EVO X30 Diagnostic Ultrasound System; EVO X20 Diagnostic Ultrasound System; EVO X10 Diagnostic Ultrasound System; EVO XP30 Diagnostic Ultrasound System; EVO XP20 Diagnostic Ultrasound System; EVO XP10 Diagnostic Ultrasound System; EVO XC30 Diagnostic Ultrasound System; EVO XC20 Diagnostic Ultrasound System; EVO XC10 Diagnostic Ultrasound System (K263182): indications, design and recorded evidence
The acquired K263182 file contains product-specific indications and users, recorded comparison and differences, non-clinical evidence actually described sections. Compare these dated manufacturer statements with your own indication and design before commissioning evidence work. They describe this submission; they do not prescribe your testing, validate performance independently or establish a suitable predicate.
Evidence retrieved 2026-10-06. Source versions and topic-specific limits are listed below.
Computed exact-code research
This decision beside its recorded product-code cohort
The 2021–2025 complete-year cohort contains 250 selected decisions under primary code IYN. 250 have valid reported receipt/decision pairs; 0 pairs are missing or invalid.
Calendar elapsed days: lower quartile 85.0, median 117.5, upper quartile 166.5. These are recorded calendar differences, not active FDA review time.
The table shows the named decision and up to four latest exact-code research records through 2026-09-27. It can include partial-year records outside the complete-year cohort. The quartiles above use the full stated cohort, not this displayed selection.
EVO X30 Diagnostic Ultrasound System; EVO X20 Diagnostic Ultrasound System; EVO X10 Diagnostic Ultrasound System; EVO XP30 Diagnostic Ultrasound System; EVO XP20 Diagnostic Ultrasound System; EVO XP10 Diagnostic Ultrasound System; EVO XC30 Diagnostic Ultrasound System; EVO XC20 Diagnostic Ultrasound System; EVO XC10 Diagnostic Ultrasound System
Use this comparison: select a record to investigate, read its actual indications and design, and document differences. A shared code or elapsed period cannot establish its relevance to your device.
Calendar elapsed days are not active FDA review time, a promised schedule or a success probability. The selection includes only the stated recorded decisions, not all applications. Latest records can postdate the named historical decision and are contextual research, not its predicates. Shared codes, summaries and observed records do not prove equivalence, current market availability, buyer applicability or predicate suitability.
Calculation, selection and source versions
Reuse the complete-endpoint exact-primary-code, documented SE-decision cohort and its stated cutoff/window. Retain its type-7 quartiles only when at least 20 valid date pairs are present. Independently subtract the named official record’s receipt date from its decision date; missing or negative pairs remain unknown. Show up to four latest exact-code research records, excluding the named ID. Parent analysis hash, source snapshots and calculation versions are retained.
Calculation: fda-named-decision-cohort-context-1; cutoff 2026-09-27; 0 parent records excluded; units record counts; calendar elapsed days.
The summary is manufacturer-submitted context hosted by FDA. Negative/no-study statements are preserved. Evidence themes are not binding legal requirements.
Short opening excerpts identify the source sections. Read the linked original for the full study context, negative statements, tables and limitations. Public quotations are limited to 120 words per acquired summary; the internal evidence packet retains exact section ranges for review.
The diagnostic ultrasound system and probes are designed to obtain ultrasound images and
analyze body fluids.
The excerpt is shortened at a complete statement. Read the complete section in the original PDF before interpreting the evidence.
Compare with your product: Compare the recorded indication, population, body site and use environment with your proposed label. Record each change instead of assuming the primary code settles intended use.
Read this statement in the original PDF; no complete statement fits the short excerpt.
Compare with your product: The summary’s comparison is a manufacturer statement about that submission. Investigate the actual design differences and cited records before considering any comparator or predicate.
The device has been evaluated for acoustic output, biocompatibility, software function,
cleaning and disinfection effectiveness as well as thermal, electrical, electromagnetic and
mechanical safety, and has been found to conform with applicable FDA guidances and
medical device safety standards.
Compare with your product: Treat these as documented evidence themes in this case, including any limitations or negative statements. Ask which protocols, design inputs and acceptance rationale would be justified for your product; these excerpts are not a mandatory test panel.
Extraction selection and limits
Select observed whole-line section headings or explicit colon-delimited inline labels on readable PDF pages, including the explicitly documented heading-spacing variants in this parser version. Preserve the original heading, character ranges and layout; do not repair excerpt text. Exclude letter boilerplate and uncertain pages. Stop at observed table headings; do not infer table columns or scalar results from layout text. Multi-column or suspicious split-numeric excerpts are excluded until reviewed alternate extraction is available. Original layout records remain retained; any alternate text has its own extractor-version locator and requires original-page review. For each dimension, prefer usable versioned alternate text where available, selecting its longest usable excerpt; otherwise select the longest usable original-layout excerpt. Ties preserve source order. Bounded to 64 PDF pages and 3,500 characters per section. This is a selection, not a complete dossier analysis.
Excluded extraction items: {}.
Known facts and deciding inputs
Known context: US. Confirm the organisation’s role, relevant activities and markets against the cited criteria.
Dated official record fact; not proof of current commercial availability or applicability to another device.
Generic device category
EVO X30 Diagnostic Ultrasound System; EVO X20 Diagnostic Ultrasound System; EVO X10 Diagnostic Ultrasound System; EVO XP30 Diagnostic Ultrasound System; EVO XP20 Diagnostic Ultrasound System; EVO XP10 Diagnostic Ultrasound System; EVO XC30 Diagnostic Ultrasound System; EVO XC20 Diagnostic Ultrasound System; EVO XC10 Diagnostic Ultrasound System [1]
Dated official record fact; not proof of current commercial availability or applicability to another device.
Dated official record fact; not proof of current commercial availability or applicability to another device.
Prepare a differences and evidence worksheet
Use this checklist to gather your business or product details before speaking with a specialist. The items below explain what to record and suggest useful supporting documents. You can add your own answers in the editable project brief.
Indications and users — what differs in our product?
Compare the recorded indication, population, body site and use environment with your proposed label. Record each change instead of assuming the primary code settles intended use.
Useful evidence: Our proposed indication, user/population and use environment beside this exact recorded indication.
Recorded comparison and differences — what differs in our product?
The summary’s comparison is a manufacturer statement about that submission. Investigate the actual design differences and cited records before considering any comparator or predicate.
Useful evidence: Feature-by-feature differences and the underlying cited documents; no automated predicate selection.
Non-clinical evidence actually described — what differs in our product?
Treat these as documented evidence themes in this case, including any limitations or negative statements. Ask which protocols, design inputs and acceptance rationale would be justified for your product; these excerpts are not a mandatory test panel.
Useful evidence: Existing protocols/results and design-specific evidence gaps, with standard editions and scope reviewed separately.
Work packages and dependencies
Conditional: Indication, design and evidence-gap comparison — Compare the named summary and underlying official records with the proposed product; document the differences, applicable route questions and evidence gaps before agreeing submission or testing deliverables.
Optional: Biological evaluation and material/contact differences — The recorded source mentions this evidence topic, including possible negative statements. Discuss this package only if the proposed product’s design/use, source differences and current requirements justify it; the recorded case is not a mandatory testing checklist.
What needs to happen first
FDA 510(k) Submission Services → Biocompatibility Testing (ISO 10993 Program): Define the proposed indication/design and compare the original source context; commission this optional work only after its separate evidence need is justified.
Questions for providers
Which specific differences from the cited indication, design and operating principle change our proposed evidence work?
What source limitations or missing protocols/results must be resolved before treating this recorded evidence as comparable?
Which additional records and current guidance support the proposed route, and how will the comparison avoid assuming predicate suitability?
Sources and data dates
Read the official document in context. The audit details identify the precise locators and preserved versions used for this page.
