wave Doppler, and CW.
Intended Use:
The device is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Abdomen, Cardiac, Small Organ (breast, testes, thyroid), heart soft tissue, Peripheral Vascular, Musculo-skeletal (Conventional and Superficial), Pediatric, Fetal, Cephalic. Ob/Gyn.
Technological Characteristics:
| Display Modes | Single and dual 2-D; Display of Duplex 2-D/M-mode; 2-D/Pulsed Doppler and
Triplex 2-D/CD/Pulsed Doppler image formats; Dual B and Color in real time |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Measurements | Distance; area; circumference; calipers; velocity, PI, RI. OB, Urology, Cardiac
and Vascular package. |
| Principle of
Operation | Applying high voltage burst to the Piezoelectric material in the transducer and
detect the reflected echo to construct the 2-D B-mode, Doppler color, and
Doppler spectrum image for diagnostic purpose. |
2
| Operating
| Controls | Low noise TGC: 8 slider settings Depth Range: 3 to 24 cm Image sector size: 32 lines to full B (256 lines) Image Sector position: Steering within full maximum B orientation flip: L/R key with marking on the screen B Dynamic range control: preset 14 curve settings Gray Scale Control: 7 Settings Focal Number: up to 12 focal zone settings B persistence: 30-90% 7 settings Image Processing: Smoothing, edge enhancement PW sweeping speed 2,4,6,8 sec over display. PW Wall filter setting: 16 settings, 0.25 to 20% of PRF PW sample volume: 1 to 20mm with 0.5mm step size. PW/B update: with UPDATE key PW cursor steering: Steer soft key PW angle correction: 0 to 70 degree user control PW trace: Peak, Mean PW spectrum dynamic range: 5 preset curve settings Spectrum baseline shift and invert Color ROI setting: trackball and set key to control size and position Color steering on flat probe: +, 0, - Color Wall Filter: Color wall filter with 16 selection, 0.25-20% Color Packet size: preset per Probe and Exam Zoom factor: 1 to 10 continuously Freeze control: Toggling freeze key Cine control: step, play backward, play continuously |
|---|---|
| Acoustic | |
| Output | Track 3; MI, TIS, TIC, TIB |
| Derated Ispta: 720mW/cm2 maximum, TIS/TIB/TIC: 0.1-4.0 Range, | |
| Mechanical Index: 1.9 Maximum, or Derated Isppa: 190 W/cm 2max |
SAFETY CONSIDERATIONS:
UP600 has been designed to meet the following voluntary and measurement standards:
- EC 60601-1 Safety of Medical Electric Equipment .
- AIUM/NEMA UD2 Acoustic Output Measurement Standard for Diagnostic Ultrasound . Equipment
- AIUM NEMA UD3 Standard for Real-time Display of Thermal and Mechanical Acoustic . Output Indices on Diagnostic Ultrasound Equipment
- Acoustic Output Measurement and Labeling Standard for Diagnostic Ultrasound Equipment . Revision 1 (AIUM 1998)
Safety and EMC Requirements for Medical Equipment
- EN 60601-1 ●
- EN 60601-1-2 ●
- EN 60601-2-37 ●
- ISO 10993 Biocompatibility �
3
10903 New Hampshire Avenue Silver Spring, MD 20993
SEP 7 2012
BenQ Medical Technology Corporation % Mr. Bob Leiker Owner/Manager Leiker Regulatory & Quality Consulting 7263 Cronin Circle DUBLIN CA 94568
Re: K121983
Trade/Device Name: UP600 Diagnostic Doppler Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory: II Product Code: IYN, IYO, ITX Dated: August 4, 2012 Received: August 7, 2012
Dear Mr. Leiker:
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 UP600 Diagnostic Doppler Ultrasound System, as described in your premarket notification:
Transducer Model Number
C52 Curved Linear Array 2-5MHz L115 Linear Array 5-11MHz P42 Phase Array 80 elements 2-4MHz
4
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 vou have any questions regarding the content of this letter, please contact Gary Levine at (301) 796-6934.
Sincerely Yours,
Muhan D'O'hern for
Janine M. Morris Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure(s)
5
BenQ Medical Technology UP600 Diagnostic Doppler Ultrasound System
510(k) Submission
Tab 3 Indications For Use
510(k) Number (if known):
Device Name:
UP600 Diagnostic Doppler Ultrasound System
Indications for Use: The device is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Abdomen, Cardiac, Small Organ (breast, testes, thyroid), heart soft tissue, Peripheral Vascular, Musculo-skeletal (Conventional and Superficial), Pediatric, Fetal, Cephalic, Ob/Gyn.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
(Division Sign-Off)
Division of Radiological Devices
Indications For Use
210/
6
BenQ Medical Technology UP600 Diagnostic Doppler Ultrasound System Diagnostic Ultrasound Indications for Use Form
System:
UP600 Diagnostic Doppler Ultrasound System Diagnostic Ultrasound Pulsed Echo System Diagnostic Ultrasound Pulsed Doppler Imaging System
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General | |||||||||
| (TRACK 1 | |||||||||
| ONLY) | Specific | ||||||||
| (TRACKS 1 & 3) | B | M | PWD | CWD | Color | ||||
| Doppler | Power | ||||||||
| (Amplitude) | |||||||||
| Doppler | Other* | ||||||||
| Combined | Tissue | ||||||||
| Harmonic | |||||||||
| Imaging | |||||||||
| Ophthalmic | Ophthalmic | N | N | N | N | N | Note 1 | N | |
| Fetal | |||||||||
| Imaging & | |||||||||
| Other | Fetal | N | N | N | N | N | Note 1 | N | |
| Abdominal | N | N | N | N | N | Note 1 | N | ||
| Intra-operative Specify | |||||||||
| Intra-operative Neuro | |||||||||
| Laparoscopic | |||||||||
| Pediatric | N | N | N | N | N | Note 1 | N | ||
| Small Organ (breast, | |||||||||
| thyroid, testes) | N | N | N | N | N | Note 1 | N | ||
| Neonatal Cephalic | N | N | N | N | N | N | Note 1 | N | |
| Adult Cephalic | N | N | N | N | N | N | Note 1 | N | |
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card) | |||||||||
| Musculo-skeletal | |||||||||
| (Conventional) | N | N | N | N | N | Note 1 | N | ||
| Musculo-skeletal | |||||||||
| (Superficial) | N | N | N | N | N | Note 1 | N | ||
| Intravascular | |||||||||
| Other (Ob/GYN) | N | N | N | N | N | Note 1 | N | ||
| Cardiac | Cardiac Adult | N | N | N | N | N | N | Note 1 | N |
| Cardiac Pediatric | N | N | N | N | N | N | Note 1 | N | |
| Intravascular(Cardiac) | |||||||||
| Trans-esoph.(Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (specify) | |||||||||
| Peripheral | |||||||||
| Vessel | Peripheral vessel | N | N | N | N | N | Note 1 | N | |
| Other (specify) |
E = added under this appendix N = new indication; P = previously cleared by FDA Note 1: Combined includes: B/M; B/PWD; B/Color Doppler; B/Color Doppler; B/Color Doppler/PWD and B/Power Doppler/PWD
Prescription Use X (Part 21 CFR 801 Subpart D)
510
Indications For Use
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Tab 3
Concurrence of CDRH, Office
(Division Sign-Off)
Division of Radiological Devices
7
Diagnostic Ultrasound Indications for Use Form
C52 Curved Linear Array 2-5MHz Transducer: Diagnostic Ultrasound Transducer
· · ·.
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General | |||||||||
| (TRACK 1 | |||||||||
| ONLY) | Specific | ||||||||
| (TRACKS 1 & 3) | B | M | PWD | CWD | Color | ||||
| Doppler | Power | ||||||||
| (Amplitude) | |||||||||
| Doppler | Other* | ||||||||
| Combined | Tissue | ||||||||
| Harmonic | |||||||||
| Imaging | |||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Imaging & | |||||||||
| Other | Fetal | N | N | N | N | N | Note 1 | N | |
| Abdominal | N | N | N | N | N | Note 1 | N | ||
| Intra-operative Specify | |||||||||
| Intra-operative Neuro | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (specify) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card) | |||||||||
| Musculo-skeletal | |||||||||
| (Conventional) | |||||||||
| Musculo-skeletal | |||||||||
| (Superficial) | |||||||||
| Intravascular | |||||||||
| Other (Ob/GYN) | N | N | N | N | N | Note 1 | N | ||
| Cardiac | Cardiac Adult | ||||||||
| Cardiac Pediatric | |||||||||
| Intravascular(Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (specify) | |||||||||
| Peripheral | |||||||||
| Vessel | Peripheral vessel | ||||||||
| Other (specify) |
E = added under this appendix N = new indication; P = previously cleared by FDA; Note 1: Combined includes: B/M; B/PWD; B/Color Doppler; B/Power Doppler; B/Color Doppler/PWD and B/Power Doppler/PWD
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
(Division Sign-Off)
Division of Radiological Devices
510k K121983
8
BenQ Medical Technology UP600 Diagnostic Doppler Ultrasound System
Diagnostic Ultrasound Indications for Use Form
L115 Linear Array 5-11MHz Transducer: Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| General | ||||||||||
| (TRACK 1 | ||||||||||
| ONLY) | Specific | |||||||||
| (TRACKS 1 & 3) | B | M | PWD | CWD | Color | |||||
| Doppler | Power | |||||||||
| (Amplitude) | ||||||||||
| Doppler | Other* | |||||||||
| Combined | Tissue | |||||||||
| Harmonic | ||||||||||
| Imaging | ||||||||||
| Ophthalmic | Ophthalmic | |||||||||
| Fetal | ||||||||||
| Imaging & | ||||||||||
| Other | Fetal | |||||||||
| Abdominal | ||||||||||
| Intra-operative Specify | ||||||||||
| Intra-operative Neuro | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | ||||||||||
| Small Organ (breast, | ||||||||||
| thyroid, testes) | N | N | N | N | N | Note 1 | N | |||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Trans-rectal. | ||||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph. (non-Card) | ||||||||||
| Musculo-skeletal | ||||||||||
| (Conventional) | N | N | N | N | N | Note 1 | N | |||
| Musculo-skeletal | ||||||||||
| (Superficial) | N | N | N | N | N | Note 1 | N | |||
| Intravascular | ||||||||||
| Other (Ob/GYN) | ||||||||||
| Cardiac | Cardiac Adult | |||||||||
| Cardiac Pediatric | ||||||||||
| Intravascular(Cardiac) | ||||||||||
| Trans-esoph. (Cardiac) | ||||||||||
| Intra-cardiac | ||||||||||
| Other (specify) | ||||||||||
| Peripheral | ||||||||||
| Vessel | Peripheral vessel | N | N | N | N | N | Note 1 | N | ||
| Other (specify) | ||||||||||
| N = new indication. |
Note 1: Combined includes: B/M; B/PWD; B/Color Doppler; B/Power Doppler; B/Color Doppler/WD and B/Power Doppler/PWD
Prescription Use X · (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | |||
|---|---|---|---|
| Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) | |||
(Division Sign-Off)
Division of Radiological Devices
510k K121983QIVD
Koivision of Radiolo
9
Diagnostic Ultrasound Indications for Use Form
P42 Phase Array 80 elements 2-4MHz Transducer: Diagnostic Ultrasound Transducer
.
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General | |||||||||
| (TRACK 1 | |||||||||
| ONLY) | Specific | ||||||||
| (TRACKS 1 & 3) | B | M | PWD | CWD | Color | ||||
| Doppler | Power | ||||||||
| (Amplitude) | |||||||||
| Doppler | Other* | ||||||||
| Combined | Tissue | ||||||||
| Harmonic | |||||||||
| Imaging | |||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Imaging & | Fetal | ||||||||
| Other | Abdominal | N | N | N | N | N | N | Note 1 | N |
| Intra-operative Specify | |||||||||
| Intra-operative Neuro | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (breast, | |||||||||
| thyroid, testes) | |||||||||
| Neonatal Cephalic | N | N | N | N | N | N | Note 1 | N | |
| Adult Cephalic | N | N | N | N | N | N | Note 1 | N | |
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card) | |||||||||
| Musculo-skeletal | |||||||||
| (Conventional) | |||||||||
| Musculo-skeletal | |||||||||
| (Superficial) | |||||||||
| Intravascular | |||||||||
| Other (Ob/GYN) | |||||||||
| Cardiac | Cardiac Adult | N | N | N | N | N | N | Note 1 | N |
| Cardiac Pediatric | N | N | N | N | N | N | Note 1 | N | |
| Intravascular(Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (specify) | |||||||||
| Peripheral | Peripheral vessel | ||||||||
| Vessel | Other (specify) | ||||||||
| N = new indication; | P = previously cleared by FDA; | E = added under this appendix |
Note 1: Combined includes: B/M; B/PWD; B/Color Doppler; B/Power Doppler; B/Color Doppler/PWD and B/Power Doppler/PWD .
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) |
|---|
| (Division Sign-Off) |
| Division of Radiological Devices |
510k K121983