(24 days)
No
The document describes a standard ultrasound system and probes, with no mention of AI or ML capabilities in the device description, intended use, or performance data sections. The performance data relies on a previously cleared device, which also does not indicate AI/ML.
No
The "Intended Use / Indications for Use" section states that the device is for "Diagnostic ultrasound imaging or fluid flow analysis," which indicates a diagnostic rather than therapeutic purpose.
Yes
The "Intended Use / Indications for Use" section explicitly states "Diagnostic ultrasound imaging or fluid flow analysis of the human body." Also, the "Device Description" mentions "EUB-525/EUB-2000 Diagnostic Ultrasound Scanner", and the predicate devices also include "Diagnostic Ultrasound Scanner".
No
The device description explicitly lists multiple hardware components including a scanner, probe connecting unit, translator, and probes. It is a hardware-based ultrasound system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Diagnostic ultrasound imaging or fluid flow analysis of the human body". This describes a medical imaging procedure performed directly on a patient, not a test performed on a sample of biological material outside the body.
- Device Description: The components listed are all related to ultrasound imaging equipment used for scanning the human body. There are no mentions of reagents, assays, or other components typically associated with IVD tests.
- Input Imaging Modality: The input modality is Ultrasound, which is a non-invasive imaging technique applied to the patient.
- Anatomical Site: The anatomical sites listed are all within the human body.
- Performance Data: The performance data refers to the device being identical to a previously cleared ultrasound system.
IVD devices are designed to perform tests on specimens such as blood, urine, or tissue to diagnose diseases or conditions. This device is clearly designed for direct imaging of the human body.
N/A
Intended Use / Indications for Use
Identical to device previously cleared by the FDA under 510(k) K011252. The intended use of the subject device is for endoscopic observation of the gastrointestinal tract (esophagus, stomach, duodenum, large intestine) and biliary system (pancreato-biliary ducts). The Ultrasound Device Indications Statements for each application and mode of the system/transducers are included with this document.
System/Transducer: EUB-525/EUB-2000 System
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application: General (Track 1 only), Specific (Tracks I & III)
Mode of Operation: B, M, PWD, CWD, Color Doppler, Amplitude Doppler, Combined* (specify), Other** (specify)
Ophthalmic: Ophthalmic
Fetal Imaging & Others: Fetal (P, P, P, P, P, P, N, P)
Abdominal: Pa, Pa, Pa, Pa, Pa, Pa, Na, Pa
Intraoperative (specify): Pb, Pb, Pb, Pb, Pb, Pb, Nb, Pb
Intraoperative (Neuro.): Not Found
Laparoscopic: P, P, P, P, P, P, N, P
Pediatric: P, P, P, P, P, P, N, P
Small Organ (specify): Pd, Pd, Pd, Pd, Pd, Pd, Nd, Pd
Neonatal Cephalic: P, P, P, P, P, P, N, P
Adult Cephalic: Not Found
Trans-rectal: Ph, Ph, Ph, Ph, Ph, Ph, Nh, Ph
Trans-vaginal: Pf, Pf, Pf, Pf, Pf, Pf, Nf, Pf
Trans-urethral: Not Found
Trans-esophageal: Not Found
Muskulo-skeletal: Not Found
Conventional: Not Found
Musculo-skeletal: Not Found
Superficial: Not Found
Intra-luminal: Ni
Other (specify): Not Found
Cardiac: Cardiac Adult (P, P, P, P, P, P, N, P)
Cardiac Pediatric: P, P, P, P, P, P, N, P
Cardiac Transesophageal Adult: P, P, P, P, P, P, N, P
Cardiac Transesophageal Pediatric: P, P, P, P, P, P, N, P
Other (specify): Not Found
Peripheral Vessel: Peripheral Vascular (P, P, P, P, P, P, N, P)
Other (specify): Not Found
N=new indication; P=previously cleared by FDA under 510(k)# K981434; E=added under appendix E
*Combination of each operating mode, B, M, PWD, CWD, and Color Doppler
** Amplitude Doppler and Harmonic Imaging
Additional Comments:
Subscript "a": Includes imaging for guidaneous biopsy of abdominal organs and structures (including amniccentesis).
Subscript "b": Includes imaging of organs and structures exposed during surgery and laparoscopic procedures).
Subscript "c": Includes thyroid, parathyroid, breast, scrotum, penis.
Subscript "d": Includes thyroid, breast, scrotum, penis and imaging for guidance of biopsy.
Subscript "e": Includes imaging for guidance of transrectal biopsy.
Subscript "f": Includes imaging for guidance of tranvaginal biopsy.
Subscript "g": For pediatric patients.
Subscript "h": Includes imaging for guidance of transrectal biopsy, cryosurgery, and brachytherapy.
Subscript "i": Includes imaging of the biliary system (pancreato-biliary) and gastrointestinal tract (esophagus, stomach, duodenum, and large intestine).
System/Transducer: PL1726-20, PL1726-15, PL1726-12, PL1726-7.5, PL1926-20, PL1926-15, PL1926-12, PL1926-7.5, PL2226-20, PL2226-15, PL2226-12, PL2226-7.5, PL2220-20, PL2220-15, PL2220-12
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application: General (Track 1 only), Specific (Tracks I & III)
Mode of Operation: B, M, PWD, CWD, Color Doppler, Amplitude Doppler, Combined* (specify), Other** (specify)
Intra-luminal: Pi (This applies to all listed transducers)
N=new indication; P=previously cleared by FDA under 510(k)# K011252; E=added under appendix E
*Combination of each operating mode, B, M, PWD, CWD, and Color Doppler
** Amplitude Doppler and Harmonic Imaging
Additional Comments relevant to the specific transducers:
Subscript "a": Includes imaging for guidaneous biopsy of abdominal organs and structures (including amniocentesis).
Subscript "b": Includes imaging of organs and structures exposed during neurosurgery and laparoscopic procedures).
Subscript "c": Includes thyroid, parathyroid, breast, scrotum, penis.
Subscript "d": Includes thyroid, breast, scrotum, penis and imaging for guidance of biopsy.
Subscript "e": Includes imaging for guidance of transrectal biopsy.
Subscript "f": Includes imaging for guidance of tranvaginal biopsy.
Subscript "g": For pediatric patients.
Subscript "h": Includes imaging for guidance of transrectal biopsy, cryosurgery, and brachytherapy.
Subscript "i": Includes imaging of the biliary system (pancreato-biliary) and gastrointestinal tract (esophagus, stomach, duodenum, and large intestine).
Product codes (comma separated list FDA assigned to the subject device)
90 IYN, 90 IYO
Device Description
The subject device consists of:
- EUB-525/EUB-2000 Diagnostic Ultrasound Scanner.
- SP-711UA Ultrasonic Probe Connecting Unit.
- TL-1A Translator.
- Probe (PL Series or PL26-7.5 Series).
- Balloon and Sheath.
The Hitachi EUB-525/EUB-2000 operating controls and their associated functions do not change with the addition of the Fujinon SP-711 Sonoprobe system. The operating controls specific to the Fujinon SP-711 system are described in the operation manuals included with this document in Section 7.
The transducers subject to this submission are the same transducers described in the previously cleared 510(k) K011252. They are:
PL1726-20, PL1726-15, PL1726-12, PL1726-7.5
PL1926-20, PL1926-15, PL1926-12, PL1926-7.5
PL2226-20, PL2226-15, PL2226-12, PL2226-7.5
PL2220-20, PL2220-15, PL2220-12, PL2220-7.5
The PL26-7.5 probe series includes one type for use with a balloon/sheath and the other type for use without a balloon. The only difference between probes is the structure of the tip. The probes made for use with a balloon/sheath have a groove on the tip to catch the balloon head. The probes made for use without a balloon are slightly shorter. The choice of the probe type is at the discretion of the physician. Since ultrasound waves are stronger in water, the physician may choose to use the balloon version to improve image quality. The probes made for use with a balloon/sheath are designated with a "B" (i.e. PL26B-7.5) and must be used with a balloon adapter, balloon sheath, and balloon as described in the operation manual.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
gastrointestinal tract (esophagus, stomach, duodenum, large intestine) and biliary system (pancreato-biliary ducts), Ophthalmic, Fetal, Abdominal, Organs and structures exposed during surgery and laparoscopic procedures, Thyroid, Parathyroid, Breast, Scrotum, Penis, Neonatal Cephalic, Transrectal, Transvaginal, Cardiac (Adult, Pediatric, Transesophageal), Peripheral Vascular.
Indicated Patient Age Range
Adult, Pediatric, Fetal, Neonatal
Intended User / Care Setting
Physician (for choice of probe type). Clinical applications suggest use in various medical settings including surgical, laparoscopic, and general diagnostic environments.
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)
Identical to device previously cleared by the FDA under 510(k) K011252.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
4.7 SUMMARY OF SAFETY AND EFFECTIVENESS
510(K) SUMMARY
Date Prepared June 14, 2001
Submitter's Information
Walter Weyburne Hitachi Medical Corporation of America 660 White Plains Road Tarrytown, NY 10591 (914) 524-9711
Joseph M. Azary III Azary Technologies LLC PO Box 2156 Huntington, CT 06484 (203) 944-9320
Trade Name, Common Name, Classification
The device trade names are:
- EUB-525 Ultrasound system ●
- EUB-2000 Ultrasound system .
- SP-711UA .
- SP-711 Sonoprobe system .
Predicate Device
The subject device consists of two separate assemblies. The Hitachi EUB-525/EUB-2000 Diagnostic Ultrasound Scanner and the Fujinon SP711 Sonoprobe system. The Fujinon SP711 Sonoprobe system is an optional add-on device for the Hitachi EUB-525/EUB-2000 which allows the EUB-525/EUB-2000 to utilize the Fujinon probes.
The Hitachi EUB-525 Diagnostic Ultrasound Scanner has previously been cleared by the FDA under 510(k) K981434. The Hitachi EUB-2000 was introduced as a modification of the EUB-525 under Appendix E of Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers, dated September 30, 1997. The Fujinon SP711 Sonoprobe system was previously cleared for use with the Hitachi EUB-6000 by the FDA under 510(k) K011252.
1
Description Of The Device
The subject device consists of:
- EUB-525/EUB-2000 Diagnostic Ultrasound Scanner .
- SP-711UA Ultrasonic Probe Connecting Unit .
- TL-1A Translator .
- Probe (PL Series or PL26-7.5 Series) .
- Balloon and Sheath .
The Hitachi EUB-525/EUB-2000 operating controls and their associated functions do not change with the addition of the Fujinon SP-711 Sonoprobe system. The operating controls specific to the Fujinon SP-711 system are described in the operation manuals included with this document in Section 7.
The transducers subject to this submission are the same transducers described in the previously cleared 510(k) K011252. They are:
| PL1726-20 | PL1726-15 | PL1726-12 | PL1726-7.5 |
|---|---|---|---|
| PL1926-20 | PL1926-15 | PL1926-12 | PL1926-7.5 |
| PL2226-20 | PL2226-15 | PL2226-12 | PL2226-7.5 |
| PL2220-20 | PL2220-15 | PL2220-12 | PL2220-7.5 |
The PL26-7.5 probe series includes one type for use with a balloon/sheath and the other type for use without a balloon. The only difference between probes is the structure of the tip. The probes made for use with a balloon/sheath have a groove on the tip to catch the balloon head. The probes made for use without a balloon are slightly shorter. The choice of the probe type is at the discretion of the physician. Since ultrasound waves are stronger in water, the physician may choose to use the balloon version to improve image quality. The probes made for use with a balloon/sheath are designated with a "B" (i.e. PL26B-7.5) and must be used with a balloon adapter, balloon sheath, and balloon as described in the operation manual.
Intended Use
Identical to device previously cleared by the FDA under 510(k) K011252. The intended use of the subject device is for endoscopic observation of the gastrointestinal tract (esophagus, stomach, duodenum, large intestine) and biliary system (pancreato-biliary ducts). The Ultrasound Device Indications Statements for each application and mode of the system/transducers are included with this document.
Technological Characteristics
Identical to device previously cleared by the FDA under 510(k) K011252.
Performance Data
Identical to device previously cleared by the FDA under 510(k) K011252.
Conclusion
We conclude that the subject device is as safe and effective as the predicate device. SECTION 4.7 Page 38 HITACHI EUB-5254FUB-2000 / FUJINON SP-711
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 eagle with three swooping lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle. The text is in all capital letters and is evenly spaced around the circle.
AUG 1 0 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Walter Weyburne Regulatory Affairs Hitachi Medical Corporation of America Hitachi Medical Systems 660 White Plans Road TARRYTOWN NY 10591-5107
Re: K012239
Trade Name: EUB-525/EUB-2000 Diagnostic Ultrasound Scanner with Fujinon SP711UA/SP711 Sonoprobe System Regulatory Class: II/21 CFR 892.1550 Product Code: 90 IYN Regulatory Class: II/21 CFR 892.1560 Product Code: 90 IYO Dated: July 16, 2001 Received: July 17, 2001
Dear Mr. Weyburne:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
This determination of substantial equivalence applies to the following transducers intended for use with the EUB-525/EUB-2000 Diagnostic Ultrasound Scanner, as described in your premarket notification:
| Transducer Model Number |
|---|
| PL1726-20 |
| PL1926-20 |
| PL2226-20 |
| PL2220-20 |
| PL1726-15 |
| PL1926-15 |
| PL2226-15 |
| PL2220-15 |
| PL1726-12 |
| PL1926-12 |
| PL2226-12 |
3
| PL2220-12 |
|---|
| PL1726-7.5 |
| PL1926-7.5 |
| PL2226-7.5 |
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic QS inspections, the FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification does not affect any obligation you may have under sections 531 and 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4591. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"
If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at (301) 594-1212.
Sincerely vours.
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
4
Diagnostic Ultrasound Indications for Use Form
System/Transducer: EUB-525/EUB-2000 System
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General | |||||||||
| (Track 1 only) | Specific | ||||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | ||||||||
| Doppler | Combined* | ||||||||
| (specify) | Other** | ||||||||
| (specify) | |||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal Imaging | |||||||||
| & Others | Fetal | P | P | P | P | P | P | N | P |
| Abdominal | Pa | Pa | Pa | Pa | Pa | Pa | Na | Pa | |
| Intraoperative (specify) | Pb | Pb | Pb | Pb | Pb | Pb | Nb | Pb | |
| Intraoperative (Neuro.) | |||||||||
| Laparoscopic | P | P | P | P | P | P | N | P | |
| Pediatric | P | P | P | P | P | P | N | P | |
| Small Organ (specify) | Pd | Pd | Pd | Pd | Pd | Pd | Nd | Pd | |
| Neonatal Cephalic | P | P | P | P | P | P | N | P | |
| Adult Cephalic | |||||||||
| Trans-rectal | Ph | Ph | Ph | Ph | Ph | Ph | Nh | Ph | |
| Trans-vaginal | Pf | Pf | Pf | Pf | Pf | Pf | Nf | Pf | |
| Trans-urethral | |||||||||
| Trans-esophageal | |||||||||
| Muskulo-skeletal | |||||||||
| Conventional | |||||||||
| Musculo-skeletal | |||||||||
| Superficial | |||||||||
| Intra-luminal | Ni | ||||||||
| Other (specify) | |||||||||
| Cardiac | Cardiac Adult | P | P | P | P | P | P | N | P |
| Cardiac Pediatric | P | P | P | P | P | P | N | P | |
| Cardiac Transesophageal | |||||||||
| Adult | P | P | P | P | P | P | N | P | |
| Cardiac Transesophageal | |||||||||
| Pediatric | P | P | P | P | P | P | N | P | |
| Other (specify) | |||||||||
| Peripheral | |||||||||
| Vessel | Peripheral Vascular | P | P | P | P | P | P | N | P |
| Other (specify) |
N=new indication; P=previously cleared by FDA under 510(k)# K981434; E=added under appendix E
*Combination of each operating mode, B, M, PWD, CWD, and Color Doppler
** Amplitude Doppler and Harmonic Imaging
Additional Comments:
Subscript "a": Includes imaging for guidaneous biopsy of abdominal organs and structures (including amniccentesis). Subscript "b": Includes imaging of organs and structures exposed during surgery and laparoscopic procedures).
Subscript "c": Includes thyroid, parathyroid, breast, scrotum, penis.
Subscript "d": Includes thyroid, breast, scrotum, penis and imaging for guidance of biopsy.
Subscript "e": Includes imaging for guidance of transrectal biopsy.
Subscript "f": Includes imaging for guidance of tranvaginal biopsy.
Subscript "g": For pediatric patients.
Subscript "h": Includes imaging for guidance of transrectal biopsy, cryosurgery, and brachytherapy.
Subscript "": Includes imaging of the biliary system (pancreato-biliary) and gastrointestinal tract (esophagus, stomach, duodenum, and large intestine).
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Tamara C. Stockton
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
And Radiological Devices
510(k) Number:
5
Diagnostic Ultrasound Indications for Use Form
System/Transducer: PL1726-20
| | Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
| -- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|---|
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General | |||||||||
| (Track 1 only) | Specific | ||||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | ||||||||
| Doppler | Combined* | ||||||||
| (specify) | Other** | ||||||||
| (specify) | |||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal Imaging | |||||||||
| & Others | Fetal | ||||||||
| Abdominal | |||||||||
| Intraoperative (specify) | |||||||||
| Intraoperative (Neuro.) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (specify) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esophageal | |||||||||
| Muskulo-skeletal | |||||||||
| Conventional | |||||||||
| Musculo-skeletal | |||||||||
| Superficial | |||||||||
| Intra-luminal | Pi | ||||||||
| Other (specify) | |||||||||
| Cardiac | Cardiac Adult | ||||||||
| Cardiac Pediatric | |||||||||
| Cardiac Transesophageal | |||||||||
| Adult | |||||||||
| Cardiac Transesophageal | |||||||||
| Pediatric | |||||||||
| Other (specify) | |||||||||
| Peripheral | Peripheral Vascular | ||||||||
| Vessel | Other (specify) |
N=new indication; P=previously cleared by FDA under 510(k)# K011252; E=added under appendix E
*Combination of each operating mode, B, M, PWD, CWD, and Color Doppler
** Amplitude Doppler and Harmonic Imaging
Additional Comments:
Subscript "a": Includes imaging for guidaneous biopsy of abdominal organs and structures (including amniccentesis).
Subscript "b": Includes imaging of organs and structures exposed during neurosurgery and laparoscopic procedures). Subscript "c": Includes thyroid, parathyroid, breast, scrotum, penis.
Subscript "d": Includes thyroid, breast, scrotum, penis and imaging for guidance of biopsy.
Subscript "e": Includes imaging for guidance of transrectal biopsy.
Subscript "1": Includes imaging for guidance of tranvaginal biopsy.
Subscript "g": For pediatric patients.
Subscript "h": Includes imaging for guidance of transrectal biopsy, cryosurgery, and brachytherapy.
Subscript "": Includes imaging of the biliary system (pancreato-biliary) and gastrointesinal tract (esophagus, stomach, duodenum, and large intestine).
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy L Brogdon
(Division Sign Off)
Division
And Radiological Devices
510(k) Number: K012239
6
Diagnostic Ultrasound Indications for Use Form
System/Transducer: PL1726-15
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ||
|---|---|---|
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General | |||||||||
| (Track 1 only) | Specific | ||||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | ||||||||
| Doppler | Combined* | ||||||||
| (specify) | Other** | ||||||||
| (specify) | |||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal Imaging | |||||||||
| & Others | Fetal | ||||||||
| Abdominal | |||||||||
| Intraoperative (specify) | |||||||||
| Intraoperative (Neuro.) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (specify) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esophageal | |||||||||
| Muskulo-skeletal | |||||||||
| Conventional | |||||||||
| Musculo-skeletal | |||||||||
| Superficial | |||||||||
| Intra-luminal | Pi | ||||||||
| Other (specify) | |||||||||
| Cardiac | Cardiac Adult | ||||||||
| Cardiac Pediatric | |||||||||
| Cardiac Transesophageal | |||||||||
| Adult | |||||||||
| Cardiac Transesophageal | |||||||||
| Pediatric | |||||||||
| Other (specify) | |||||||||
| Peripheral Vascular | |||||||||
| Peripheral | |||||||||
| Vessel | Other (specify) |
N=new indication; P=previously cleared by FDA under 510(k)# K011252; E=added under appendix E
- Combination of each operating mode, B, M, PWD, CWD, and Color Doppler
** Amplitude Doppler and Harmonic Imaging
Additional Comments:
Additional Comments:
Subscript "a": Includes imaging for guidaneous biopsy of abdominal organs and strestures (including annosences procedes procedes procedes procede
Subscript a : mcludes inaging of goldance of perculancede bropsy (excluding neurosurgery and laparoscopic procedures).
Subscript to: Includes imaging of organs and structures Subscript "c": Includes thyroid, parathyroid, breast, scrotum, penis.
Subscript "c": includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy.
Subscript "e": Includes imaging for guidance of transrectal biopsy.
Subscript "1": Includes imaging for guidance of tranvaginal biopsy.
Subscript "g": For pediatric patients.
Subscript "h": Includes imaging for guidance of transrectal biopsy, cryosurgery, and brachytherapy.
Subscript I : Includes inaging of the billiary system (pancreato-biliary) and gastrontestinal tract (esophagus, stomach, ducdenum, and large intestine).
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C. braggdon
hdomintal FNT Division of
510(k) Number: K012239
7
Diagnostic Ultrasound Indications for Use Form
System/Transducer: PL1726-12
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General | |||||||||
| (Track 1 only) | Specific | ||||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | ||||||||
| Doppler | Combined* | ||||||||
| (specify) | Other** | ||||||||
| (specify) | |||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Abdominal | |||||||||
| Intraoperative (specify) | |||||||||
| Intraoperative (Neuro.) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (specify) | |||||||||
| Neonatal Cephalic | |||||||||
| Fetal Imaging | |||||||||
| & Others | Adult Cephalic | ||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esophageal | |||||||||
| Muskulo-skeletal | |||||||||
| Conventional | |||||||||
| Musculo-skeletal | |||||||||
| Superficial | |||||||||
| Intra-luminal | Pi | ||||||||
| Other (specify) | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Cardiac Transesophageal | |||||||||
| Adult | |||||||||
| Cardiac | Cardiac Transesophageal | ||||||||
| Pediatric | |||||||||
| Adult | |||||||||
| Cardiac Transesophageal | |||||||||
| Pediatric | |||||||||
| Other (specify) | |||||||||
| Peripheral | |||||||||
| Vessel | Peripheral Vascular | ||||||||
| Other (specify) |
ﺍﻟﻤﻮﺍﻗﻊ ﺍﻟﻤﻮﺍﻗﻊ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤ
*Combination of each operating mode, B, M, PWD, CWD, and Color Doppler **Amplitude Doppler and Harmonic Imaging
Additional Comments:
Subscript "a": Includes imaging for guidaneous biopsy of abdominal organs and structures (including amniocentesis).
Subscript "b": Includes imaging of organs and structures exposed during surgery and laparoscopic procedures). Subscript "c": Includes thyroid, parathyroid, breast, scrotum, penis.
Subscript "d": Includes thyroid, paralhyroid, breast, scrotum, penis and imaging for guidance of biopsy.
Subscript "e": Includes imaging for guidance of transrectal biopsy
Subscript "f": Includes imaging for guidance of tranvaginal biopsy.
Subscript "g": For pediatric patients.
Subscript "n": Includes imaging for guidance of transrectal biopsy, cryosurgery, and brachytherapy.
Subscript "": Includes imaging of the biliary system (pancreato-biliary) and gastrointestinal Iract (esophagus, stornach, ducdenum, and large intestine).
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Marge Brogdon
Division
510(k) Number: KC
er: K012234
8
Diagnostic Ultrasound Indications for Use Form
System/Transducer: PL1726-7.5
intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General | |||||||||
| (Track 1 only) | Specific | ||||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | ||||||||
| Doppler | Combined* | ||||||||
| (specify) | Other** | ||||||||
| (specify) | |||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Abdominal | |||||||||
| Intraoperative (specify) | |||||||||
| Intraoperative (Neuro.) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (specify) | |||||||||
| Neonatal Cephalic | |||||||||
| Fetal Imaging | |||||||||
| & Others | Adult Cephalic | ||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esophageal | |||||||||
| Muskulo-skeletal | |||||||||
| Conventional | |||||||||
| Musculo-skeletal | |||||||||
| Superficial | |||||||||
| Intra-luminal | Pi | ||||||||
| Other (specify) | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Cardiac Transesophageal | |||||||||
| Adult | |||||||||
| Cardiac | Cardiac Transesophageal | ||||||||
| Pediatric | |||||||||
| Pediatric | |||||||||
| Other (specify) | |||||||||
| Peripheral | |||||||||
| Vessel | Peripheral Vascular | ||||||||
| Other (specify) |
N=new indication; P=previously cleared by FDA under 510(k)# K011252; E=added under appendix
*Combination of each operating mode, B, M, PWD, CWD, and Color Doppler
** Amplitude Doppler and Harmonic Imaging
Additional Comments:
Additional Comments.
Subscript "a": Includes imaging for guidaneous biopsy of abdominal organs and strenurser and lancessories procedes procedes procedes
Subscript a : niciouss inaging of goldane of percularied organs and structures and laparosurgery and laparoscopic procedures). Subscript "c": Includes thyroid, parathyroid, breast, scrotum, penis.
Subscript "d": Includes thyroid, breast, scrotum, penis and imaging for guidance of biopsy.
Subscript "e": Includes imaging for guidance of transrectal biopsy.
Subscript "1": Includes imaging for guidance of tranvaginal biopsy.
Subscript "g": For pediatric patients.
Subscript "h": Includes imaging for guidance of transrectal biopsy, cryosurgery, and brachytherapy.
Subscript in : mcloces imaging of the blockers of the received inal tract (esophagus, stomach, ducdenum, and large intestine).
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Nanny C. Brogdon
(Division Sign-Off)
Division of
510(k) Number:
9
Diagnostic Ultrasound Indications for Use Form
System/Transducer: PL1926-20
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General | |||||||||
| (Track 1 only) | Specific | ||||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | ||||||||
| Doppler | Combined* | ||||||||
| (specify) | Other** | ||||||||
| (specify) | |||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Abdominal | |||||||||
| Intraoperative (specify) | |||||||||
| Intraoperative (Neuro.) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (specify) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Fetal Imaging | |||||||||
| & Others | Trans-rectal | ||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esophageal | |||||||||
| Muskulo-skeletal | |||||||||
| Conventional | |||||||||
| Musculo-skeletal | |||||||||
| Superficial | |||||||||
| Intra-luminal | Pi | ||||||||
| Other (specify) | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Cardiac Transesophageal | |||||||||
| Adult | |||||||||
| Cardiac | Cardiac Transesophageal | ||||||||
| Pediatric | |||||||||
| Other (specify) | |||||||||
| Peripheral | |||||||||
| Vessel | Peripheral Vascular | ||||||||
| Other (specify) |
**Amplitude Doppler and Harmonic Imaging Additional Comments:
Additional Comments:
Subscript "a": Includes imaging for guidaneous biopsy of abdominal organs (nouvding pourceurgen); procedi
Subscript a": Includes imaging of gularie of percularieds biopsy of abouting organd and laparoscopic procedures).
Subscript "b": Includes imaging of organs and structures exp Subscript "c": Includes thyroid, parathyroid, breast, scrotum, penis.
Subscript "c": Includes thyroid, breast, scrotum, penis and imaging for guidance of biopsy.
Subscript "o": Includes imaging for guidance of transrectal biopsy.
Subscript "1": Includes imaging for guidance of tranvaginal biopsy.
Subscript "g": For pediatric patients.
Subscript "I . I or pediatio patistic of transrectal biopsy, cryosurgery, and brachytherapy.
Subscript "h": Includes imaging of thanslestal boysy, Crystirer), and practicely .
Subscript ":". Includes imaging of the biliary system (pancreato-biliary) and gastrointest large intestine).
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C. Brogdon
(Division Sign Off)
Division of F
||
510(k) Number: K012239
10
Diagnostic Ultrasound Indications for Use Form
System/Transducer: PL1926-15
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General | |||||||||
| (Track 1 only) | Specific | ||||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | ||||||||
| Doppler | Combined* | ||||||||
| (specify) | Other** | ||||||||
| (specify) | |||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal Imaging | |||||||||
| & Others | Fetal | ||||||||
| Abdominal | |||||||||
| Intraoperative (specify) | |||||||||
| Intraoperative (Neuro.) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (specify) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esophageal | |||||||||
| Muskulo-skeletal | |||||||||
| Conventional | |||||||||
| Musculo-skeletal | |||||||||
| Superficial | |||||||||
| Intra-luminal | Pi | ||||||||
| Other (specify) | |||||||||
| Cardiac | Cardiac Adult | ||||||||
| Cardiac Pediatric | |||||||||
| Cardiac Transesophageal | |||||||||
| Adult | |||||||||
| Cardiac Transesophageal | |||||||||
| Pediatric | |||||||||
| Other (specify) | |||||||||
| Peripheral | |||||||||
| Vessel | Peripheral Vascular | ||||||||
| Other (specify) |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Combination of each operating mode, B, M, PWD, CWD, and Color Doppler
- Amplitude Doppler and Harmonic Imaging
Additional Comments:
Subscript "a": Includes imaging for guidaneous biopsy of abdominal organs and structures (including amniocentesis).
Subscript "b": Includes imaging of organs and structures exposed during neurosurgery and laparoscopic procedures). Subscript "c": Includes thyroid, parathyroid, breast, scrotum, penis.
Subscript "d": Includes thyroid, parathyroid, breast, scrolum, penis and imaging for guidance of biopsy.
Subscript "e": Includes imaging for guidance of transrectal biopsy.
Subscript "1": Includes imaging for guidance of tranvaginal biopsy.
Subscript "g": For pediatric patients.
Subscript "h": Includes imaging for guidance of transrectal biopsy, cryosurgery, and brachytherapy.
Subscript "i": Includes imaging of the biliary system (panceato-biliary) and gastrontestinal tract (esophagus, stomach, duodenum, and large intestine).
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Janus/C brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT
And Radiological Devices
And Radiological Devices
510(k) Number: K012239
11
Diagnostic Ultrasound Indications for Use Form
System/Transducer: PL1926-12
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General | |||||||||
| (Track 1 only) | Specific | ||||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | ||||||||
| Doppler | Combined* | ||||||||
| (specify) | Other** | ||||||||
| (specify) | |||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Abdominal | |||||||||
| Intraoperative (specify) | |||||||||
| Intraoperative (Neuro.) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (specify) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Fetal Imaging | |||||||||
| & Others | Trans-rectal | ||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esophageal | |||||||||
| Muskulo-skeletal | |||||||||
| Conventional | |||||||||
| Musculo-skeletal | |||||||||
| Superficial | |||||||||
| Intra-luminal | Pi | ||||||||
| Other (specify) | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Cardiac | Cardiac Transesophageal | ||||||||
| Adult | |||||||||
| Cardiac Transesophageal | |||||||||
| Pediatric | |||||||||
| Other (specify) | |||||||||
| Peripheral | Peripheral Vascular | ||||||||
| Vessel | Other (specify) |
*Combination, I -provieusly enode B. M. PWD, CWD, and Color Doppler
** Amplitude Doppler and Harmonic Imaging
Additional Comments:
Additional Comments:
Subscript "a": Includes imaging for guidaneous biopsy of abdominal organs and structures and leaseeopling recogni
Subscript a": Includes imaging of gulance of percualledus blogs of abouting neurosurgery and laparoscopic procedures). Subscript "c": Includes thyroid, parathyroid, breast, scrotum, penis.
Subscript "C": Includes thyroid, breast, scrotum, penis and imaging for guidance of biopsy.
Subscript "e": Includes imaging for guidance of transrectal biopsy.
Subscript "f": Includes imaging for guidance of tranvaginal biopsy.
Subscript "g": For pediatric patients.
Subscript "h": Includes imaging for guidance of transrectal biopsy, cryosurgery, and brachytherapy.
Subscript n : nclodes maging of the billiary system (pancreato-blian) and (esophagus, stomach, duodenum, and large intestine).
large intestine).
(PLEASE DO NOT V
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy L. Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
And Radiological Devices
510(k) Number: K
12
Diagnostic Ultrasound Indications for Use Form
System/Transducer: PL1926-7.5
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General | |||||||||
| (Track 1 only) | Specific | ||||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | ||||||||
| Doppler | Combined* | ||||||||
| (specify) | Other** | ||||||||
| (specify) | |||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Abdominal | |||||||||
| Intraoperative (specify) | |||||||||
| Intraoperative (Neuro.) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (specify) | |||||||||
| Neonatal Cephalic | |||||||||
| Fetal Imaging | |||||||||
| & Others | Adult Cephalic | ||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esophageal | |||||||||
| Muskulo-skeletal | |||||||||
| Conventional | |||||||||
| Musculo-skeletal | |||||||||
| Superficial | |||||||||
| Intra-luminal | Pi | ||||||||
| Other (specify) | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Cardiac Transesophageal | |||||||||
| Adult | |||||||||
| Cardiac | Cardiac Transesophageal | ||||||||
| Pediatric | |||||||||
| Other (specify) | |||||||||
| Peripheral | Peripheral Vascular | ||||||||
| Vessel | Other (specify) |
N=new indication; P=previously cleared by FDA under 510(K)# R
*Combination of each operating mode, B, M, PWD, CWD, and Color Doppler
** Amplitude Doppler and Harmonic Imaging
Additional Comments:
Subscript "a": Includes imaging for guidaneous biopsy of abdominal organs and structures (including amniocentesis).
Subscript "b": Includes imaging of organs and structures exposed during neurosurgery and laparoscopic procedures). Subscript "c": Includes thyroid, parathyroid, breast, scrotum, penis.
Subscript "d": Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy,
Subscript "e": Includes imaging for guidance of transrectal biopsy.
Subscript "f": Includes imaging for guidance of tranvaginal biopsy.
Subscript "g": For pediatric patients.
Subscript "h": Includes imaging for guidance of transrectal biopsy, cryosurgery, and brachytherapy.
Subscript ":" Includes imaging of the biliary system (pancreato-biliary) and gastrointestinal tract (esophagus, stomach, and large intestine).
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C. Gurydon
(Division Sign Off)
Division of
510(k) Number: KD12239
13
Diagnostic Ultrasound Indications for Use Form
System/Transducer: PL2226-20
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | B | M | PWD | CWD | Mode of Operation
Color
Doppler | Amplitude
Doppler | Combined*
(specify) | Other**
(specify) |
|---------------------------|--------------------------------------|----|---|-----|-----|---------------------------------------|----------------------|------------------------|----------------------|
| General
(Track 1 only) | Specific
(Tracks I & III) | | | | | | | | |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal | | | | | | | | |
| | Abdominal | | | | | | | | |
| | Intraoperative (specify) | | | | | | | | |
| | Intraoperative (Neuro.) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ (specify) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| Fetal Imaging
& Others | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esophageal | | | | | | | | |
| | Muskulo-skeletal | | | | | | | | |
| | Conventional | | | | | | | | |
| | Musculo-skeletal | | | | | | | | |
| | Superficial | | | | | | | | |
| | Intra-luminal | Pi | | | | | | | |
| | Other (specify) | | | | | | | | |
| | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| | Cardiac Transesophageal
Adult | | | | | | | | |
| Cardiac | Cardiac Transesophageal
Pediatric | | | | | | | | |
| | Adult | | | | | | | | |
| | Cardiac Transesophageal | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Other (specify) | | | | | | | | |
| | Peripheral Vascular | | | | | | | | |
| Peripheral
Vessel | Other (specify) | | | | | | | | |
N=new indication; P=previously cleared by FDA under 510(k)# K011252; E=added under a
N=1ew indication, 1 =previously crodice by . DWD, and Color Doppler
** Amplitude Doppler and Harmonic Imaging
Additional Comments:
Additional Comments:
Subscript "a": Includes imaging for guideneous biopsy of aboninal organs and stuchurger and lanaroscopic noced
Subscript a": Includes imaging of gularie of perculariedis oldpsy of abouting neurosurgery and laparoscopic procedures).
Subscript the locus imaging of organs and structures Subscript "c": Includes thyroid, parathyroid, breast, scrotum, penis.
Subscript "C": Includes thyroid, paralhyroid, breast, scrotum, penis and imaging for guidance of biopsy.
Subscript "e": Includes imaging for guidance of transrectal biopsy.
Subscript "f": Includes imaging for guidance of tranvaginal biopsy.
Subscript "q": For pediatric patients.
Subscript "h": Includes imaging for guidance of transrectal biopsy, cryosurgery, and brachytherapy.
Subscript Includes inaging of the billance of featuredpolity) and gastrointestinal Iract (esophagus, stomach, duodenum, and large intestine).
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C. Hogdon
(Division Sign-Off)
Reproductive, Abdom Division of
510(k) Number: KD12239
14
Diagnostic Ultrasound Indications for Use Form
System/Transducer: PL2226-15
| ****************************************************************************************************************************************************************************** | |
|---|---|
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General | |||||||||
| (Track 1 only) | Specific | ||||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | ||||||||
| Doppler | Combined* | ||||||||
| (specify) | Other** | ||||||||
| (specify) | |||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal Imaging | |||||||||
| & Others | Fetal | ||||||||
| Abdominal | |||||||||
| Intraoperative (specify) | |||||||||
| Intraoperative (Neuro.) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (specify) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esophageal | |||||||||
| Muskulo-skeletal | |||||||||
| Conventional | |||||||||
| Musculo-skeletal | |||||||||
| Intra-luminal | |||||||||
| Superficial | Pi | ||||||||
| Other (specify) | |||||||||
| Cardiac | Cardiac Adult | ||||||||
| Cardiac Pediatric | |||||||||
| Cardiac Transesophageal | |||||||||
| Adult | |||||||||
| Cardiac Transesophageal | |||||||||
| Pediatric | |||||||||
| Other (specify) | |||||||||
| Peripheral | |||||||||
| Vessel | Peripheral Vascular | ||||||||
| Other (specify) |
N=new indication; P=previously cleared by FDA under 510(k)# K011252; E=added under appendi
N-new indication, F-Eprovisely enours of A, PWD, CWD, and Color Doppler
** Amplitude Doppler and Harmonic Imaging
Additional Comments:
Abultional Orimients.
Subscript "a": Includes imaging for guidaneous biopsy of abdominal organs and structures (includes and seconder procession procession procession proces
Subscript " : Includes inaging of galanse of problemovies exposed during surgery and laparoscopic procedures). Subscript "c": Includes thyroid, parathyroid, breast, scrotum, penis.
Subscript C. includes thyroid, parathyroid, breast, scrotum, penis.
| Subscript "d": Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy. |
|---|
| Subscript "e": Includes imaging for guidance of transrectal biopsy. |
| Subscript "f": Includes imaging for guidance of tranvaginal biopsy. |
| Subscript "g": For pediatric patients. |
Subscript "h": Includes imaging for guidance of transrectal biopsy, cryosurgery, and brachytherapy.
Subscript in . Includes inaging of the Sicolar Boys) of your series in artistial tract (esophagus, stomach, duodenum, and large intestine).
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy Brogdon
Division of Reproductive, Abdon
510(k) Number: K012234
15
Diagnostic Ultrasound Indications for Use Form
System/Transducer: PL2226-12
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | Mode of Operation | | | | | | Combined*
(specify) | Other**
(specify) |
|---------------------------|------------------------------|-------------------|---|-----|-----|------------------|----------------------|------------------------|----------------------|
| General
(Track 1 only) | Specific
(Tracks I & III) | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | | |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal | | | | | | | | |
| | Abdominal | | | | | | | | |
| | Intraoperative (specify) | | | | | | | | |
| | Intraoperative (Neuro.) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ (specify) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| Fetal Imaging
& Others | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esophageal | | | | | | | | |
| | Muskulo-skeletal | | | | | | | | |
| | Conventional | | | | | | | | |
| | Musculo-skeletal | | | | | | | | |
| | Superficial | | | | | | | | |
| | Intra-luminal | Pi | | | | | | | |
| | Other (specify) | | | | | | | | |
| | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| Cardiac | Cardiac Transesophageal | | | | | | | | |
| | Adult | | | | | | | | |
| | Cardiac Transesophageal | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Other (specify) | | | | | | | | |
| Peripheral
Vessel | Peripheral Vascular | | | | | | | | |
| | Other (specify) | | | | | | | | |
Vesser
N=new indication, 1 =previously onodice = M, PWD, CWD, and Color Doppler
** Amplitude Doppler and Harmonic Imaging
Additional Comments
Additional Comments:
Subscript "a": Includes imaging for guide of perculaneous biopsy of absorners (including neurosurgery and Janaroscopic procedu
Subscript "a": Includes imaging for guidaneous biopsy of abounnal organs and street of the may one in analysis one and aparoscopic procedures).
Subscript "b": Includes imagin
Subscript "c": Includes thyroid, parathyroid, breast, scrotum, penis.
Subscript "c": Includes thyrold, breast, scrolum, penis and imaging for guidance of biopsy. Subscript "e": Includes imaging for guidance of transrectal biopsy.
Subscript "f": Includes imaging for guidance of tranvaginal biopsy.
Subscript "g": For pediatric patients.
Subscript "h": Includes imaging for guidance of transrectal biopsy, cryosurgery, and bractical treat (seat
Subscript "h": Includes imaging of gulance of flansfectar und blacknifications of esophagus, stomach, duodenum, and large intestine).
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED] Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy Snogdon
(Division Sign-off)
Division of F
510(k) Number: K012239
16
Diagnostic Ultrasound Indications for Use Form
System/Transducer: PL2226-7.5
| ntended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | ||
|---|---|---|
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General | |||||||||
| (Track 1 only) | Specific | ||||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | ||||||||
| Doppler | Combined* | ||||||||
| (specify) | Other** | ||||||||
| (specify) | |||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Abdominal | |||||||||
| Intraoperative (specify) | |||||||||
| Intraoperative (Neuro.) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (specify) | |||||||||
| Neonatal Cephalic | |||||||||
| Fetal Imaging | |||||||||
| & Others | Adult Cephalic | ||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esophageal | |||||||||
| Muskulo-skeletal | |||||||||
| Conventional | |||||||||
| Musculo-skeletal | |||||||||
| Superficial | |||||||||
| Intra-luminal | Pi | ||||||||
| Other (specify) | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Cardiac Transesophageal | |||||||||
| Adult | |||||||||
| Cardiac | Cardiac Transesophageal | ||||||||
| Pediatric | |||||||||
| Other (specify) | |||||||||
| Peripheral | |||||||||
| Vessel | Peripheral Vascular | ||||||||
| Other (specify) |
N=new indication; P=previously cleared by FDA under 510(k)# K011252; E=added under appendix E
*Combination of each operating mode, B, M, PWD, CWD, and Color Doppler
** Amplitude Doppler and Harmonic Imaging
Additional Comments:
Abbitional Online no:
Subscript "a": Includes imaging for guidaneous biopsy of abdominal organs and structures (including amonesis).
Subscript "d": Includes imaging of organs and structures exposed during surgery and Japarosopic procedures), Subscript "c": Includes thyroid, parathyroid, breast, scrotum, penis.
Subscript "d": Includes thyroid, parathyroid, breast, scrolum, penis and imaging for guidance of biopsy.
Subscript "e": Includes imaging for guidance of transrectal biopsy.
Subscript "1": Includes imaging for guidance of tranvaginal biopsy.
Subscript "g": For pediatric patients.
Subscript "h": Includes imaging for guidance of transrectal biopsy, cryosurgery, and brachytherapy.
510(k) Number:
Subscript ":" Includes imaging of the biliary system (pancreato-biliary) and gastrointestinal tract (esophagus, stomach, duodenum, and large intestine).
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Narvey C. Groydon
Division of Reproductive, Abdominal, ENT,
And Radiological Devices
And Radiological Devices
VN177364
17
Diagnostic Ultrasound Indications for Use Form
System/Transducer: PL2220-20
| the read I Ise: Ujaqnostic ultrasound imaging or fluid flow analvsis of the human body as follows. | ||
|---|---|---|
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General | |||||||||
| (Track 1 only) | Specific | ||||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | ||||||||
| Doppler | Combined* | ||||||||
| (specify) | Other** | ||||||||
| (specify) | |||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Abdominal | |||||||||
| Intraoperative (specify) | |||||||||
| Intraoperative (Neuro.) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Fetal Imaging | |||||||||
| & Others | Small Organ (specify) | ||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esophageal | |||||||||
| Muskulo-skeletal | |||||||||
| Conventional | |||||||||
| Musculo-skeletal | |||||||||
| Superficial | |||||||||
| Intra-luminal | Pi | ||||||||
| Other (specify) | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Cardiac Transesophageal | |||||||||
| Adult | |||||||||
| Cardiac | Cardiac Transesophageal | ||||||||
| Pediatric | |||||||||
| Adult | |||||||||
| Cardiac Transesophageal | |||||||||
| Pediatric | |||||||||
| Other (specify) | |||||||||
| Peripheral | |||||||||
| Vessel | Peripheral Vascular | ||||||||
| Other (specify) |
- Vessel - - | Other (Specif))
N=new indication; P=previously cleared by FDA under 510(k)# K011252; E=added under appendix E
N=rew indication, F =promotion mode, B, M, PWD, CWD, and Color Doppler
** Amplitude Doppler and Harmonic Imaging
Additional Comments:
Additional Comments:
Subscript *a": Includes imaging for guidaneous biopsy of abdominal organs and structures (including powers); procedes groced
Subscript a" Includes inlaging of gridaties of percualledis bropsy of abouting neurosurgery and laparoscopic procedures). Subscript "c": Includes thyroid, parathyroid, breast, scrotum, penis.
Subscript "c": Includes thyrold, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy.
Subscript "e": Includes imaging for guidance of transrectal biopsy. Subscript "f": Includes imaging for guidance of tranvaginal biopsy.
Subscript "g": For pediatric patients.
Subscript "h": Includes imaging for guidance of transrectal biopsy, cryosurgery, and brachytherapy.
Subscript in : ncludes inaging of the billiary system popul, or conservation tract (esophagus, stomach, duodenum, and large intestine).
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C. Burton
Division of
And Radiological Devices
510(k) Number: K612239
18
Diagnostic Ultrasound Indications for Use Form
System/Transducer: PL2220-15
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | PWD | CWD | Color | |||||
| Doppler | Amplitude | |||||||||
| Doppler | Combined* | |||||||||
| (specify) | Other** | |||||||||
| (specify) | ||||||||||
| General | ||||||||||
| (Track 1 only) | Specific | |||||||||
| (Tracks I & III) | ||||||||||
| Ophthalmic | Ophthalmic | |||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | ||||||||||
| Intraoperative (Neuro.) | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Fetal Imaging | ||||||||||
| & Others | Trans-rectal | |||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esophageal | ||||||||||
| Muskulo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal | ||||||||||
| Superficial | ||||||||||
| Intra-luminal | Pi | |||||||||
| Other (specify) | ||||||||||
| Cardiac | Cardiac Adult | |||||||||
| Cardiac Pediatric | ||||||||||
| Cardiac Transesophageal | ||||||||||
| Adult | ||||||||||
| Cardiac Transesophageal | ||||||||||
| Pediatric | ||||||||||
| Other (specify) | ||||||||||
| Peripheral | ||||||||||
| Vessel | Peripheral Vascular | |||||||||
| Other (specify) |
N=new indication; P=previously cleared by PBA and Color (w)
*Combination of each operating mode, B, M, PWD, CWD, and Color Doppler
**Amplitude Doppler and Harmonic Imaging
Additional Comments:
Additional Comments:
Subscript "a": Includes imaging for guidaneous biopsy of abdominal organs and structures (including amocontesis).
Subscript "a": Includes imaging for guidances s botsy of abount and crossed on the consumer of the mail of the mail of the mail of the mail of the surgery and laparsopic proc
Subscript "c": Includes thyroid, parathyroid, breast, scrotum, penis. Subscript "c": Includes thyrold, breast, scrolum, penis.
Subscript "d": Includes thyroid, breast, scrotum, penis and imaging for guidance of biopsy.
Subscript "e": Includes imaging for guidance of transrectal biopsy.
Subscript "f": Includes imaging for guidance of tranvaginal biopsy.
Subscript 1. Includes imaging for pediatric patients.
Subscript "g": For pediatric patients. Subscript "g": For pediatic patients.
Subscript "h": Includes imaging for guidance of transmate bilion), and gastrointestinal tract (fract (fract (fract (fract (fract (fract
Subscript "h": Includes imaging for guidance of transfectal blopsy, cryosugery, and dachynelop, stomach, duodenum, and
large intestine).
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) EASE DONOT WHITE BECOW Instine - Sevice Evaluation (ODE)
Nancy Burgdon
(Division Sign-Off)
Division
510(k) Number: K012239
19
Diagnostic Ultrasound Indications for Use Form
System/Transducer: PL2220-12
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General | |||||||||
| (Track 1 only) | Specific | ||||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | ||||||||
| Doppler | Combined* | ||||||||
| (specify) | Other** | ||||||||
| (specify) | |||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal Imaging | |||||||||
| & Others | Fetal | ||||||||
| Abdominal | |||||||||
| Intraoperative (specify) | |||||||||
| Intraoperative (Neuro.) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (specify) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esophageal | |||||||||
| Muskulo-skeletal | |||||||||
| Conventional | |||||||||
| Musculo-skeletal | |||||||||
| Superficial | |||||||||
| Intra-luminal | Pi | ||||||||
| Other (specify) | |||||||||
| Cardiac | Cardiac Adult | ||||||||
| Cardiac Pediatric | |||||||||
| Cardiac Transesophageal | |||||||||
| Adult | |||||||||
| Cardiac Transesophageal | |||||||||
| Pediatric | |||||||||
| Other (specify) | |||||||||
| Other (specify) | |||||||||
| Peripheral | |||||||||
| Vessel | Peripheral Vascular | ||||||||
| Other (specify) |
N=new indication; P=previously cleared by FDA under 510(k)# K011252; E=added under appel
*Combination of each operating mode, B, M, PWD, CWD, and Color Doppler
** Amplitude Doppler and Harmonic Imaging
Additional Comments:
Additional Comments:
Subscript "a"; Includes imaging for guidaneous biopsy of abdominal organs and structures (including seconds model
Subscript "a": Includes imaging of presententes exposed dyring surgery (excluding neurosurgery and laparoscopic procedures). Subscript "c": Includes thyroid, parathyroid, breast, scrotum, penis.
Subscript "d": Includes thyroid, breast, scrotum, penis and imaging for guidance of biopsy.
Subscript "e": Includes imaging for guidance of transrectal biopsy.
Subscript "(": Includes imaging for guidance of tranvaginal biopsy.
Subscript "g": For pediatric patients.
Subscript "h": Includes imaging for guidance of transrectal biopsy, cryosurgery, and brachytherapy.
Subscript 11: Includes inaging of the billary of the respectives inal tract (esophagus, stomach, ducdenum, and
large intestine).
(PLEASE GO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Yinaylberogdon
(Division Sign-Off)
Division of Reproductive. And Radiological
510(k) Number:
: K012239