Cleared Special

K081757 - VERISTA IMAGING ISOCAM II GAMMA CAMERA

K081757 is an FDA 510(k) clearance for VERISTA IMAGING ISOCAM II GAMMA CAMERA, manufactured by Verista Imaging, Inc.. The device is a Class 1 Radiology device with product code IYX cleared through the Special 510(k) pathway after a 56-day FDA review.

K081757 · Verista Imaging, Inc. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2008
Decision
56d
Days
Class 1
Risk

K081757 is an FDA 510(k) clearance for the VERISTA IMAGING ISOCAM II GAMMA CAMERA. Classified as Camera, Scintillation (gamma) (product code IYX), Class I - General Controls.

Submitted by Verista Imaging, Inc. (Great Neck, US). The FDA issued a Cleared decision on August 15, 2008 after a review of 56 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1100 - the FDA radiology and imaging software oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K081757

510(k) Number K081757 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 2008
Decision Date August 15, 2008
Days to Decision 56 days
Submission Type Special
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
51d faster than avg
Panel avg: 107d · This submission: 56d
Pathway characteristics
Modification to existing cleared device.

IYX Device Classification - Class 1, General Controls

Product Code IYX Camera, Scintillation (gamma)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.1100
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - IYX Camera, Scintillation (gamma)

All 109
Devices cleared under the same product code (IYX) and FDA review panel - the closest regulatory comparables to K081757.
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K081757 · VERISTA IMAGING ISOCAM II GAMMA CAMERA
Download PDF FDA Summary Verista Imaging, Inc.