(34 days)
No
The document does not mention AI, ML, or any related terms, and the device description focuses on standard ultrasound imaging modes and functionalities.
No
The device is described as an "ultrasonic diagnostic imaging system" and its function is to "acquire and display ultrasound data," indicating it is used for diagnosis rather than treatment.
Yes
The device explicitly describes itself as a "Digital Ultrasonic Diagnostic Imaging System" in both the "Intended Use / Indications for Use" and "Device Description" sections.
No
The device description explicitly states it is a "Digital Ultrasonic Diagnostic Imaging System" and mentions employing "an array of transducers including linear array and convex array," which are hardware components essential for ultrasound imaging. It also mentions being "portable/mobile {with mobile ultrasound trolley}".
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device function: The DP-20 and DP-30 Digital Ultrasonic Diagnostic Imaging System is described as a system that "acquire and display ultrasound data." Ultrasound is an imaging modality that uses sound waves to create images of internal body structures. It does not involve testing samples taken from the body.
- Intended Use: The intended use describes various anatomical sites and patient populations for imaging, not for analyzing biological samples.
Therefore, this device falls under the category of medical imaging devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The DP-20 and DP-30 Digital Ultrasonic Diagnostic Imaging System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, intraoperative(abdominal, thoracic, and vascular), pediatric, small organ(breast, thyroid, testes), neonatal cephalic, trans-rectal, trans-rectal, trans-vaginal, musculo-skeletal(conventional, superficial), cardiac(adult, pediatric), peripheral vascular and urology exams.
The DP-20 and DP-30 Digital Ultrasonic Diagnostic Imaging System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, intraoperative (abdominal, thoracic, and vascular), pediatric, small organ (breast, thyroid, testes), neonatal cephalic, adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal (conventional, superficial), cardiac (adult, pediatric), peripheral vascular and urology.
Product codes
IYO, ITX
Device Description
The DP-20 and DP-30 Digital Ultrasonic Diagnostic Imaging System are general purpose, portable/mobile {with mobile ultrasound trolley}, software controlled, ultrasonic diagnostic systems. Its function is to acquire and display ultrasound data in B-Mode, M-Mode, or their combined mode B+M Mode. The systems are Track 1 device that employs an array of transducers including linear array and convex array. The frequency range of DP-20 is approximately 2.0 MHz to 10.0 MHz and that of DP-30 is approximately 2.0 MHz to 12.0 MHz.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasonic
Anatomical Site
Fetal, Abdominal, Intraoperative (abdominal, thoracic, and vascular), Pediatric, Small organ (breast, thyroid, testes), Neonatal cephalic, Adult cephalic, Trans-rectal, Trans-vaginal, Musculo-skeletal (conventional, superficial), Cardiac (adult, pediatric), Peripheral Vascular, Urology.
Indicated Patient Age Range
adults, pregnant women, pediatric patients and neonates.
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)
Non-clinical tests were performed. DP-20 and DP-30 Digital Ultrasonic Diagnostic Imaging System has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical and mechanical safety, and has been found to conform with applicable medical safety standards. This device has been designed to meet the following standards: UD 2, IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-2-37, IEC 60601-1-4, ISO 10993-1 and IEC 62304.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
KII3/53
NOV 28 2011
510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92(c).
The assigned 510(k) number is: K 1 1 153.
1. Submitter:
Shenzhen Mindray Bio-medical Electronics Co., LTD Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan, Shenzhen, 518057, P. R. China
Tel: +86 755 8188 5615 Fax: +86 755 2658 2680
Contact Person:
Tan Chuanbin Shenzhen Mindray Bio-medical Electronics Co., LTD Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan, Shenzhen, 518057, P. R. China
Date Prepared: October 10th, 2011
2. Device Name:
DP-20 Digital Ultrasonic Diagnostic Imaging System (new added sub-model) DP-30 Digital Ultrasonic Diagnostic Imaging System (new added sub-model)
Classification
Regulatory Class: II 21 CFR 892.1560 Ultrasonic Pulsed Echo Imaging System (90-IYO) 21 CFR 892.1570 Diagnostic Ultrasound Transducer (90-ITX)
3. Device Description:
The DP-20 and DP-30 Digital Ultrasonic Diagnostic Imaging System are general purpose, portable/mobile {with mobile ultrasound trolley}, software controlled, ultrasonic diagnostic systems. Its function is to acquire and display ultrasound data in B-Mode,
1
M-Mode, or their combined mode B+M Mode. The systems are Track 1 device that employs an array of transducers including linear array and convex array. The frequency range of DP-20 is approximately 2.0 MHz to 10.0 MHz and that of DP-30 is approximately 2.0 MHz to 12.0 MHz.
4. Intended Use:
The DP-20 and DP-30 Digital Ultrasonic Diagnostic Imaging System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, intraoperative(abdominal, thoracic, and vascular), pediatric, small organ(breast, thyroid, testes), neonatal cephalic, trans-rectal, trans-rectal, trans-vaginal, musculo-skeletal(conventional, superficial), cardiac(adult, pediatric), peripheral vascular and urology exams.
5. Comparison with Predicate Device:
DP-20 and DP-30 Digital Ultrasonic Diagnostic Imaging System is comparable with and substantially equivalent to the Mindray DP-6900 Digital Ultrasonic Diagnostic Imaging System (K090912), M5 Diagnostic Ultrasound System(K102991) and M7 Diagnostic Ultrasound System(K103677). They have the same technological characteristics, are comparable in key safety and effectiveness features, and have the same intended uses and basic operating modes as the predicate device.
6. Non-clinical Tests:
DP-20 and DP-30 Digital Ultrasonic Diagnostic Imaging System has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical and mechanical safety, and has been found to conform with applicable medical safety standards. This device has been designed to meet the following standards: UD 2, IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-2-37, IEC 60601-1-4, ISO 10993-1 and IEC 62304.
Conclusion:
Intended uses and other key features are consistent with traditional clinical practices, FDA guidelines and established methods of patient examination. The design, development and quality process of the manufacturer confirms with 21 CFR 820, ISO 9001 and ISO 13485 quality systems. The device conforms to applicable medical device safety standards. Therefore, the DP-20 and DP-30 Digital Ultrasonic Diagnostic Imaging System is substantially equivalent with respect to safety and effectiveness to devices
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, with three human profiles incorporated into the design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle image.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
DEC -6 2011
Shenzhen Mindray Bio-Medical Electronics Co., Ltd. % Ms. Susan D. Goldstein-Falk Official Correspondent MDI Consultants. Inc. 55 Northern Blvd, Suite 200 GREAT NECK NY 11021
Re: K113153
Trade/Device Name: DP-20, DP-30 Digital Ultrasonic Diagnostic Imaging System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO and ITX Dated: October 10, 2011 Received: October 25, 2011
Dear Ms. Goldstein-Falk:
This letter corrects our substantially equivalent letter of November 28, 2011.
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 DP-20, DP-30 Digital Ultrasonic Diagnostic Imaging System, as described in your premarket notification:
Transducer Model Number
| 35C20EA | 65EC10EB | 75L53EA |
|---|---|---|
| 35C50EB | 65EL60EA | 75LT38EA |
| 65C15EA | 75L38EB | 35C20EA |
3
| 35C50EA
65C15EA
65EC10EA
65EL60EA | 65EB10EA
65EC10ED
75L38EA
75L53EA | 75LT38EA
10L24EA |
| -------------------------------------------- | -------------------------------------------- | --------------------- |
|---|
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
If you have any questions regarding the content of this letter, please contact Lauren Hefner at (301) 796-6881.
Sincerely yours.
Michael D. O'Hare for
Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
4
NOV. 29. 2011 3:13PM
P
Indications for Use
- : 510(k) Number (if known):
Device Name: DP-20, DP-30 Digital Ultrasonic Diagnostic Imaging System
Indications for Use:
The DP-20 and DP-30 Digital Ultrasonic Diagnostic Imaging System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, intraoperative (abdominal, thoracic, and vascular), pediatric, small organ (breast, thyroid, testes), neonatal cephalic, adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal (conventional, superficial), cardiac (adult, pediatric), peripheral vascular and urology.
AND/OR Over - The - Counter Use Prescription Use X (21 CFR Part 801 Subpart D) (21 CFR Part B07 Support C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (O(VD)
Ar. A. ADDI
Office of the Vitty Disc man was was and Ba
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1 - 1
Sussan D. Galdeterin-Falk
BABSCOPED DO TH FAX FAX 999925544
5
NOV. 29. 2011 3:13PM
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Diagnostic Uttrasound Indications for Use Form Transdiscer x |
System Modol: 510(k) Number(a)
DP-20 KITSTED
| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Combined (specify) | Other (specify) |
|---|---|---|---|---|---|---|---|---|
| Ophthalmic | ||||||||
| Fetal | N | N | N | Note 1, Note2 | ||||
| Abdominal | N | N | N | Note 1, Note2 | ||||
| Intraoperative (specify)* | N | N | N | Note 2 | ||||
| Intraoperative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | N | N | N | Note 1, Note 2 | ||||
| Small organ (specify)** | N | N | N | Note 2 | ||||
| Neonatal Cephalic | N | N | N | Note 2 | ||||
| Adult Cephalic | N | N | N | Note 2 | ||||
| Trans-rectal | N | N | N | Note 2 | ||||
| Trans-vaginal | N | N | N | Note 2 | ||||
| Trans-urethral | ||||||||
| Trans-esoph.(non-Card.) | ||||||||
| Musculo-skeletal Conventional | N | N | N | Note 1, Note 2 | ||||
| Musculo-skeletal Superficial | N | N | N | Note 2 | ||||
| Intravascular | ||||||||
| Cardiac Adult | N | N | N | Note 2 | ||||
| Cardiac Pediatric | N | N | N | Note 2 | ||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-Cardiac | ||||||||
| Peripheral Vascular | N | N | N | Note 2 | ||||
| Other (specify)*** | N | N | N | Note 1, Note 2 | ||||
| N=new indication; P=previously cleared by FDA; E=added under Appendix E | ||||||||
| Additional comments: Combined modes: B+M | ||||||||
| *Intraoperative includes abdominal, thoracic, and vascular. | ||||||||
| **Small organ-breast, thyroid, testes. | ||||||||
| ***Other use includes Urology. | ||||||||
| Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents. | ||||||||
| Note 2: Biopsy Guidance |
(PL&ASE DO NOT WATERS OW Achte 1.64 Concurrence of CDRE, Office of Device Evoluntion(ODE)
Pressentation USD (Par 21 CFR.
801.109)
h. DOK
Christian Blen-Ott
Division at Rockon Sign Only City of in Viseo Disampeda Chryse Melocano and Sefuly
510x k11342
0030
Assan B. Goddstein-Falk
6
11/28/2011 00:01 FAX 8484295846
۲۰ NU. 1241
NOV. 29. 2011 1:44PM
Diagnostic Ultrasound Indications for Use Form Transchoer 赛
Frankshis Model:
- Number (3)
ACTICA
| Clinical Application | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Combined
(specify) | Other
(specify) |
|----------------------------------------------------------------------------|---|---|-----|-----|------------------|----------------------|-----------------------|--------------------|
| Ophthalmic | | | | | | | | |
| Fetal | | | | | | P | Note 2 | |
| Abdominal | P | P | | | | | | |
| Intraoperative (specify)* | | | | | | | | |
| Intraoperative (Neuro) | | | | | | | | |
| Laparoscopic | | | | | | | P | Note 2 |
| Pediatric | P | P | | | | | | |
| Small organ (specify)** | | | | | | | | |
| Neonatal Cephalic | | | | | | | | |
| Adult Cephalic | | | | | | | | |
| Trans-rectal | | | | | | | | |
| Trans-vaginal | | | | | | | | |
| Trans-urethral | | | | | | | | |
| Trans-esoph.(non-Card.) | | | | | | | | |
| Musculo-skeletal Conventional | P | P | | | | | P | Note 2 |
| Musculo-skeletal Superficial | | | | | | | | |
| Intravascular | | | | | | | P | Note 2 |
| Cardiac Adult | P | P | | | | | | |
| Cardiac Pediatric | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | |
| Intra-Cardiac | | | | | | | | Note |
| Peripheral Vascular | P | P | | | | | P | |
| Other (specify)*** | | | | | | | | |
| N=new indication; P=previously cleared by FDA; E=added under Appendix E | | | | | | | | |
| Additional comments: Combined modes: B+M | | | | | | | | |
| *Intraoperative includes abdominal, thoracic, and vascular. | | | | | | | | |
| **Small organ-breast, thyroid, testes. | | | | | | | | |
| ***Other use includes Urology. | | | | | | | | |
| Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents. | | | | | | | | |
| Note 2: Biopsy Guidance | | | | | | | | |
(FLBASE DO NO NORH, Office of Doviev Evelastian(ODDE)
Prosctiption USE (Par 2 ) CFR 801-109)
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7
11/29/2011 @0:01 FAX 9494295B46 NOV. 29. 2011 1:44PM
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1
Diagnastic Ultrasound Indications for Use Barn Transduscr 개
System Model:
910();) Number(s)
35CSGRE - In 155
| Clinical Application | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Combined
(specify) | Other (specify) |
|----------------------------------|---|---|-----|-----|------------------|----------------------|-----------------------|-----------------|
| Ophthalmic | | | | | | | | |
| Fetal | N | N | | | | | N | Note 1, Note 2 |
| Abdominal | N | N | | | | | N | Note 1, Note 2 |
| Intraoperative (specify)* | | | | | | | | |
| Intraoperative (Neuro) | | | | | | | | |
| Laparoscopic | | | | | | | | |
| Pediatric | N | N | | | | | N | Note 1, Note 2 |
| Small organ(specify)** | | | | | | | | |
| Neonatal Cephalic | | | | | | | | |
| Adult Cephalic | | | | | | | | |
| Trans-rectal | | | | | | | | |
| Trans-vaginal | | | | | | | | |
| Trans-urethral | | | | | | | | |
| Trans-esoph.(non-Card.) | | | | | | | | |
| Musculo-skeletal
Conventional | N | N | | | | | N | Note 1, Note 2 |
| Musculo-skeletal Superficial | | | | | | | | |
| Intravascular | | | | | | | | |
| Cardiac Adult | | | | | | | | |
| Cardiac Pediatric | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | |
| Trans-esoph.(Cardiac) | | | | | | | | |
| Intra-Cardiac | | | | | | | | |
| Peripheral Vascular | | | | | | | | |
| Other (specify)*** | N | N | | | | | N | Note 1, Note 2 |
we other use includes Urology_ Note I: Tissue Hornonia limaging. The formers does not use contrast agents.
Note 2: Blapsy Guiduzes
(PLEASEDO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED).
Concurrents of CDRH, Office of Devies Evaluation(GDB)
Prosuription USE Car 21 CFR 601.109
Marshal Dillah
on of house POST Viso Dischoolio Device Exalcation and Solesy OTHOS CHAN
STOK L 113153
1 Bell
8
11/29/2011 00:02 FAX 19494295848 11 1 1 Susan D 1601Østein-Falker 1
Susan Q. Goldstein-Falk
@008/011
30V. 29. 2011 1:44PM
Blagantic Ultrasound Indications for Use Form Trensdicer ×
| System
| Modal: | 65EC10RB | Transducer | ||||||
|---|---|---|---|---|---|---|---|---|
| 510(k) Number(s) | K43153 | |||||||
| Clinical Application | B | M | PWD | CWD | Color | |||
| Doppler | Amplitude | |||||||
| Doppler | Combined | |||||||
| (specify) | Other | |||||||
| (specify) | ||||||||
| Ophthalmic | Note 2 | |||||||
| Fetal | N | N | N | Note 2 | ||||
| Abdominal | ||||||||
| Intraoperative (specify)* | ||||||||
| Intraoperative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small organ (specify)** | N | Note 2 | ||||||
| Neonatal Cephalic | N | N | N | Note 2 | ||||
| Adult Cephalic | Note 2 | |||||||
| Trans-rectal | N | N | N | Note 2 | ||||
| Trans-vaginal | N | N | N | |||||
| Trans-urethral | ||||||||
| Trans-esoph.(non-Card.) | ||||||||
| Musculo-skeletal Conventional | ||||||||
| Musculo-skeletal Superficial | ||||||||
| Intravascular | ||||||||
| Cardiac Adult | ||||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph (Cardiac) | ||||||||
| Intra-Cardiac | ||||||||
| Peripheral Vascular | N | Note 2 | ||||||
| Other (specify)*** | N | N | ||||||
| N=new indication; P=previously cleared by FDA; E=added under Appendix E | ||||||||
| Additional comments: Combined modes: B+M. | ||||||||
| *Intraoperative includes abdominal, thoracic, and vascular. | ||||||||
| **Small organ-breast, thyroid, testes. | ||||||||
| ***Other use includes Urology. | ||||||||
| Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents. |
Pressiption USE (Fer 21 CFR 80L 109)
હ્ય છાર્
M. L. O'Dell
Bander and of Read Section Office of in Viro D on east Group
K11232
0034
Brand States of Children
9
System
Dingmostic Clarasound Indications for Use Form Transdocket
SELLATE
NOV. 29. 2011 1:44 PM
uu. 1741
મ
| Model: | 65EL60EA |
|---|---|
| 510(k) Number(s) | K113152 |
| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Combined (specify) | Other (specify) |
|---|---|---|---|---|---|---|---|---|
| Ophthalmic | ||||||||
| Fetal | ||||||||
| Abdominal | ||||||||
| Intraoperative (specify)* | ||||||||
| Intraoperative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small organ(specify)** | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | P | P | P | Note 2 | ||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph(non-Card.) | ||||||||
| Musculo-skeletal Conventional | ||||||||
| Musculo-skeletal Superficial | ||||||||
| Intravascular | ||||||||
| Cardiac Adult | ||||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph(Cardiac) | ||||||||
| Intra-Cardiac | ||||||||
| Peripheral Vascular | P | P | P | Note 2 | ||||
| Other(specify)*** |
New indication: P=previously cleared by FDA; E=added under Appendix E
Additional comments: Combined modes: B+M
*Intraoperative includes abdominal, thoracic, and vascular.
**Small organ=breast, thyroid, testis.
***Other can includes Urology.
Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
Note 2: Biopsy Guidance
Proscription USE (Por 21 CPR 801.109)
Division Sign-Off
Dogsino of Rad Chica
SIOK K112653
0035
10
11/29/2011 00.02 FAX 9494295846
. . . .
System
1 på 1
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11
NOV. 29. 2011 1:45PM
리뷰 - 대표 - 1975 - 147
Disquostic Ukrareand Indications for Use Form Trunsmoer - Se
.
| Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | FWD | CWD | Color | |||
| Doppler | Amplitude | |||||||
| Doppler | Combined | |||||||
| (specify) | Other | |||||||
| (specify) | ||||||||
| Ophthalmic | ||||||||
| Fetal | N | Note 2 | ||||||
| Abdominal | N | N | ||||||
| Intraoperative (specify)* | ||||||||
| Intraoperative (Neuro) | ||||||||
| Laparoscopic | N | Note 2 | ||||||
| Pediatric | N | N | Note 2 | |||||
| Small organs (specify)** | N | N | N | Note 2 | ||||
| Neonatal Cephalic | N | N | ||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph.(non-Card.) | N | Note 2 | ||||||
| Musculo-skeletal Conventional | N | N | N | Note 2 | ||||
| Musculo-skeletal Superficial | N | N | ||||||
| Intravascular | ||||||||
| Cardiac Adult | ||||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-Cardiac | N | Note 2 | ||||||
| Peripheral Vascular | N | N | ||||||
| Other (specify)*** | ||||||||
| N=new indication; P=previously cleared by FDA; *added under Appendix E | ||||||||
| Additional comments: Combined modes: B+M. | ||||||||
| *Intraoperative includes abdominal, thoracic, and vascular. | ||||||||
| **Small organ-breast, thyroid, testes. | ||||||||
| ***Other use includes Urology. | ||||||||
| Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents. | ||||||||
| Note 2: Biopsy Guidance |
Copaurement of CDRH, Office of Device Evelusion(ODE)
Preseription USB (Per 21 CFR 801-109)
Aad OJK
(Citizen Sign-On)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
sick K13153
0036
ਤਿੰਦਾ ਹੈ।
and and the state of the starter
:
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
11 - 11:41 - 11
11
ਾ ਦੀ ਸੀ।
,第二十
1947
| Symon
| Model: | 751.53EA |
|---|---|
| 510(k) Number(s) | K1/3153 |
| Clinical Application | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Combined
(specify) | Other
(specify) |
|-------------------------------|---|---|-----|-----|------------------|----------------------|-----------------------|--------------------|
| Ophthalmic | | | | | | | | |
| Fetal | | | | | | | | |
| Abdominal | P | P | | | | | P | Note 2 |
| Intraoperative (specify)* | | | | | | | | |
| Intraoperative (Neuro) | | | | | | | | |
| Laparoscopic | | | | | | | | |
| Pediatric | P | P | | | | | P | Note 2 |
| Small organ(specify)** | P | P | | | | | P | Note 2 |
| Neonatal Cephalic | P | P | | | | | P | Note 2 |
| Adult Cephalic | | | | | | | | |
| Trans-rectal | | | | | | | | |
| Trans-vaginal | | | | | | | | |
| Trans-urethral | | | | | | | | |
| Trans-esoph (non-Card) | | | | | | | | |
| Musculo-skeletal Conventional | P | P | | | | | P | Note 2 |
| Musculo-skeletal Superficial | P | P | | | | | P | Note 2 |
| Intravascular | | | | | | | | |
| Cardiac Adult | | | | | | | | |
| Cardiac Pediatric | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | |
| Trans-esoph (Cardiac) | | | | | | | | |
| Intra-Cardiac | | | | | | | | |
| Peripheral Vascular | P | P | | | | | P | Note 2 |
| Other (specify)*** | | | | | | | | |
N=new indication; P=previously cleared by FDA; B=added under Appendix E
Additional comments: Combined modes: B+M.
*Intraoperative includes abdominal, thoracic, and vascular.
**Small organ-breast, thyroid, testes.
***Other use includes Urology.
Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
Note 2: Biopsy Guidance
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRE, Office of Device Evaluation (ODE)
Proses prion USE (Por 21 CFR 801.109)
Mr. A. O. Dike
Division of Radiological Devices
Bureau of on Vitro Diagnostic Device Evaluation and Safety
sick E 113/51
0037
11 11:42 1
1135 - - 5 pharal Socied hat hand - a - a r d min 4 i = = ( . + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + +
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.
12
NOV. 29. 2011 3:13PW
이 대한 이상 등 1
and the comments of the comments of the comments of the
的主要最新的位置
ਸਿੰਘ ਸੀ। ਇਸ ਦੀ ਸਾਰੇ ਦੇ ਮੁ
ﺍﻟﻤﻮﺿﻮﻉ ﺍﻟﻤﺴﺎﻋﺪ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘ
이 대한 사용
1941 - 1944
11,97
1
Diagnostic Ultrasound Indications for Use Form
| System | |
|---|---|
| Model | TSLT3REA |
| 510(k) Number(s) | 5113153 |
Transducer
Mode of Operation
| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Combined (specify) | Other (specify) |
|---|---|---|---|---|---|---|---|---|
| Ophthalmic | ||||||||
| Fetal | ||||||||
| Abdominal | P | P | P | Note 2 | ||||
| Intraoperative (specify)* | P | P | P | Note 2 | ||||
| Intraoperative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | Note 2 | ||||
| Small organ (specify)** | P | P | P | Note 2 | ||||
| Neonatal Cephalic | P | P | P | Note 2 | ||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph (non-Card.) | ||||||||
| Musculo-skeletal Conventional | P | P | P | Note 2 | ||||
| Musculo-skeletal Superficial | P | P | P | Note 2 | ||||
| Intravascular | ||||||||
| Cardiac Adult | ||||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph (Cardiac) | ||||||||
| Trans-Cardiac | ||||||||
| Peripheral Vascular | P | P | P | Note 2 | ||||
| Other (specify)**** |
N=new indication; P=previously cleared by FDA; E=added under Appendix E
Additional comments: Combined modes: B+M
*Intraoperative includes abdominal, thoracic, and vascular.
**Small organ-breast, thyroid, testes.
***Other use includes Urology.
Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
Note2: Biopsy Guidance
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CORE, Office of Device Evaluation (ODE)
Preseription USC (Per 21 CFR 801.109)
Arda D.K.
[signature]
Offica and Smary
DTOR K113153
0038 11:51 11
:
1 - 1
문의 대학교 대학
8985829898 88 FAJ BP Fra BP:00 FLO2762111 ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・
13
11/28/2011 00:21 FAX 9494295848 XDV. 29. 2011 1:53PM
国001/014
P. 13/24 NO. 124 /
Dingnostia Ultrassund Indications for Use Form Transquaer
DP-30
11:316
- gyestu ?નવીધી:
510(g) Number(s)
| Clinical Application | B | M | FWD | CWD | Color
Doppler | Amplitude
Doppler | Combined
(specify) | Other (specify) |
|----------------------------------|---|---|-----|-----|------------------|----------------------|-----------------------|-----------------|
| Ophthalmic | N | N | | | | | N | Note 1, Note2 |
| Fetal | N | N | | | | | N | Note 1, Note2 |
| Abdominal | N | N | | | | | N | Note 2 |
| Intraoperative (specify)* | N | N | | | | | | |
| Intraoperative (Neuro) | | | | | | | | |
| Laparoscopic | | | | | | | | |
| Pediatric | N | N | | | | | N | Note 1, Note 2 |
| Small organ(specify)** | N | N | | | | | N | Note 2 |
| Neonatal Cephalic | N | N | | | | | N | Note 2 |
| Adult Cephalic | N | N | | | | | N | Note 2 |
| Trans-rectal | N | N | | | | | N | Note 2 |
| Trans-vaginal | N | N | | | | | N | Note 2 |
| Trans-urethral | | | | | | | | |
| Trans-esoph(non-Card.) | | | | | | | N | Note 1, Note 2 |
| Musculo-skeletal
Conventional | N | N | | | | | N | Note 2 |
| Musculo-skeletal Superficial | N | N | | | | | | |
| Intravascular | | | | | | | N | Note 2 |
| Cardiac Adult | N | N | | | | | N | Note 2 |
| Cardiac Pediatric | N | N | | | | | | |
| Intravascular (Cardiac) | | | | | | | | |
| Trans-esoph.(Cardiac) | | | | | | | | |
| Intra-Cardiac | | | | | | | N | Note 2 |
| Peripheral Vascular | N | N | | | | | N | Note 1, Note 2 |
| Other (specify)*** | N | N | | | | | -N | Note 1, Note 2 |
Intervention includes abdominal, thoracic, and
- at Small ongag-breast, thyroid, tastes.
xxx (Jiber ust meludes Urolagy.
Note 1. Tissue Hornomio Ilmiging, The feature doos nor use nontrast agains.
Note I; Biopsy Guidence
810
(FLBASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED)
(FLBASE DO NOT WRITE BELLOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED)
(FLBASE DO NOT WRITE BELLOW Concurrante of CDRH, Office of Device Evalustian(ODE)
Prestoritstica USE (Par 21 CFR 801-109)
Marth D. Kirk
Division Sign-Off
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
14
Dingnoote Clerasound ladications for Use Form Tasistadiaat
欧002/014
P. 16/24
| System | 35C205A |
|---|---|
| Model: | |
| 510(K) Number(s) | K113153 |
| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Combined (specify) | Other (specify) |
|---|---|---|---|---|---|---|---|---|
| Ophthalmic | ||||||||
| Femoral | ||||||||
| Abdominal | P | P | P | Note 2 | ||||
| Intraoperative (specify)* | ||||||||
| Invasive/Interventional (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | Note 2 | ||||
| Small organ(specify)** | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph (non-Card.) | ||||||||
| Musculo-skeletal Conventional | P | P | P | Note 2 | ||||
| Musculo-skeletal Superficial | ||||||||
| Intravascular | ||||||||
| Cardiac Adult | P | P | P | Note 2 | ||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph(Cardiac) | ||||||||
| Intra-Cardiac | ||||||||
| Peripheral Vascular | P | P | P | Note 2 | ||||
| Other (specify)*** |
N=new indication: P=previously cleared by FDA; E=added under Appendix E
Additional comments: Combined modes: B+M.
*Intraoperative includes abdominal, thoracic, and vascular.
**Small organ-breast, thyroid, testes.
***Other use includes Urology.
Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
Note 2: Biopsy Guidance
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation(ODE)
Presentpeion USE (Per 21 CPR 801.109)
ﻬﻢ ﺍﻟﻤﺘﺤﺪﺓ
Mashad R. J.M.
State As Subly office of the STITUTE ARD .
න්නේ පිහිටා විසින් පිහිටි බවට පිහිටි පිහිටි බවට පිහිටි පිහිටි බවට පිහිටි පිහිටි පිහිටි බවට පිහිටි පිහිටි පිහිටි බවට පිහිටි පිහිටි පිහිටි බවට පිහිටි පිහිටි පිහිටි බවට පිහිටි
SIOK K113/53
0040
.
15
11/28/2011 00.22 FAX 94942956146
0003/014
NOV. 29. 2011, 1:53PM
Dingnostic Uttrasonad Indications for Use Form
Transdates *
System Modal: 510kk) Nizabea (s)
35 50RA 113157
| Clinical Application | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Combined
(specify) | Other (specify) |
|----------------------------------|---|---|-----|-----|------------------|----------------------|-----------------------|-----------------|
| Ophthalmic | | | | | | | | |
| Fetal | P | P | | | | | P | Note 1, Note 2 |
| Abdominal | P | P | | | | | P | Note 1, Note 2 |
| Intraoperative (specify)* | | | | | | | | |
| Intraoperative (Neuro) | | | | | | | | |
| Laparoscopic | | | | | | | | |
| Pediatric | P | P | | | | | P | Note 1, Note 2 |
| Small organs (specify)** | | | | | | | | |
| Neonatal Cephalic | | | | | | | | |
| Adult Cephalic | | | | | | | | |
| Trans-rectal | | | | | | | | |
| Trans-vaginal | | | | | | | | |
| Trans-urethral | | | | | | | | |
| Trans-esoph.(non-Card.) | | | | | | | | |
| Musculo-skeletal
Conventional | P | P | | | | | P | Note 1, Note 2 |
| Musculo-skeletal Superficial | | | | | | | | |
| Intravascular | | | | | | | | |
| Cardiac Adult | | | | | | | | |
| Cardiac Pediatric | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | |
| Trans-esoph.(Cardiac) | | | | | | | | |
| Intra-Cardiac | | | | | | | | |
| Peripheral Vascular | | | | | | | | |
| Other (specify) | P | P | | | | | P | Note 1, Note 2 |
Pressuiption USE (Par 21 CFR 801 109)
:
-
- No. 1. 1.
Ars. A. DDA
[Director Sign-Off]
Division of Realding and Dentose Office of In Unite Disamostic Device Element
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
k 11311 510K,
0041
16
11/29/2011 00:22 FAX 8484295846
团 004/014
HCV. 29, 2011 1:59PM
Diagagene Ultrasonnd Indications for Use Form antinas ਮ
System Modal: 510() Number (s)
| 65CLSEA |
|---|
| 511315 |
| Clinical Application | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Combined
(specify) | Other
(specify) |
|----------------------------------------------------------------------------|---|---|-----|-----|------------------|----------------------|-----------------------|--------------------|
| Ophthalmic | | | | | | | | |
| Fetal | | | | | | | | |
| Abdominal | P | P | | | | | | Note 2 |
| Intraoperative (specify)* | | | | | | | | |
| Intraoperative (Neuro) | | | | | | | | |
| Laparoscopic | | | | | | | P | Note 2 |
| Pediatric | P | P | | | | | | |
| Small organ(specify)** | | | | | | | P | Note 1 |
| Neonatal Cephalic | P | P | | | | | P | Note 2 |
| Adult Cephalic | P | P | | | | | P | Note 2 |
| Trans-rectal | | | | | | | | |
| Trans-vaginal | | | | | | | | |
| Trans-urethral | | | | | | | | |
| Trans-esoph.(non-Card.) | | | | | | | | |
| Musculo-skeletal Conventional | P | P | | | | | P | Note 2 |
| Musculo-skeletal Superficial | | | | | | | | |
| Intravascular | | | | | | | | |
| Cardiac Adult | | | | | | | | |
| Cardiac Pediatric | P | P | | | | | P | Note 2 |
| Intravascular (Cardiac) | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | |
| Intra-Cardiac | | | | | | | | |
| Peripheral Vascular | P | P | | | | | P | Note 2 |
| Other (specify)*** | | | | | | | | |
| Notes: Indication; P=previously cleared by FDA, E=added under Appendix E | | | | | | | | |
| Additional comments: Combined modes: B+M | | | | | | | | |
| *Intraoperative includes abdominal, thoracic, and vascular. | | | | | | | | |
| **Small organ-breast, thyroid, testes. | | | | | | | | |
| ***Other are includes Urology. | | | | | | | | |
| Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents. | | | | | | | | |
| Note 2: Biopsy Guidance | | | | | | | | |
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) | | | | | | | | |
Presentption USB (Per 21 CFR 80J.109)
، • • ﺳﻢ
Puss D'H
Oversion of Radiolor Citics of in Boon gives Sinters
6103/53
17
11/28/2011 00.22 Fax 9494285846 NOV. 29. 2011 1:59PM
1974 - 1
NU. 1241 - 124 11/24
团 005/014
이 지원할 수
- 2.3.2.2.11 3-1131
| Diagnostic Ultrasound Indications for Use Form |
|---|
| Transducer |
| 65PC10EA |
K 113123
Model: 510(k) Number(s)
System
.
1, 201
在线上
我要的一个人
| Clinical Application | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Combined
(specify) | Other
(specify) |
|----------------------------------------------------------------------------|---|---|-----|-----|------------------|----------------------|-----------------------|--------------------|
| Ophthalmic | P | P | | | | | P | Note 2 |
| Fetal | | | | | | | | |
| Abdominal | | | | | | | | |
| Intraoperative (specify)* | | | | | | | | |
| Intraoperative (Neuro) | | | | | | | | |
| Laparoscopic | | | | | | | | |
| Pediatric | | | | | | | | |
| Small organ (specify)** | | | | | | | | |
| Neonatal Cephalic | P | P | P | | | | P | Note 2 |
| Adult Cephalic | | | | | | | | |
| Transrectal | P | P | | | | | P | Note |
| Trans-vaginal | P | P | | | | | P | Note |
| Trans-urethral | | | | | | | | |
| Trans-esoph.(non-Card.) | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | |
| Intravascular | | | | | | | | |
| Cardiac Adult | | | | | | | | |
| Cardiac Pediatric | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | |
| Trans-esoph.(Cardiac) | | | | | | | | |
| Intra-Cardiac | | | | | | | | |
| Peripheral Vascular | | | | | | | | |
| Other (specify)*** | P | P | | | | | P | Note |
| N=new indication; P=previously cleared by FDA; E= added under Appendix E | | | | | | | | |
| Additional comments: Combined modes: B+M | | | | | | | | |
| *Intraoperative includes abdominal, thoracic, and vascular. | | | | | | | | |
| **Small organ=breast, thyroid, testes. | | | | | | | | |
| ***Other use includes Urology. | | | | | | | | |
| Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents. | | | | | | | | |
| Note 2: Biopsy Guidance | | | | | | | | |
Preseription USB (Per 21 CFR 801 109)
SICK.
a 2017 - 1
A. A. D'A
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
0043
ਦਾ ਦੀ ਉਸਦੇ ਦਾ ਸਾਂ ਅੰਤਿਆ ਸੀ। ਇਸ ਦੇ ਸ
18
11/28/2011 00:22 FAX 99904285846
团 006 /0 14
1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1
NOV. 29 2011 1:55PM
r. 16/ 14 110. 1141
.
Diagnostic Ultrasound Indications for Use Form
| Transducer | x |
|---|---|
| ------------ | --- |
11 2016 6. 00-6-6System Model: 510(k) Number(s)
65BLOUDA 6113158
| Clinical Application | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Combined
(specify) | Other
(specify) |
|----------------------------------------------------------------------------|---|---|-----|-----|------------------|----------------------|-----------------------|--------------------|
| Ophthalmic | | | | | | | | |
| Foni | | | | | | | | |
| Abdominal | | | | | | | | |
| Intraoperative (specify)* | | | | | | | | |
| Intraoperative (Neuro) | | | | | | | | |
| Laparoscopic | | | | | | | | |
| Pediatric | | | | | | | | |
| Small organ(specify)** | | | | | | | | |
| Neonatal Cephalic | | | | | | | | |
| Adult Cephalic | | | | | | | | |
| Transrectal | P | P | | | | | P | Note 2 |
| Trans-vaginal | | | | | | | | |
| Trans-urethral | | | | | | | | |
| Trans-esoph.(non-Card.) | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | |
| Intravascular | | | | | | | | |
| Cardiac Adult | | | | | | | | |
| Cardiac Pediatric | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | |
| Trans-esoph.(Cardiac) | | | | | | | | |
| Intra-Cardiac | | | | | | | | |
| Peripheral Vascular | | | | | | | | |
| Other (specify)*** | P | P | | | | | P | Note |
| N=new indication; P=previously cleared by FDA; E=added under Appendix E | | | | | | | | |
| Additional comments: Combined modes: B+M | | | | | | | | |
| *Intraoperative includes abdominal, thoracic, and vascular. | | | | | | | | |
| **Small organ-breast, thyroid, testes. | | | | | | | | |
| ***Other use includes Urology. | | | | | | | | |
| Note 1: Tissue Harmonic imaging. The feature does not use contrast agents. | | | | | | | | |
| Note 2: Biopsy Guidance | | | | | | | | |
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) | | | | | | | | |
Preseription USE (Por 2) CBR 801.109)
A. L. D. D. K.
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
312
09:51:5
19
11/29/2011 00:22 FAX 8484285846
137
NOV. 29. 2011 1:59PM
Dinganstic Citrasound Indications for Use Form Transducer 14
| Model: | 66EB10EA |
|---|---|
| 510(k) Number(s) | K1613153 |
| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Combined (specify) | Other (specify) |
|---|---|---|---|---|---|---|---|---|
| Ophthalmic | ||||||||
| Femoral | ||||||||
| Abdominal | ||||||||
| Intraoperative (specify)* | ||||||||
| Intraoperative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small organ (specify)** | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | N | Note 2 | ||||||
| Trans-rectal | N | N | ||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph.(non-Card.) | ||||||||
| Musculo-skeletal Conventional | ||||||||
| Musculo-skeletal Superficial | ||||||||
| Intravascular | ||||||||
| Cardiac Adult | ||||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-Cardiac | ||||||||
| Peripheral Vascular | ||||||||
| Other (specify)*** | N | N | N | Note 2 |
N=new indication; P=previously cleared by FDA; Bradded under Appendix E
Additional comments:Combined modes: B+M.
*Intraoperative includes abdominal, thoracic, and vascular.
**Small organ-breast, thyroid, testes.
***Other use includes Urology.
Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
Note 2: Biopsy Guidance
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRJI, Office of Device Evaluation(ODE)
BLOK.
Posstarty doo USB (Por 21 CFR 801.109)
Ress DDK
Chicon of Rack the Brahaman will SSIALY Office of in Viro Dis France France
20
r. Lucity NU. 1241
1 - 59 PM NOV. 29. 2011
Dingnostic Ultrasound Indications for Use Form Transducer ਮ
System Model: SIOUs) Namaker (s)
SECTORD CITY 153
| Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Combined (specify) | Other (specify) |
| Ophthalmic | ||||||||
| Fetal | N | N | N | Note 2 | ||||
| Abdominal | ||||||||
| Intraoperative (specify)* | ||||||||
| Intraoperative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small organ (specify)** | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | N | N | N | Note 2 | ||||
| Transurethral | ||||||||
| Trans-esoph.(non-Card.) | ||||||||
| Musculo-skeletal Conventional | ||||||||
| Musculo-skeletal Superficial | ||||||||
| Intravascular | ||||||||
| Cardiac Adult | ||||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph.(Cardiac) | ||||||||
| Extra-Cardiac | ||||||||
| Peripheral Vascular | ||||||||
| Other (specify)*** |
N=new indication; F=previously cleared by FDA; E=added under Appendix E
Additional comments: Combined modes: B+M
*Intraoperative includes abdominal, thoracic, and vascular.
**Small organ-breast, thyroid, testes.
***Other use includes Urology.
Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
Note 2: Biopsy Guidance
(PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation(ODE)
Pressiptive USE (Por 21 CFR 801.109)
ﺔ ﻣﻦ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ
M.L.D.D.A.
[Mission Plan-Out]
Orvision of Radiological Dav and 18577 offen at in Vitre Disgrosms Davice
Stok K10153
21
11/28/2011 00:22 FAK 9494295846
۲۰ 19124 NU. | LA 1
NOV. 29, 2011 1:59 PM
Dlagnostic Curasound Indications for The Form Transdaoer メ
System Madel:
5100k) Number (8)
791.380 A (((1)(2)(2)(2)(2)(2)(2)(2)(2)(2)(2)(2)(2)(2)(2)(2)(2)(2)(2)(2)(2)(2)(2)(2)(2)(2)(2)(2)(2)(2)(2)(2)(2)(2)(2)(2)(2)(2)(2)(2)(2)(2)(2)(2)(2)(2)(2)(2)(2)(2)(2)(2)(2)(2)(2)(2)(2)(
| Clinical Application | Mode of Operation | | | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Combined
(specify) | Other
(specify) |
|-------------------------------|-------------------|---|---|---|---|-----|-----|------------------|----------------------|-----------------------|--------------------|
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | P | P | P | | | | | P | | Note 2 |
| Intraoperative (specify)* | | | | | | | | | | | |
| Intraoperative (Neuro) | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | Note 2 |
| Podiatric | | P | P | | | | | | P | | Note 2 |
| Small organ(specify)** | | P | P | | | | | | P | | Note 2 |
| Neonatal Cephalic | | P | P | | | | | | P | | Note 2 |
| Adult Cephalic | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | |
| Trans-esoph.(ans-Card.) | | | | | | | | | | | |
| Musculo-skeletal Conventional | | P | P | | | | | | P | | Note 2 |
| Musculo-skeletal Superficial | | P | P | | | | | | P | | Note 2 |
| Intravascular | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | | | |
| Trans-esoph.(Cardiac) | | | | | | | | | | | |
| Intra-Cardiac | | | | | | | | | | | |
| Peripheral Vascular | | P | P | | | | | | P | | Note 2 |
| Other (specify)*** | | | | | | | | | | | |
Pressiption USE (Por Z) CFR 801.109)
Fri .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Jassh D. H
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
કાવત
0047
22
- 10:24
. LLILY : 上一篇:
XOY. 29. 2011 2 . 00PM
Diagnastic Ultrasound Indications for Use Form Transchucer ਨੇ
System Model: 510(2) Number(3)
110
731.53EA 11315
| Clinical Application | B | M | FWD | CWD | Color
Doppler | Amplitude
Doppler | Combined
(specify) | Other
(specify) |
|----------------------------------------------------------------------------|---|---|-----|-----|------------------|----------------------|-----------------------|--------------------|
| Ophthalmic | | | | | | | | |
| Fetal | | | | | | P | Note 2 | |
| Abdominal | P | P | | | | | | |
| Intraoperative (specify)* | | | | | | | | |
| Intraoperative (Neuro) | | | | | | | | |
| Laparoscopic | | | | | | | P | Note 2 |
| Pediatric | P | P | P | | | | P | Note 2 |
| Small organ (specify)** | P | P | P | | | | P | Note 2 |
| Neonatal Cephalic | P | P | | | | | | |
| Adult Cephalic | | | | | | | | |
| Trans-rectal | | | | | | | | |
| Trans-vaginal | | | | | | | | |
| Trans-urethral | | | | | | | | |
| Trans-esoph (incl. Card.) | | | | | | | | |
| Musculo-skeletal Conventional | P | P | P | | | | P | Note 1 |
| Musculo-skeletal Superficial | P | P | P | | | | P | Note 2 |
| Intravascular | | | | | | | | |
| Cardiac Adult | | | | | | | | |
| Cardiac Pediatric | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | |
| Trans-esoph (Cardiac) | | | | | | | | |
| Intra-Cardiac | | | | | | | | |
| Peripheral Vascular | P | P | | | | | P | Note |
| Other (specify)*** | | | | | | | | |
| N=new indication; P=previously cleared by FDA; E=added under Appendix E | | | | | | | | |
| Additional comments: Combined modes: B+M. | | | | | | | | |
| *Intraoperative includes abdominal, thoracic, and vascular. | | | | | | | | |
| **Small organ-breast, thyroid, testes. | | | | | | | | |
| ***Other use includes Urology. | | | | | | | | |
| Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents. | | | | | | | | |
| Note 2: Biopsy Guidance | | | | | | | | |
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) | | | | | | | | |
| Concurrence of CDRH, Office of Device Evaluation (ODE) | | | | | | | | |
Preseription USP. (Par 21 CFR, 801.109)
ﮨﯽ
notw ten Siber Off
philipp of Fistic sains Devi Devon Erstustion and Salety affec of the asso Demosta
9102 113153
0048
,拥出版。
23
11/29/2011 00:23 FAX 8484295846
Susan O Goldstoin-Falk
团011/014
r. Zille 40. 1241
NOV. 29. 2011 2:00PM
Diagnestic Ultrusound Indications for Die Form メ
System Model:
510(k) Number(s)
Tresscients 75LT38EA KITS 153
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||
| Doppler | Combined | |||||||
| (specify) | Other | |||||||
| (specify) | ||||||||
| Ophthalmic | ||||||||
| Fetal | ||||||||
| Abdominal | P | P | P | Note 2 | ||||
| Intraoperative (specify)* | P | P | P | Note 2 | ||||
| Intraoperative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Podiatric | P | P | P | Note 2 | ||||
| Small organ(specify)** | P | P | P | Note 2 | ||||
| Neonatal Cephalic | P | P | P | Note 2 | ||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph.(non-Card.) | ||||||||
| Musculo-skeletal Conventional | P | P | P | Note 2 | ||||
| Musculo-skeletal Superficial | P | P | P | Note 2 | ||||
| Intravascular | ||||||||
| Cardiac Adult | ||||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph.(Cardiac) | ||||||||
| Intra-Cardiac | ||||||||
| Peripheral Vascular | P | P | P | Note 2 | ||||
| Other (specify)*** |
Pressipilon USE (Per 21 CPR 801-109)
ـــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــ
Aall DDK
(Division Signed)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
K03152
24
11/28/2011 00:23 FAX 8484295848
Susan D. Boldstein-Falk
团 012/014 HU. 1241 1. 23/24
Dirghostic Ultrasound Indicutions for Die Form x
System Model: 5100k) Pounder(s)
Transducer
75LT98EA
KI13153
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||
| Doppler | Combined | |||||||
| (specify) | Other | |||||||
| (specify) | ||||||||
| Ophthalmic | ||||||||
| Fetal | ||||||||
| Abdominal | P | P | P | Note 2 | ||||
| Intraoperative (specify)* | P | P | P | Note 2 | ||||
| Intraoperative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | Note 2 | ||||
| Small organ(specify)** | P | P | P | Note 2 | ||||
| Neonatal Cephalic | P | P | P | Note 2 | ||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph.(non-Card.) | ||||||||
| Musculo-skeletal Conventional | P | P | P | Note 2 | ||||
| Musculo-skeletal Superficial | P | P | P | Note 2 | ||||
| Intravascular | ||||||||
| Cardiac Adult | ||||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph (Cardiac) | ||||||||
| Intra-Cardiac | ||||||||
| Peripheral Vascular | P | P | P | Note 2 | ||||
| Other (specify)*** | ||||||||
| N=new indication; P=previously cleared by FDA; E=added under Appendix E | ||||||||
| Additional comments: Combined modes: B+M | ||||||||
| *Intraoperative includes abdominal, thoracic, and vascular. | ||||||||
| **Small organ-breast, thyroid, testes. | ||||||||
| ***Other use includes Urology. | ||||||||
| Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents. | ||||||||
| Note 2: Biopsy Guidance | ||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE |