Cleared Special

K013548 - STANDARD IMAGING IVB 1000 WELL CHAMBER

K013548 is an FDA 510(k) clearance for STANDARD IMAGING IVB 1000 WELL CHAMBER, manufactured by Standard Imaging, Inc.. The device is a Class 2 Radiology device with product code KPT cleared through the Special 510(k) pathway after a 16-day FDA review.

K013548 · Standard Imaging, Inc. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2001
Decision
16d
Days
Class 2
Risk

K013548 is an FDA 510(k) clearance for the STANDARD IMAGING IVB 1000 WELL CHAMBER. Classified as Calibrator, Dose, Radionuclide (product code KPT), Class II - Special Controls.

Submitted by Standard Imaging, Inc. (Middleton, US). The FDA issued a Cleared decision on November 9, 2001 after a review of 16 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1360 - 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 - K013548

510(k) Number K013548 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 2001
Decision Date November 09, 2001
Days to Decision 16 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
91d faster than avg
Panel avg: 107d · This submission: 16d
Pathway characteristics
Modification to existing cleared device.

KPT Device Classification - Class 2, Special Controls

Product Code KPT Calibrator, Dose, Radionuclide
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1360
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 - KPT Calibrator, Dose, Radionuclide

All 21
Devices cleared under the same product code (KPT) and FDA review panel - the closest regulatory comparables to K013548.
MENTOR ISOLOADER AUTOMATIC NEEDLE LOADING SYSTEM AND PHYSICS WORKSTATION FOR BRACHYTHERAPY
K011493 · Mentor Corp. · Oct 2002
CRC-15BT
K020150 · Capintec, Inc. · Aug 2002
RE-ENTRANT CHAMBER
K013689 · Sun Nuclear Corp. · Jul 2002
CAL/RAD MARK IV-DOSE CALIBRATOR 34-162 VEENSTRA MODEL # VDC-304
K010417 · Nuclear Assoc., Div. Inovision LP · Apr 2001
MODIFICATION TO STANDARD IMAGING PT 1000 ION CHAMBER
K002833 · Standard Imaging, Inc. · Sep 2000
BETA C COUNTER
K943072 · Capintec Instruments, Inc. · Sep 1994
K013548 · STANDARD IMAGING IVB 1000 WELL CHAMBER
Download PDF FDA Summary Standard Imaging, Inc.