Cleared Traditional

PATLOG 2.0 (K092939) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K092939 · Oncolog Medical QA AB · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2009
Decision
15d
Days
Class 2
Risk

K092939 is an FDA 510(k) clearance for the PATLOG 2.0. Classified as Accelerator, Linear, Medical (product code IYE), Class II - Special Controls.

Submitted by Oncolog Medical QA AB (Uppsala, SE). The FDA issued a Cleared decision on October 9, 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.

View all Oncolog Medical QA AB devices

Submission Details

510(k) Number K092939 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 2009
Decision Date October 09, 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
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.

Device Classification

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 Peers - IYE Accelerator, Linear, Medical

All 204
Devices cleared under the same product code (IYE) and FDA review panel - the closest regulatory comparables to K092939.
VARIAN TREATMENT
K093967 · Varian Medical Systems, Inc. · Jul 2010
ARIA RADIATION ONCOLOGY WITH MIRS
K093527 · Varian Medical Systems, Inc. · Dec 2009
TRILOGY MX
K092871 · Varian Medical Systems, Inc. · Nov 2009
160MLC OPTION
K092145 · Siemens Medical Solutions USA, Inc. · Sep 2009
PORTALVISION ADVANCED IMAGING
K091209 · Varian Medical Systems, Inc. · Jun 2009
SYNGO RT THERAPIST CONNECT
K090683 · Siemens Medical Solutions USA, Inc. · May 2009