Cleared Traditional

K241266 - Imaging system of positron emission and...

K241266 is an FDA 510(k) clearance for Imaging system of positron emission and..., manufactured by Raysolution Healthcare Co., Ltd.. The device is a Class 2 Radiology device with product code KPS cleared through the Traditional 510(k) pathway after a 266-day FDA review.

K241266 · Raysolution Healthcare Co., Ltd. · Radiology device
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Jan 2025
Decision
266d
Days
Class 2
Risk

K241266 is an FDA 510(k) clearance for the Imaging system of positron emission and X-ray computed tomography (DigitMI 930). Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by Raysolution Healthcare Co., Ltd. (Hefei, CN). The FDA issued a Cleared decision on January 27, 2025 after a review of 266 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1200 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Raysolution Healthcare Co., Ltd. devices

FDA 510(k) Submission Details - K241266

510(k) Number K241266 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 2024
Decision Date January 27, 2025
Days to Decision 266 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
159d slower than avg
Panel avg: 107d · This submission: 266d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KPS Device Classification - Class 2, Special Controls

Product Code KPS System, Tomography, Computed, Emission
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1200
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Consultant

Beijing Believe-Med Technology Service Co., Ltd.
Ray Wang

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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