Cleared Traditional

K182683 - Z-Robot Patient Positioning System

K182683 is an FDA 510(k) clearance for Z-Robot Patient Positioning System, manufactured by Chinan Biomedical Technology, Inc.. The device is a Class 2 Radiology device with product code JAI cleared through the Traditional 510(k) pathway after a 274-day FDA review.

K182683 · Chinan Biomedical Technology, Inc. · Radiology device
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Jun 2019
Decision
274d
Days
Class 2
Risk

K182683 is an FDA 510(k) clearance for the Z-Robot Patient Positioning System. Classified as Couch, Radiation Therapy, Powered (product code JAI), Class II - Special Controls.

Submitted by Chinan Biomedical Technology, Inc. (Hsinchu County, TW). The FDA issued a Cleared decision on June 27, 2019 after a review of 274 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Chinan Biomedical Technology, Inc. devices

FDA 510(k) Submission Details - K182683

510(k) Number K182683 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2018
Decision Date June 27, 2019
Days to Decision 274 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
167d slower than avg
Panel avg: 107d · This submission: 274d
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 20
Devices cleared under the same product code (JAI) and FDA review panel - the closest regulatory comparables to K182683.
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K132084 · Med-Tec, Inc. D/B/A Civco Medical Solutions · Sep 2013
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K122413 · Forte Automation Systems, Inc. · Sep 2012
PROTURA COUCH SOFTWARE
K122201 · Med-Tec, Inc. D/B/A Civco Medical Solutions · Aug 2012