Cleared Special

STANDARD IMAGING HDR 1000 PLUS ION CHAMBER (K001825) - FDA 510(k) Clearance

Also marketed or referenced as:
STANDARD IMAGING IVB 1000 ION CHAMBER

Class II Radiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K001825 · Standard Imaging, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2000
Decision
47d
Days
Class 2
Risk

K001825 is an FDA 510(k) clearance for the STANDARD IMAGING HDR 1000 PLUS ION CHAMBER. Classified as System, Applicator, Radionuclide, Remote-controlled (product code JAQ), Class II - Special Controls.

Submitted by Standard Imaging, Inc. (Middleton, US). The FDA issued a Cleared decision on August 2, 2000 after a review of 47 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5700 - 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.

View all Standard Imaging, Inc. devices

Submission Details

510(k) Number K001825 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 2000
Decision Date August 02, 2000
Days to Decision 47 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 107d · This submission: 47d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code JAQ System, Applicator, Radionuclide, Remote-controlled
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5700
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 - JAQ System, Applicator, Radionuclide, Remote-controlled

All 69
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