Cleared Traditional

K091602 - MUCHECK V8

K091602 is an FDA 510(k) clearance for MUCHECK V8, manufactured by Oncology Data Systems, Inc.. The device is a Class 2 Radiology device with product code IYE cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K091602 · Oncology Data Systems, Inc. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2009
Decision
15d
Days
Class 2
Risk

K091602 is an FDA 510(k) clearance for the MUCHECK V8. Classified as Accelerator, Linear, Medical (product code IYE), Class II - Special Controls.

Submitted by Oncology Data Systems, Inc. (Oklahoma City, US). The FDA issued a Cleared decision on June 18, 2009 after a review of 15 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 - K091602

510(k) Number K091602 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 2009
Decision Date June 18, 2009
Days to Decision 15 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
92d faster than avg
Panel avg: 107d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

IYE Device Classification - Class 2, Special Controls

Product Code IYE Accelerator, Linear, Medical
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

Regulatory Technology Services, LLC
MARK JOB

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 - IYE Accelerator, Linear, Medical

All 704
Devices cleared under the same product code (IYE) and FDA review panel - the closest regulatory comparables to K091602.
GOLD ANCHOR
K091645 · Naslund Medical AB · Jul 2009
TIGRT MLC, TIGRT DMLC
K090802 · Linatech, LLC · Jul 2009
PORTALVISION ADVANCED IMAGING
K091209 · Varian Medical Systems, Inc. · Jun 2009
4D INTEGRATED TREATMENT CONSOLE
K091132 · Varian Medical Systems · Jun 2009
SYNGO RT THERAPIST CONNECT
K090683 · Siemens Medical Solutions USA, Inc. · May 2009
SENTINEL, MODEL SP-001
K082582 · C-Rad Positioning AB · Mar 2009
K091602 · MUCHECK V8
Download PDF FDA Summary Oncology Data Systems…