Cleared Traditional

K981678 - STRATA, MODEL V.O.95

K981678 is an FDA 510(k) clearance for STRATA, manufactured by Rosses Medical Systems. The device is a Class 2 Radiology device with product code MUJ cleared through the Traditional 510(k) pathway after a 213-day FDA review.

K981678 · Rosses Medical Systems · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1998
Decision
213d
Days
Class 2
Risk

K981678 is an FDA 510(k) clearance for the STRATA, MODEL V.O.95. Classified as System, Planning, Radiation Therapy Treatment (product code MUJ), Class II - Special Controls.

Submitted by Rosses Medical Systems (Jessup, US). The FDA issued a Cleared decision on December 11, 1998 after a review of 213 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5050 - 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 Rosses Medical Systems devices

FDA 510(k) Submission Details - K981678

510(k) Number K981678 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 1998
Decision Date December 11, 1998
Days to Decision 213 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
106d slower than avg
Panel avg: 107d · This submission: 213d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MUJ Device Classification - Class 2, Special Controls

Product Code MUJ System, Planning, Radiation Therapy Treatment
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5050
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 - MUJ System, Planning, Radiation Therapy Treatment

All 174
Devices cleared under the same product code (MUJ) and FDA review panel - the closest regulatory comparables to K981678.
INTERPLANT
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ROCS TPS
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MODIFICATION TO PROWESS PRO-SIM
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ACQPLAN
K974770 · Philips Medical Systems (Cleveland), Inc. · Sep 1998