(8 days)
No
The document does not mention AI, ML, deep learning, or any related terms, nor does it describe training or test sets typically associated with AI/ML development.
No
The device is described as a diagnostic ultrasound system and its intended use is for various types of studies (fetal, abdominal, etc.), which are diagnostic in nature, not therapeutic.
Yes
Explanation: The Intended Use/Indications for Use section states that the device is an ultrasound system intended for various studies (fetal, abdominal, cardiac, etc.). The predicate device K041499 is also named "Toshiba SSA-770A, Aplio Version 5.5 Diagnostic Ultrasound," which explicitly includes "Diagnostic Ultrasound."
No
The device description explicitly states it is a "mobile system" and employs "a wide array of probes," indicating it includes hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device being used for various in vivo (within a living organism) ultrasound studies on different anatomical sites. IVDs are used to examine specimens (like blood, urine, tissue) in vitro (outside of a living organism) to provide information about a patient's health.
- Device Description: The description clearly states it's an "Ultrasound System," which is a medical imaging device used for visualizing internal structures of the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other components typically associated with IVD devices.
Therefore, the Xario Ultrasound System is a medical imaging device, not an IVD.
N/A
Intended Use / Indications for Use
The Xario is intended to be used for the following type of studies; fetal, abdominal. pediatric, small organs, cardiac, transvaginal, transvaginal, transesophageal, peripheral vascular and musculo-skeletal (both conventional and superficial).
Product codes
90-IYN, 90-IYO, 90-ITX
Device Description
The Xario Ultrasound System is a mobile system. This system is a Track 3 device that employs a wide array of probes that include flat linear array, convex linear array, and sector array with a frequency range of approximately 2 MHz to 12 MHz.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
fetal, abdominal, pediatric, small organs (thyroid, parathyroid, breast, scrotum and penis), cardiac, transvaginal, transesophageal, peripheral vascular, musculo-skeletal (conventional and superficial), transrectal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
This determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Secking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.
§ 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
FEB 2 3 2005
510(k) Summary of Safety and Effectiveness: 21 CFR 807.92
| Submitter's Name: | Toshiba America Medical Systems, Inc. |
|---|---|
| Address: | PO Box 2068,2441 Michelle Drive Tustin, CA 92781-206 |
| Contact: | Paul Biggins, Sr. Manager of Regulatory Affairs |
| Telephone No.: | (714) 730-5000 |
| Device Proprietary Name: | SSA-660A, Xario Version 1.00 |
|---|---|
| Common Name: | Diagnostic Ultrasound System |
Classification:
Regulatory Class: II Review Category: Tier II
Ultrasonic Pulsed Doppler Imaging System - Product Code: 90-IYN [Fed.Reg.No.:892.1550] Ultrasonic Pulsed Echo Imaging System - Product Code: 90-IYO [Fed.Reg.No .: 892.1560] Diagnostic Ultrasonic Transducer - Product Code: 90-ITX [Fed. Reg. No.: 892.1570]
Identification of Predicate Devices:
Toshiba America Medical Systems believes that this device is substantially equivalent to:
-
- Toshiba SSA-770A, Aplio Version 5.5 Diagnostic Ultrasound; 510(k) control number K041499
Device Description:
The Xario Ultrasound System is a mobile system. This system is a Track 3 device that employs a wide array of probes that include flat linear array, convex linear array, and sector array with a frequency range of approximately 2 MHz to 12 MHz.
Intended Use:
The Xario is intended to be used for the following type of studies; fetal, abdominal. pediatric, small organs, cardiac, transvaginal, transvaginal, transesophageal, peripheral vascular and musculo-skeletal (both conventional and superficial).
Safety Considerations:
This device is designed and manufactured in conjunction with the Quality System Regulation, IEC 60601-1 (applicable portions), IEC 60601-1-2 (applicable portion), IEC60601-2-37 (applicable portions), and the AIUM-NEMA UD2 Output Measurement Standard as applied to Track 3 Ultrasound systems and the AIUM-NEMA UD3 Output Display Standard.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
FEB 2 3 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Toshiba America Medical Systems, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
Re: K050380
Trade Name: XARIO Diagnostic Ultrasound System, Model SSA-660A Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: 90 IYN, IYO, and ITX Dated: February 11, 2005 Received: February 15, 2005
Dear Mr. Job:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
This determination of substantial equivalence applies to the following transducers intended for use with the XARIO Diagnostic Ultrasound System, Model SSA-660A, as described in your premarket notification:
Transducer Model Number
PVT-375BT PVT-661VT
2
PLT-805AT
PLT-1204AT
PC-20M
PET-510MB
PST-30BT
PLT-704AT
PLT-604AT
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all 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 determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Secking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.
The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:
Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850
This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled,
3
Page 3 - Mr. Job
"Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at (301) 594-1212.
Sincerely yours,
David A. Legum
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
4
System X_ Transducer________________________________________________________________________________________________________________________________________________________ Model_ SSA-660A______________________________________________________________________________________________________________________________________________________________________ 510(k) Number(s)
| Mode of Operation | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | P | |||||||||
| W | ||||||||||||
| D | C | |||||||||||
| W | ||||||||||||
| D | Color | |||||||||||
| Doppler | Amplitude | |||||||||||
| Doppler | Color | |||||||||||
| Velocity | ||||||||||||
| Imaging | Combined | |||||||||||
| (Specify) | Harmonic | |||||||||||
| Imaging | 1.5 | |||||||||||
| Harmonic | 1.5 | |||||||||||
| RSI | TDI- | |||||||||||
| Q | ||||||||||||
| Ophthalmic | ||||||||||||
| Fetal | N | N | N | N | N | N | N | N | ||||
| Abdominal | N | N | N | N | N | N | N | N | N | |||
| Intraoperative (Specify) | ||||||||||||
| Intraoperative | ||||||||||||
| Neurological | ||||||||||||
| Pediatric | N | N | N | N | N | N | N | N | N | |||
| Small Organ (Specify)* | N | N | N | N | N | N | N | N | ||||
| Neonatal Cephalic | ||||||||||||
| Adult Cephalic | ||||||||||||
| Cardiac | N | N | N | N | N | N | N | N | N | N | N | N |
| Transesophageal | N | N | N | N | N | N | N | N | N | N | N | |
| Transrectal | N | N | N | N | N | N | N | N | ||||
| Transvaginal | N | N | N | N | N | N | N | N | ||||
| Transurethral | ||||||||||||
| Intravascular | ||||||||||||
| Peripheral Vascular | N | N | N | N | N | N | N | N | ||||
| Laparoscopic | ||||||||||||
| Musculo-skeletal | ||||||||||||
| Superficial | N | N | N | N | N | N | N | N | ||||
| Musculo-skeletal | ||||||||||||
| Conventional | N | N | N | N | N | N | N | N |
N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)
Combined Modes: B/M; B/PWD; Additional Comments: _ BDF/PWD; BDF/MDF; BDF/MDF/PWD;B-TDI; M-TDI; 2D/CWD; BDF/CWD; CHI/2D; FEI/2D; CHI/BDF; FEVBDF
- : For example: thyroid, parathyroid, breast, scrotum and penis
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON OTHER PAGES IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)11
David G. Egnor
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number
5
Transducer_X System _ PVT-375BT_____________________________________________________________________________________________________________________________________________________________________ Model_ 510(k) Number(s)
| Mode of Operation | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | P | ||||||||||
| W | |||||||||||||
| D | C | ||||||||||||
| W | |||||||||||||
| D | Color | ||||||||||||
| Doppler | Amplitude | ||||||||||||
| Doppler | Color | ||||||||||||
| Velocity | |||||||||||||
| Imaging | Combined | ||||||||||||
| (Specify) | Harmonic | ||||||||||||
| Imaging | 1.5 | ||||||||||||
| Harmonic | 1.5 | ||||||||||||
| RSI | TDI- | ||||||||||||
| Q | |||||||||||||
| Ophthalmic | |||||||||||||
| Fetal | N | N | N | N | N | N | N | N | |||||
| Abdominal | N | N | N | N | N | N | N | N | |||||
| Intraoperative (Specify) | |||||||||||||
| Intraoperative Neurological | |||||||||||||
| Pediatric | N | N | N | N | N | N | N | N | |||||
| Small Organ (Specify) | |||||||||||||
| Neonatal Cephalic | |||||||||||||
| Adult Cephalic | |||||||||||||
| Cardiac | |||||||||||||
| Transesophageal | |||||||||||||
| Transrectal | |||||||||||||
| Transvaginal | |||||||||||||
| Transurethral | |||||||||||||
| Intravascular | |||||||||||||
| Peripheral Vascular | |||||||||||||
| Laparoscopic | |||||||||||||
| Musculo-skeletal Superficial | |||||||||||||
| Musculo-skeletal | |||||||||||||
| Conventional |
N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)
Additional Comments: Combined Modes: B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD;B-TDI; M-TDI; 2D/CWD; BDF/CWD; CHI/2D; FEI/2D; CHI/BDF; FEI/BDF; FEI/BDF
Previous 510(k) for this device K013633
(I'lease do not write below this line - continue on other pages if needed i Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Timid A. Ayon
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devic
510(k) Number K050380
6
Transducer_X System _______________________________________________________________________________________________________________________________________________________________________ PVT-661VT_____________________________________________________________________________________________________________________________________________________________________ Model_________________________________________________________________________________________________________________________________________________________________________ 510(k) Number(s)
| Mode of Operation | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | P | |||||||||
| W | ||||||||||||
| D | C | |||||||||||
| W | ||||||||||||
| D | Color | |||||||||||
| Doppler | Amplitude | |||||||||||
| Doppler | Color | |||||||||||
| Velocity | ||||||||||||
| Imaging | Combined | |||||||||||
| (Specify) | Harmonic | |||||||||||
| Imaging | 1.5 | |||||||||||
| Harmonic | 1.5 | |||||||||||
| RSI | TDI | |||||||||||
| Q | ||||||||||||
| Ophthalmic | ||||||||||||
| Fetal | ||||||||||||
| Abdominal | ||||||||||||
| Intraoperative (Specify) | ||||||||||||
| Intraoperative | ||||||||||||
| Neurological | ||||||||||||
| Pediatric | ||||||||||||
| Small Organ (Specify) | ||||||||||||
| Neonatal Cephalic | ||||||||||||
| Adult Cephalic | ||||||||||||
| Cardiac | ||||||||||||
| Transesophageal | ||||||||||||
| Transrectal | N | N | N | N | N | N | N | N | ||||
| Transvaginal | N | N | N | N | N | N | N | N | ||||
| Transurethral | ||||||||||||
| Intravascular | ||||||||||||
| Peripheral Vascular | ||||||||||||
| Laparoscopic | ||||||||||||
| Musculo-skeletal | ||||||||||||
| Superficial | ||||||||||||
| Musculo-skeletal | ||||||||||||
| Conventional |
N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)
Combined Modes: B/M; B/PWD; Additional Comments: BDF/PWD; BDF/MDF; BDF/MDF/PWD;B-TDI; M-TD]; 2D/CWD; BDF/CWD; CHI/2D; FEI/2D; CHI/BDF; FEI/BDF; FEI/BDF
(PLEASE DO NOT WRITE BELOW THIS LINE · CONTINUE ON OTHER PAGES IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Esmond G. Skenn
(Division Sign-Off) Ofvision of Reproductive, Abdominal, and Rudiological Devices 10(k) Number
7
Transducer X System __ Model_________________________________________________________________________________________________________________________________________________________________________ 510(k) Number(s)
| Mode of Operation | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | P | ||||||||||
| W | |||||||||||||
| D | C | ||||||||||||
| W | |||||||||||||
| D | Color | ||||||||||||
| Doppler | Amplitude | ||||||||||||
| Doppler | Color | ||||||||||||
| Velocity | |||||||||||||
| Imaging | Combined | ||||||||||||
| (Specify) | Harmonic | ||||||||||||
| Imaging | 1.5 | ||||||||||||
| Harmonic | 1.5 | ||||||||||||
| RSI | TDI- | ||||||||||||
| Q | |||||||||||||
| Ophthalmic | |||||||||||||
| Fetal | |||||||||||||
| Abdominal | |||||||||||||
| Intraoperative (Specify) | |||||||||||||
| Intraoperative | |||||||||||||
| Neurological | |||||||||||||
| Pediatric | |||||||||||||
| Small Organ (Specify) | N | N | N | N | N | N | N | N | |||||
| Neonatal Cephalic | |||||||||||||
| Adult Cephalic | |||||||||||||
| Cardiac | |||||||||||||
| Transesophageal | |||||||||||||
| Transrectal | |||||||||||||
| Transvaginal | |||||||||||||
| Transurethral | |||||||||||||
| Intravascular | |||||||||||||
| Peripheral Vascular | N | N | N | N | N | N | N | N | |||||
| Laparoscopic | |||||||||||||
| Musculo-skeletal | |||||||||||||
| Superficial | N | N | N | N | N | N | N | N | |||||
| Musculo-skeletal | |||||||||||||
| Conventional | N | N | N | N | N | N | N | N |
N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)
Additional Comments: Combined Modes: B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD;B-TDI; M-TDI; 2D/CWD; BDF/CWD; CHI/2D; FEI/2D; CHI/BDF; FEI/BDF; FEI/BDF
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON OTHER PAGES IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
David A. Ingram
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number K050380
8
Transducer _ X System _ PLT-1204AT____________________________________________________________________________________________________________________________________________________________________ Model 510(k) Number(s)
| Mode of Operation | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | P | ||||||||||
| W | |||||||||||||
| D | C | ||||||||||||
| W | |||||||||||||
| D | Color | ||||||||||||
| Doppler | Amplitude | ||||||||||||
| Doppler | Color | ||||||||||||
| Velocity | |||||||||||||
| Imaging | Combined | ||||||||||||
| (Specify) | Harmonic | ||||||||||||
| Imaging | 1.5 | ||||||||||||
| Harmonic | 1.5 | ||||||||||||
| RSI | TDI- | ||||||||||||
| Q | |||||||||||||
| Ophthalmic | |||||||||||||
| Fetal | |||||||||||||
| Abdominal | |||||||||||||
| Intraoperative (Specify) | |||||||||||||
| Intraoperative | |||||||||||||
| Neurological | |||||||||||||
| Pediatric | |||||||||||||
| Small Organ (Specify) | N | N | N | N | N | N | N | N | N | ||||
| Neonatal Cephalic | |||||||||||||
| Adult Cephalic | |||||||||||||
| Cardiac | |||||||||||||
| Transesophageal | |||||||||||||
| Transrectal | |||||||||||||
| Transvaginal | |||||||||||||
| Transurethral | |||||||||||||
| Intravascular | |||||||||||||
| Peripheral Vascular | N | N | N | N | N | N | N | N | N | ||||
| Laparoscopic | |||||||||||||
| Musculo-skeletal | |||||||||||||
| Superficial | N | N | N | N | N | N | N | N | N | ||||
| Musculo-skeletal | |||||||||||||
| Conventional | N | N | N | N | N | N | N | N | N |
N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)
Additional Comments: Combined Modes: B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD;B-TDI; M-TDI; 2D/CWD; BDF/CWD; CHI/2D; FEI/2D; CHI/BDF; FEI/BDF; FEI/BDF
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON OTHER PAGES IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Torill le homann
(Division Sign-Off) Olvision of Reproductive, Abdominal, and Radiological Devices :10(k) Number_
9
Transducer X System __ PC-20M________________________________________________________________________________________________________________________________________________________________________ Model_ 510(k) Number(s)
| Clinical Application | Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| B | M | P W D | C W D | Color Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (Specify) | Harmonic Imaging | 1.5 Harmonic | 1.5 RSI | TDI-Q | |
| Ophthalmic | ||||||||||||
| Fetal | ||||||||||||
| Abdominal | ||||||||||||
| Intraoperative (Specify) | ||||||||||||
| Intraoperative | ||||||||||||
| Neurological | ||||||||||||
| Pediatric | N | |||||||||||
| Small Organ (Specify) | ||||||||||||
| Neonatal Cephalic | ||||||||||||
| Adult Cephalic | ||||||||||||
| Cardiac | N | |||||||||||
| Transesophageal | ||||||||||||
| Transrectal | ||||||||||||
| Transvaginal | ||||||||||||
| Transurethral | ||||||||||||
| Intravascular | ||||||||||||
| Peripheral Vascular | ||||||||||||
| Laparoscopic | ||||||||||||
| Musculo-skeletal | ||||||||||||
| Superficial | ||||||||||||
| Musculo-skeletal | ||||||||||||
| Conventional |
N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)
Additional Comments: _ Combined Modes: B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD;B-TDI; M-TDI; 2D/CWD; BDF/CWD; CHI/2D; FEI/2D; CHI/BDF; FEI/BDF; FEI/BDF
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON OTHER PACES IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Ingram
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number
Prescription Use (Per 21 CFR 801.109)
10
Transducer X System _______________________________________________________________________________________________________________________________________________________________________ Model_ PET-510MB_____________________________________________________________________________________________________________________________________________________________________ 510(k) Number(s)
| Mode of Operation | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | ໄປ | |||||||||||
| W | ||||||||||||||
| D | C | |||||||||||||
| W | ||||||||||||||
| D | Color | |||||||||||||
| Doppler | Amplitude | |||||||||||||
| Doppler | Color | |||||||||||||
| Velocity | ||||||||||||||
| Imaging | Combined | |||||||||||||
| (Specify) | Harmonic | |||||||||||||
| Imaging | ાં ર | |||||||||||||
| Harmonic | । રે | |||||||||||||
| RSI | TDI- | |||||||||||||
| Q | ||||||||||||||
| Ophthalmic | ||||||||||||||
| Fetal | ||||||||||||||
| Abdominal | ||||||||||||||
| Intraoperative (Specify) | ||||||||||||||
| Intraoperative | ||||||||||||||
| Neurological | ||||||||||||||
| Pediatric | ||||||||||||||
| Small Organ (Specify) | ||||||||||||||
| Neonatal Cephalic | ||||||||||||||
| Adult Cephalic | ||||||||||||||
| Cardiac | ||||||||||||||
| Transesophageal | N | N | N | N | N | N | N | N | N | N | N | |||
| Transrectal | ||||||||||||||
| Transvaginal | ||||||||||||||
| Transurethral | ||||||||||||||
| Intravascular | ||||||||||||||
| Peripheral Vascular | ||||||||||||||
| Laparoscopic | ||||||||||||||
| Musculo-skeletal | ||||||||||||||
| Superficial | ||||||||||||||
| Musculo-skeletal | ||||||||||||||
| Conventional |
dded under Appendix E (LTF)
Additional Comments: Combined Modes: B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD;B-TDI; M-TDI; 2D/CWD; BDF/CWD; CHI/2D, FEI/2D; CHVBDF; FEI/BDF; FEI/BDF
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON OTHER PAGES IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Kyrem
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices
KOS 510(k) Number ................................................................................................................................................................
Prescription Use (Per 21 CFR 801.109)
11
System ____ Transducer X PST-30BT_____________________________________________________________________________________________________________________________________________________________________ Model_________________________________________________________________________________________________________________________________________________________________________ 510(k) Number(s)
| Mode of Operation | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | P | |||||||||
| W | ||||||||||||
| D | C | |||||||||||
| w | ||||||||||||
| D | Color | |||||||||||
| Doppler | Amplitude | |||||||||||
| Doppler | Color | |||||||||||
| Velocity | ||||||||||||
| Imaging | Combined | |||||||||||
| (Specify) | Harmonic | |||||||||||
| Imaging | 1.5 | |||||||||||
| THI | 1.5 | |||||||||||
| RSI | TDI-Q | |||||||||||
| Ophthalmic | ||||||||||||
| Fetal | ||||||||||||
| Abdominal | N | N | N | N | N | N | N | N | N | |||
| Intraoperative | ||||||||||||
| (Specify) | ||||||||||||
| Intraoperative | ||||||||||||
| Neurological | ||||||||||||
| Pediatric | N | N | N | N | N | N | N | N | N | |||
| Small Organ | ||||||||||||
| (Specify) | ||||||||||||
| Neonatal Cephalic | ||||||||||||
| Adult Cephalic | ||||||||||||
| Cardiac | N | N | N | N | N | N | N | N | N | N | N | N |
| Transesophageal | ||||||||||||
| Transrectal | ||||||||||||
| Transvaginal | ||||||||||||
| Transurethral | ||||||||||||
| Intravascular | ||||||||||||
| Peripheral Vascular | ||||||||||||
| Laparoscopic | ||||||||||||
| Musculo-skeletal | ||||||||||||
| Superficial | ||||||||||||
| Musculo-skeletal | ||||||||||||
| Conventional |
Combined Modes: B/M; B/PWD; Additional Comments: '_ BDF/PWD; BDF/MDF; BDF/MDF/PWD;B-TDI; M-TDI; 2D/CWD; BDF/CWD; CHI/2D; FEW2D; CHI/BDF; FEVBDF
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON OTHER PAGES IF NJA Concurrence of CDRH, Office of Device Evaluation (OD)
(ODE)
Uavid A. Seppom
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number
Prescription Use (Per 21 CFR 801.109)
12
Transducer X System __ Model__ PLT-704AT_____________________________________________________________________________________________________________________________________________________________________ 510(k) Number(s)
| Mode of Operation | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | P | ||||||||||
| W | |||||||||||||
| D | C | ||||||||||||
| W | |||||||||||||
| D | Color | ||||||||||||
| Doppler | Amplitude | ||||||||||||
| Doppler | Color | ||||||||||||
| Velocity | |||||||||||||
| Imaging | Combined | ||||||||||||
| (Specify) | Harmonic | ||||||||||||
| Imaging | 1.5 | ||||||||||||
| THI | 1.5 | ||||||||||||
| RSI | TDI-Q | ||||||||||||
| Ophthalmic | |||||||||||||
| Fetal | |||||||||||||
| Abdominal | |||||||||||||
| Intraoperative (Specify) | |||||||||||||
| Intraoperative | |||||||||||||
| Neurological | |||||||||||||
| Pediatric | |||||||||||||
| Small Organ (Specify) | N | N | N | N | N | N | N | N | |||||
| Neonatal Cephalic | |||||||||||||
| Adult Cephalic | |||||||||||||
| Cardiac | |||||||||||||
| Transesophageal | |||||||||||||
| Transrectal | |||||||||||||
| Transvaginal | |||||||||||||
| Transurethral | |||||||||||||
| Intravascular | |||||||||||||
| Peripheral Vascular | N | N | N | N | N | N | N | N | |||||
| Laparoscopic | |||||||||||||
| Musculo-skeletal | N | N | N | N | N | N | N | N | |||||
| Superficial | |||||||||||||
| Musculo-skeletal | |||||||||||||
| Conventional | N | N | N | N | N | N | N | N |
N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)
Additional Comments: Combined Modes: B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD;B-TDI; M-TDI; 2D/CWD; BDF/CWD; CHI/2D; FEI/2D; CHVBDF; FEVBDF; FEVBDF
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON OTHER PAGES IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
David R. Lyons
(Division Sign-Off)
Vision of Reproductive, Abdominal, .. i Radiological Devices 1(::k) Number _
Prescription Use (Per 21 CFR 801.109)
A-12
13
Transducer X System __ Model_ PLT-604AT_____________________________________________________________________________________________________________________________________________________________________ 510(k) Number(s)
| Mode of Operation | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | P | ||||||||||
| W | |||||||||||||
| D | C | ||||||||||||
| W | |||||||||||||
| D | Color | ||||||||||||
| Doppler | Amplitude | ||||||||||||
| Doppler | Color | ||||||||||||
| Velocity | |||||||||||||
| Imaging | Combined | ||||||||||||
| (Specify) | Harmonic | ||||||||||||
| Imaging | 1.5 | ||||||||||||
| THI | 1.5 | ||||||||||||
| RSI | TDI-Q | ||||||||||||
| Ophthalmic | |||||||||||||
| Fetal | |||||||||||||
| Abdominal | |||||||||||||
| Intraoperative (Specify) | |||||||||||||
| Intraoperative | |||||||||||||
| Neurological | |||||||||||||
| Pediatric | |||||||||||||
| Small Organ (Specify) | N | N | N | N | N | N | N | N | N | ||||
| Neonatal Cephalic | |||||||||||||
| Adult Cephalic | |||||||||||||
| Cardiac | |||||||||||||
| Transesophageal | |||||||||||||
| Transrectal | |||||||||||||
| Transvaginal | |||||||||||||
| Transurethral | |||||||||||||
| Intravascular | |||||||||||||
| Peripheral Vascular | N | N | N | N | N | N | N | N | N | ||||
| Laparoscopic | |||||||||||||
| Musculo-skeletal | |||||||||||||
| Superficial | N | N | N | N | N | N | N | N | N | ||||
| Musculo-skeletai | |||||||||||||
| Conventional | N | N | N | N | N | N | N | N | N |
N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)
Additional Comments: __ Combined Modes: B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD;B-TDI; M-TDI; 2D/CWD; BDF/CWD; CHI/2D; FEV2D; CHI/BDF; FEVBDF
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON OTHER PAGES IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
David A. Hyrum
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number __