Cleared Traditional

K030061 - PS 3000 DIGATAL PHOTOSPOT SYSTEM

K030061 is the FDA 510(k) clearance for PS 3000 DIGATAL PHOTOSPOT SYSTEM by Precise Optics. It is a Class 2 Radiology device (product code OWB) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K030061 · Precise Optics · Radiology device
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Apr 2003
Decision
90d
Days
Class 2
Risk

K030061 is an FDA 510(k) clearance for the PS 3000 DIGATAL PHOTOSPOT SYSTEM. Classified as Interventional Fluoroscopic X-ray System (product code OWB), Class II - Special Controls.

Submitted by Precise Optics (Stamford, US). The FDA issued a Cleared decision on April 7, 2003 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1650 - 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 Precise Optics devices

Submission Details

510(k) Number K030061 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 07, 2003
Decision Date April 07, 2003
Days to Decision 90 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 107d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OWB Interventional Fluoroscopic X-ray System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1650
Definition Interventional Fluoroscopy
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 - OWB Interventional Fluoroscopic X-ray System

All 242
Devices cleared under the same product code (OWB) and FDA review panel - the closest regulatory comparables to K030061.
DIGITAL FLUOROSCOPIC IMAGING SYSTEM, MODEL INNOVA 4100 WITH TILT TABLE OPTION
K033244 · Ge Medical Systems, Inc. · Oct 2003
INNOVA 3100
K031637 · GE Medical Systems · Aug 2003
PHILLIPS OMNIDIAGNOST ELEVA
K032046 · Philips Medical Systems, Inc. · Jul 2003
INNOVA 2000 AND INNOVA 2000S (MOBILE VERSION)
K024200 · Ge Medical Systems, Inc. · Jan 2003
INNOVA 4100
K023178 · Ge Medical Systems, Inc. · Nov 2002
INNOVA AND INNOVA 2000 S
K022322 · Ge Medical Systems, Inc. · Oct 2002