(13 days)
Not Found
No
The provided 510(k) summary does not contain any mention of AI, ML, deep learning, or related terms, nor does it describe features or performance metrics typically associated with AI/ML-powered devices.
No.
The intended use describes diagnostic studies (e.g., "fetal, abdominal, intraoperative, pediatric, small organs, neonatal cephalic, adult cephalic, cardiac, transrectal, transvaginal, transesophageal, peripheral vascular, musculo-skeletal"), and the device description identifies it as a "Diagnostic Ultrasound System" in the predicate entry.
Yes
Explanation: The "Predicate Device(s)" section lists "SSA-550A/NEMIO Diagnostic Ultrasound System," indicating that a similar device is explicitly described as "Diagnostic."
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, the Nemio XG system is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the system as being used for various types of ultrasound studies on different anatomical sites and patient age ranges. This involves imaging the internal structures of the body.
- Device Description: The description confirms it's a mobile ultrasound system that uses probes to generate images.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) outside the body to provide information about a person's health. The Nemio XG system is used to image the body directly.
Therefore, the Nemio XG system is a medical imaging device, specifically an ultrasound system, and not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Nemio XG system is intended to be used for the following type of studies; fetal, abdominal, intraoperative, pediatric, small organs, neonatal cephalic, adult cephalic, cardiac, transrectal, transvaginal, transesophageal, peripheral vascular, musculo-skeletal (both conventional and superficial)..
Product codes
IYN, IYO, ITX
Device Description
The Nemio XG will be offered in one variation which is a mobile system. It 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
Ultrasonic
Anatomical Site
fetal, abdominal, intraoperative, pediatric, small organs, neonatal cephalic, adult cephalic, cardiac, transrectal, transvaginal, transesophageal, peripheral vascular, musculo-skeletal
Indicated Patient Age Range
pediatric, neonatal, adult
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)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
JUN 2 2 2006
510(k) Summary of Safety and Effectiveness: 21 CFR 807.92
| Submitter's Name: | Toshiba America Medical Systems, Inc. |
|---|---|
| Address: | P.O. Box 2068,2441 Michelle Drive Tustin, CA 92781-206 |
| Contact: | Paul Biggins, Regulatory Affairs Specialist |
| Telephone No.: | (714) 730-5000 |
| Device Proprietary Name: | Nemio XG, SSA-580A |
| Common Name: | Ultrasound Imaging System |
| Classification: | |
| Regulatory Class: | II |
| Review Category: | Tier II |
| Ultrasonic Pulsed Doppler Imaging System - Procode: 90-IYN | |
| [Fed.Reg.No.:892.1550] | |
| Ultrasonic Pulsed Echo Imaging System - Procode: 90-IYO | |
| [Fed.Reg.No.:892.1560] | |
| Diagnostic Ultrasonic Transducer - Procode: 90-ITX |
[Fed. Reg. No .: 892.1570]
Identification of Predicate Devices:
Toshiba America Medical Systems believes that this device is substantially equivalent to the Following device; SSA-550A/NEMIO Diagnostic Ultrasound System, 510(k) control number K010631.
Device Description:
The Nemio XG will be offered in one variation which is a mobile system. It 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 Nemio XG system is intended to be used for the following type of studies; fetal, abdominal, intraoperative, pediatric, small organs, neonatal cephalic, adult cephalic, cardiac, transrectal, transvaginal, transesophageal, peripheral vascular, musculo-skeletal (both conventional and superficial)..
Safety Considerations:
The device is designed and manufactured in conjunction with the Quality System Regulation, IEC- 60601 (applicable portions), and IEC 60601-2-37. international standard for ultrasound safety. This unit is similar to that of the Toshiba SSA-550A/NEMIO and engineering assessments identify no new issues of risk or safety.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The symbol is placed to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 222 2006
Toshiba America Medical Systems, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
Re: K061605
Trade Name: NEMIO XG SSA-580A Diagnostic Ultrasound System 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: IYN, IYO, and ITX Dated: June 6, 2006 Received: June 9, 2006
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 NEMIO XG SSA-580A Diagnostic Ultrasound System as described in your premarket notification:
Image /page/1/Picture/11 description: The image is a circular logo with the letters "FDA" in a stylized font at the center. Above the letters, the text "THE THE" is arranged in an arc. Below the letters, the word "Centennial" is written in a cursive font. The entire logo is surrounded by a dotted circle, with additional text following the curve of the circle. The text is difficult to read due to the image quality.
oling Public . I
2
Transducer Model Number
| PLM-703AT |
|---|
| PC-19M |
| PSM-20CT |
| PSM-30BT |
| PEF-510MB |
| PVM-651VT |
| PSM-375AT |
| PLM-1202S |
| PVM-740RT |
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 Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.
The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:
Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850
3
This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
If you have any questions regarding the content of this letter, please contact Ralph Shuping at (301) 594-1212.
Sincerely yours.
Daniel A. Segrem
for
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 _X Transducer Model Nemio XG, SSA-580A 510(k) Number(s)
K$\phi$61 6$\beta$S
Mode of Operation PWD CWD Amplitude B M Color Color A Combined Harmonic Clinical Application Doppler Doppler Velocity (Specify) Imaging Imaging Ophthalmic N N Z N Fetal N N N N ત્ત્વ N N N N N N Abdominal N N પ N N Intraoperative (Specify) N N N N N N Intraoperative Neurological Pediatric N N N N N N N N N Small Organ (Specify) N N N N N N N N N N N N N Neonatal Cephalic N N N N N N Adult Cephalic N N N N N N N N N N N N N Cardiac N N N N N N N N N N N Transesophagea! N N N N N N N N N Transrectal N N N N N N N N Transvaginal Transurethral Intravascular N N N N Peripheral Vascular N N N N Laparoscopic Musculo-skeletal Superficial N N N N N N N N N N N N N Musculo-skeletal N N N Conventional N N N N N N N Endoscopic Other (specify)
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; B-TDI; M-TDI
RI EASE DO NOT VIRTIE REI OW THIS LINE. CONTINUE ON OTHER RAGES IC Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)
Daniel B. Ingram
11
5
DUCER TABLE
Kp616ø2
Transducer Model Number: PLM-703AT 510(k) Control Number:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (Specify) | Harmonic | |||||||||
| Imaging | ||||||||||
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (Specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (Specify) | P | P | P | P | P | P | P | P | ||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | P | P | P | P | P | P | P | P | ||
| Laparoscopic | ||||||||||
| Musculo-skeletal Superficial | P | P | P | P | P | P | P | P | ||
| Musculo-skeletal | P | P | P | P | P | P | P | P | ||
| Conventional | ||||||||||
| Other (specify) |
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; B-TDI; M-TDI
Previous 510(k) control # K010361
Concurrence of CDRHI, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Eavid H. Legman
(Division Sign-Off) Division of Reproductive, At ാൻ Radiological Devices != 10(k) Number
12
6
Transducer Model Number: PC-19M 510(k) Control Number:
Kp616ø5
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (Specify) | Other | |||||||||
| (Specify) | ||||||||||
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (Specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | P | |||||||||
| Small Organ (Specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | P | |||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Other (specify) |
N= new indication: P = Previously Cleared by FDA = E = Added under Appendix 8 (510(k)
N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)
Additional Comments:
Previous 510(k) control # K010361
EDO Concurrence of CDRH, Office of Device Eve
David A. Hanson
(Division Sign-Off) Division of Reproductive and Radiological Devices 510(k) Number
Prescription Use (Per 21 CFR 801.109)
13
7
Transducer Model Number: PSM-20CT 510(k) Control Number:
Kg616øS
| Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | |||||
| Doppler | Amplitude | ||||||||||
| Doppler | Color | ||||||||||
| Velocity | |||||||||||
| Imaging | Combined | ||||||||||
| (Specify) | Harmonic | ||||||||||
| Imaging | |||||||||||
| Ophthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intraoperative (Specify) | |||||||||||
| Intraoperative Neurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ (Specify) | |||||||||||
| Neonatal Cephalic | P | P | P | P | P | P | P | P | P | ||
| Adult Cephalic | P | P | P | P | P | P | P | P | P | ||
| Cardiac | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletal Superficial | |||||||||||
| Musculo-skeletal | |||||||||||
| Conventional | |||||||||||
| Other (specify) |
N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)
| Additional Comments: | TDI; M-TDI |
|---|---|
| Combined Modes: | B/M; B/PWD; BDF/PWD; BDF/MDF; B- |
Previous 510(k) control # K010361
Previous 510(k) Control # k01036 1
(Previous Province of CDRH, Office of Device of Device Evaluation (ODE)
Concurrence of CDRH, Office of DRH, Office of Device Evaluation (OD
David h. Ayerson
(Division Sign-Off) Division of Reproductive, Abe and Radiological Devices 510(k) Number
Prescription Use (Per 21 CFR 801.109)
8
Transducer Model Number: PSM-30BT 510(k) Control Number:
Kp614øS
| Clinical Application | Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| A | B | M | PWD | CWD | Color | |||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (Specify) | Harmonic | |||||||||
| Imaging | ||||||||||
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | E | E | E | E | E | E | E | E | E | |
| Intraoperative (Specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | E | E | E | E | E | E | E | E | E | |
| Small Organ (Specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | E | E | E | E | E | E | E | E | E | |
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Other (specify) | ||||||||||
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; B-TDI; M-TDI
Added under appendix E to 510(k) control # K010361 ow This Ling CONTINUE ON OTHE
TE DO NOT WATE BEL Concurrence of CDRH, Office of Device Evaluation
David A. Hanson
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices >10(k) Number _
Prescription Use (Per 21 CFR 801.109)
9
Transducer Model Number: PEF-510MB 510(k) Control Number:
| K461605 |
|---|
| --------- |
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (Specify) | Harmonic | |||||||||
| Imaging | ||||||||||
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (Specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (Specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | P | P | P | P | P | P | P | P | P | |
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Other (specify) |
N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)
Additional Comments: ______________________________________________________________________________________________________________________________________________________ TDI; M-TDI ___________________________________________________________________________________________________________________________________________________________________
Previous 510(k) control # K010361
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Leggett
(Division Sign-Off)
Division of Reproductive, Abdominal,
And Radiological Devices
K Number
K0610
Prescription Use (Per 21 CFR 801.109)
.. ...
14.00
10
11661609
Transducer Model Number: PVM-651VT 510(k) Control Number:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (Specify) | Other | |||||||||
| (Specify) | ||||||||||
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (Specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (Specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | P | P | P | P | P | P | P | P | ||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Other (specify) | ||||||||||
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; B-TDI; M-TDI
Previous 510(k) control # K010361 C
SE DO NOT WRITE BELOW THIS LINE CONTINUE ON OTHER PAGES IF ACEDED Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Seymann
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________
Prescription Use (Per 21 CFR 801.109)
11
Transducer Model Number: PSM-375AT 510(k) Control Number:
Kd616b5
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (Specify) | Harmonic | |||||||||
| Imaging | ||||||||||
| Ophthalmic | ||||||||||
| Fetal | P | P | P | P | P | P | P | P | ||
| Abdominal | P | P | P | P | P | P | P | P | ||
| Intraoperative (Specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | P | P | P | P | P | P | P | P | ||
| Small Organ (Specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Other (specify) | ||||||||||
| N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF) |
| Additional Comments: | TDI; M-TDI |
|---|---|
| Combined Modes: | B/M; B/PWD; BDF/PWD; BDF/MDF; B- |
Previous 510(k) control # K010361
Previous 510(k) control # k01036 1
Previous S10(k) Concurrence of CDRH, Office of Device Evaluation (ODE)
David h. Sypon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K06160
Prescription Use (Per 21 CFR 801.109)
...
12
Transducer Model Number: PLM-1202S 510(k) Control Number:
| /
124
ાજ | 0 | વિત્ત
1 |
| ---------------- | --- | ------------ |
|---|
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (Specify) | Harmonic | |||||||||
| Imaging | ||||||||||
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative | P | P | P | P | P | P | P | P | ||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (Specify) | P | P | P | P | P | P | P | P | ||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | P | P | P | P | P | P | P | P | ||
| Laparoscopic | ||||||||||
| Musculo-skeletal Superficial | P | P | P | P | P | P | P | P | ||
| Musculo-skeletal | P | P | P | P | P | P | P | P | ||
| Conventional | ||||||||||
| Other (specify) |
N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)
Previously Cleared by FDA; E dication; } e Added under Appendix E (L
Additional Comments: _________________________________________________________________________________________________________________________________________________________ Combined Modes: B/M; B/EWD; BDF/EWD; BDF/MDF; B-TDI; M-TDI
Previous 510(k) control # K010361
Previous 510(k) control # K010361
(ELLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON OTHER EAGES IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE)
David R. Leggett
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices . 04:10 Number - ---------
Prescription Use (per 21 CFR 801.109)
.
13
Transducer Model Number: PVM-740RT 510(k) Control Number:
ER TABLE
Kf616ф5
| Clinical Application | A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (Specify) | Harmonic Imaging |
|---|---|---|---|---|---|---|---|---|---|---|
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (Specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | P | P | P | P | P | P | P | P | ||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Musculo-skeletal Conventional | ||||||||||
| Other (specify) |
N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)
Combined Modes: B/M; B/EWD; BDF/EWD; BDF/MDF; B-Additional Comments: TDI; M-TDI
Previous 510(k) control # K010361
(ELEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON OTHER Concurrence of CDRH, Office of Device Evaluation (ODE)
David Ch. Wegman
(Division Sign-Off) Amsion of Reproductive, Abdomina " Dadiological Devices : 99kj Number
Prescription Use (per 21 CFR 801.109)