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K Number
K171716
Device Name
SKR 3000
Manufacturer
Konica Minolta, Inc.
Date Cleared
2017-08-25

(77 days)

Product Code
MQB,LLZ
Regulation Number
892.1680
Type
Traditional
Panel
Radiology
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The SKR 3000 is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen system in general-purpse diagnostic procedures.

The SKR 3000 is not indicated for use in mammography, tomography and angiography applications.

Device Description

Not Found

AI/ML Overview

It looks like you've provided an FDA 510(k) clearance letter for the Konica Minolta SKR 3000, which is a stationary x-ray system. However, this document does not contain information about acceptance criteria or a study proving the device meets those criteria, particularly in the context of an AI-powered medical device.

The provided text only states:

  • The device name (SKR 3000)
  • Its regulation number and name (21 CFR 892.1680, Stationary x-ray system)
  • Its regulatory class (II)
  • Its intended use: "generating radiographic images of human anatomy" and "intended to replace radiographic film/screen system in general-purpose diagnostic procedures."
  • Its contraindications: "not indicated for use in mammography, tomography and angiography applications."
  • That it is a Prescription Use device.

There is no information within this document about:

  • Specific image quality metrics or performance targets (acceptance criteria).
  • Any studies conducted to validate its performance beyond simply replacing film/screen systems.
  • Any AI component, ground truth, expert readers, or sample sizes for training/testing.

Therefore, I cannot fulfill your request using the provided text. The document is a clearance letter for a conventional X-ray system, not an AI/ML-enabled device, and does not detail performance studies or acceptance criteria for an AI algorithm.

§ 892.1680 Stationary x-ray system.

(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.