TrueView 200 Pro-US Specimen Radiography System
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K230136 FDA 510(k)
- FDA Product Code
- MWP FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1680 FDA 510(k)
- Regulation Number
- 892.1680 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The TrueView 200 Pro-US Specimen Radiography System is a cabinet-based X-ray device designed for radiography of small medical specimens. Classified as a Cabinet, X-Ray System under the FDA’s nomenclature, it is intended for imaging small anatomical or pathological samples in a radiology setting, providing clear visualisation for diagnostic assessment.
This system is supplied as a reusable medical device, featuring a touchscreen interface, system monitor, exposure indicator, and imaging cabinet mounted on casters for mobility. It operates under FDA 510(k) clearance (K230136) and IVDR compliance, with registration numbers 3010478247, 3017889703, 3005496266, 3006051164, 3026962577, and 3027847687. Storage and use require adherence to standard radiology protocols, with no specific sterility requirements stated beyond typical pre-procedure hygiene.
Frequently asked questions
What types of medical specimens can the TrueView 200 Pro-US be used to image, and how does its design support diagnostic assessment?
The TrueView 200 Pro-US is specifically designed for radiography of small anatomical or pathological specimens, such as biopsies, surgical samples, or other tiny tissue fragments. Its cabinet-based X-ray system provides precise imaging within a controlled environment, ensuring clear visualization for radiologists or pathologists to assess internal structures, bone integrity, or foreign objects. The integrated touchscreen interface and exposure indicator streamline workflows, while the mobile casters allow flexibility in positioning the specimen for optimal imaging angles.
Is the TrueView 200 Pro-US a single-use or reusable device, and what maintenance considerations should be noted?
The TrueView 200 Pro-US is a reusable medical device, meaning it is built for repeated use in radiology settings after proper cleaning and maintenance. Since it is not sterile by design, standard radiology hygiene protocols—such as disinfection between uses—should be followed to prevent cross-contamination. The manufacturer does not specify additional sterility requirements beyond typical pre-procedure hygiene, so adherence to facility-specific decontamination guidelines is recommended.
How does the regulatory pathway for the TrueView 200 Pro-US impact its use in clinical settings?
The TrueView 200 Pro-US holds FDA 510(k) clearance (K230136) under the Traditional pathway, confirming it is substantially equivalent to a predicate device, and it also complies with the EU’s In Vitro Diagnostic Regulation (IVDR). This means it can legally be used in U.S. and EU radiology settings for its intended purpose—imaging small specimens—without additional clinical trials. However, facilities must ensure compliance with local radiology protocols and maintenance schedules to sustain performance and safety.
What storage and handling requirements should be followed for the TrueView 200 Pro-US to ensure optimal performance?
The system should be stored in a clean, dry environment protected from extreme temperatures or humidity, as with most X-ray equipment. Since it is mounted on casters for mobility, it should be placed on stable, flat surfaces during use to prevent tipping or damage. No special sterility requirements are stated beyond standard radiology hygiene, so routine cleaning and adherence to facility protocols for reusable medical devices are advised. Avoid exposure to direct sunlight or corrosive substances.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PDF TrueView 200 Pro-US Specimen Radiography System, COMPAI 200 Pro-US Specimen Radiography System User Guide, PDF TrueView 200 Pro-US - dilon.com, Trueview Pro 100 | Specimen Radiography System
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K230136 | Class II | Active |
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Manufacturer
- Manufacturer
- CompAI Healthcare (Suzhou) Co., ltd
- FDA Applicant
- Compai Healthcare (Suzhou) Co.,Ltd
Sources (2)
- FDA 510(k) K230136 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026