Predicate Devices

Not Found

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and provides no information about training or test sets, which are typical for AI/ML-based devices.

Therapeutic

No
The Intended Use clearly states "Diagnostic ultrasound imaging or Doppler analysis," indicating its purpose is for diagnosis, not therapy.

Diagnostic

Yes
The "Intended Use / Indications for Use" section explicitly states "Diagnostic ultrasound imaging or Doppler analysis of the human body".

SaMD (Software as a Medical Device)

No

The device description explicitly lists various transducers, which are hardware components essential for ultrasound imaging. This indicates it is a hardware-based medical device, not software-only.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to examine these samples outside of the body.
Device Function: The description clearly states that this is a "Diagnostic Ultrasound System." Ultrasound imaging is a non-invasive technique that uses sound waves to create images of internal body structures. It is performed in vivo (within the living body), not in vitro (outside the living body).
Intended Use: The intended use describes imaging and Doppler analysis of various anatomical sites within the human body.

Therefore, this device falls under the category of medical imaging devices, not in vitro diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:

For SDU-2000, PA probe 2,5:

Abdominal: PWD, Color Doppler, Power (Amplitude) Doppler
Cardiac Adult: A, B, M, PWD, CWD, Color Doppler, Power (Amplitude) Doppler, Color Velocity Imaging, Combined (B/M, B/PWD, Color/PWD, B/PWD/M, Color/M and Color/PWD/M mode)
Cardiac Pediatric: A, B, M, PWD, CWD, Color Doppler, Power (Amplitude) Doppler, Color Velocity Imaging, Combined (B/M, B/PWD, Color/PWD, B/PWD/M, Color/M and Color/PWD/M mode)

For SDU-2000, PA probe 3.5:

Abdominal: PWD, Color Doppler, Power (Amplitude) Doppler
Cardiac Adult: B, M, PWD, CWD, Color Doppler, Power (Amplitude) Doppler, Color Velocity Imaging, Combined (B/M, B/PWD, Color/PWD, B/PWD/M, Color/M and Color/PWD/M mode)
Cardiac Pediatric: B, M, PWD, CWD, Color Doppler, Power (Amplitude) Doppler, Color Velocity Imaging, Combined (B/M, B/PWD, Color/PWD, B/PWD/M, Color/M and Color/PWD/M mode)

For SDU-2000, PA probe 5.0:

Abdominal: PWD, Color Doppler, Power (Amplitude) Doppler
Cardiac Adult: B, M, PWD, CWD, Color Doppler, Power (Amplitude) Doppler, Color Velocity Imaging, Combined (B/M, B/PWD, Color/PWD, B/PWD/M, Color/M and Color/PWD/M mode)
Cardiac Pediatric: B, M, PWD, CWD, Color Doppler, Power (Amplitude) Doppler, Color Velocity Imaging, Combined (B/M, B/PWD, Color/PWD, B/PWD/M, Color/M and Color/PWD/M mode)

For SDU-2000, CA probe 3.5 R40:

Fetal: B, M, PWD, Color Doppler, Power (Amplitude) Doppler, Color Velocity Imaging, Combined
Abdominal: A, B, M, PWD, Color Doppler, Power (Amplitude) Doppler, Color Velocity Imaging, Combined

For SDU-2000, CA probe 3.5 R76:

Fetal: B, M, PWD, Color Doppler, Power (Amplitude) Doppler, Color Velocity Imaging, Combined
Abdominal: B, M, PWD, Color Doppler, Power (Amplitude) Doppler, Color Velocity Imaging, Combined

For SDU-2000, LA probe 7.5 PV:

Small Organ (Thyroid, Testicles, Breast): A, B, M, PWD, Color Doppler, Power (Amplitude) Doppler, Color Velocity Imaging, Combined (B/M, B/PWD, Color/PWD, B/PWD/M, Color/M and Color/TWD/M mode)
Peripheral vessel: A, B, M, PWD, Color Doppler, Power (Amplitude) Doppler, Color Velocity Imaging, Combined

For SDU-2000, TV probe 5.5 11R:

Fetal: B, M, PWD, Color Doppler, Power (Amplitude) Doppler, Color Velocity Imaging, Combined
Small Organ: B, M, PWD, Color Doppler, Power (Amplitude) Doppler, Color Velocity Imaging, Combined
Trans-rectal: B, M, PWD, Color Doppler, Power (Amplitude) Doppler, Color Velocity Imaging, Combined
Trans-vaginal: B, M, PWD, Color Doppler, Power (Amplitude) Doppler, Color Velocity Imaging, Combined

Product codes (comma separated list FDA assigned to the subject device)

90 IYO

Device Description

Echo View SDU-2000 Diagnostic Ultrasound System

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Human body, Abdominal, Cardiac, Fetal, Small Organ (Thyroid, Testicles, Breast), Peripheral vessel, Trans-rectal, Trans-vaginal.

Indicated Patient Age Range

Adult, Pediatric, Neonatal. Fetal patients are also indicated. Specific ranges are not defined beyond these categories.

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): 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.

Not Found

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

Regulation Number and Section

§ 892.1560 Ultrasonic pulsed echo imaging system.

(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Summary

0

Image /page/0/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 wavy lines extending from its body, representing the department's services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Yasuhuru Ishii Manager, Ultrasound Product ... ... .. . . . . . . . . . . . . . . . . Engineering and Technical Support ............................................................................................................................................ Shimazu Medical Systems 20101 South Vermont Ave. Torrence, CA 90502

Re: K970508 Echo View SDU-2000 Diagnostic Ultrasound System Dated: June 20, 1997 Received: June 23, 1997 Regulatory class: II 21 CFR 892.1550/Procode: 90 IYO

Dear Mr. Yashuhuru:

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 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. You may, therefore, market the device, subject to the general controls provisions Act (Act). The general controls provisions of the Act include requirements for registration, listing of devices, good manufacturing practices, labeling, and prohibitions against misbranding and adulteration.

This determination of substantial equivalence applies to the following transducers intended for use with the SDU-2000, as described in your premarket notification:

Transducer Model Number 2.5 MHz PA SECTOR 3.5 MHz PA SECTOR 5.0 MHz PA SECTOR 3.5 MHz R40 CA CONVEX 3.5 MHz R76 CA CONVEX 7.5 . MHz LA LINEAR ARRAY 5.5 MHZ TV CONVEX

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 regulation ( CFR Part 820) and that, through periodic QS inspections, the Food and

1

Page 2 - Yasuhuru Ishii

Drug Administration (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 Ecderal 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. ----------------------------------------------------------------------------------------------------------

Please be advised that the determination above is based on the fact that no medical devices have been demonstrated to be safe and effective for in vitro fertilization or percutaneous umbilical blood sampling, nor have any devices been marketed for these uses in interstate commerce prior to May 28, 1976, or reclassified into class I (General Controls) or class II (Special Controls). FDA considers devices specifically intended for in vitro fertilization and percutaneous umbilical blood sampling to be investigational, and subject to the provision of the investigational device exemptions (IDE) regulations, 21 CFR, Part 812. Therefore, your product labeling must be consistent with FDA's position on this use.

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 February 17, 1993 "Revised 510(k) Diagnostic Ultrasound Guidance for 1993." 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 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-fiee number (800) 638-2041 or at (301) 443-6597 or at its internet address http://www.fda.gov/cdrh/dsmamain.html",

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Page 3 - Yasuhuru Ishii\

If you have any questions regarding the content of this letter, please contact Maureen Butler at (301) 594-1212.

Sincerely yours,

Lillian Yin, Ph.D.

Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

ﻤﺴ

Enclosure

3

510(k) Number (if known) : 910(K) Name : Diagnostic Ultrasound System SDU-2000, PA probe 2,5

Fill out one form for each ultrasound system or transducer.

Indications for use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:

| Clinical
Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) ** | Other
(Specify) |
|---------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|--------------------------|--------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | X | | X | X | | | |
| Intra-operative
(Specify) | | | | | | | | | | |
| Intra-operative
Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ
(Specify) * | | | | | | | | | | |
| Neonatal | | | | | | | | | | |
| Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac Adult | X | X | X | X | X | X | X | X | X | |
| Cardiac
Pediatric | X | X | X | X | X | X | X | X | X | |
| Trans-
esophageal | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | |
| Intra-luminal | | | | | | | | | | |
| Trans-utethral | | | | | | | | | | |
| Peripheral
vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |

Mode of Operation

Other Indications or Modes:

(PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED)
Совситевое of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices

Prescription Use (Per 21 CFR 801.109)
510(k) Number K970508
LY

4

510(k) Number (if known) :

Device Name : Diagnostic Ultrasound System SDU-2000, PA probe 3.5

Fill out one form for each ultrasound system or transducer.

Indications for use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows: -. -. -. -. -. -. -.

Mode of Operation
Clinical
Application	A	B	M	PWD	CWD	Color
Doppler	Power
(Amplitude)
Doppler	Color
Velocity
Imaging	Combined
(Specify) **	Other
(Specify)
Ophthalmic
Fetal
Abdominal				X		X	X
Intra-operative
(Specify)
Intra-operative
Neurological
Pediatric
Small Organ
(Specify) *
Neonatal
Cephalic
Adult Cephalic
Cardiac Adult		X	X	X	X	X	X	X	X
Cardiac
Pediatric		X	X	X	X	X	X	X	X
Trans-
esophageal
Trans-rectal
Trans-vaginal
Intra-luminal
Trans-utethral
Peripheral
vessel
Laparoscopic

Other Indications or Modes:

** B/M, B/PWD, Color/PWD, B/PWD/M, Color/M and Color/PWD/M mode

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGES IF NEEDED)
Соволитемое оf CDRH, Office of Device Erahsation (ODE)

(Division Sign-Off)

S

Division of Reproductive, Abdominal, ENT and Radiological Device

Prescription Use (Per 21 CFR 801.109)

510(k) Number K970508

5

Ultrasound Device Indications Statement

Page 3 of _ 7 _ .

510(k) Number (if known) :

Device Name : Diagnostic Ultrasound System SDU-2000, PA probe 5.0

Fill out one form for each ultrasound system or transducer.

Indications for use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows: -----------------------------------------------

| Clinical
Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) ** | Other
(Specify) |
|---------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|--------------------------|--------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | X | | X | X | | | |
| Intra-operative
(Specify) | | | | | | | | | | |
| Intra-operative
Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ
(Specify) * | | | | | | | | | | |
| Neonatal | | | | | | | | | | |
| Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac Adult | | X | X | X | X | X | X | X | X | |
| Cardiac
Pediatric | | X | X | X | X | X | X | X | X | |
| Trans-
esophageal | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | |
| Intra-luminal | | | | | | | | | | |
| Trans-utethral | | | | | | | | | | |
| Peripheral
vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |

Mode of Operation

Other Indications or Modes:

** B/M, B/PWD, Color/PWD, B/PWD/M, Color/M and Color/PWD/M mode

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEWDED Concerrence of CDRH, Office of Dev on Evaluati (ODE)

510(k) Number

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices

Prescription Use (Per 21 CFR 801.109)

6

Page _ 4_ of __ 7__

Ultrasound Device Indications Statement

510(k) Number (if known) :

5 ro(x) Name : Diagnostic Ultrasound System SDU-2000, CA probe 3.5 R40

Fill out one form for each ultrasound system or transducer.

Indications for use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows: -- ------------------------------------------------

	Mode of Operation
Clinical
Application	A	B	M	PWD	CWD	Color
Doppler	Power
(Amplitude)
Doppler	Color
Velocity
Imaging	Combined
(Specify) **	Other
(Specify)
Ophthalmic
Fetal		X	X	X		X	X	X	X
Abdominal	X	X	X	X		X	X	X	X
Intra-operative
(Specify)
Intra-operative
Neurological
Pediatric
Small Organ
(Specify) *
Neonatal
Cephalic
Adult Cephalic
Cardiac Adult
Cardiac
Pediatric
Trans-
esophageal
Trans-rectal
Trans-vaginal
Intra-luminal
Trans-utethral
Peripheral
vessel
Laparoscopic

Mode of Oneration

Other Indications or Modes:

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NELDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Dadiolo

7

510(k) Number (if known) :

9 rott) Name : Diagnostic Ultrasound System SDU-2000, CA probe 3.5 R76

Fill out one form for each ultrasound system or transducer.

Indications for use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows. - . . - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

| Clinical
Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify)** | Other
(Specify) |
|---------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-------------------------|--------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | X | X | X | | X | X | X | X | |
| Abdominal | | X | X | X | | X | X | X | X | |
| Intra-operative
(Specify) | | | | | | | | | | |
| Intra-operative
Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ
(Specify) * | | | | | | | | | | |
| Neonatal | | | | | | | | | | |
| Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | |
| Cardiac
Pediatric | | | | | | | | | | |
| Trans-
esophageal | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | |
| Intra-luminal | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | |
| Peripheral
vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |

Mode of Oneration

Other Indications or Modes:

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K970508

LLY

8

Page 6 _ of __ .

510(k) Number (if known) :

Device Name : Diagnostic Ultrasound System SDU-2000, LA probe 7.5 PV

Fill out one form for each ultrasound system or transducer.

Indications for use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows: . ...... . ..

						Mode of Operation
Clinical
Application	A	B	M	PWD	CWD	Color
Doppler	Power
(Amplitude)
Doppler	Color
Velocity
Imaging	Combined
(Specify) **	Other
(Specify)
Ophthalmic
Fetal
Abdominal
Intra-operative
(Specify)
Intra-operative
Neurological
Pediatric
Small Organ
(Specify) *	X	X	X	X		X	X	X	X
Neonatal
Cephalic
Adult Cephalic
Cardiac Adult
Cardiac
Pediatric
Trans-
esophageal
Trans-rectal
Trans-vaginal
Intra-luminal
Trans-utethral
Peripheral
vessel	X	X	X	X		X	X	X	X
Laparoscopic

Other Indications or Modes:

Thyroid, Testicles, Breast

** B/M, B/PWD, Color/PWD, B/PWD/M, Color/M and Color/TWD/M mode

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Dev Evel tion (ODE) 0 ব S (Division Sign Off) (Division of Reproductive, Abdominal, ENT and Radiological Devices 510(k) Number _

Prescription Use (Per 21 CFR 801.109)

9

Page _ 7 _ of _ 7 _ . Ultrasound Device Indications Statement

510(k) Number (if known) : JTo(K) Name : Diagnostic Ultrasound System SDU-2000, TV probe 5.5 11R

Fill out one form for each ultrasound system or transducer.

Indications for use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows: ..

| Clinical
Application | A | B | M | PWD Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify)** | Other
(Specify) |
|------------------------------|---|---|---| | Ophthalmic | | | | | Fetal | | X | X | X | | Abdominal | | | | | Intra-operative
(Specify) | | | | | | | Intra-operative | | | | | Neurological | | | | | Pediatric | | | | | Small Organ
(Specify) * | | X | X | X | | X | Neonatal | | | | | Cephalic | | | | | Adult Cephalic | | | | | Cardiac Adult | | | | | Cardiac
Pediatric | | | | | | | Trans-esophageal | | | | | Trans-rectal | | X | X | X | | Trans-vaginal | | X | X | X | | Intra-luminal | | | | | Trans-utethral | | | | | Peripheral
vessel | | | | | | | Laparoscopic | | | | | CWD | Color
-----|-----|------------------|---------------------------------|------------------------------|-------------------------|--------------------|
| | | | | | |
| X | X | X | X | |
| | | | | | |
| | | | |
| | | | | | |
| | | | | | |
| | | | | | |
| X | X | X | |
| | | | | | |
| | | | | | |
| | | | | | |
| | | | | | |
| | | | |
| | | | | | |
| X | X | X | X | |
| X | X | X | X | |
| | | | | | |
| | | | | | |
| | | | |
| | | | | | |

・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・

Mode of Operation

Other Indications or Modes:

(PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Othoe of Device E a (DDE) ivision Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Dev Prescription Use (Per 21 CFR 801.109) 510(k) Number