Cleared Traditional

K983567 - IMAGE TECHNOLOGIES STERICAM, COUPLER-DRAPE AND TROVIEW IMAGING SYSTEM

K983567 is an FDA 510(k) clearance for IMAGE TECHNOLOGIES STERICAM, manufactured by Med Images, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GCJ cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K983567 · Med Images, Inc. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Jan 1999
Decision
86d
Days
Class 2
Risk

K983567 is an FDA 510(k) clearance for the IMAGE TECHNOLOGIES STERICAM, COUPLER-DRAPE AND TROVIEW IMAGING SYSTEM. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Med Images, Inc. (North Attleboro, US). The FDA issued a Cleared decision on January 7, 1999 after a review of 86 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 876.1500 - the FDA general and plastic surgery device 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 Med Images, Inc. devices

FDA 510(k) Submission Details - K983567

510(k) Number K983567 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 1998
Decision Date January 07, 1999
Days to Decision 86 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 115d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GCJ Device Classification - Class 2, Special Controls

Product Code GCJ Laparoscope, General & Plastic Surgery
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
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 General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - GCJ Laparoscope, General & Plastic Surgery

All 949
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K983567.
MODIFICATION TO MULTAPORT CANNULA, REDUCER AND ACCESSORIES
K990379 · Dexide, Inc. · Mar 1999
MICROENDOSCOPE, MINIATURIZED BIOPSY SCOPE
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DCI ENDOSCOPE
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MODULAP
K983623 · Atc Technologies, Inc. · Dec 1998
AUTO SUTURE LAPAROSCOPES DEVICE
K983293 · United States Surgical, A Division of Tyco Healthc · Dec 1998