Advanced Imaging Modality (AIM) Sterilization Tray
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- Advanced Imaging Modality (AIM) Sterilization Tray EUDAMEDFDA UDI
- Generic Name
- Instrument tray, reusable FDA UDI
- Device Name
- Cases & Trays EUDAMEDAdvanced Imaging Modality (AIM) Sterilization Tray FDA UDI
- Model / Reference
- 0233-032-301 EUDAMEDFDA UDITRAYS EUDAMED
- Description
- Advanced Imaging Modality (AIM) Sterilization Tray FDA UDI
Identifiers
- Catalog Number
- 0233-032-301 FDA UDI
- Primary DI / UDI-DI
- 00857387006008 EUDAMEDFDA UDI
- Basic UDI-DI
- 0857387006TRAYAY EUDAMED
- Direct Marketing DI
- 00857387006008 EUDAMED
- 510(k) Number
- K152951 FDA 510(k)
- FDA Product Code
- KCT FDA 510(k)FDA UDI
- EMDN Code
- S010401 TRAYS, BASKETS, TUBS FOR STERILISATION AND THEIR COMPONENTS EUDAMED
- GMDN Term
- Instrument tray, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 880.6850 FDA 510(k)
- Regulation Number
- 880.6850 FDA 510(k)FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
The Advanced Imaging Modality (AIM) Sterilization Tray is a sterilization tray designed for processing endoscopes and imaging cameras. It provides a structured platform to organize and safely sterilize reusable medical devices, ensuring compliance with infection control protocols in clinical settings.
This tray is intended for use in general hospital environments and is supplied as a reusable device. It is not classified as single-use and requires proper cleaning, sterilization, and maintenance between procedures. The device holds FDA 510(k) clearance (K152951) and MDR compliance, adhering to regulatory standards for medical device sterilization trays.
Frequently asked questions
Is this sterilization tray designed for single-use or reusable medical devices, and how should it be maintained between procedures?
This tray is explicitly designed for reusable medical devices, including endoscopes and imaging cameras. Since it is not single-use, it must be thoroughly cleaned, sterilized, and maintained between each use to prevent cross-contamination and ensure compliance with infection control protocols. Proper sterilization is required to preserve its functionality and safety for repeated clinical use.
What types of medical devices can be processed in this sterilization tray, and in what clinical settings is it intended for use?
The tray is specifically designed for processing endoscopes and imaging cameras, providing a structured platform to organize and safely sterilize these reusable devices. It is intended for use in general hospital environments, where infection control and standardized sterilization procedures are critical.
How is the regulatory compliance of this sterilization tray established, and what does that mean for buyers?
The tray holds FDA 510(k) clearance (K152951) under the Traditional review pathway, with a decision of *Substantially Equivalent* to a predicate device, and it also complies with MDR (Medical Device Regulation) standards. This means it has undergone regulatory evaluation to meet safety and performance requirements for sterilization trays in clinical settings, giving buyers confidence in its adherence to established medical device regulations.
Are there different models or sizes available for this sterilization tray, and how is it typically supplied?
The data provided does not specify distinct models or sizes, but the tray is supplied as a single reusable device intended for general hospital use. While the exact dimensions or variations aren’t detailed, its design is standardized for organizing endoscopes and cameras, ensuring compatibility with common sterilization processes in clinical settings.
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.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K152951 | Class II | Active |
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Manufacturer
- Manufacturer
- Paragon Medical, Inc.
Sources (3)
- FDA 510(k) K152951 24 fields · synced Sep 18, 2026
- FDA UDI 0bf0cc00-946e-4897-b2a7-e4535231d20c 35 fields · synced May 30, 2026
- EUDAMED 4f29df36-512a-40b8-997f-1fec4517aaf2 61 fields · synced Jun 20, 2026