Cleared Traditional

K060870 - AVANZA

K060870 is an FDA 510(k) clearance for AVANZA, manufactured by Mds Nordion. The device is a Class 2 Radiology device with product code JAI cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K060870 · Mds Nordion · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2006
Decision
46d
Days
Class 2
Risk

K060870 is an FDA 510(k) clearance for the AVANZA. Classified as Couch, Radiation Therapy, Powered (product code JAI), Class II - Special Controls.

Submitted by Mds Nordion (Ottawa, CA). The FDA issued a Cleared decision on May 15, 2006 after a review of 46 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5770 - 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 - K060870

510(k) Number K060870 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 2006
Decision Date May 15, 2006
Days to Decision 46 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
61d faster than avg
Panel avg: 107d · This submission: 46d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JAI Device Classification - Class 2, Special Controls

Product Code JAI Couch, Radiation Therapy, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5770
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 - JAI Couch, Radiation Therapy, Powered

All 29
Devices cleared under the same product code (JAI) and FDA review panel - the closest regulatory comparables to K060870.
HEXAPOD EVO RT COUCH TOP
K072898 · Medical Intelligence Medizintechnik GmbH · Oct 2007
HEXAPOD RT COUCH TOP
K071870 · Medical Intelligence Medizintechnik GmbH · Jul 2007
MODIFICATION TO HEXAPOD RT COUCH TOP
K062639 · Medical Intelligence Medizintechnik-GmbH-An Elekta · Sep 2006
KVUE IGRT TREATMENT TABLE TOP, RT-4551KV, KVUE INSERTS AND ACCESSORIES, VARIOUS
K060671 · Wfr/Aquaplast Corp. · May 2006
550 TXT TREATMENT TABLE
K050422 · Siemens Medical Solutions USA, Inc. · Mar 2005
ROBOCOUCH PATIENT SUPPORT SYSTEM
K042146 · Accuray Incorporated · Sep 2004
K060870 · AVANZA
Download PDF FDA Summary Mds Nordion