Cleared Traditional

K082221 - RAYDOSE

K082221 is an FDA 510(k) clearance for RAYDOSE, manufactured by Raysearch Laboratories AB. The device is a Class 2 Radiology device with product code MUJ cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K082221 · Raysearch Laboratories AB · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2008
Decision
77d
Days
Class 2
Risk

K082221 is an FDA 510(k) clearance for the RAYDOSE. Classified as System, Planning, Radiation Therapy Treatment (product code MUJ), Class II - Special Controls.

Submitted by Raysearch Laboratories AB (Stockholm, SE). The FDA issued a Cleared decision on October 22, 2008 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5050 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K082221

510(k) Number K082221 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 2008
Decision Date October 22, 2008
Days to Decision 77 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 107d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

MUJ Device Classification - Class 2, Special Controls

Product Code MUJ System, Planning, Radiation Therapy Treatment
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5050
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

Intertek Testing Services
DANIEL W LEHTONEN

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.

Regulatory Peers - MUJ System, Planning, Radiation Therapy Treatment

All 256
Devices cleared under the same product code (MUJ) and FDA review panel - the closest regulatory comparables to K082221.
RAYAUTOPLAN 1.0
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K082642 · Nucletron Corporation · Nov 2008
MODIFICATION TO HI-ART TREATMENT SYSTEM
K082005 · Tomotherapy Incorporated · Aug 2008
FLEXIPLAN BRACHYTHERAPY TREATMENT PLANNING SYSTEM
K081112 · Isodose Control B.V. · Jul 2008
MODEIFICATION TO IPLAN RT DOSE
K080888 · Brainlab AG · Jun 2008