(129 days)
No
The document describes standard ultrasound imaging and a "Virtual Navigator" feature that overlays images from other modalities (CT/MR) for additional information. There is no mention of AI or ML being used for image analysis, interpretation, or any other function.
No
The device is described as a "diagnostic general ultrasound system" used to "perform diagnostic general ultrasound studies," indicating its purpose is for diagnosis, not therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the systems are "used to perform diagnostic general ultrasound studies."
No
The device is described as a "mainframe ultrasound system" with various hardware components like probes and displays. While it includes a "Virtual Navigator" software license, the core device is a hardware system.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions.
- Device function: The description clearly states that the MyLab systems are "mainframe ultrasound systems used to perform diagnostic general ultrasound studies." Ultrasound is an imaging modality that uses sound waves to create images of internal body structures. The Virtual Navigator adds information from other imaging modalities (CT, MR) to the ultrasound image.
- Lack of mention of samples: There is no mention of the device analyzing samples taken from the body. Its function is based on external imaging techniques.
Therefore, the device falls under the category of medical imaging equipment, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
Esaote's Model 6150 (MyLab70) and Model 6100 (MyLab90) are mainframe ultrasound systems used to perform diagnostic general ultrasound studies including Cardine unc Transesophageal, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small organ, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative: Abdominal, and Other: Urologic. Additionally, the MyLab90 is indicated for Laparoscopic use.
The Virtual Navigator is a MyLab optional license that provides additional image information from a second modality like CT or MR, during a clinical ultrasond session. The second modality provides additional security in assessing the morphalogy of the ultrasound image.
Virtual Navigator can be used in the following application: Abdominal, Musculo-skeletal, Urologic, and Vascular.
The second modality image is not intended to be used as a standalone diagnostic image since it represents information of a patient that could not be congreent with the current (actual) patient position and shall therefore always been as an additional source of information.
The Virtual Navigator tracking system should not be used on or around persons with a cardiac pacemaker, and should not be used around life supporting equipment.
Product codes
90IYN, 90IYO, ITX
Device Description
The MyLab70 and MyLab90 system designs remain the same as those previously cleared by FDA via K051837, K051308, and K060827, respectively, except for those features being added via this submission.
They are compact ultrasound systems used to perform diagnostic general ultrasound studies. Their primary modes of operation are: B-Mode, M-Mode, Doppler and Color Flow Mapping and, on lower frequency probes and, Tissue Enhancement Imaging (CE), The systems are equipped with an optional LCD Color Display and can drive phased (PA), convex (CA) and linear array (LA) and Doppler probes.
The MyLab70 and MyLab90 systems are able to produce Real Time 2D images and 3D images (in manual mode) with all probes. The MyLab70 and MyLab90 systems are manufactured under an ISO 9001:2000 and ISO 13485 certified quality system.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound, CT, MR
Anatomical Site
Cardiac, Transesophageal, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small organ, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Other: Urologic, Laparoscopic, Ophthalmic, Intraoperative Neurological, Transurethral, Extravascular, Intravascular, Scrotal
Indicated Patient Age Range
Adult, Pediatric, Neonatal (Cephalic)
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)
K070106, K062086, K042391, K012564, K042512
Reference Device(s)
K051308, K051837, K060827, K013722
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 MyLab70, 90 Systems Esaote. S.p.A.
SEP 2 5 2008
510(k) Summary
The following 510(k) summary has been prepared pursuant to requirements specified in 21CFR 807.92(a).
807.92(a)(1)
Submitter Information
Allison Scott The Anson Group 11460 N Meridian St., Ste 150 Carnel, Indiana 46032 Phone: (317) 569-9500 x106 Facsimile: (317) 569-9520 Ascott(a)ansongroup.com
Contact Person: Allison Scott
Date: August 12, 2008
807.92(a)(2)
Trade Name: MyLab70 & MyLab90 Systems
Common Name: Ultrasound Imaging System
Classification Name(s): Ultrasonic pulse doppler imaging system 892.1550 Ultrasonic pulsed echo imaging system 892.1560
Classification Number: 90IYN; 90IYO
807.92(a)(3)
Predicate Device(s)
| K070106, K062086,
K042391, K012564, and
| K042512 | BrainLab | IGSonic |
|---|---|---|
| K051308 | MyLab70 | Esaote, S.p.A |
| K051837 | MyLab90 | Esaote, S.p.A |
| K060827 | MyLab 70, 90 | Esaote, S.p.A |
| K013722 | RVS | Hitachi |
1
510(k) Summary MyLab70, 90 Systems Esaote, S.p.A.
807.92 (a)(4)
Device Description
The MyLab70 and MyLab90 system designs remain the same as those previously cleared by FDA via K051837, K051308, and K060827, respectively, except for those features being added via this submission.
They are compact ultrasound systems used to perform diagnostic general ultrasound studies. Their primary modes of operation are: B-Mode, M-Mode, Doppler and Color Flow Mapping and, on lower frequency probes and, Tissue Enhancement Imaging (CE), The systems are equipped with an optional LCD Color Display and can drive phased (PA), convex (CA) and linear array (LA) and Doppler probes.
The MyLab70 and MyLab90 systems are able to produce Real Time 2D images and 3D images (in manual mode) with all probes. The MyLab70 and MyLab90 systems are manufactured under an ISO 9001:2000 and ISO 13485 certified quality system.
807.92(a)(5)
Intended Use(s)
Esaote's Model 6150 (MyLab70) and Model 6100 (MyLab90) are mainframe ultrasound systems used to perform diagnostic general ultrasound studies including Cardine unc Transesophageal, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small organ, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative: Abdominal, and Other: Urologic. Additionally, the MyLab90 is indicated for Laparoscopic use.
The Virtual Navigator is a MyLab optional license that provides additional image information from a second modality like CT or MR, during a clinical ultrasond session. The second modality provides additional security in assessing the morphalogy of the ultrasound image.
Virtual Navigator can be used in the following application: Abdominal, Musculo-skeletal, Urologic, and Vascular.
The second modality image is not intended to be used as a standalone diagnostic image since it represents information of a patient that could not be congreent with the current (actual) patient position and shall therefore always been as an additional source of information.
The Virtual Navigator tracking system should not be used on or around persons with a cardiac pacemaker, and should not be used around life supporting equipment.
2
510(k) Summary
MyLab70, 90 Systems
Esaote. S.p.A.
807.92(a)(6)
Technological Characteristics
: : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : :
| | Hitachi RVS
K013722
Predicate | IGSonic
BrainLab
K012564
Predicate | Esaote
MyLab 90
(6100)
K051837 | Esaote
MyLab 70
(6150)
K051308 |
|-------------------------------|-------------------------------------|---------------------------------------------|-----------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|
| Virtual Navigator
software | YES | YES | To be cleared with
this submission | To be cleared
with this
submission |
| Primary application | Abdominal | NeuroSurgery | Abdominal,
Musculoskeletal
Conventional and
Superficial,
Peripheral Vascular
and, Urologic | Abdominal,
Musculoskeletal
Conventional &
Superficial.
Peripheral
Vascular and,
Urologic |
| Tracking System | Electromagnetic
(Ascension) | Optical (NDI) | Electromagnetic
(Ascension) | Electromagnetic
(Ascension) |
| Registration
Procedure | External Marker
- one scan plane | External
Marker | External and
Internal Marker,
one scan plane | External and
Internal Marker,
one scan plane |
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/15 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, along with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" arranged in a circular pattern around the eagle. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 5 2008
Esaote, S.p.A. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
Re: K081386
Trade/Device Name: MyLab70 and MyLab90 Systems Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: September 9, 2008 Received: September 10, 2008
Dear Mr. Job:
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 MyLab70 and MyLab90 Systems, as described in your premarket notification:
Transducer Model Number
| CA 421 | CA 631 | LA 523 |
|---|---|---|
| CA 430 | EC 123 | LA 532 |
| CA 431 | LA 435 | PA 122 |
| CA 621 | LA 522 | PA 230 |
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
4
Page 2 - Mr. Mark Job
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 clectronic 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 (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 Ms. Lauren Hefner at (240) 276-3666.
Sincerely yours,
Ioque M. Whay
Joyce M. Whang, Ph.D Acting Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
5
Indications for Use
510(k) Number (if known):
Device Name: MyLab70 and MyLab90 Systems
Indications For Use:
Esaote's Model 6150 (MyLab70) and Model 6100 (MyLab90) are mainframe ultrasound systems used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small organ, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative: Abdominal, and Other: Urologic. Additionally, the MyLab90 is indicated for Laparoscopic use.
The Virtual Navigator is a MyLab optional license that provides additional image information from a second modality like CT or MR, during a clinical ultrasound session. The second modality provides additional security in assessing the morphology of the ultrasound image.
Virtual Navigator can be used in the following application: Abdominal, Musculo-skeletal, Urologic, and Vascular.
The second modality image is not intended to be used as a standalone diagnostic image since it represents information of a patient that could not be congruent with the current (actual) patient position and shall therefore always been seen as an additional source of information.
The Virtual Navigator tracking system should not be used on or around persons with a cardiac pacemaker, and should not be used around life supporting equipment.
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 Device Evaluation (ODE)
Arzuh Mry
Page 1 of 1
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K08/386
8A
6
lyLab90 & 70XV
| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Combined [4] | Color Velocity Mapping (TVM) | Tissue Enhacement Imaging (TEI) | CnTi | Other (specify) |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Ophthalmic | P | P | K051837 | K051837 | P | P | P | K051837 | K051837 | K051837 | 6, 7, 8, 9, 12 |
| Fetal | P | P | K051837 | K051837 | P | P | P | K051837 | K051837 | K051837 | 6, 7, 8, 9, 12, 13 |
| Abdominal | P | P | K051837 | K051837 | P | P | P | K051837 | K051837 | K051837 | 6, 8, 9, 12, 13 |
| Intraoperative (Abdominal) | P | P | K051837 | K051837 | P | P | P | K051837 | K051837 | K051837 | 6, 8, 9, 12, 13 |
| Intraoperative Neurological | P | P | K051837 | K051837 | P | P | P | K051837 | K051837 | K051837 | 6, 7, 8, 9, 12, 13 |
| Pediatric | P | P | K051837 | K051837 | P | P | P | K051837 | K051837 | K051837 | 6, 8, 9, 12, 13 |
| Small Organ [1] | P | P | K051837 | K051837 | P | P | P | K051837 | K051837 | K051837 | 6, 8, 9, 12 |
| Neonatal Cephalic | P | P | K051837 | K051837 | P | P | P | K051837 | K051837 | K051837 | 6, 8, 9, 12 |
| Adult Cephalic | P | P | K051837 | K051837 | P | P | P | K051837 | K051837 | K051837 | 6, 7, 8, 9, 12 |
| Cardiac [2] (MtF369) | P | P | K051837 | K051837 | P | P | P | K051837 | K051837 | K051837 | 6, 8, 9, 12 |
| Transesophageal (Cardiac) | P | P | K051837 | K051837 | P | P | P | K051837 | K051837 | K051837 | 6, 8, 9, 12, 13 |
| Transesophageal (Non Cardiac) | P | P | K051837 | K051837 | P | P | P | K051837 | K051837 | K051837 | 6, 8, 9, 12 |
| Transrectal | P | P | K051837 | K051837 | P | P | P | K051837 | K051837 | K051837 | 6, 7, 8, 9, 12, 13, 14 |
| Transvaginal | P | P | K051837 | K051837 | P | P | P | K051837 | K051837 | K051837 | 6, 8, 9, 12 |
| Transurethral | P | P | K051837 | K051837 | P | P | P | K051837 | K051837 | K051837 | 6, 8, 9, 12, 13 |
| Extravascular | P | P | K051837 | K051837 | P | P | P | K051837 | K051837 | K051837 | 6, 7, 8, 9, 12, 13 |
| Peripheral Vascular | P | P | K051837 | K051837 | P | P | P | K051837 | K051837 | K051837 | 6, 7, 8, 9, 12, 13 |
| Laparoscopic | P | P | K051837 | K051837 | P | P | P | K051837 | K051837 | K051837 | 6, 7, 8, 9, 12, 13 |
| Musculo-skeletal Conventional [3] | P | P | K051837 | K051837 | P | P | P | K051837 | K051837 | K051837 | 6, 7, 8, 9, 12, 13 |
| Musculo-skeletal Superficial [3] | P | P | K051837 | K051837 | P | P | P | K051837 | K051837 | K051837 | 6, 7, 8, 9, 12, 13 |
| Other (Urological) | P | P | K051837 | K051837 | P | P | P | K051837 | K051837 | K051837 | 6, 7, 8, 9, 12, 13 |
| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude | |||||
| Doppler | Combined [4] | Color Velocity | |||||||||
| Mapping (TVM) | Tissue Enhacement Imaging | ||||||||||
| (TEI) | CnTI | Other | |||||||||
| (specify) | |||||||||||
| Ophthalmic | |||||||||||
| Fetal | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | K051837 | K051837 | 6, 8, 9, 12 | ||||||||
| Abdominal | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | K051837 | K051837 | 6, 8, 9, 12 | ||||||||
| Intraoperative (Abdominal) | |||||||||||
| Intraoperative Neurological | |||||||||||
| Pediatric | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | K051837 | K051837 | 6, 8, 9, 12 | ||||||||
| Small Organ [1] | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac [2] | |||||||||||
| Adult Cephalic | |||||||||||
| Transesophageal (Non Cardiac) | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | K051837 | K051837 | 6, 8, 9, 12 | ||||||||
| Laparoscopic | K051837 | ||||||||||
| Musculo-skeletal Conventional [3] | P | ||||||||||
| MtF374 | P | ||||||||||
| MtF374 | P | ||||||||||
| MtF374 | P | ||||||||||
| MtF374 | P | ||||||||||
| MtF374 | MtF374 | MtF374 | 6, 8, 9, 12 | ||||||||
| Musculo-skeletal Superficial [3] | P | ||||||||||
| MtF374 | P | ||||||||||
| MtF374 | P | ||||||||||
| MtF374 | P | ||||||||||
| MtF374 | P | ||||||||||
| MtF374 | MtF374 | MtF374 | 6, 8, 9, 12 | ||||||||
| Other (Urological) | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | K051837 | K051837 | 6, 8, 9, 12 | ||||||||
| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude | |||||
| Doppler | Combined [4] | Color Velocity | |||||||||
| Mapping (TVM) | Tissue Enhacement Imaging | ||||||||||
| (TEI) | CnTI | Other | |||||||||
| (specify) | |||||||||||
| Ophthalmic | P | P | P | P | |||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | 6, 8, 9, 12 | ||||||||||
| Fetal | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | 6, 8, 9, 12 | ||||||||||
| Abdominal | P | P | P | P | |||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | |||||||||||
| Intraoperative (Abdominal) | |||||||||||
| Intraoperative Neurological | |||||||||||
| Pediatric | P | ||||||||||
| MtF374 | P | ||||||||||
| MtF374 | P | ||||||||||
| MtF374 | P | ||||||||||
| MtF374 | P | ||||||||||
| MtF374 | P | ||||||||||
| MtF374 | P | ||||||||||
| MtF374 | P | ||||||||||
| MtF374 | 6,8,9,12 | ||||||||||
| Small Organ (1) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac [2] | |||||||||||
| Adult Cephalic | |||||||||||
| Transesophageal (Non Cardiac) | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | 6, 8, 9, 12 | ||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletal Conventional [3] | P | ||||||||||
| MtF374 | P | ||||||||||
| MtF374 | P | ||||||||||
| MtF374 | P | ||||||||||
| MtF374 | P | ||||||||||
| MtF374 | P | ||||||||||
| MtF374 | P | ||||||||||
| MtF374 | P | ||||||||||
| MtF374 | 6,8,9,12 | ||||||||||
| Musculo-skeletal Superficial [3] | P | ||||||||||
| MtF374 | P | ||||||||||
| MtF374 | P | ||||||||||
| MtF374 | P | ||||||||||
| MtF374 | P | ||||||||||
| MtF374 | P | ||||||||||
| MtF374 | P | ||||||||||
| MtF374 | P | ||||||||||
| MtF374 | 6,8,9,12 | ||||||||||
| Other (Urological) | P | ||||||||||
| MtF374 | P | ||||||||||
| MtF374 | P | ||||||||||
| MtF374 | P | ||||||||||
| MtF374 | P | ||||||||||
| MtF374 | P | ||||||||||
| MtF374 | P | ||||||||||
| MtF374 | P | ||||||||||
| MtF374 | 6,8,9,12 |
Concurrence of CDRH, Office of Device Evaluation (ODE
[7] 4D K060827 & MtF369
[3] Musculo Skeletal includes Nerve Block
MtE377
(14) IMT MtF374
(12) Compound K051837 [9] XView K051837
(Division Sign-Off) F
7
Lab90 & 70XVG - CA4
Concurrence of CDRH, Office of Device Evaluation (ODE [12] Compound K051837 [4] Combined modes
[4] Combined modes
are:B+M+PW+CFM+PD
[6] 3D K051837
[9] XView - K051837
[3] Musculoskeletal - Nerve Block
TRAINING SAMPLE PICTURE - DOCUMENT TYPE
(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number
K081386
8
MyLab90 & 70XVG - CA43
RESEARCH LIBRARY - PSYCHOLOGY
(3) Musculoskeletal - Nerve Block
(4) 30 Musculoskeletals - Republikas (4) 30 Maria Maria Maria Maria Maria Maria Maria Maria Maria Maria Mari Componima Kossi Componumar (12
e:B+M+PW+CFM+P
rel.sb.krcss
[g]3DK051837
913DK051837
147-171
8J vpan - MTF-374
}Xyview - KD51837
121, Compound K05183
12] Compound K051837
[112] Compound K05183?
L2] Compound K051837
Concurrence of CDRH, Office of Device Evaluation (ODE
(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number
K081 386
9
| 1 | |
|---|---|
| 1 | |
| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Combined [4] | Color Velocity Mapping (TVM) | Tissue Enhacement Imaging (TEI) | CnTI | Other (specify) | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Ophthalmic | P | P | P | P | P | P | P | P | P | P | 6, 8, 9 | |
| Fetal | MtF329 | MtF329 | MtF329 | MtF329 | MtF329 | MtF329 | MtF329 | MtF329 | MtF329 | MtF329 | MtF329 | 6, 8, 9 |
| Abdominal | P | P | P | P | P | P | P | P | P | P | 6, 8, 9 | |
| Intraoperative (Abdominal) | MtF329 | MtF329 | MtF329 | MtF329 | MtF329 | MtF329 | MtF329 | MtF329 | MtF329 | MtF329 | MtF329 | 6, 8, 9 |
| Intraoperative Neurological | ||||||||||||
| Pediatric | P | P | P | P | P | P | P | P | 6, 8, 9 | |||
| Small Organ [1] | ||||||||||||
| Neonatal Cephalic | ||||||||||||
| Adult Cephalic | ||||||||||||
| Cardiac [2] | ||||||||||||
| Adult Cephalic | ||||||||||||
| Transesophageal (Non Cardiac) | ||||||||||||
| Transrectal | ||||||||||||
| Transvaginal | ||||||||||||
| Transurethral | ||||||||||||
| Intravascular | ||||||||||||
| Peripheral Vascular | P | P | P | P | P | P | P | P | 6, 8, 9 | |||
| MtF329 | MtF329 | MtF329 | MtF329 | MtF329 | MtF329 | MtF329 | ||||||
| Laparoscopic | ||||||||||||
| Musculo-skeletal Conventional [3] | P | P | P | P | P | P | MtF329 | P | 6, 8, 9 | |||
| MtF329 | MtF329 | MtF329 | MtF329 | MtF329 | MtF329 | MtF329 | ||||||
| Musculo-skeletal Superficial [3] | P | P | P | P | P | P | MtF329 | P | 6, 8, 9 | |||
| MtF329 | MtF329 | MtF329 | MtF329 | MtF329 | MtF329 | MtF329 | ||||||
| Other (Urological) | P | P | P | P | P | P | MtF329 | 6, 8, 9 | ||||
| MtF329 | MtF329 | MtF329 | MtF329 | MtF329 | MtF329 | |||||||
| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude | ||||||
| Doppler | Combined [4] | Color Velocity | ||||||||||
| Mapping (TVM) | Tissue Enhacement Imaging | |||||||||||
| (TEI) | CnTI | Other | ||||||||||
| (specify) | ||||||||||||
| Ophthalmic | P | P | P | P | P | P | P | P | P | |||
| Fetal | P | K051837 | K051837 | K051837 | K051837 | K051837 | K051837 | P | 6, 8, 9, 12 | |||
| Abdominal | P | K051837 | K051837 | P | P | P | K051837 | P | 6, 8, 9, 12 | |||
| Intraoperative (Abdominal) | ||||||||||||
| Intraoperative Neurological | ||||||||||||
| Pediatric | MtF374 | MtF374 | MtF374 | MtF374 P | MtF374 P | MtF374 | MtF374 | P | 6,8,9,12 | |||
| Small Organ [1] | ||||||||||||
| Neonatal Cephalic | ||||||||||||
| Adult Cephalic | ||||||||||||
| Cardiac [2] | ||||||||||||
| Adult Cephalic | ||||||||||||
| Transesophageal (Non Cardiac) | ||||||||||||
| Transrectal | ||||||||||||
| Transvaginal | ||||||||||||
| Transurethral | ||||||||||||
| Intravascular | ||||||||||||
| Peripheral Vascular | P | K051837 | K051837 | K051837 | K051837 | K051837 | K051837 | P | 6, 8, 9, 12 | |||
| Laparoscopic | ||||||||||||
| Musculo-skeletal Conventional [3] | MtF374 | MtF374 | MtF374 | MtF374 P | MtF374 P | MtF374 | MtF374 | P | 6,8,9,12 | |||
| Musculo-skeletal Superficial [3] | MtF374 | MtF374 | MtF374 | MtF374 P | MtF374 | MtF374 | MtF374 | P | 6,8,9.12 | |||
| Other (Urological) | P | |||||||||||
| K051837 | K051837 | K051837 | K051837 | K051837 | KOS1837 | K051837 | P | 6, 8, 9, 12 | ||||
| N = New; P = Previously Cleared by FDA |
New, P = Previously Cleared by FDA
N = New; P = Previously Cleared
(4) Cousbilled kenetal - Nerve Block
(4) Cousbilled Kenetal - Nerve Block
(4) Cousbilled Marine Marive Block
(6) 3D KOS 1837 (7) 14 - 1
(9)
A] Musculocutaneous NERVE DIVISION
B] Combined mcps
[4] combined modes
[24] COMBINED MODES
are: R-M+PW-CFM+PD
e:B.+M.+PW.+CFM+PD
[8] YBan, MTE 372
pydantic - Mtf 374
31xyiew - KDS1837
Concurrence of CDRH, Office of Device Evaluation (ODE
(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number
K081386
10
yLab90 & 70 XVG - CA62
N = New; P = Previously Cleared by FDA
Intermolecular, Noncovalent
[3] Muscullesteletals: Nerve Block
[6] Muscullest Latin Marve Block
[6] 30 Kost Latin Market Status Creditorial Research
[18] Virgin - TVTF 333 1
[32] Componimo Rouss Brass
[4] Combined modes
e.B+M+PW+CFM+P
[6]3DK051837
RIC,D.M.C.INT
3DK051837
el ypan - MTF374
5D K02857
Oran - NIF 374
XYYview - K051837
[6] Xylem + K051837
[16] XYVIEW - K051837
3] Compound K051837
Concurrence of CDRH, Office of Device Evaluation (ODB
(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number
K081386
11
| CA631 |
|---|
| l |
| 70XVG |
| & |
| MyLab90 |
| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude
Doppler | Combined [4] | Color Velocity
Mapping (TVM) | Tissue Enhacement Imaging
(TEI) | CnTl | Other
(specify) |
|-----------------------------------|-------------|-------------|-------------|-----|---------------|----------------------|--------------|---------------------------------|------------------------------------|-------------|--------------------|
| Ophthalmic | P | P | P | | P
MtF369 | P
MtF369 | P
MtF369 | | P
MtF369 | P | 6,8,9 |
| Fetal | P
MtF369 | P
MtF369 | P
MtF369 | | P
MtF369 | P
MtF369 | P
MtF369 | | P
MtF369 | P
MtF369 | 6,8,9 |
| Abdominal | P
MtF369 | P
MtF369 | P
MtF369 | | P
MtF369 | P
MtF369 | P
MtF369 | | P
MtF369 | P
MtF369 | 6,8,9 |
| Intraoperative (Abdominal) | | | | | | | | | | P
MtF369 | |
| Intraoperative Neurological | | | | | | | | | | | |
| Pediatric | P
MtF369 | P
MtF369 | P
MtF369 | | P
MtF369 | P
MtF369 | P
MtF369 | | P
MtF369 | P
MtF369 | |
| Small Organ [1] | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac [2] | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | P
MtF369 | P
MtF369 | P
MtF369 | | P
MtF369 | P
MtF369 | P
MtF369 | | P
MtF369 | P
MtF369 | 6,8,9 |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal Conventional [3] | P
MtF369 | P
MtF369 | P
MtF369 | | P
MtF369 | P
MtF369 | P
MtF369 | | P
MtF369 | P
MtF369 | 6,8,9 |
| Musculo-skeletal Superficial [3] | P
MtF369 | P
MtF369 | P
MtF369 | | P
MtF369 | P
MtF369 | P
MtF369 | | P
MtF369 | P
MtF369 | 6,8,9 |
| Other (Urological) | P
MtF369 | P
MtF369 | P
MtF369 | | P
MtF369 | P
MtF369 | P
MtF369 | | P
MtF369 | P
MtF369 | 6,8,9 |
= New, P.P., Previously, Cleared by DPC
[3] Musculoskeletal - Nerve Block
(4) Gombined models modes
(4) Gambined (Frodes
(4) Kraft Krailero
(8) VPan - MTT 3374
(8) VPan - MTT 3374
(8) XView - K0513837
- Combined modes
[4] COMBINED MODES
ars.R+M+PW+FEM+PF
hre.p+M+PY+W+F+M+
rc1.3D K051827
[8] yp3n - MTF32/
YVRAI-MTF374
VVJIAW VUE1937
Concurrence of CDRH, Office of Device Evaluation (ODE
(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices K081386
510(k) Number
12
| t | 1 |
|---|---|
| 1 | |
| 1 | |
| = | |
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | |
| - | |
| - | |
| 1 | |
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | |
| 1 | |
| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude
Doppler | Combined [4] | Color Velocity
Mapping (TVM) | Tissue Enhacement
Imaging (TEI) | CnTI | Other
(specify) |
|-----------------------------------|--------------|--------------|--------------|-----|---------------|----------------------|--------------|---------------------------------|------------------------------------|--------------|--------------------|
| Ophthalmic | | | | | | | | | | | |
| Fetal | K051837
P | K051837
P | K051837
P | | P
K051837 | P
K051837 | P
K051837 | | P
K051837 | P
K051837 | 6, 8, 9, 12 |
| Abdominal | | | | | | | | | | | |
| Intraoperative (Abdominal) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ [1] | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac [2] | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | | |
| Transrectal | P
K051837 | P
K051837 | P
K051837 | | P
K051837 | P
K051837 | P
K051837 | | P
K051837 | KOS1837
P | 6, 8, 9, 12 |
| Transvaginal | P
K051837 | P
K051837 | P
K051837 | | P
K051837 | P
K051837 | P
K051837 | | K051837
P | K051837
P | 6, 8, 9, 12 |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal Conventional [3] | | | | | | | | | | | |
| Musculo-skeletal Superficial [3] | | | | | | | | | | | |
| Other (Urological) | P
K051837 | P | P
K051837 | | P | P | P | | P
K051837 | P | 6, 8, 9, 12 |
N = New; P = Previously Cleared by
Combined modes are:
[4] Combined modes are:
B+M+PW+CFM+PD
[6] 3D K051837
[6] 3DK051837
[8] ypan - MITF37
[8] VPan - MTF 374
[9] XView - K051837
[12] Compound - K051837
[12] Compound - K051837
COMPOUND REFRACTIVITY
Concurrence of CDRH, Office of Device Evaluation (ODE
Joy
(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number
K081386
13
| 1 |
|---|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Combined [4] | Color Velocity Mapping (TVM) | Tissue Enhacement Imaging (TEI) | CnTI | Other (specify) |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Ophthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intraoperative (Abdominal) | |||||||||||
| Intraoperative Neurological | |||||||||||
| Pediatric | P | ||||||||||
| MtF329 | P | ||||||||||
| MtF329 | P | ||||||||||
| MtF329 | P | ||||||||||
| MtF329 | MtF329 | MTF 329 | |||||||||
| P | 6, 8, 9, 13 | ||||||||||
| Small Organ [1] | P | ||||||||||
| MtF329 | P | ||||||||||
| MtF329 | P | ||||||||||
| MtF329 | P | ||||||||||
| MtF329 | MtF329 | MTF 329 | |||||||||
| P | 6, 8, 9, 13 | ||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac [2] | |||||||||||
| Adult Cephalic | |||||||||||
| Transesophageal (Non Cardiac) | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | P | ||||||||||
| MtF329 | P | ||||||||||
| MtF329 | P | ||||||||||
| MtF329 | P | ||||||||||
| MtF329 | MtF329 | MTF 329 | |||||||||
| P | 6, 8, 9, 13 | ||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletal Conventional [3] | P | ||||||||||
| MtF329 | P | ||||||||||
| MtF329 | P | ||||||||||
| MtF329 | P | ||||||||||
| MtF329 | MtF329 | MTF 329 | |||||||||
| P | 6, 8, 9, 13 | ||||||||||
| Musculo-skeletal Superficial [3] | P | ||||||||||
| MtF329 | P | ||||||||||
| MtF329 | P | ||||||||||
| MtF329 | P | ||||||||||
| MtF329 | MtF329 | MTF 329 | |||||||||
| P | 6, 8, 9, 13 | ||||||||||
| Other (Urological) | |||||||||||
| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Combined [4] | Color Velocity Mapping (TVM) | Tissue Enhacement Imaging (TEI) | CnTI | Other (specify) |
| Ophthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intraoperative (Abdominal) | |||||||||||
| Intraoperative Neurological | |||||||||||
| Pediatric | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | 6, 8, 9, 12, 13 | ||||||||||
| Small Organ [1] | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | 6, 8, 9, 12, 13 | ||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac [2] | |||||||||||
| Adult Cephalic | |||||||||||
| Transesophageal (Non Cardiac) | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | 6, 8, 9, 12, 13, | ||||||||||
| 14 | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletal Conventional [3] | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | 6, 8, 9, 12, 13 | ||||||||||
| Musculo-skeletal Superficial [3] | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | 6, 8, 9, 12, 13 | ||||||||||
| Other (Urological) | |||||||||||
| N = New; P = Previously Cleared by FDA | |||||||||||
| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Combined [4] | Color Velocity Mapping (TVM) | Tissue Enhacement Imaging (TEI) | CnTI | Other (specify) |
| Ophthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intraoperative (Abdominal) | |||||||||||
| Intraoperative Neurological | |||||||||||
| Pediatric | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | K051837 | 6, 8, 9, 12, 13 | |||||||||
| Small Organ [1] | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | K051837 | 6, 8, 9, 12, 13 | |||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac [2] | |||||||||||
| Adult Cephalic | |||||||||||
| Transesophageal (Non Cardiac) | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | K051837 | 6, 8, 9, 12, 13, 14 | |||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletal Conventional [3] | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | K051837 | 6, 8, 9, 12, 13 | |||||||||
| Musculo-skeletal Superficial [3] | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | K051837 | 6, 8, 9, 12, 13 | |||||||||
| Other (Urological) | |||||||||||
| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude | |||||
| Doppler | Combined [4] | Color Velocity | |||||||||
| Mapping (TVM) | Tissue Enhacement Imaging | ||||||||||
| (TEI) | CnTI | Other | |||||||||
| (specify) | |||||||||||
| Ophthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intraoperative (Abdominal) | |||||||||||
| Intraoperative Neurological | |||||||||||
| Pediatric | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | 6, 8, 9, 12, 13 | ||||||||||
| Small Organ [1] | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | 6, 8, 9, 12, 13 | ||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac [2] | |||||||||||
| Adult Cephalic | |||||||||||
| Transesophageal (Non Cardiac) | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | 6, 8, 9, 12, 13 | ||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletal Conventional [3] | P | ||||||||||
| MtF369 | P | ||||||||||
| MtF369 | P | ||||||||||
| MtF369 | P | ||||||||||
| MtF369 | P | ||||||||||
| MtF369 | P | ||||||||||
| MtF369 | P | ||||||||||
| MtF369 | 6, 8, 9, 12, 13 | ||||||||||
| Musculo-skeletal Superficial [3] | |||||||||||
| Other (Urological) | |||||||||||
| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Combined [4] | Color Velocity Mapping (TVM) | Tissue Enhacement Imaging (TEI) | CnTI | Other (specify) |
| Ophthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intraoperative (Abdominal) | |||||||||||
| Intraoperative Neurological | |||||||||||
| Pediatric | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | 6, 8, 9, 12 | ||||||||||
| Small Organ [1] | |||||||||||
| Neonatal Cephalic | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | 6, 8, 9, 12 | ||||||||||
| Adult Cephalic | |||||||||||
| Cardiac [2] | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | 6, 8, 9, 12 | ||||||||||
| Adult Cephalic | |||||||||||
| Transesophageal (Non Cardiac) | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | P | ||||||||||
| K051837 | 6, 8, 9, 12 | ||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletal Conventional [3] | |||||||||||
| Musculo-skeletal Superficial [3] | |||||||||||
| Other (Urological) | |||||||||||
| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Combined [4] | Color Velocity Mapping (TVM) | Tissue Enhacement Imaging (TEI) | CnTi | Other (specify) |
| Ophthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | K051837 | P | P | P | K051837 | K051837 | 6, 8, 9, 12 | ||||
| Intraoperative (Abdominal) | |||||||||||
| Intraoperative Neurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ [1] | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | K051837 | P | P | K051837 | K051837 | K051837 | P | K051837 | K051837 | 6, 8, 9, 12 | |
| Cardiac [2] | K051837 | P | P | K051837 | K051837 | K051837 | P | K051837 | K051837 | 6, 8, 9, 12 | |
| Adult Cephalic | |||||||||||
| Transesophageal (Non Cardiac) | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | MTF369 | P | P | MTF369 | MTF369 | MTF369 | P | MTF369 | MTF369 | 6, 8, 9, 12 | |
| Laparoscopic | |||||||||||
| Musculo-skeletal Conventional [3] | |||||||||||
| Musculo-skeletal Superficial [3] | |||||||||||
| Other (Urological) | |||||||||||
| Clinical Application | B | M | PWD | CWD | Color | ||||||
| Doppler | Amplitude | ||||||||||
| Doppler (PD) | Combined [4] | Color Velocity | |||||||||
| Mapping (TVM) | |||||||||||
| K052805 & MtF323 | Tissue | ||||||||||
| Enhancement | |||||||||||
| Imaging (TEI) | |||||||||||
| MtF323 | CnTI | ||||||||||
| K052805 & | |||||||||||
| MtF323 | Other | ||||||||||
| (specify) | |||||||||||
| Ophthalmic | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K052805 | P | ||||||||||
| K051308 | P | ||||||||||
| K052805 | 5, 6, 7, 8, 9, 12, 13 | ||||||||||
| Fetal | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K052805 | P | ||||||||||
| K051308 | P | ||||||||||
| K052805 | 5, 6, 7, 8, 9, 12 | ||||||||||
| Abdominal | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K052805 | P | ||||||||||
| K051308 | P | ||||||||||
| K052805 | 6, 8, 9, 12, 13 | ||||||||||
| Intraoperative (Abdominal) | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K052805 | P | ||||||||||
| K051308 | P | ||||||||||
| K052805 | 5, 6, 7, 8, 9, 12, 13 | ||||||||||
| Intraoperative Neurological | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K052805 | P | ||||||||||
| K051308 | P | ||||||||||
| K052805 | 5, 6, 7, 8, 9, 12, 13 | ||||||||||
| Pediatric | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K052805 | P | ||||||||||
| K051308 | P | ||||||||||
| K052805 | 5, 6, 8, 9, 12 | ||||||||||
| Small Organ [1] | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K052805 | P | ||||||||||
| K051308 | P | ||||||||||
| K052805 | 5, 6, 9, 12 | ||||||||||
| Neonatal Cephalic | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K052805 | P | ||||||||||
| K051308 | P | ||||||||||
| K052805 | 5, 6, 7, 8, 9, 12 | ||||||||||
| Adult Cephalic (MtF346) | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K052805 | P | ||||||||||
| K051308 | P | ||||||||||
| K052805 | 5, 6, 9, 12 | ||||||||||
| Cardiac [2] (MtF356) | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K052805 | P | ||||||||||
| K051308 | P | ||||||||||
| K052805 | 5, 6, 7, 8, 9, 12 | ||||||||||
| Transesophageal (Cardiac) | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K052805 | P | ||||||||||
| K051308 | P | ||||||||||
| K052805 | 5, 6, 9, 12 | ||||||||||
| Transesophageal (Non Cardiac) | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K052805 | P | ||||||||||
| K051308 | P | ||||||||||
| K052805 | 5, 6, 8, 9, 12, 13 | ||||||||||
| Transrectal | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K052805 | P | ||||||||||
| K051308 | P | ||||||||||
| K052805 | 5, 6, 8, 9, 12 | ||||||||||
| Transvaginal | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K052805 | P | ||||||||||
| K051308 | P | ||||||||||
| K052805 | 5, 6, 8, 9, 12 | ||||||||||
| Transurethral | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K052805 | P | ||||||||||
| K051308 | P | ||||||||||
| K052805 | 5, 6, 7, 8, 9, 12, 13, 14 | ||||||||||
| Intravascular | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K052805 | P | ||||||||||
| K051308 | P | ||||||||||
| K052805 | 5, 6, 7, 8, 9, 12, 13 | ||||||||||
| Peripheral Vascular | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K052805 | P | ||||||||||
| K051308 | P | ||||||||||
| K052805 | 5, 6, 7, 8, 9, 12, 13 | ||||||||||
| Laparoscopic | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K052805 | P | ||||||||||
| K051308 | P | ||||||||||
| K052805 | 5, 6, 7, 8, 9, 12, 13 | ||||||||||
| Musculo-skeletal Conventional [3] | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K052805 | P | ||||||||||
| K051308 | P | ||||||||||
| K052805 | 5, 6, 7, 8, 9, 12, 13 | ||||||||||
| Musculo-skeletal Superficial [3] | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K052805 | P | ||||||||||
| K051308 | P | ||||||||||
| K052805 | 5, 6, 7, 8, 9, 12, 13 | ||||||||||
| Other (Urological) | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K052805 | P | ||||||||||
| K051308 | P | ||||||||||
| K052805 | 5, 6, 7, 8, 9, 12, 13 | ||||||||||
| N = New; P = Previously Cleared by FDA | |||||||||||
| [1] Small Organs includes Breast, Thyroid and | |||||||||||
| [2] Cardiac is Adult and Pediatric | |||||||||||
| [3] Musculo Skeletal - Nerve Block- K071996 | |||||||||||
| [4] Combined modes are: B+M+PW+CW+CFM+PD | |||||||||||
| [6] 3D K060827 | |||||||||||
| [7] 4D K060827 MtF356 | |||||||||||
| [8] VPan K052805, MtF323 & 374 | |||||||||||
| [9] XView MtF336 | |||||||||||
| [10] Stress K051308 | |||||||||||
| [11] Xstrain K060827 | |||||||||||
| [12] Compound Imaging - K052805 | |||||||||||
| [13] TP-View - MTF#374 | |||||||||||
| [14] IMT - MTF#331 & 374 | |||||||||||
| [15] Automatic Gain - MTF#374 |
Concurrence of CDRH, Office of Device Evaluation (ODE)
Wh
(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number
K081386
14
yLab90 & 70XVG - LA52
[9] XView - K051837
[12] Compound - K051837
[13] TP-View -MTF 374 (14) IMT -MTF 374 [8] VPan - MTF 374 [3] Musculoskeletal - Nerve Block
[4] Combined modes are:
B+M+PW+CFM+PD
[6] 3D - K060827 & MTF 369 [1] Small Organs includes Breast
and Testicles
[2] Cardiac is Adult and Pediatric
Concurrence of CDRH, Office of Device Evaluation (ODE
(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number
Tout m wly
15
MyLab90 & 70XVG - LA52
Concurrence of CDRH, Office of Device Evaluation (ODE)
[4] Combined modes are:
B+M+PW+CFM+PD
Prescription Use (Per 21 CFR 801.109)
(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number
K081386
Why
16
1yLab90 & 70XVG - LA53
[9] XView - K051837
[12] Compound - K051837 [13] TP-View - MTF 374 [1] Small Organs includes Breast, Treast, Treast, Treast, Treasti Trasticles
[3] Tresticles
[3] Comedical modes are:
[3] Comber modes are:
[6] 3D K051837
Concurrence of CDRH, Office of Device Evaluation (ODE
(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number
K081386
17
lyLab90 & 70XVG-PA12
ીની સા [1] Small Organs includes Breast, Thyre
and Testicles
[2] Cardiac is Adult and Pediatric
(616)-447-3714
[8] VPan MTF 374
[9] XView K051837
[12] Compound K051837
[3] Musculoskeletal - Nerve Block
[4] Combined modes are:
B+M+PW+CW+CFM+PD
Concurrence of CDRH, Office of Device Evaluation (ODE
(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number
K081386
18
MyLab90 & XVG - PA236
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
W
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number
K081386
Division of Reproductive
Radiological Devices
510(K) Number
19
MyLab70
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) 17
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number
K081386
20
| ﺮﺍ |
|---|
| CA42 |
| l |
| 0 |
| 1 |
| Mode of Operations | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| nical Application | B | M | PWD | CWD | Color Doppler | Amplitude | ||||||||
| Doppler | Combined [4] | Color Velocity | ||||||||||||
| Mapping (TVM) | Tissue Enhacement Imaging | |||||||||||||
| (TEI) | CnTI | Other | ||||||||||||
| (specify) | ||||||||||||||
| Ophthalmic | P | |||||||||||||
| K051308 | P | |||||||||||||
| K051308 | P | |||||||||||||
| K051308 | P | |||||||||||||
| K051308 | P | |||||||||||||
| K051308 | P | |||||||||||||
| K051308 | P | |||||||||||||
| K051308 | MtF323 | |||||||||||||
| P | P | |||||||||||||
| K051308 | 6, 8, 9 | |||||||||||||
| etal | P | |||||||||||||
| K051308 | P | |||||||||||||
| K051308 | P | |||||||||||||
| K051308 | P | |||||||||||||
| K051308 | P | |||||||||||||
| K051308 | P | |||||||||||||
| K051308 | P | |||||||||||||
| K051308 | MtF323 | |||||||||||||
| P | P | |||||||||||||
| K051308 | 6, 8, 9 | |||||||||||||
| dominal | P | |||||||||||||
| K051308 | P | |||||||||||||
| K051308 | P | |||||||||||||
| K051308 | P | |||||||||||||
| K051308 | P | |||||||||||||
| K051308 | P | |||||||||||||
| K051308 | P | |||||||||||||
| K051308 | MtF323 | |||||||||||||
| P | P | |||||||||||||
| K051308 | 6, 8, 9 | |||||||||||||
| raoperative (Abdominal) | ||||||||||||||
| raoperative Neurological | ||||||||||||||
| Pediatric | P | |||||||||||||
| K051308 | P | |||||||||||||
| K051308 | P | |||||||||||||
| K051308 | P | |||||||||||||
| K051308 | P | |||||||||||||
| K051308 | P | |||||||||||||
| K051308 | P | |||||||||||||
| K051308 | MtF323 | |||||||||||||
| P | P | |||||||||||||
| K051308 | 6, 8, 9 | |||||||||||||
| Small Organ [1] | ||||||||||||||
| Neonatal Cephalic | ||||||||||||||
| Adult Cephalic | ||||||||||||||
| Cardiac [2] | ||||||||||||||
| Transesophageal (Cardiac) | ||||||||||||||
| Transesophageal (Non Cardiac) | ||||||||||||||
| Transrectal | ||||||||||||||
| Transvaginal | ||||||||||||||
| Transurethral | ||||||||||||||
| Intravascular | ||||||||||||||
| Peripheral Vascular | P | |||||||||||||
| K051308 | P | |||||||||||||
| K051308 | P | |||||||||||||
| K051308 | P | |||||||||||||
| K051308 | P | |||||||||||||
| K051308 | P | |||||||||||||
| K051308 | P | |||||||||||||
| K051308 | MtF323 | |||||||||||||
| P | P | |||||||||||||
| K051308 | 6, 8, 9 | |||||||||||||
| Laparoscopic | ||||||||||||||
| Musculo-skeletal Conventional [3] | P | |||||||||||||
| MtF356 | P | |||||||||||||
| MtF356 | P | |||||||||||||
| MtF356 | P | |||||||||||||
| MtF356 | P | |||||||||||||
| MtF356 | P | |||||||||||||
| MtF356 | P | |||||||||||||
| MtF356 | P | |||||||||||||
| MtF356 | 6, 8, 9 | |||||||||||||
| Musculo-skeletal Superficial [3] | P | |||||||||||||
| MtF356 | P | |||||||||||||
| MtF356 | P | |||||||||||||
| MtF356 | P | |||||||||||||
| MtF356 | P | |||||||||||||
| MtF356 | P | |||||||||||||
| MtF356 | P | |||||||||||||
| MtF356 | P | |||||||||||||
| MtF356 | 6, 8, 9 | |||||||||||||
| (Urological) | P | |||||||||||||
| K051308 | P | |||||||||||||
| K051308 | P | |||||||||||||
| K051308 | P | |||||||||||||
| K051308 | P | |||||||||||||
| K051308 | P | |||||||||||||
| K051308 | P | |||||||||||||
| K051308 | MtF323 | |||||||||||||
| P | P | |||||||||||||
| K051308 | 6, 8, 9 | |||||||||||||
| N = New; P = Previously Cleared by FDA |
Musculo Skeletal - Nerve Block
X
Y
Z
4] Combined modes are:
[3] Musculo Skeletal - Nerve Block
[4] Copyright M4CF M400Es are:
[4] Copyright M4CF M400Es are:
[6] Strikit P356 23
[8] VPan - M7 255 233
[9] XView - MTF 3336
B+M+PY+5CM+9D
[6] 3D-MTF-356
[8] ypan - MTF323
[16] XView - MTF 336
Concurrence of CDRH, Office of Device Evaluation (ODF
(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K081386
21
| CA430 |
|---|
| I |
| 0 |
| 1 |
| Mode of Operations | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| nical Application | B | M | PWD | CWD | Color Doppler | Amplitude | |||||
| Doppler | Combined [4] | Color Velocity | |||||||||
| Mapping (TVM) | Tissue Enhacement Imaging | ||||||||||
| (TEI) | CnTI | Other | |||||||||
| (specify) | |||||||||||
| Ophthalmic | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | 6, 8, 9 | ||||||||||
| Retinal | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | 6, 8, 9 | ||||||||||
| Abdominal | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | MTF323 | 6, 8, 9 | |||||||||
| Intraoperative (Abdominal) | |||||||||||
| Intraoperative Neurological | |||||||||||
| Pediatric | P | ||||||||||
| MtF347 | P | ||||||||||
| MtF347 | P | ||||||||||
| MtF347 | P | ||||||||||
| MtF347 | P | ||||||||||
| MtF347 | P | ||||||||||
| MtF347 | P | ||||||||||
| MtF347 | 6, 8, 9 | ||||||||||
| Small Organ [1] | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac [2] | |||||||||||
| Transesophageal (Cardiac) | |||||||||||
| Transesophageal (Non Cardiac) | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | P | ||||||||||
| K051308 | MTF323 | 6, 8, 9 | |||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletal Conventional [3] | |||||||||||
| Musculo-skeletal Superficial [3] | |||||||||||
| Other (Urological) | P | ||||||||||
| MtF347 | P | ||||||||||
| MtF347 | P | ||||||||||
| MtF347 | P | ||||||||||
| MtF347 | P | ||||||||||
| MtF347 | P | ||||||||||
| MtF347 | P | ||||||||||
| MtF347 | 6, 8, 9 |
10-NEW-2-PHYSICIAN'S CHOICE
N = New; P = New; P = Pre
B+M+PWineFl modes arous
(6) 3D - Mitf 3:30 - Mitres are
(6) 3D - Mitr 3:35
(8) VPan - Mirr 3:33
(8) VPan - Mirr 3:23 (8) Trip 3:36
+MPW+CFM+PD
16I3D-MTF-356
[R] VYPR - MTFE 373
pixview - MTP 335
Concurrence of CDRH, Office of Device Evaluation (OD
(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number
K081386
22
| I |
|---|
| ન |
| CA43 |
| 1 |
| 70 |
| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude
Doppler | Combined [4] | Color Velocity
Mapping (TVM) | Tissue Enhacement Imaging
(TEI) | CnTI | Other
(specify) |
|-----------------------------------|--------|--------|--------|--------|---------------|----------------------|--------------|---------------------------------|------------------------------------|--------|--------------------|
| Ophthalmic | P | P | P | P | P | P | P | P | P | MtF329 | 6, 8, 9 |
| Fetal | MtF329 | MtF329 | MtF329 | MtF329 | MtF329 | MtF329 | MtF329 | MtF329 | MtF329 | MtF346 | 6, 8, 9 |
| Abdominal | P | P | P | P | P | P | P | P | P | MtF329 | 6, 8, 9 |
| Intraoperative (Abdominal) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Pediatric | P | P | P | P | P | P | P | P | P | MtF329 | 6, 8, 9 |
| Small Organ [1] | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac [2] | | | | | | | | | | | |
| Transesophageal (Cardiac) | | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | P | P | P | P | P | P | P | P | P | MtF329 | 6, 8, 9 |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal Conventional [3] | | | | | | | | | | | |
| Musculo-skeletal Superficial [3] | | | | | | | | | | | |
| Other (Urological) | P | P | P | P | P | P | P | P | P | MtF329 | 6, 8, 9 |
Clearspring
Combined modes are:
R+Σ+CE+M+PD
REI 30°-MRF350
[4] Combine New; Previous
BAMombineElimondows are:
[6] 3D = With 336
[6] 3D = With 336
[8] ViPan = MTF 3360
[8] ViPan = MTF 3350
[9] XView = MTF 3336
[9] XView = MTF 3336
PIXYVIEW - MITES36
Concurrence of CDRH, Office of Device Evaluation (ODE
(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number
K081386
23
70 - CA621
| Mode of Operations | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| nical Application | B | M | PWD | CWD | Color Doppler | Amplitude | |||||||
| Doppler | Combined [4] | Color Velocity Mapping | |||||||||||
| (TVM) | Tissue Enhacement Imaging | ||||||||||||
| (TEI) | CnTl | Other | |||||||||||
| (specify) | |||||||||||||
| Ophthalmic | |||||||||||||
| Retinal | P | ||||||||||||
| K051308 | P | ||||||||||||
| K051308 | P | ||||||||||||
| K051308 | P | ||||||||||||
| K051308 | P | ||||||||||||
| K051308 | P | ||||||||||||
| K051308 | P | ||||||||||||
| K051308 | MtF323 | P | |||||||||||
| K051308 | MtF323 | 6, 8, 9 | |||||||||||
| Abdominal | P | ||||||||||||
| K051308 | P | ||||||||||||
| K051308 | P | ||||||||||||
| K051308 | P | ||||||||||||
| K051308 | P | ||||||||||||
| K051308 | P | ||||||||||||
| K051308 | P | ||||||||||||
| K051308 | MtF323 | P | |||||||||||
| K051308 | MtF323 | 6, 8, 9 | |||||||||||
| Intraoperative (Abdominal) | |||||||||||||
| Intraoperative Neurological | |||||||||||||
| Pediatric | Mtf347 | Mtf347 | Mtf347 | Mtf347 | Mtf347 | P | |||||||
| Mtf347 | Mtf347 | 6, 8, 9 | |||||||||||
| Small Organ [1] | |||||||||||||
| Neonatal Cephalic | |||||||||||||
| Adult Cephalic | |||||||||||||
| Cardiac [2] | |||||||||||||
| Transesophageal (Cardiac) | |||||||||||||
| Transesophageal (Non Cardiac) | |||||||||||||
| Transrectal | |||||||||||||
| Transvaginal | |||||||||||||
| Transurethral | |||||||||||||
| Intravascular | |||||||||||||
| Peripheral Vascular | P | ||||||||||||
| K051308 | P | ||||||||||||
| K051308 | P | ||||||||||||
| K051308 | P | ||||||||||||
| K051308 | P | ||||||||||||
| K051308 | P | ||||||||||||
| K051308 | MtF323 | P | |||||||||||
| K051308 | MtF323 | 6, 8, 9 | |||||||||||
| Laparoscopic | |||||||||||||
| Musculo-skeletal Conventional [3] | |||||||||||||
| Musculo-skeletal Superficial [3] | |||||||||||||
| Other (Urological) | P | ||||||||||||
| K051308 | P | ||||||||||||
| K051308 | P | ||||||||||||
| K051308 | P | ||||||||||||
| K051308 | P | ||||||||||||
| K051308 | P | ||||||||||||
| K051308 | MtF323 | P | |||||||||||
| K051308 | MtF323 | 6, 8, 9 |
= Now, Previously Cleared, or Day PSA
- combined modes are:
[4] Combined modes are:
B+M+PW+CFM+PW+CFM+PD
[6] 3D -- MTF 355
[6] 3D -- MTF 3325
[8] VPan -- MTF 3323
[9] XView - MTF 335
B+M+PW+CF+N+PC
RT13D. VET. SEC.
(6) 3D-MTF 356
[8] Yvan - MTF 32
[a] XYIpw - MTF33/3
Concurrence of CDRH, Office of Device Evaluation (ODB
(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number
K081386
24
| 0-CA631 |
|---|
| Mode of Operations | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude | |||||||||
| Doppler | Combined [4] | Color Velocity | |||||||||||||
| Mapping (TVM) | Tissue Enhacement Imaging | ||||||||||||||
| (TEI) | CnTI | Other | |||||||||||||
| (specify) | |||||||||||||||
| Ophthalmic | |||||||||||||||
| Fetal | MtF356 | ||||||||||||||
| P | MtF356 | ||||||||||||||
| P | MtF356 | ||||||||||||||
| P | MtF356 | ||||||||||||||
| P | MtF356 | ||||||||||||||
| P | MtF356 | ||||||||||||||
| P | MtF356 | ||||||||||||||
| P | 6, 8, 9 | ||||||||||||||
| Abdominal | MtF356 | ||||||||||||||
| P | MtF356 | ||||||||||||||
| P | MtF356 | ||||||||||||||
| P | MtF356 | ||||||||||||||
| P | MtF356 | ||||||||||||||
| P | MtF356 | ||||||||||||||
| P | MtF356 | ||||||||||||||
| P | 6, 8, 9 | ||||||||||||||
| Intraoperative (Abdominal) | |||||||||||||||
| Intraoperative Neurological | |||||||||||||||
| Pediatric | |||||||||||||||
| Small Organ [1] | |||||||||||||||
| Neonatal Cephalic | |||||||||||||||
| Adult Cephalic | |||||||||||||||
| Cardiac [2] | |||||||||||||||
| Transesophageal (Cardiac) | |||||||||||||||
| Transesophageal (Non Cardiac) | |||||||||||||||
| Transrectal | |||||||||||||||
| Transvaginal | |||||||||||||||
| Transurethral | |||||||||||||||
| Transvascular | |||||||||||||||
| Peripheral Vascular | MtF356 | ||||||||||||||
| P | MtF356 | ||||||||||||||
| P | MtF356 | ||||||||||||||
| P | MtF356 | ||||||||||||||
| P | MtF356 | ||||||||||||||
| P | MtF356 | ||||||||||||||
| P | MtF356 | ||||||||||||||
| P | 6, 8, 9 | ||||||||||||||
| Laparoscopic | |||||||||||||||
| Musculo-skeletal Conventional [3] | |||||||||||||||
| Musculo-skeletal Superficial [3] | |||||||||||||||
| Other (Urological) | MtF356 | ||||||||||||||
| P | MtF356 | ||||||||||||||
| P | MtF356 | ||||||||||||||
| P | MtF356 | ||||||||||||||
| P | MtF356 | ||||||||||||||
| P | MtF356 | ||||||||||||||
| P | MtF356 | ||||||||||||||
| P | 6, 8, 9 |
e:
combined modes
RAM+BK+CEM+BD
[E], COMBINED RISKS
B+t+d+∞+p+CF+CF+p+d
(63D-MTE356)
[8] ypan - MTF356
[8] Years - MIPS 333
(a) YYVdK-MTF350
Concurrence of CDRH, Office of Device Evaluation (ODE
(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number
K081386
Division of Reproductive, Abdominal
Radiological Devices
510(K) Number K08138
Division of
Radiological Devices
510(K) Number
25
| 23 |
|---|
| 1 |
| I |
| EC |
| l |
| 0 |
| L |
| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Combined [4] | Color Velocity Mapping (TVM) | Tissue Enhacement Imaging (TEI) | CnTI | Other (specify) | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Ophthalmic | |||||||||||||
| Fetal | P | ||||||||||||
| K051308 | P | ||||||||||||
| K051308 | P | ||||||||||||
| K051308 | P | ||||||||||||
| K051308 | P | ||||||||||||
| K051308 | P | ||||||||||||
| K051308 | MtF323 | ||||||||||||
| P | K051308 | ||||||||||||
| P | MtF323 | ||||||||||||
| P | 6, 8, 9 | ||||||||||||
| Abdominal | |||||||||||||
| Intraoperative (Abdominal) | |||||||||||||
| Intraoperative Neurological | |||||||||||||
| Pediatric | |||||||||||||
| Small Organ [1] | |||||||||||||
| Neonatal Cephalic | |||||||||||||
| Adult Cephalic | |||||||||||||
| Cardiac [2] | |||||||||||||
| Transesophageal (Cardiac) | |||||||||||||
| Transesophageal (Non Cardiac) | |||||||||||||
| Transrectal | P | ||||||||||||
| K051308 | P | ||||||||||||
| K051308 | P | ||||||||||||
| K051308 | P | ||||||||||||
| K051308 | P | ||||||||||||
| K051308 | P | ||||||||||||
| K051308 | MtF323 | ||||||||||||
| P | K051308 | ||||||||||||
| P | MtF323 | ||||||||||||
| P | 6, 8, 9 | ||||||||||||
| Transvaginal | P | ||||||||||||
| K051308 | P | ||||||||||||
| K051308 | P | ||||||||||||
| K051308 | P | ||||||||||||
| K051308 | P | ||||||||||||
| K051308 | P | ||||||||||||
| K051308 | MtF323 | ||||||||||||
| P | K051308 | ||||||||||||
| P | MtF323 | ||||||||||||
| P | 6, 8, 9 | ||||||||||||
| Transurethral | |||||||||||||
| Intravascular | |||||||||||||
| Peripheral Vascular | |||||||||||||
| Laparoscopic | |||||||||||||
| Musculo-skeletal Conventional [3] | |||||||||||||
| Musculo-skeletal Superficial [3] | |||||||||||||
| Other (Urological) | P | ||||||||||||
| K051308 | P | ||||||||||||
| K051308 | P | ||||||||||||
| K051308 | P | ||||||||||||
| K051308 | P | ||||||||||||
| K051308 | P | ||||||||||||
| K051308 | MtF323 | ||||||||||||
| P | K051308 | ||||||||||||
| P | MtF323 | ||||||||||||
| P | 6, 8, 9 | ||||||||||||
| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude | |||||||
| Doppler | Combined [4] | Color Velocity | |||||||||||
| Mapping (TVM) | Tissue Enhacement Imaging | ||||||||||||
| (TEI) | CnTI | Other | |||||||||||
| (specify) | |||||||||||||
| Ophthalmic | |||||||||||||
| Scrotal | |||||||||||||
| Abdominal | |||||||||||||
| Intraoperative (Abdominal) | |||||||||||||
| Intraoperative Neurological | |||||||||||||
| Pediatric | P | MtF329 | P | P | MtF329 | MtF329 | MTF 329 | 6, 8, 9, 13 | |||||
| Small Organ [1] | P | MtF329 | P | P | MtF329 | MtF329 | MTF 329 | 6, 8, 9, 13 | |||||
| Neonatal Cephalic | |||||||||||||
| Adult Cephalic | |||||||||||||
| Cardiac [2] | |||||||||||||
| Transesophageal (Cardiac) | |||||||||||||
| Transesophageal (Non Cardiac) | |||||||||||||
| Transrectal | |||||||||||||
| Transvaginal | |||||||||||||
| Transurethral | |||||||||||||
| Intravascular | |||||||||||||
| Peripheral Vascular | P | MtF329 | P | P | MtF329 | MtF329 | MTF 329 | 6, 8, 9, 13 | |||||
| Laparoscopic | |||||||||||||
| Musculo-skeletal Conventional [3] | P | MtF329 | P | P | MtF329 | MtF329 | MTF 329 | 6, 8, 9, 13 | |||||
| Musculo-skeletal Superficial [3] | P | MtF329 | P | P | MtF329 | MtF329 | MTF 329 | 6, 8, 9, 13 | |||||
| Other (Urological) | |||||||||||||
| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Combined [4] | Color Velocity Mapping (TVM) | Tissue Enhacement Imaging (TEI) | CnTl | Other (specify) | ||
| Ophthalmic | |||||||||||||
| Fetal | |||||||||||||
| Abdominal | |||||||||||||
| Intraoperative (Abdominal) | P | ||||||||||||
| K051308 | P | ||||||||||||
| K051308 | P | ||||||||||||
| K051308 | P | ||||||||||||
| K051308 | P | ||||||||||||
| K051308 | P | ||||||||||||
| K051308 | MTF 323 | 6,8,9,13 | |||||||||||
| Intraoperative Neurological | |||||||||||||
| Pediatric | P | ||||||||||||
| K051308 | P | ||||||||||||
| K051308 | P | ||||||||||||
| K051308 | P | ||||||||||||
| K051308 | P | ||||||||||||
| K051308 | P | ||||||||||||
| K051308 | MTF 323 | 6,8,9,13 | |||||||||||
| Small Organ [1] | |||||||||||||
| Neonatal Cephalic | |||||||||||||
| Adult Cephalic | |||||||||||||
| Cardiac [2] | |||||||||||||
| Transesophageal (Cardiac) | |||||||||||||
| Transesophageal (Non Cardiac) | |||||||||||||
| Transrectal | |||||||||||||
| Transvaginal | |||||||||||||
| Transurethral | |||||||||||||
| Intravascular | |||||||||||||
| Peripheral Vascular | P | ||||||||||||
| K051308 | P | ||||||||||||
| K051308 | P | ||||||||||||
| K051308 | P | ||||||||||||
| K051308 | P | ||||||||||||
| K051308 | MTF323 | 6, 8, 9, 13, 14 | |||||||||||
| Laparoscopic | P | ||||||||||||
| K051308 | P | ||||||||||||
| K051308 | P | ||||||||||||
| K051308 | |||||||||||||
| Musculo-skeletal Conventional [3] | P | ||||||||||||
| K051308 | P | ||||||||||||
| K051308 | P | P | P | MTF 323 | 6, 8, 9, 13 | ||||||||
| Musculo-skeletal Superficial [3] | P | ||||||||||||
| K051308 | P | ||||||||||||
| K051308 | P | ||||||||||||
| K051308 | P | ||||||||||||
| K051308 | P | ||||||||||||
| KOS1308 | P | ||||||||||||
| K051308 | MTF 323 | 6, 8, 9, 13 | |||||||||||
| Other (Urological) | |||||||||||||
| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude | |||||||
| Doppler | Combined [4] | Color Velocity | |||||||||||
| Mapping (TVM) | Tissue Enhacement Imaging | ||||||||||||
| (TEI) | CnTI | Other | |||||||||||
| (specify) | |||||||||||||
| Ophthalmic | |||||||||||||
| Fetal | |||||||||||||
| Abdominal | |||||||||||||
| Intraoperative (Abdominal) | |||||||||||||
| Intraoperative Neurological | |||||||||||||
| Pediatric | P | ||||||||||||
| K051308 | P | ||||||||||||
| K051308 | P | ||||||||||||
| K051308 | P | ||||||||||||
| K051308 | P | ||||||||||||
| K051308 | P | ||||||||||||
| K051308 | Mtf323 | K051308 | P | 6, 8, 9, 13 | |||||||||
| Small Organ [1] | P | ||||||||||||
| K051308 | P | ||||||||||||
| K051308 | P | ||||||||||||
| K051308 | P | ||||||||||||
| K051308 | P | ||||||||||||
| K051308 | P | ||||||||||||
| K051308 | Mtf323 | K051308 | P | 6, 8, 9, 13 | |||||||||
| Neonatal Cephalic | |||||||||||||
| Adult Cephalic | |||||||||||||
| Cardiac [2] | |||||||||||||
| Transesophageal (Cardiac) | |||||||||||||
| Transesophageal (Non Cardiac) | |||||||||||||
| Transrectal | |||||||||||||
| Transvaginal | |||||||||||||
| Transurethral | |||||||||||||
| Intravascular | |||||||||||||
| Peripheral Vascular | P | ||||||||||||
| K051308 | P | ||||||||||||
| K051308 | P | ||||||||||||
| K051308 | P | ||||||||||||
| K051308 | P | P | |||||||||||
| K051308 | Mtf323 | K051308 | P | 6, 8, 9, 13, 14 | |||||||||
| Laparoscopic | |||||||||||||
| Musculo-skeletal Conventional [3] | P | ||||||||||||
| K051308 | P | ||||||||||||
| K051308 | P | ||||||||||||
| K051308 | P | ||||||||||||
| K051308 | P | P | |||||||||||
| K051308 | Mtf323 | K051308 | P | 6, 8, 9, 13 | |||||||||
| Musculo-skeletal Superficial [3] | P | ||||||||||||
| K051308 | P | ||||||||||||
| K051308 | P | ||||||||||||
| K051308 | P | ||||||||||||
| K051308 | P | P | |||||||||||
| K051308 | Mtf323 | K051308 | P | 6, 8, 9, 13 | |||||||||
| Other (Urological) | |||||||||||||
| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Combined [4] | Color Velocity Mapping (TVM) | Tissue Enhacement Imaging (TEI) | CnTI | Other (specify) | ||
| Ophthalmic | |||||||||||||
| Fetal | |||||||||||||
| Abdominal | |||||||||||||
| Intraoperative (Abdominal) | |||||||||||||
| Intraoperative Neurological | |||||||||||||
| Pediatric | P | ||||||||||||
| K051308 | P | ||||||||||||
| K051308 | P | ||||||||||||
| K051308 | P | ||||||||||||
| K051308 | P | ||||||||||||
| K051308 | P | ||||||||||||
| K051308 | MtF323 | P | |||||||||||
| K051308 | 6, 8, 9, 13 | ||||||||||||
| Small Organ [1] | P | ||||||||||||
| K051308 | P | ||||||||||||
| K051308 | P | ||||||||||||
| K051308 | P | ||||||||||||
| K051308 | P | ||||||||||||
| K051308 | P | ||||||||||||
| K051308 | MtF323 | P | |||||||||||
| K051308 | 6, 8, 9, 13 | ||||||||||||
| Neonatal Cephalic | |||||||||||||
| Adult Cephalic | |||||||||||||
| Cardiac [2] | |||||||||||||
| Transesophageal (Cardiac) | |||||||||||||
| Transesophageal (Non Cardiac) | |||||||||||||
| Transrectal | |||||||||||||
| Transvaginal | |||||||||||||
| Transurethral | |||||||||||||
| Travascular | |||||||||||||
| Peripheral Vascular | P | ||||||||||||
| K051308 | P | ||||||||||||
| K051308 | P | ||||||||||||
| K051308 | P | ||||||||||||
| K051308 | P | ||||||||||||
| K051308 | P | ||||||||||||
| K051308 | MtF323 | P | |||||||||||
| K051308 | 6, 8, 9, 13 | ||||||||||||
| Laparoscopic | |||||||||||||
| Musculo-skeletal Conventional [3] | P | ||||||||||||
| MtF356 | P | ||||||||||||
| MtF356 | P | ||||||||||||
| MtF356 | P | ||||||||||||
| MtF356 | P | ||||||||||||
| MtF356 | P | ||||||||||||
| MtF356 | P | ||||||||||||
| MtF356 | 6, 8, 9, 13 | ||||||||||||
| Musculo-skeletal Superficial [3] | P | ||||||||||||
| MtF356 | P | ||||||||||||
| MtF356 | P | ||||||||||||
| MtF356 | P | ||||||||||||
| MtF356 | P | ||||||||||||
| MtF356 | P | ||||||||||||
| MtF356 | P | ||||||||||||
| MtF356 | 6, 8, 9, 13 | ||||||||||||
| Oher (Urological) | |||||||||||||
| 70-PA122 | Mode of Operations | ||||||||||||
| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude | |||||||
| Doppler | Combined [4] | Color Velocity | |||||||||||
| Mapping (TVM) | Tissue Enhacement Imaging | ||||||||||||
| (TEI) | CnTI | Other | |||||||||||
| (specify) | |||||||||||||
| Ophthalmic | |||||||||||||
| Fetal | |||||||||||||
| Abdominal | |||||||||||||
| Intraoperative (Abdominal) | |||||||||||||
| Intraoperative Neurological | |||||||||||||
| Pediatric | P | ||||||||||||
| K051308 | P | ||||||||||||
| K051308 | P | ||||||||||||
| K051308 | P | ||||||||||||
| K051308 | P | ||||||||||||
| K051308 | P | ||||||||||||
| K051308 | P | ||||||||||||
| K051308 | MTF 323 | ||||||||||||
| P | 6, 9 | ||||||||||||
| Small Organ [1] | |||||||||||||
| Neonatal Cephalic | P | ||||||||||||
| K051308 | P | ||||||||||||
| K051308 | P | ||||||||||||
| K051308 | P | ||||||||||||
| K051308 | P | ||||||||||||
| K051308 | P | ||||||||||||
| K051308 | P | ||||||||||||
| K051308 | MTF 323 | ||||||||||||
| P | 6, 9 | ||||||||||||
| Adult Cephalic | |||||||||||||
| Cardiac [2] | P | ||||||||||||
| K051308 | P | ||||||||||||
| K051308 | P | ||||||||||||
| K051308 | P | ||||||||||||
| K051308 | P | ||||||||||||
| K051308 | P | ||||||||||||
| K051308 | P | ||||||||||||
| K051308 | MtF356 | ||||||||||||
| P | MTF 323 | ||||||||||||
| P | 6, 9 | ||||||||||||
| Transesophageal (Cardiac) | |||||||||||||
| Transesophageal (Non Cardiac) | |||||||||||||
| Transrectal | |||||||||||||
| Transvaginal | |||||||||||||
| Transurethral | |||||||||||||
| Extravascular | |||||||||||||
| Peripheral Vascular | P | ||||||||||||
| K051308 | P | ||||||||||||
| K051308 | P | ||||||||||||
| K051308 | P | ||||||||||||
| K051308 | P | ||||||||||||
| K051308 | P | ||||||||||||
| K051308 | P | ||||||||||||
| K051308 | MTF 323 | ||||||||||||
| P | 6, 9 | ||||||||||||
| Laparoscopic | |||||||||||||
| Musculo-skeletal Conventional [3] | |||||||||||||
| Musculo-skeletal Superficial [3] | |||||||||||||
| Other (Urological) |
N = New; P = Previously Cleared by FD.
- Combined modes are:
B+M+PW+CFM+PD
B+MF+NITED
[5] 30, MITE 356
[6] 30 - NIF 33B
[6] 30 - NIF 33B
[8] Ypan - MJF 323
[4] Combined modes are:
B+M+PW+CFM+PW+CFM+PD
[6] 3D - MTF 3356
[6] 3D - MTF 3233
[8]] VPan - MTF 3233
[9] XView - MTF 336
Concurrence of CDRH, Office of Device Evaluation (ODE
Joh
f
(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number
K081386
26
70-LA435
Human Organs includes Breast, Thyroid
[1] Small Organs includes Breast, Thyroir
and Testicles
[4] Combined modes are:
B+M+PW+CFM+PD
[13] TP-View
[6] 3D -
[8] VPən
Concurrence of CDRH, Office of Device Evaluation (ODI
(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number
K081386
27
70 - LA522
[1] Small (1) Small (1) Small (1) Small (1) Streation (1) Small (1)
and Teams (1) Strail of Streast, Thyrold
(1) Cardiac (8 Advint and Peediatric
B-M-Blined models are:
(9) XView
[13] TP-View
[14] IMT
oncurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number
K081386
28
70 - LA523
[11] Small Organs includes Breast, Thyroid
[14] IMT - MTF 331 [8] VPan [1] Small Organs includes Breast, Thyroid
and Testicles
[2] Cardiac is Adult and Pediatric
[2] Cardiac is Adult and Pediatric
B+M+PW+CFM+PD
[6] 3D
[9] XView
[13] TP-View
[9] XView
[13] TP-View
- . [14] IMT -
Concurrence of CDRH, Office of Device Evaluation (Ol
(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number
K081386
29
70 - LA532
HENRY P. PENDEXTER, FSA
Consulting Actuary by POA
N = New; P = Previously Cleared by Fleared by Fleared by Fleared by Fleared by Fleared by Fleared by Fleating Fresticles
and Tresticles
B+M+PW+CFM+PD
Testicles
[4] Combined modes
B+M+PW+CFM+PD
f6l3D
[f6]3D
នាគារ សានា នោះ នោះ នោះ នោះ នោះ នោះ នេះ នេះ នេះ នេះ នេះ នេះ នេះ នេះ នេះ នេះ នេះ នេះ នេះ នេះ នេះ នេះ នេះ នេះ នេះ នេះ នេះ នេះ នេះ នេះ នេះ នេះ នេះ នេះ
នេះ
[6] MarView
Preview
[CFTP-View]
[13] TP-View
Concurrence of CDRH, Office of Device Evaluation (ODE
(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number
K081386
30
N = New, P = Previously Designed by P.C. fd
11 Small Organs includes Breast
[1] Small Organs includes Breast,
M) Combined modes can
[4] Combined modes are:
B+M+PW+CW+CFM+PD
[6] 3D - MTF 356
[6] 3D - MTF 356
[9] XView - MTF 356
[9] XView - MTF 336
Concurrence of CDRH, Office of Device Evaluation (OD
(Division Sign-Off) V
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number
K081386
31
| 0 | |
|---|---|
| A23 | |
| d | |
| I | |
| 0 | |
| 1 |
| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude
Doppler (PD) | Combined [4] | Color Velocity
Mapping (TVM) | Tissue
Enhancement
Imaging (TEI) | CnTI | Other
(specify) | |
|-----------------------------------|-------------|-------------|-------------|-------------|---------------|---------------------------|--------------|---------------------------------|----------------------------------------|-------------|--------------------|------|
| Ophthalmic | P | P | P | P | P | P | P | P
MtF323 | K051308 | P
MtF323 | 6, 9 | |
| Fetal | P | P | P | P | P | P | P | P
MtF323 | K051308 | P
MtF323 | 6, 9 | |
| Abdominal | P | P | P | P | P | P | P | P
MtF323 | K051308 | P
MtF323 | 6, 9 | |
| Intraoperative (Abdominal) | P | P | P | P | P | P | P | P
MtF323 | K051308 | P
MtF323 | 6, 9 | |
| Intraoperative Neurological | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | |
| Small Organ [1] | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac [2] | | | | | | | | | | | | |
| Transesophageal (Cardiac) | | | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Peripheral Vascular | P
MtF356 | P
MtF356 | P
MtF356 | P
MtF356 | P
MtF356 | P
MtF356 | P
MtF356 | P
MtF356 | P
MtF356 | P
MtF356 | P
MtF356 | 6, 9 |
| Laparoscopic | | | | | | | | | | | | |
| Musculo-skeletal Conventional [3] | | | | | | | | | | | | |
| Musculo-skeletal Superficial [3] | | | | | | | | | | | | |
| Other (Urological) | | | | | | | | | | | | |
(2) Cardian N = New; P = Previously Cleared by FDA
(4) Combac is Adult and Pediatric
(4) Combined moders are aradiatric
B+M+PWined moders (2) CPM+PD
(6] 3D -MTF 3356
[22] Cancer is Adult and Pediatric
[4] Combined modes are:
R+M+PY+CW+CEM+2D
[25] 3D MTE 255
[b]-R1t-330
[9] xyview - MTF336
Concurrence of CDRH, Office of Device Evaluation (OD
(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number
K081384