The official product page shows the exact model, but no explicit editorial reuse license was found. No local copy is published.
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Overview
Sonosite PX is a FUJIFILM Sonosite platform in the pocus category. The manufacturer describes it as using Portable diagnostic ultrasound system with touch panel, physical controls, and configuration-specific transducers for cardiac, abdominal, lung, vascular, musculoskeletal, nerve and procedural imaging. Those specifications are company-reported, not an independent performance conclusion.
The current product page and user guide document a portable system with touch and physical controls, optional voice control that requires a microphone accessory, DICOM functions, and a transducer-specific exam matrix. These are company-reported system specifications. The cited FDA records establish only the device names, classifications, or indications stated in those records. They do not establish comparative superiority, outcomes for every patient, or current commercial terms.
Before purchase, request the exact model, cleared indications, software version, handpieces, service coverage, training, and a written quote. Pricing and operating economics remain unknown where a current source packet was not available.
TREATMENT AREAS
Cardiac, Abdominal, Lung, Vascular, Musculoskeletal, Nerve and procedural imaging
TREATMENT TIME
Exam-dependent; no universal scan time
SESSIONS
Diagnostic use follows the ordered exam and qualified operator protocol
PER SESSION
Not applicable; diagnostic workflow
CONSUMABLES/YR
Gel, covers, guides, cleaning supplies, and optional printer media depend on use
MAINTENANCE/YR
Warranty and service scope require a configuration-specific quote
Pros & Cons
Pros
K200964 and K213763 identify the Sonosite PX system in FDA records
The manufacturer publishes a current user guide and detailed transducer matrix
Touch and physical controls provide two input paths for bedside work
The reviewed documentation lists DICOM and security configuration details
Cons
The system capability depends on the purchased transducers, stand, software, and accessories
Voice control requires a separate microphone accessory
No independent PX-specific comparative outcomes study was established in this packet
Acquisition, service, software-update, cybersecurity-support, and transfer terms were not publicly reconciled
Clinical Evidence
The reviewed packet establishes regulatory identity and system specifications. It does not contain a completed independent PX-specific comparative study table, so claims about image quality, procedure success, diagnostic accuracy, or workflow time remain unverified here.
This profile does not treat a clearance record or manufacturer page as proof of superior outcomes. Match each clinical claim to the exact model, indication, study design, sample size, source date, and funding disclosure.
The current packet supports product identification and the limited regulatory statements shown here. Independent comparative effectiveness, local demand, and practice economics remain open diligence questions.
ROI Analysis
Device Pulse is not publishing a payback estimate for Sonosite PX because current transaction price, financing, service, consumables, staffing, and local patient demand have not been independently verified.
Build the decision from your written quote. Model conservative monthly treatment volume, realized revenue per treatment, consumables, operator time, service, downtime, financing, and patient-acquisition cost. Run a downside case before using the model in a purchase decision.
A manufacturer projection is an input to test, not a forecast. Ask for every assumption in writing and compare it with your scheduling capacity and historical conversion data.
Best For
Acute-care and procedural teams comparing a portable system with physical and touch controls and prepared to map each required exam to the quoted transducers, security configuration, stand, accessories, and service terms.
Use that as a short-list hypothesis. Confirm the exact indication, patient mix, operator training, local service, workflow, and written commercial terms before deciding that the platform fits the practice.
Buying Guide
Request a written, model-specific quote for Sonosite PX. Separate the console, handpieces, software, training, installation, warranty, service, and recurring supplies or licensing.
Confirm the serial number, current software, cleared indications, ownership-transfer terms, parts availability, response time, and local service provider. Do not assume a product-page feature applies to every configuration.
Ask FUJIFILM Sonosite to identify which statements are specifications, which are company-reported claims, and which are supported by independent clinical evidence. Keep those records with the final contract.
Alternatives to review
Use these profiles to build a short list. An alternative listing is not a claim of equivalence or superiority.
Kosmos: Emergency medicine and cardiology practices that want AI-assisted cardiac imaging in a handheld. Hospital internal medicine teams that need rapid triage ultraso
Philips Lumify: Cardiology, OB, and specialty practices that want single-application image quality. Buyers that already use Philips imaging and value brand continuity.
NEW $5,995-$9,995 (probe + subscription) · USED $2,500-$5,000
GE Vscan Air: Emergency medicine, hospital internal medicine, and cardiology practices that want the GE imaging pedigree in a handheld form factor. Practices already using GE
NEW $4,995-$7,995 (probe) + subscription · USED $2,500-$4,500
Butterfly iQ+: Primary care, urgent care, and emergency physicians who want bedside ultrasound capability without a $50K cart investment. Medical students and residents.
NEW $2,499-$3,999 (probe) + $420/yr (subscription) · USED $1,500-$2,500
Mindray TE Air i3P: Emergency, critical-care, and office teams comparing a wireless phased-array handheld and willing to test the exact mobile hardware, charging, cleaning, connect
NEW Manufacturer quote required · USED No reconciled dated sample
A current acquisition price was not published in the reviewed source packet. Request a written quote from FUJIFILM Sonosite that separates the console, handpieces, software, training, installation, warranty, service, and recurring supplies.
What is the FDA status of Sonosite PX?
FDA 510(k) K200964 names the Sonosite PX Ultrasound System and records a substantially equivalent decision dated May 8, 2020. Later K213763 documents another PX submission. Buyers should match the quoted software, transducers, and accessories to the current labeling.
What evidence supports this Sonosite PX profile?
The reviewed packet establishes regulatory identity and system specifications. It does not contain a completed independent PX-specific comparative study table, so claims about image quality, procedure success, diagnostic accuracy, or workflow time remain unverified here. The source packet separates FDA public records from manufacturer-reported product information. It does not establish comparative superiority.
Which practices should evaluate Sonosite PX?
Acute-care and procedural teams comparing a portable system with physical and touch controls and prepared to map each required exam to the quoted transducers, security configuration, stand, accessories, and service terms. That is an editorial fit question, not a clinical or financial conclusion.
What should a buyer verify before ordering Sonosite PX?
Verify the exact model, cleared indications, handpieces, software, serial-number history, training, service response, warranty, ownership-transfer terms, recurring supplies, and every commercial assumption in writing.
What are the main limitations in this Sonosite PX profile?
Current limitations include: The system capability depends on the purchased transducers, stand, software, and accessories; Voice control requires a separate microphone accessory; No independent PX-specific comparative outcomes study was established in this packet. Recheck the dated primary sources before using the profile in a purchase decision.
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