Cleared Traditional

ORCA (K960907) - FDA 510(k) Clearance

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

K960907 · Lunar Corp. · Radiology device
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May 1996
Decision
76d
Days
Class 2
Risk

K960907 is an FDA 510(k) clearance for the ORCA. Classified as Image-intensified Fluoroscopic X-ray System, Mobile (product code OXO), Class II - Special Controls.

Submitted by Lunar Corp. (Madison, US). The FDA issued a Cleared decision on May 20, 1996 after a review of 76 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1650 - 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 Lunar Corp. devices

Submission Details

510(k) Number K960907 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 1996
Decision Date May 20, 1996
Days to Decision 76 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 107d · This submission: 76d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OXO Image-intensified Fluoroscopic X-ray System, Mobile
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1650
Definition Fluoroscopy Of The Human Body.
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 - OXO Image-intensified Fluoroscopic X-ray System, Mobile

All 23
Devices cleared under the same product code (OXO) and FDA review panel - the closest regulatory comparables to K960907.
ACCENT 16, ACCENT 22
K980322 · GE Medical Systems · Apr 1998
SIREMOBIL CO2
K973598 · Siemens Medical Solutions USA, Inc. · Nov 1997
SIREMOBIL COMPACT
K963093 · Siemens Medical Solutions USA, Inc. · Sep 1996
STENOSCOP MOBILE FLUOROSCOPIC XRAY SYSTEM
K933447 · GE Medical Systems · Aug 1993
MOBILE X-RAY SYSTEM
K913525 · Siemens Medical Solutions USA, Inc. · Oct 1991
SXT-60F/60M MOBILE C ARM X-RAY UNIT
K896387 · Toshiba America Medical Systems, In.C · Feb 1990