Cleared Traditional

K941927 - THE NOMOS CRANE

K941927 is an FDA 510(k) clearance for THE NOMOS CRANE, manufactured by Nomos Corp.. The device is a Class 2 Radiology device with product code JAI cleared through the Traditional 510(k) pathway after a 295-day FDA review.

K941927 · Nomos Corp. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1995
Decision
295d
Days
Class 2
Risk

K941927 is an FDA 510(k) clearance for the THE NOMOS CRANE. Classified as Couch, Radiation Therapy, Powered (product code JAI), Class II - Special Controls.

Submitted by Nomos Corp. (Sewickley, US). The FDA issued a Cleared decision on February 9, 1995 after a review of 295 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 Nomos Corp. devices

FDA 510(k) Submission Details - K941927

510(k) Number K941927 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 1994
Decision Date February 09, 1995
Days to Decision 295 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
188d slower than avg
Panel avg: 107d · This submission: 295d
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.