(13 days)
K97367, K991805
No
The document describes a standard ultrasound system with Doppler and Harmonic imaging modes and provides technical specifications. There is no mention of AI, ML, or related concepts in the provided text.
No
Explanation: The device is described as being "intended for diagnostic ultrasound imaging or fluid flow analysis of the human body," indicating a diagnostic rather than therapeutic purpose.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device "is intended for diagnostic ultrasoundimaging or fluid flow analysis of the human body."
No
The device description explicitly details hardware components such as transducers, a monitor display, a laptop computer, a smart probe, and a battery pack, along with their technical specifications and safety standards. This indicates it is a hardware device with integrated software, not a software-only medical device.
Based on the provided information, the TERATECH Model 2000 Handheld Ultrasound System with Doppler and Harmonic Imaging Modes 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 used on the human body for imaging and analysis, not a device used to test samples from the human body (which is the definition of an IVD).
- Device Description: The technical specifications describe an ultrasound system with transducers, display, power, etc., all consistent with an imaging device used externally or internally on a patient. There is no mention of reagents, assays, or analysis of biological samples.
- Anatomical Site: The listed anatomical sites are all parts of the human body that are imaged or analyzed directly by the ultrasound system.
- Lack of IVD Characteristics: There is no mention of sample types (blood, urine, tissue, etc.), analytical methods, or any other characteristics typically associated with IVD devices.
Therefore, the TERATECH Model 2000 is a diagnostic imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The TERATECH Model 2000 Handheld Ultrasound System with Doppler and Harmonic Imaging Modes is intended for diagnostic ultrasoundimaging or fluid flow analysis of the human body; specific indications for use a tabulated in Section 4.3 of this submission.
The tables include the following "Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:" for various transducers and applications.
Product codes (comma separated list FDA assigned to the subject device)
90 IYN, 90 IYO, 90-ITX
Device Description
Technical specifications for the Model 2000 Handheld Ultrasound System with Doppler and Harmonic Imaging Modes are as follows:
System 2-4 MHz (4C2 and 4V2), 4-8 MHz (8EC4, Transducer frequencies: 8L4) 15 - 58 fps (Imaging only) Frame rate: Ultrasound lines/frame: 128 2.5 - 24 cm Fields of View: Composite Video, VGA Monitor External Video Output: 15.7" SXGA TFT Liquid-Crystal Display: 13.125" Size: Width: 11.25" Height: 1.62" Depth: 8.6 lb. Weight: Laptop Computer 10 oz Smart Probe Electrical Input: 115-250 VAC, Output: 19 VDC @ 4A External Power: Li-Ion battery pack (70 Whr) Battery: 50 µA maximum Leakage Current: Primary Breakdown Voltage: greater than 1500 V AC IEC 601-1, UL 2601, Can/CSA C22.2 601.1 Safety Standards: Class I: per IEC 601-1 Protection Class: Type BF: per IEC 601-1 Degree of Protection: Environmental Mechanical Shock (Smart Probe): IEC 68-2-27 compliant (Smart Probe only) Sinusoidal: IEC 68-2-6 (Smart Probe only) Mechanical Vibration: Drop Test (to concrete): 3 feet 0 to 50 C (Smart Probe only) Operating Temperature: 20 to 80% RH, non-condensing Humidity: Transducer array watertight to the strain relief Water Resistance: 0 -- 12,500 feet (operating) Altitude: Refer to computer manufacturer's documentation for relevant environmental specifications. Storage -25 to 60 C Temperature: 15 to 98% RH, non-condensing Humidity:
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Ophthalmic, Fetal, Abdominal, Intra-operative (Neuro), Pediatric, Small Organ (Thyroid, Breast, Testes, etc.), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-esoph. (non-Card.), Musculo-skeletal (Conventional), Musculo-skeletal (Superficial), Cardiac Adult, Cardiac Pediatric, Peripheral Vessel.
Indicated Patient Age Range
Adult, Pediatric, Fetal, Neonatal
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.
K97367, K991805
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.
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 for TERATECH Model 2000 Handheld Ultrasound System with Doppler and Harmonic Imaging Modes
-
- SPONSOR
Teratech Corporation 77-79 Terrace Hall Rd. Burlington, MA 01803
- SPONSOR
| Contact Person: | Charles F. Hottinger, Ph.D., RAC, |
|---|---|
| Regulatory Affairs Consultant |
408-741-1006 Telephone:
July 2, 2001 Date Prepared:
2. DEVICE NAME
| Proprietary Name: | TERATECH Model 2000 Handheld Ultrasound |
|---|---|
| System with Doppler and | |
| Harmonic Imaging Modes | |
| Common/Usual Name: | Ultrasound System and Transducers |
| Classification Name: | Ultrasonic Pulsed Doppler Imaging System |
| (21 CFR 892.1550, 90 IYN) | |
| Ultrasonic Pulsed Echo Imaging System | |
| (21 CFR 892.1560, 90 IYO) | |
| Diagnostic Ultrasound Transducer | |
| (21 CFR 892.1570, 90-ITX) |
3. PREDICATE DEVICES
Acuson Sequoia™ Ultrasound System and Harmonic Imaging (K97367) Acuson Aspen™ Ultrasound System (K991805)
- INTENDED USE 4.
The TERATECH Model 2000 Handheld Ultrasound System with Doppler and Harmonic Imaging Modes is intended for diagnostic ultrasoundimaging or fluid flow analysis of the human body; specific indications for use a tabulated in Section 4.3 of this submission.
1
DEVICE DESCRIPTION 5.
Technical specifications for the Model 2000 Handheld Ultrasound System with Doppler and Harmonic Imaging Modes are as follows:
- System 2-4 MHz (4C2 and 4V2), 4-8 MHz (8EC4, Transducer frequencies: 8L4) 15 - 58 fps (Imaging only) Frame rate: Ultrasound lines/frame: 128 2.5 - 24 cm Fields of View: Composite Video, VGA Monitor External Video Output: 15.7" SXGA TFT Liquid-Crystal Display: 13.125" Size: Width: 11.25" Height: 1.62" Depth: 8.6 lb. Weight: Laptop Computer 10 oz Smart Probe Electrical Input: 115-250 VAC, Output: 19 VDC @ 4A External Power: Li-Ion battery pack (70 Whr) Battery: 50 µA maximum Leakage Current: Primary Breakdown Voltage: greater than 1500 V AC IEC 601-1, UL 2601, Can/CSA C22.2 601.1 Safety Standards: Class I: per IEC 601-1 Protection Class: Type BF: per IEC 601-1 Degree of Protection: Environmental Mechanical Shock (Smart Probe): IEC 68-2-27 compliant (Smart Probe only) Sinusoidal: IEC 68-2-6 (Smart Probe only) Mechanical Vibration: Drop Test (to concrete): 3 feet 0 to 50 C (Smart Probe only) Operating Temperature: 20 to 80% RH, non-condensing Humidity: Transducer array watertight to the strain relief Water Resistance: 0 -- 12,500 feet (operating) Altitude: Refer to computer manufacturer's documentation for relevant environmental specifications. Storage -25 to 60 C Temperature:
15 to 98% RH, non-condensing
Humidity:
2
BASIS FOR SUBSTANTIAL EQUIVALENCE 6.
The TERATECH Model 2000 Handheld Ultrasound System with Doppler and Harmonic Imaging Modes is substantially equivalent to Deppter and Sequoia™ and Aspen™, which are currently in commercial distribution in the United States, since the subject device has intended uses and modes of operation which are a subset of those of the predicates.
3
Image /page/3/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with text around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 6 2001
TERATECH Corporation % Mr. Mark Job TÜV Product Service 1775 Old Highway 8 NEW BRIGHTON MN 55112-1891
Re: K012191
Trade Name: Teratech Model 2000 Handheld Ultrasound System with Doppler and Harmonic Imaging Modes Regulatory Class: II/21 CFR 892.1550 Product Code: 90 IYN Regulatory Class: II/21 CFR 892.1560 Product Code: 90 IYO Dated: July 12, 2001 Received: July 13, 2001
Dear Mr. Job:
We have reviewed your Section 510(k) 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 Teratech Model 2000 Handheld Ultrasound System as described in your premarket notification:
| Transducer Model Number |
|---|
| 4C2 |
| 4V2 |
| 8EC4 |
| 8L4 |
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) 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. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic QS inspections, the FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA)
4
may publish further announcements concerning your device in the Federal Register. Please note: this may publish further minouncentent condone not affect any obligation you may have under sections 531 Tesponse to your premarket neurounters Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This determination of substantial equivalence is granted on the condition that prior to shipping the first I his decemination of baseance special report. This report should contain complete information, device, you submit a postereasurements based on production line devices, requested in Appendix G, mending doodstle output member 30, 1997 "Information for Manufacturers Seeking Marketing (Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or Clearance of Diagnostic Criticouns Cycitic output greater than approved levels), then the 510(k) comains unaceopmone variable (eigh action 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 I ne special report should rolers 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 and additionally If you desire speently ad roo roo rees), please contact the Office of Compliance at (301) 594-4591. 00711 for in fir fir questions on the promotion and advertising of your device, please contact the Office of Audionally, tor questions on and po, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the premaince nontroundon (2) OF Small Manufacturers Assistance at its toll-free number (800) 638-2017 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
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
| 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 | |||
| Dopplera | Combined | |||||||
| Modesb | Otherc | |||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging | ||||||||
| & Other | Fetal | P1 | N | N | N | N | N | |
| Abdominal | P1 | N | N | N | N | N | ||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P1 | N | N | N | N | N | ||
| Small Organ (Thyroid, | ||||||||
| Breast, Testes, etc.) | N | N | N | N | N | N | ||
| Neonatal Cephalic | P1 | N | N | N | N | N | ||
| Adult Cephalic | P1 | N | N | N | N | N | ||
| Trans-rectal | P2 | N | N | N | N | N | ||
| Trans-vaginal | P2 | N | N | N | N | N | ||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. | ||||||||
| (Conventional) | N | N | N | N | N | N | ||
| Musculo-skel. (Superficial) | N | N | N | N | N | N | ||
| Intra-luminal | ||||||||
| Other (Specify) | ||||||||
| Cardiac | Cardiac Adult | P1 | N | N | N | N | N | |
| Cardiac Pediatric | P1 | N | N | N | N | N | ||
| Trans-esoph. (Cardiac) | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | P1 | N | N | N | N | N | |
| Other (Specify) |
Teratech Model 2000 System with Doppler and Harmonic Imaging Modes____________________________________________________________________________________________________________ System: (see comments) Transducer:
und imaging or fluid flow analysis of the human hody as follows
N= new indication: P= previously cleared by FDA; E= added under Appendix E
ª Includes Color Doppler (CD), Directional Power Doppler (DPD, and (non-directional) Power Doppler. *B+M; B+PWD; B+CD; B+DPD; B+PD.
°Harmonic Imaging (HI)
Additional Comments: P : uses previously cleared under K992505 with 3 MHz Model L3 (Linear) Transducer (including use in military field settings in addition to hospital/clinic settings):
P2: uses previously cleared under K010883 with Model 8EC4.
N: subject of this submission.
(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 C Brogdon
(Division Sign Off)
Division of Reproductive, Abdomin and Radiological Device 510(k) Number
6
| System: Teratech 2000 System with Doppler and Harmonic Imaging Modes | ||||||||
|---|---|---|---|---|---|---|---|---|
| Transducer: 4C2_ | ||||||||
| Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | ||||||||
| Clinical Application | Mode of Operation | |||||||
| B | M | PWD | CWD | Color | ||||
| Dopplera | Combined | |||||||
| Modesb | Otherc | |||||||
| General | ||||||||
| (Track I Only) | Specific | |||||||
| (Tracks I & III) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | P1 | N | N | N | N | N | ||
| Abdominal | P1 | N | N | N | N | N | ||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Fetal Imaging | ||||||||
| & Other | Pediatric | P1 | N | N | N | N | N | |
| Small Organ (Thyroid, | ||||||||
| Breast, Testes, etc.) | ||||||||
| 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 | |||||||
| 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
ª Includes Color Doppler (CD), Directional Power Doppler (DPD, and (non-directional) Power Doppler.
් B+M; B+PWD; B+CD; B+DPD; B+PD.
Harmonic Imaging (HI)
Additional Comments: P : uses previously cleared under K992505 with 3 MHz Model L3 (Linear) Transducer (including use in military field settings in addition to hospital/clinic settings):
N: subject of this submission.
(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 C Broadon
(Division Sign-Division of Re oroduk and Ra 510(k) Number
Confidential Page 4.3-3
7
| System: Teratech Model 2000 System with Doppler and Harmonic Imaging Modes
Transducer: 4V2_
| 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 | |||
| Dopplera | Combined | |||||||
| Modesb | Otherc | |||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging | ||||||||
| & Other | Fetal | P1 | N | N | N | N | N | |
| Abdominal | P1 | N | N | N | N | N | ||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P1 | N | N | N | N | N | ||
| Small Organ (Thyroid, | ||||||||
| Breast, Testes, etc.) | ||||||||
| Neonatal Cephalic | P1 | N | N | N | N | N | ||
| Adult Cephalic | P1 | N | N | N | N | N | ||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Conventional) | ||||||||
| Musculo-skel. (Superficial) | ||||||||
| Intra-luminal | ||||||||
| Other (Specify) | ||||||||
| Cardiac | Cardiac Adult | P1 | N | N | N | N | N | |
| Cardiac Pediatric | P1 | N | N | N | N | N | ||
| Trans-esoph. (Cardiac) | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (Specify) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
4 Includes Color Doppler (CD), Directional Power Doppler (DPD, and (non-directional) Power Doppler. *B+M; B+PWD; B+CD; B+DPD; B+PD.
"Harmonic Imaging (HI)
Additional Comments: P': uses previously cleared under K992505 with 3 MHz Model L3 (Linear) Transducer
(including use in military field settings in addition to hospital/clini
N: subject of this submission.
(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 C. Gordon
(Division Sign-Off)
Division of Reproductive, Abdominal. ano Radiological Device 510(k) Number _
8
| System: Teratech Model 2000 System with Doppler and Harmonic Imaging Modes
Transducer: 8EC4
| 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 | |||
| Dopplera | Combined | |||||||
| Modesb | Otherc | |||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Fetal Imaging | ||||||||
| & Other | Abdominal | |||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Thyroid, | ||||||||
| Breast, Testes, etc.) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | P2 | N | N | N | N | N | ||
| Trans-vaginal | P2 | N | N | N | N | N | ||
| 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
4 Includes Color Doppler (CD), Directional Power Doppler (DPD, and (non-directional) Power Doppler.
°B+M; B+PWD; B+CD; B+DPD; B+PD.
°Harmonic Imaging (HI)
Additional Comments: P1: uses previously cleared under K992505 with 3 MHz Model L3 (Linear) Transducer (including use in military field settings in addition to hospital/clinic settings):
P2: uses previously cleared under K010883 with Model 8EC4.
N: subject of this submission.
N: Subject of this Jublinsolor:
(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 C Brogdon
(Division Sign-Off) Division of Reproductive, Abdo and Radiological Devices 510(k) Number ___
CONFIDENTIAL Page 4.3-5
9
| Teratech Model f2000 System with Doppler and Harmonic Imaging Modes | ||||||||
|---|---|---|---|---|---|---|---|---|
| System: | ||||||||
| Transducer: | 8L4 | |||||||
| 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 | |||
| Dopplera | Combined | |||||||
| Modesb | Otherc | |||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging | ||||||||
| & Other | Fetal | |||||||
| Abdominal | P1 | N | N | N | N | N | ||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P1 | N | N | N | N | N | ||
| Small Organ (Thyroid, | ||||||||
| Breast, Testes, etc.) | N | N | N | N | N | N | ||
| Neonatal Cephalic | P1 | N | N | N | N | N | ||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. | ||||||||
| (Conventional) | N | N | N | N | N | N | ||
| Musculo-skel. (Superficial) | N | N | N | N | N | N | ||
| Intra-luminal | ||||||||
| Other (Specify) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | P1 | N | N | N | N | N | |
| Other (Specify) |
Vessel
N= new indication; P= previously cleared by FDA; E= added under Appendix E
N= new indication; P= previously cleared by PDA, E= added ander Ipperient>
ª Includes Color Doppler (CD), Directional Power Doppler (DPD, and (non-directional) Power Doppler 8+M; B+PWD; B+CD; B+DPD; B+PD.
B+M, B+WWD, B+OD, B+L
©Harmonic Imaging (HI)
°Harmonic Imaging (HI) °Harmonic Imaging (H))
Additional Comments: P': uses previously cleared under K992505 with 3 MHz Model L3 (Linear) Transducer
(including use in military field settings in ad
N: subject of this submission.
N: subject of this submission.
(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 A. Brogdon
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices, 510(k) Number __
Confidential Page 4.3-6