XR-MX/1000

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K200965 ↗

FDA Product Code

JAA

FDA applicant

Karl Storz Endoscopy America, Inc.

Device Class

Class II

Regulation

21 CFR Part 892.1650

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K010785 Active Cleared 21 Aug 2001

• Karl Storz Slotted Whisker Arthroscopic Blade

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• Storz SLX-F2 Storm Touch

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• Karl Storz Micro-Instrument for Cochlear Implantation

  Class I

  FDA 510(k) K946332 Active Cleared 5 Jun 1995

• Flexible Video-Uretero-Renoscope System Open recall

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See all devices from Karl Storz Endoscopy-America, Inc. →

• Is the XR-MX/1000 designed for single-use or reusable applications, and what reprocessing requirements apply?

  The XR-MX/1000 is supplied as a reusable system and must undergo appropriate reprocessing between uses to ensure safety and functionality. Since it is classified as a reusable medical device, adherence to established reprocessing protocols—including cleaning, disinfection, and sterilization—is essential to maintain performance and prevent cross-contamination in radiology settings.

• What type of imaging technology does the XR-MX/1000 utilize, and where is it primarily intended for use?

  The XR-MX/1000 employs fluoroscopic imaging with image intensification technology, which enhances real-time visualization of internal anatomical structures. It is specifically designed for diagnostic and interventional procedures in radiology settings, where precise imaging is critical for procedures like orthopedics, cardiology, or gastrointestinal evaluations.

• How is the regulatory pathway for the XR-MX/1000 defined, and what does this mean for its use in clinical settings?

  The XR-MX/1000 received FDA 510(k) clearance under the Traditional pathway, classified as a Class 2 medical device. This means it has been determined to be substantially equivalent to a legally marketed predicate device and meets regulatory standards outlined in 21 CFR 892.1650. Clinically, this classification ensures it undergoes rigorous review for safety and effectiveness, but it does not imply any specific clinical indication—only that it adheres to FDA requirements for fluoroscopic imaging systems.

• Are there multiple models or configurations of the XR-MX/1000, or is it a single unified system?

  The provided data does not specify distinct models or configurations of the XR-MX/1000 beyond its core classification as a fluoroscopic, image-intensified X-ray system. However, the registration numbers and FEI numbers listed suggest it may be associated with various accessory components or software updates under the same primary device designation, though these are not detailed as separate models. For precise specifications, consulting the manufacturer’s documentation or support team is recommended.