Cleared Special

K050422 - 550 TXT TREATMENT TABLE

K050422 is an FDA 510(k) clearance for 550 TXT TREATMENT TABLE, manufactured by Siemens Medical Solutions USA, Inc.. The device is a Class 2 Radiology device with product code JAI cleared through the Special 510(k) pathway after a 28-day FDA review.

K050422 · Siemens Medical Solutions USA, Inc. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2005
Decision
28d
Days
Class 2
Risk

K050422 is an FDA 510(k) clearance for the 550 TXT TREATMENT TABLE. Classified as Couch, Radiation Therapy, Powered (product code JAI), Class II - Special Controls.

Submitted by Siemens Medical Solutions USA, Inc. (Concord, US). The FDA issued a Cleared decision on March 18, 2005 after a review of 28 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K050422

510(k) Number K050422 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 2005
Decision Date March 18, 2005
Days to Decision 28 days
Submission Type Special
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
79d faster than avg
Panel avg: 107d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

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 31
Devices cleared under the same product code (JAI) and FDA review panel - the closest regulatory comparables to K050422.
MODIFICATION TO HEXAPOD RT COUCH TOP
K062639 · Medical Intelligence Medizintechnik-GmbH-An Elekta · Sep 2006
AVANZA
K060870 · Mds Nordion · May 2006
KVUE IGRT TREATMENT TABLE TOP, RT-4551KV, KVUE INSERTS AND ACCESSORIES, VARIOUS
K060671 · Wfr/Aquaplast Corp. · May 2006
ROBOCOUCH PATIENT SUPPORT SYSTEM
K042146 · Accuray Incorporated · Sep 2004
HEXAPOD RT COUCHTOP
K041448 · Medical Intelligence Medizintechnik GmbH · Jun 2004
TABLE TILT DEVICE
K033316 · Brainlab AG · May 2004
K050422 · 550 TXT TREATMENT TABLE
Download PDF FDA Summary Siemens Medical Solut…