Predicate Devices

K992505, K010833, K012191, K030191, K040840, K043278, K051334

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and describes the device as identical to previous models without mentioning any new AI/ML capabilities.

Therapeutic

No.
The intended use explicitly states "diagnostic ultrasound imaging or fluid flow analysis," which indicates a diagnostic rather than therapeutic purpose.

Diagnostic

Yes

Explanation: The 'Intended Use / Indications for Use' section explicitly states that "The Acuson P50 ™ Ultrasound System is intended for diagnostic ultrasound imaging or fluid flow analysis of the human body".

SaMD (Software as a Medical Device)

No

The device description explicitly states it is an "Ultrasound System" and references predicate devices that are also ultrasound systems, which are hardware-based imaging devices.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use clearly states "diagnostic ultrasound imaging or fluid flow analysis of the human body." This describes a device used to image structures and analyze flow within the living body, not to test samples outside the body.
Device Description: The description refers to it as an "Ultrasound System," which is a type of medical imaging equipment used for in-vivo diagnostics.
Input Imaging Modality: The input modality is "Ultrasound," which is used for imaging the body directly.
Anatomical Site: The listed anatomical sites are all locations within the human body.

IVD devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a person's health. This device operates by sending and receiving ultrasound waves to create images of internal structures.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Acuson P50 ™ Ultrasound System is intended for diagnostic ultrasound imaging or fluid flow analysis of the human body; specific indications for use are tabulated in Section 4.3 of this submission.
Intended Use: Diagnostic ultrasound Imaging or fluid flow analysis of the human body as follows:

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

IYO, IYN, ITX

Device Description

The Acuson P50 ™ Ultrasound System is identical to the Teratech 2000 and previous Teratech models as identified in the predicate device section.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Ophthalmic, Fetal, Abdominal, Intra-operative (Spec.), Intra-operative (Neuro), Laparoscopic, Pediatric, Small Organ (Thyroid, Breast, Testes, etc.), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-urethral, Trans-esoph. (non-Card.), Musculo-skel. (Convent.), Musculo-skel. (Superfic), Intra-luminal, Cardiac Adult, Cardiac Pediatric, Trans-esoph. (Cardiac), Peripheral vessel

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): 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.

K992505, K010833, K012191, K030191, K040840, K043278, K051334

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.

K063085, K042055, K051334

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

§ 892.1570 Diagnostic ultrasonic transducer.

(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.

Summary

0

K072266
page 1 of 2

AUG 2 9 2007

510(k) Summary Siemens Medical Solutions Siemens P50 ™ Ultrasound System

Siemens Medical Solutions SPONSOR 1. Ultrasound Division 1230 Shorebird Way Mountain View, California
- Sheila W. Pickering Ph.D. Contact Person: Regulatory Affairs

650 943 7187 Telephone:

July 31 2007 Date Prepared:

DEVICE NAME 2.

Proprietary Name:	Acuson P50 ™ Ultrasound System
Common/Usual Name:	Diagnostic Ultrasound System
Classification Name:	Diagnostic Ultrasound Transducer
(21 CFR 892.1570, 90-ITX)
Ultrasonic Pulsed Echo Imaging System
(21 CFR 892.1560, 90-IYO)
Diagnostic Ultrasonic Transducer
(21 CFR 892.1570, 90-ITX)

PREDICATE DEVICES 3.

K992505	TERATECH Model 2000 Imaging System
K010833	TERATECH Model 8C4 Endocavity Smart Probe
K012191	TERATECH Model 2000 Handheld Ultrasound System with
	Doppler and Harmonic Imaging Modes
K030191	SIEMENS ™ Model 2000/BAS Portable Ultrasound Systems
K040840	TERATECH Model 10V5 Smart Probe
K043278	TERATECH Model 8IOC4, 8IOL4, and 10LAP4 Probes
K051334	TERASON™ Ultrasound System with Continuous Wave (CW)
	Doppler and add-to-file submissions

1

K072266
Page 2 of 2

Intended Use 4.

The Acuson P50 ™ Ultrasound System is intended for diagnostic ultrasound imaging or fluid flow analysis of the human body; specific indications for use are tabulated in Section 4.3 of this submission.

DEVICE DESCRIPTION 5.

The Acuson P50 ™ Ultrasound System is identical to the Teratech 2000 and previous Teratech models as identified in the predicate device section.

	TERATECH 2000	Acuson P50
Hardware	Specified in K051334	No change
Transducers	Specified in K051334	Increase number of
transducers
Software	Specified in K051334	No change
Labeling	Specified in K051334	Changed only to
reflect additional
transducers

BASIS FOR SUBSTANTIAL EQUIVALENCE 6.

The Siemens P50 ™ Ultrasound System is substantially equivalent to the Teratech devices listed above which are currently in commercial distribution in the United States. It is equivalent in modes of operation, and intended for the same clinical applications.

2

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circle around the symbol. The text is in all caps and is evenly spaced around the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Siemens Medical Solutions USA, Inc. c/o Mr. Mark Job Responsible Third Party Official Regulatory Technology Services 1394 25th Street, NW BUFFALO MN 55313

AUG 2 9 2007

Re: K072266

Trade/Device Name: Acuson P50TM Ultrasound System Regulation Number: 21 CFR §892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO, IYN, ITX Dated: August 14, 2007 Received: August 15, 2007

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 ACUSON P50 Ultrasound System, as described in your premarket notification:

Transducer Model Number

4V2 Phased Array	7L3 Linear Array	12HL7 Hockeystick Linear Array
12L5 Linear Array	AuxCW 2MHz Pedof

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.

3

Page 2 - Mr. Mark Job

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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 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 Mr. Paul Hardy at (240) 276-3666.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosures

4

Attachment 1

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

System:	ACUSON P50 Ultrasound System
Transducer:	(see comments)
	Intended Use: Diagnostic ultrasound Imaging or fluid flow analysis of the human body as follows:
Clinical Application		Mode of Operation						Other
General
(Track I Only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppa	Comb.
Modesb
	Ophthalmic
Fetal
Imaging
& Other	Fetal	Nd	N	N	N	Nd	N	Nd
	Abdominal	Nd	N	N	N	Nd	N	Nd
	intra-operative (Spec.)e	Nd	N	N	N	Nd	N	Nd
	Intra-operative (Neuro)	N	N	N	N	N	N	N
	Laparoscopic
	Pediatric	Nd	N	N	N	Nd	N	Nd
	Small Organ (Thyroid,
Breast, Testes, etc.)	Nd	N	N	N	Nd	N	Nd
	Neonatal Cephalic	N	N	N	N	N	N	N
	Adult Cephalic	N	N	N	N	N	N	N
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)	Nd	N	N	N	Nd	N	Nd
	Musculo-skel. (Superfic)	Nd	N	N	N	Nd	N	Nd
	Intra-luminall	N	N	N	N	Nd	N	N
	Other (Specify)
Cardiac	Cardiac Adult	N	N	Nf	N	Nd	N	N
	Cardiac Pediatric	N	N	Nf	N	Nd	N	N
	Trans-esoph. (Cardiac)	N	N	Nf	N	Nd	N	N
	Other (Specify)
Peripheral
Vessel	Peripheral vessel	Nd	N	N	N	N	N	Nd
	Other (Specify)

N= new indication; P= previously cleared by FDA; E= added under Appendix E

" Includes Color Doppler (CD) and (non-directional) Power Doppler.

B+M; B+PWD; B+CWD; B+CD; B+PD;

° Harmonic Imaging (HI)

4 Includes ultrasound guidance for placement of needles & catheters.

· Abdominal organs and peripheral vessel.

PW includes PW Doppler Tissue Imaging (DTI).

9 includes Doppler Tissue Imaging (DT)}

Includes uses in milltary field settings in addition to hospital/clinic settings.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of Center for Devices and Radiological Health, Office of Device Evaluation Prescription Use (Per 21 CFR 801.109)

Nancy C. Brogdon

(Division Siğn-Off) Division of Reproductive, Abdominal, an Radiological Devices 510(k) Number

5

System:	ACUSON P50 Ultrasound System
Transducer:	4V2 Phased Array (K063085)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application		Mode of Operation						Other
General
(Track I Only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppa	Comb
Modesb
Ophthalmic	Ophthalmic	Pd	P			Pd	P	Pd
	Fetal	Pd	P	P		Pd	P	Pd
	Abdominal	Pd	P	P	P	Pd	P	Pd
	Intra-operative (Spec.)	Pd	P	P	P	Pd	P	Pd
	Intra-operative (Neuro)
	Laparoscopic
Fetal
Imaging
& Other	Pediatric	Pd	P	P	P	Pd	P	Pd
	Small Organ (Thyroid,
Breast, Testes, etc.)
	Neonatal Cephalic	P	P	P	P	P	P	P
	Adult Cephalic:	P	P	P	P	P	P	P
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic)
	Intra-luminal
	Other (Specify)
Cardiac	Cardiac Adult	P	P	P	P	P	P	P
	Cardiac Pediatric	P	P	P	P	P	P	P
	Trans-esoph. (Cardiac)
	Other (Specify)
Peripheral
Vessel	Peripheral vessel
	Other (Specify)

N= new indication; P= praviously cleared by FDA; E= added under Appendix E

" Includes Color Doppler (CD) and (non-directional) Power Doppler.

8 +M; B+PWD; B+CWD; B+CD; B+PD.

് Harmonic Imaging (HI)

Harmonic infaging (11)
9 Includes ultrasound guidance for placement of needles, catheters.

Abdominal organs and peripheral vessel.

PW includes PW Doppler Tissue Imaging (DTI).

9 includes Doppler Tissue Imaging (DTI) .

Includes uses in military lieid settings in addition to hospital/clinic settings.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of Center for Devices and Radiological Health, Office of Device Evaluation

VPrescription Use (Per 21 CFR 801.109)

Nancy Brogdon

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

6

System:	ACUSON P50 Ultrasound Systems
Transducer:	7L3 Linear Array (K042055)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application			Mode of Operation
General
(Track I Only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppa	Comb.
Modesb	Otherc
Ophthalmic	Ophthalmic
Fetal
Imaging
& Other	Fetal
	Abdominal
	Intra-operative (Spec.)a	Pa	P	P		Pa	P	Pa
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Thyroid,
Breast, Testes, etc.)	Pa	P	P		Pa	P	Pa
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)	Pa	P	P		Pa	P	Pa
	Musculo-skel. (Superfic)	Pa	P	P		Pa	P	Pa
	Intra-luminal
	Other (Specify)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esoph. (Cardiac)
	Other (Specify)
Peripheral
Vessel	Peripheral vessel	Pa	P	P		Pa	P	Pa
	Other (Specify)

N= new indication; P= previously cleared by FDA; E= added under Appendix E

4 Includes Color Doppler (CD) and (non-directional) Power Doppler.

° B+M; B+PWD; B+CWD; B+CD; B+PD.

° Harmonic Imaging (HI)

6 Includes ultrasound guidance for placement of needles, catheters.

Abdominal organs and peripheral vessel.

PW includes PW Doppier Tissue Imaging (DTI).

& includes Doppler Tissue Imaging (DTI) .

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of Center for Devices and Radiological Health, Office of Device Evaluation Prescription Use (Per 21 CFR 801. 109)

Nancy C. Brogdon

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

7

System: ACUSON P50 Ultrasound Systems Transducer 12HL7 Hockeystlck Linear Array (K051334) Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Mode of Operation Clinical Application Other Comb. Specific B દિવેલા ગામના લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામમાં મુખ્યત્વે ખેત-ઉત PWD CWD Color General Dopp® Modes (Track I Only) (Tracks 1 & III) Ophthalmic Ophthalmic Felal Abdominal p P pr P P P Intra-operative (Spec.) P P P P P P Intra-operative (Neuro) Laparoscopic Pediatric Fetal P P a P P ರಿ Small Organ (Thyroid, Imaging & Other Breast, Testes, etc.) Neonatal Cephalic Adult Cephalic Trans-rectal Trans-vaginal Trans-urethral Trans-esoph. (non-Card.) pa p ﺔ ﺍﻟﻤ P P p Musculo-skel. (Convent.) ਨਾਂ ിച്ച് p Musculo-skel. (Superfic) P P P Intra-luminal Other (Specify) Cardiac Adult Cardiac Pediatric Cardiac Trans-esoph. (Cardiac) Other (Specify) p " ﺔ ﺍﻟﻤ P p Peripheral Peripheral vessel P P Vessel Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under Appendix E

Includes Color Doppler (CD) and (non-directional) Power Doppler.

B+M; B+PWD; B+CWD; B+CD; B+PD.

° Harmonic Imaging (HI)

4 Includes ultrasound guidance for placement of needles, catheters.

Abdominal organs and peripheral vessel.

PW includes PW Doppler Tissue Imaging (DTI).

8 includes Doppler Tissue Imaging (DTI) .

Includes uses in military lield settings in addition to hospital/clinic settings.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of Center for Devices and Radiological Health, Office of Device Evaluation Prescription Use (Per 21 CFR 801.109)

Nancy C. Brogdon

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

8

| System:
Transducer. | ACUSON P50 Ultrasound Systems
12L5 Linear Array (K051334)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|---|-----|-----|----------------|-----------------|--------|
| Clinical Application | | Mode of Operation | | | | | | |
| General
(Track I Only) | Specific
(Tracks I & III) | B | M | PWD | CWD | Color
Doppa | Comb.
Modesb | Otherc |
| | Ophthalmic | | | | | | | |
| | Fetal
Abdominal
Intra-operative (Spec.) | Pd | P | P | | Pd | P | Pd |
| Fetal
Imaging
& Other | Intra-operative (Neuro)
Laparoscopic
Pediatric | | | | | | | |
| | Small Organ (Thyroid,
Breast, Testes, etc.)
Neonatal Cephalic | Pd | P | P | | Pd | P | Pd |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal
Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.)
Musculo-skel. (Convent.) | Pd | P | P | | Pd | P | Pd |
| | Musculo-skel. (Superfic) | Pd | P | P | | Pd | P | Pd |
| | Intra-luminal
Other (Specify) | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric
Trans-esoph. (Cardiac) | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral
Vessel | Peripheral vessel | Pd | P | P | | Pd | P | Pd |
| | Other (Specify) | | | | | | | |

N = new indication; P = previously cleared by FDA; E= added under Appendix E

Includes Color Doppler (CD) and (non-directional) Power Doppler.

8 + M; B+PWD; B+CWD; B+CD; B+PD.

° Harmonic Imaging (HI)

I hamments maging ( ... )
4 Includes ultrasound guidance for placement of needles, catheters.

Abdominal organs and peripheral vessel.

PW includes PW Doppler Tissue Imaging (DTI).

9 includes Doppler Tissue Imaging (DTI) .

Includes uses in military field settings in addition to hospital/clinic settings.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Goncurrence of Center for Devices and Radiological Health, Office of Device Evaluation Prescription Use (Per 21 CFR 801.109)

Nancy C. Brogdon
(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number

9

System:	ACUSON P50 Ultrasound Systems
Transducer:	AuxCW 2MHz Pedof (K063085)
	Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application		Mode of Operation					Other
General
(Track I Only)	Specific
(Tracks I & II)	B	M	PWD	CWD	Color Dopp	Comb.
Modes
Ophthalmic	Ophthalmic
Fetal
Imaging
& Other	Fetal
	Abdominal
	Intra-operative (Spec.)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Thyroid,
Breast, Testes, etc.)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic)
	Intra-luminal
	Other (Specify)
Cardiac	Cardiac Adult				P
	Cardiac Pediatric				P
	Trans-esoph. (Cardiac)
	Other (Specify)
Peripheral
Vascular	Peripheral vessel
	Other (Specify)

ACUSON P50 Ultrasound Systems

N= new indication; P= previously cleared by FDA; E= added under Appendix E

Includes Color Doppler (CD) and (non-directional) Power Doppler.

8 +M; B+PWD; B+CWD; B+CD; B+PD.

° Harmonic Imaging (Hi)

Includes ultrasound guidance for placement of needles, catheters.

Abdominal organs and peripheral vessel.

PW includes PW Doppler Tissue Imaging (DTI).

9 includes Doppler Tissue Imaging (DTI) .

Includes uses in military field settings in addition to hospital/clinic settings.

Includes uses in military (11) :
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Goncurrence of Center for Devices and Radlological Health, Office of Device Evaluation

Prescription Use (Par 21 CFR 801.1 V

Nancy C. Brogdon

(Division Sigh-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number