5000 Compact Series Ultrasound Systems (Ultrasound System 5500 G, Ultrasound System 5500 P, Ultrasound System 5500 W, Ultrasound System 5500 CV, Ultrasound System 5300 G, Ultrasound System 5300 P, Ultrasound System 5300 W)

K222648 · Philips Ultrasound, LLC · IYN · Sep 27, 2022 · Radiology

Device Facts

• Record ID: K222648
• Device Name: 5000 Compact Series Ultrasound Systems (Ultrasound System 5500 G, Ultrasound System 5500 P, Ultrasound System 5500 W, Ultrasound System 5500 CV, Ultrasound System 5300 G, Ultrasound System 5300 P, Ultrasound System 5300 W)
• Applicant: Philips Ultrasound, LLC
• Product Code: IYN · Radiology
• Decision Date: Sep 27, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

The 5000 Compact Series Ultrasound Systems (Ultrasound System 5500G, Ultrasound System 5500P, Ultrasound System 5500W, Ultrasound System 5500CV, Ultrasound System 5300G, Ultrasound System 5300P, Ultrasound System 5300W) are intended for diagnostic Ultrasound imaging in B (or 2D), 3D/4D, Color Doppler, Continuous Wave Doppler, Pulse Wave Doppler, Tissue Doppler, M-mode (including anatomical M-mode), Harmonics (Tissue and Contrast), Color Power Angio (CPA), and Combined modes. 5000 Compact series is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: Abdominal, Adult Cephalic, Cardiac Adult, Cardiac Pediatric, Carotid, Cerebral vascular, Fetal Echo, Fetal/Obstetric, Gynecological, Intra-operative (Vascular), Lung, Musculoskeletal (conventional), Musculoskeletal (superficial), Neonatal Cephalic, Ophthalmic, Pediatric, Peripheral Vessel, Small Organs (breasts, testicles, thyroid), Transesophageal (cardiac), Trans-rectal, Trans-vaginal, Urology. The clinical environments where the 5000 Compact Series Ultrasound Systems can be used are: hospitals, surgery centers, clinics, physicians' office, diagnostic centers, critical care and emergency room environments, point-of-care clinical settings for diagnosis of patients. The systems are intended to be installed, used, and operated only in accordance with the safety procedures and operating instructions given in the product user information. However, nothing stated in the user information reduces the user's responsibility for sound clinical judgment and best clinical procedure. Systems are to be operated only by appropriately trained healthcare professionals for the purposes for which they were designed.

Device Story

Portable, laptop-style diagnostic ultrasound system; battery or AC powered. Acquires ultrasound data via transducers; displays in various modes (B, 3D/4D, Doppler, M-mode, etc.). Operated by trained healthcare professionals in clinical environments (hospitals, clinics, point-of-care). System includes monitor, control panel, transducer/ECG receptacles. Outputs digital images and measurements for clinical review. Healthcare providers use output for diagnosis and fluid flow analysis. Benefits include portability for point-of-care use and efficient diagnostic imaging.

Clinical Evidence

No clinical data required. Substantial equivalence demonstrated through design features, indications for use, fundamental scientific technology, and non-clinical performance testing (verification/validation).

Technological Characteristics

Portable laptop-style ultrasound system; battery/AC powered. Imaging modes: B, 3D/4D, Doppler (Color, CW, PW, Tissue), M-mode, Harmonics, CPA. Connectivity: Wired/wireless network, DICOM. Software-controlled; common codebase across configurations. Transducers: Compatible with existing Philips transducers (K200304/K162329). Safety standards: ANSI/AAMI ES 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-37, IEC 62359, IEC 62304. Not provided sterile.

Indications for Use

Indicated for diagnostic ultrasound imaging and fluid flow analysis in abdominal, cephalic (adult/neonatal), cardiac (adult/pediatric/fetal), vascular (carotid/cerebral/peripheral/intra-operative), fetal/obstetric, gynecological, lung, musculoskeletal, ophthalmic, small organ (breast/testicle/thyroid), transesophageal, trans-rectal, trans-vaginal, and urological applications. For use by trained healthcare professionals in hospitals, clinics, surgery centers, physician offices, diagnostic centers, and critical/emergency care settings.

Regulatory Classification

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.

Predicate Devices

• Philips Affiniti Ultrasound System (K200304)

Reference Devices

• Philips CX 50 Ultrasound Systems (K162329)

Submission Summary (Full Text)

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September 27, 2022

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.

Philips Ultrasound LLC % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k SAINT PAUL MN 55114

# Re: K222648

Trade/Device Name: 5000 Compact Series Ultrasound Systems (Ultrasound System 5500 G, Ultrasound System 5500 P, Ultrasound System 5500 W, Ultrasound System 5500 CV, Ultrasound System 5300 G, Ultrasound System 5300 P, Ultrasound System 5300 W) Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: August 31, 2022 Received: September 1, 2022

Dear Prithul Bom:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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542 of the Act); 21 CFR 1000-1050.

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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Yanna Kang, Ph.D.

Assistant Director Mammography and Ultrasound Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K222648

#### Device Name

5000 Compact Series Ultrasound Systems (Ultrasound System 5500G, Ultrasound System 5500W, Ultrasound System 5500CV, Ultrasound System 5300G, Ultrasound System 5300P, Ultrasound System 5300W)

#### Indications for Use (Describe)

The 5000 Compact Series Ultrasound Systems (Ultrasound System 5500G, Ultrasound System 5500P, Ultrasound System 5500W, Ultrasound System 5500CV, Ultrasound System 5300C, Ultrasound System 5300P, Ultrasound System 5300W) are intended for diagnostic Ultrasound imaging in B (or 2D), 3D/4D, Color Doppler, Continuous Wave Doppler, Pulse Wave Doppler, Tissue Doppler, M-mode (including anatomical M-mode), Harmonics (Tissue and Contrast), Color Power Angio (CPA), and Combined modes.

5000 Compact series is indicated for diasound imaging and fluid flow analysis in the following applications: Abdominal, Adult Cephalic, Cardiac Adult, Cardiac Pediatric, Carotid, Cerebral vascular, Fetal Echo, Fetal/Obstetric, Gynecological, Intra-operative (Vascular), Lung, Musculoskeletal (conventional), Musculoskeletal (superficial), Neonatal Cephalic, Ophthalmic, Peripheral Vessel, Small Organs (breasts, testicles, thyroid), Transesophageal (cardiac), Trans-rectal, Trans-vaginal, Urology.

The clinical environments where the 5000 Compact Series Ultrasound Systems can be used are: hospitals, surgery centers, clinics, physicians' office, diagnostic centers, critical care and emergency room environments, point-of-care clinical settings for diagnosis of patients.

The systems are intended to be installed, used, and operated only in accordance with the safety procedures and operating instructions given in the product user information. However, nothing stated in the user information reduces the user's responsibility for sound clinical judgment and best clinical procedure. Systems are to be operated only by appropriately trained healthcare professionals for the purposes for which they were designed.

Type of Use (Select one or both, as applicable)

| <span style="font-family: Arial;"> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span style="font-family: Arial;"> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |
|---------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|
|---------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|

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### K22648

# 5000 Compact Series Ultrasound Systems (Ultrasound System 5500G, Ultrasound System 5500P, Ultrasound System 5500W, Ultrasound System 5500CV, Ultrasound System 5300G, Ultrasound System 5300P, Ultrasound System 5300W)

This summary of safety and effectiveness information is submitted in accordance with 21 CFR 8807.92

### 1. Submitter's name, address, telephone number, contact person

- Manufacturer: Philips Ultrasound LLC 22100 Bothell Everett Hwy Bothell, WA 98021-8431
- Contact Person: Shilpa Rapaka Senior Regulatory Affairs Specialist 22100 Bothell Everett Hwy Bothell, WA 98021-8431 Phone: [phone]
- Secondary Contact: Tamara Daniels Senior Regulatory Affairs Manager 22100 Bothell Everett Hwy Bothell, WA 98021-8431 Phone: [phone]
- Date Prepared: September 27, 2022

# 2. Name of the device, including the trade of proprietary name if applicable, the common or usual name, and the classification name, if known:

| Proprietary Name: | 5000 Compact Series Ultrasound Systems<br>Marketed under the following models:<br>Ultrasound System 5500G<br>Ultrasound System 5500P<br>Ultrasound System 5500W<br>Ultrasound System 5500CV<br>Ultrasound System 5300G<br>Ultrasound System 5300P<br>Ultrasound System 5300W |
|-------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Names: | Ultrasonic pulsed doppler imaging system<br>Ultrasonic pulsed echo imaging system<br>Diagnostic ultrasonic transducer |

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Regulation Description:

| Classification Name | 21 CFR Section | Product Code |
|---------------------------------------------|----------------|--------------|
| System, imaging, pulsed doppler, ultrasonic | 892.1550 | IYN |
| System, imaging, pulsed echo, ultrasonic | 892.1560 | IYO |
| Transducer, ultrasonic, diagnostic | 892.1570 | ITX |

As stated in 21 CFR parts 892.1550, 892.1560, and 892.1570, each of these generic types of devices have been classified as Class II.

Device Class: Class II

# 3. Indications for Use

The 5000 Compact Series Ultrasound Systems (Ultrasound System 5500G, Ultrasound System 5500P, Ultrasound System 5500W, Ultrasound System 5500CV, Ultrasound System 5300G, Ultrasound System 5300P, Ultrasound System 5300W) are intended for diagnostic Ultrasound imaging in B (or 2D), 3D/4D, Color Doppler, Continuous Wave Doppler, Pulse Wave Doppler, Tissue Doppler, M-mode (including anatomical M-mode), Harmonics (Tissue and Contrast), Color Power Angio (CPA), and Combined modes.

5000 Compact series is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: Abdominal, Adult Cephalic, Cardiac Adult, Cardiac Pediatric, Carotid, Cerebral vascular, Fetal Echo, Fetal/Obstetric, Gynecological, Intra-operative (Vascular), Lung, Musculoskeletal (conventional), Musculoskeletal (superficial), Neonatal Cephalic, Ophthalmic, Pediatric, Peripheral Vessel, Small Organs (breasts, testicles, thyroid), Transesophageal (cardiac), Trans-rectal, Trans-vaginal, Urology.

The clinical environments where the 5000 Compact Series Ultrasound Systems can be used are: hospitals, surgery centers, clinics, physicians' office, diagnostic centers, critical care and emergency room environments, point-of-care clinical settings for diagnosis of patients.

The systems are intended to be installed, used, and operated only in accordance with the safety procedures and operating instructions given in the product user information. However, nothing stated in the user information reduces the user's responsibility for sound clinical judgment and best clinical procedure. Systems are to be operated only by appropriately trained healthcare professionals for the purposes for which they were designed.

# 4. Device Description Summary

The proposed Philips 5000 Compact Series Ultrasound Systems (Ultrasound System 5500G, Ultrasound System 5500P, Ultrasound System 5500W, Ultrasound System 5500CV, Ultrasound System 5300G, Ultrasound System 5300P, Ultrasound System 5300W) are general purpose, compact, battery or alternating current (AC) powered, software controlled, diagnostic ultrasound

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systems. The ultrasound system is housed in a portable, laptop-style chassis. The ultrasound system function is to acquire ultrasound data and to display the data in various modes of operation. The ultrasound system components include the monitor, control panel, transducer receptacles, ECG/physio receptacles, and AC adapter/battery charger. The ultrasound system can be attached to an optional cart. The cart height is adjustable to accommodate a range of operator heights and operating positions. The cart has wheels for maneuverability and may provide isolated power for system and peripheral components (such as black and white image printer or a report printer).

The 5000 Compact Series Ultrasound Systems comprises of different configurations which differ in terms of features, transducer options, and license options (features available as purchasable options in addition to the standard features available in the system. The types of options available include clinical options, QLAB Advanced Quantification Software, protocols, imaging capabilities, connectivity capabilities, etc.). The 5500G is the primary configuration with the most available capabilities. Identical software architecture is used in all configurations and all configurations are derived from a common codebase. Similarly, the hardware is same for all configurations. All the 5000 Compact Series Ultrasound System configurations are compatible with existing Philips transducers cleared in Philips Affiniti Ultrasound System (K200304). 5500 Compact Series POC (point-of-care) configurations leverage POC features from the CX50 platform (K162329) to enable efficient POC ultrasound capability.

# 5. Substantially Equivalent Devices

Primary Predicate Device: Philips Affiniti Ultrasound System (K200304)

Reference Device: Philips CX 50 Ultrasound Systems (K162329)

# 6. Technological Comparison to Predicate Devices

The proposed 5000 Compact Series Ultrasound Systems are substantially equivalent to the currently marketed predicate devices. The following is an overview of the similarities between the proposed 5000 Compact Series Ultrasound System and the currently marketed predicate and reference devices.

- The systems emplov the same fundamental scientific technology for imaging. doppler ● functions, and signal processing and have the same grayscale and doppler capabilities
- The systems are all are indicated for diagnostic ultrasonic imaging and fluid flow analysis ● for use by the same type of users in the same type of use environments
- The systems have the same clinical intended uses and indications for use
- The systems have the same imaging modes ●
- The transducers are identical ●
- The systems are manufactured with materials which have been evaluated and found to be . safe for the intended use of the device

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- . The systems have acoustic power levels which are within the Track 3 FDA limits
- . The systems have similar capability in terms of performing measurements, capturing digital images, reviewing, and reporting studies
- . The systems have been designed and manufactured to the same electrical and physical safety standards manufactured under equivalent quality systems

A comparison of the subject 5000 Compact Series Ultrasound Systems and the predicate and reference devices is shown in Table 8-1 below.

Table 8-1. Comparison of the proposed 5000 Compact Series Ultrasound Systems to the currently marketed predicate and reference devices

| Standard Feature/<br>Technology<br>Characteristics | Proposed Philips<br>5000 Compact Series<br>Ultrasound Systems | Predicate<br>EPIQ/Affiniti<br>Ultrasound System<br>(K200304) | Reference CX50<br>Ultrasound Systems<br>(K162329) |
|----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification | Class II | Class II | Class II |
| Product Codes | IYN<br>IYO<br>ITX | IYN<br>IYO<br>ITX | IYN<br>IYO<br>ITX |
| Classification<br>Regulation Numbers | 21 CFR 892.1550<br>21 CFR 892.1560<br>21 CFR 892.1570 | 21 CFR 892.1550<br>21 CFR 892.1560<br>21 CFR 892.1570 | 21 CFR 892.1550<br>21 CFR 892.1560<br>21 CFR 892.1570 |
| Indications for Use<br>and Modes of<br>Operation | Abdominal,<br>Adult Cephalic,<br>Cardiac Adult,<br>Cardiac Pediatric,<br>Carotid,<br>Cerebral vascular,<br>Fetal Echo,<br>Fetal/Obstetric,<br>Gynecological,<br>Intra-operative<br>(Vascular),<br>Lung,<br>Musculoskeletal<br>(conventional),<br>Musculoskeletal<br>(superficial),<br>Neonatal Cephalic,<br>Ophthalmic,<br>Pediatric,<br>Peripheral Vessel,<br>Small Organs<br>(breasts, testicles,<br>thyroid), | Fetal/Obstetric,<br>Abdominal,<br>Intraoperative<br>(Vascular),<br>Intraoperative<br>(Cardiac),<br>Pediatric, Small<br>Organ (Breast,<br>Thyroid, Testicle),<br>Cephalic (Neonatal),<br>Cephalic (Adult),<br>Transrectal,<br>Transvaginal<br>Musculoskeletal<br>(Conventional),<br>Musculoskeletal<br>(Superficial)<br>Gynecological, Other:<br>Urology,<br>Cardiac Adult,<br>Cardiac Pediatric,<br>Transesophageal<br>(Cardiac),<br>Cardiac other (Fetal). | Ophthalmic,<br>Intracardiac echo,<br>Intraoperative,<br>Laparoscopic, Fetal,<br>Abdominal, Pediatric,<br>Small Organ,<br>Adult Cephalic,<br>Neonatal Cephalic,<br>Trans-vaginal,<br>Musculoskeletal,<br>Gynecological,<br>Cardiac Adult,<br>Cardiac pediatric,<br>Trans-Esophageal.<br>(Cardiac), Peripheral<br>Vessel, Other<br>(Carotid), Trans-rectal<br><b>Modes of Operation:</b><br>Sparq<br>B (or 2-D), M-mode<br>(including<br>Anatomical M-mode),<br>Pulse Wave Doppler,<br>Continuous Wave |
| | Transesophageal<br>(cardiac),<br>Trans-rectal,<br>Trans-vaginal,<br>Urology | Peripheral Vessel,<br>Cerebral Vascular,<br>Modes of Operation:<br>B (2D), M, PWD,<br>CWD, Color Doppler,<br>Combined (B+PWD,<br>B+Color,<br>B+Amplitude, B+M,<br>B+M+Color,<br>B+Color+PWD,<br>B+Amplitude+PWD,<br>B+CWD;<br>B+Color+CWD;<br>B+Amplitude+CWD),<br>SonoCT, Imaging for<br>guidance of biopsy,<br>Panoramic Imaging,<br>Color Power Angio<br>(CPA), Harmonic<br>Imaging, Contrast,<br>3D/4D Imaging,<br>XRES | Doppler, Color<br>Doppler, Tissue<br>Doppler Imaging and<br>Harmonics (Tissue<br>and Contrast)<br>CX50<br>B (or 2-D), M-mode<br>(including<br>Anatomical M-mode),<br>Pulse Wave Doppler,<br>Continuous Wave<br>Doppler, Color<br>Doppler, Tissue<br>Doppler Imaging and<br>Harmonics (Tissue<br>and Contrast) modes |
| Transducers | Modes of Operation:<br>B (or 2D),<br>3D/4D,<br>Color Doppler,<br>Continuous Wave<br>Doppler,<br>Pulse Wave Doppler,<br>Tissue Doppler,<br>M-mode (including<br>anatomical M-mode),<br>Harmonics (Tissue<br>and Contrast),<br>Color Power Angio<br>(CPA), Combined<br>modes | Affiniti<br>3D9-3v, C5-1, C6-2,<br>C8-5, C9-2, C9-4V,<br>C10-4ec, D2cwc,<br>D2tcd, D5cwc, BP10-<br>5ec, eL18-4, L12-3,<br>L12-3ERGO, L12- 4,<br>L12-5 50, L15-7io,<br>L18-5, S4-2, S5-1<br>S7-3t, S8-3, S12-4,<br>V6-2, VL13-5, X7-<br>2t, V9-2, mC7-2<br>EPIQ<br>C5-1, C8-5, C9-2,<br>C10-3v, C10-4ec,<br>D2cwc, D5cwc,<br>eL18-4, L12-3, L12-5<br>50, L15-7io, L18-5,<br>S5-1, S7-3t, S8-3, S8-<br>3t, S12-4, V6-2, X7-<br>2t, X8-2t, D2tcd, X5-<br>1, X6-1, VL13-5, X7-<br>2, X8-2ti, XL14-3,<br>3D9-3v, V9-2, mC7-<br>2, mC12-3 | C5-1<br>C8-5<br>C9-3io<br>C9-3v<br>C10-3v<br>D2cwc<br>D5cwc<br>L10-4 lap<br>L12-3<br>L12-5 50<br>L15-7io<br>S5-1<br>S8-3<br>S12-4<br>S7-3t<br>X7-2t<br>C6-2<br>C9-4v<br>L12-4<br>S4-2 |
| | No new transducers<br>introduced as part of<br>5000 Compact Series.<br>All transducers that<br>are part of the 5000<br>Compact Series are<br>already cleared in<br>K200304 or<br>K162329. | | |
| Power Supply | Same | Rechargeable lithium<br>ion batteries, AC<br>Adapter | Rechargeable lithium<br>ion batteries, AC<br>Adapter |
| Optional<br>Accessories/Peripherals | Various hardcopy, recording and printing products, black-and-white image printer, USB storage devices, Biopsy guides, Footswitch, Barcode scanner | Various hardcopy, recording and printing devices: digital video recorder (DVR), digital video disc (DVD), report printer, thermal printer (B/W, color), USB, PercuNav Instruments, Biopsy guides, Footswitch | Various hardcopy, recording and printing devices: report printer, DVD, USB, Biopsy guides, Footswitch |
| Form factor | Portable Laptop that can be placed on a mobile cart | Cart based, with an articulating monitor arm | CX50= Portable Laptop that can be placed on a mobile cart<br>Sparq= Cart based, with an articulating monitor arm |
| Battery Life | System operates via internal battery or AC power.<br>System battery supports up to 30 min scanning. Extended battery up to 2 hours with optional batteries | System operates on AC power. A battery is provided to put the system in Sleep mode for up to 30 minutes allowing the system to be transported to a new location without powering down the system. | The system operates via an internal battery or AC Power. System battery supports up to 30 minute scanning. |
| Wireless Network<br>Functions | Integrated on PC module<br>Wired and wireless | Integrated on PC module<br>Wired and wireless | Wired Ethernet<br>Wireless USB<br>Adapter |
| Software Features | Imaging Modes<br>Patient Data Entry<br>Patient Database and Storage<br>Generic Measurement Tools<br>Analysis and Calculation Packages<br>Annotations | Imaging Modes<br>Patient Data Entry<br>Patient Database and Storage<br>Generic Measurement Tools<br>Analysis and Calculation Packages<br>Annotations | Imaging Modes<br>Patient Data Entry<br>Patient Database and Storage<br>Generic Measurement Tools<br>Analysis and Calculation Packages<br>Annotations |
| Clinical Options | Abdomen Clinical Option<br>Adult Cardiology<br>Clinical Option | Abdomen Clinical Option<br>Adult Cardiology<br>Clinical Option | Abdomen Clinical Option<br>Adult Cardiology<br>Clinical Option |
| | Advanced | Advanced | Fetal Echo Clinical |
| | Capabilities Limited | Capabilities Limited | Option |
| | Clinical Option | Clinical Option | GYN Clinical Option |
| | Breast Clinical Option | Breast Clinical Option | Musculoskeletal |
| | Fetal Echo Clinical | Fetal Echo Clinical | Clinical Option |
| | Option | Option | OB Clinical Option |
| | GYN Clinical Option | GYN Clinical Option | Pediatric Cardiology |
| | Musculoskeletal | Musculoskeletal | Clinical Option |
| | Clinical Option | Clinical Option | Pediatric GI Clinical |
| | OB Clinical Option | OB Clinical Option | Option |
| | Pediatric Cardiology | Pediatric Cardiology | Small Parts including |
| | Clinical Option | Clinical Option | Breast Clinical Option |
| | Pediatric GI Clinical | Pediatric GI Clinical | Cerebrovascular |
| | Option | Option | including TCD |
| | Small Parts Clinical | Small Parts Clinical | Clinical Option |
| | Option | Option | Vascular Clinical |
| | TCD Clinical Option | TCD Clinical Option | Option |
| | Urology Clinical | Urology Clinical | Peripheral Vascular |
| | Option | Option | Clinical Option |
| | Vascular Clinical | Vascular Clinical | Regional Anesthesia |
| | Option | Option | Clinical Option |
| | POC Clinical Option | | Acute Care Clinical |
| | | | Option |
| Performance Options | Advanced Cardiac UI | Advanced Cardiac UI | Anatomic M mode |
| | Anatomic Mmode | Anatomic Mmode | Auto Doppler |
| | Auto Doppler | Auto Doppler | Auto Scan |
| | Auto Scan | Auto Scan | iScan |
|…