Cleared Traditional

BP-SPECT V1.O (K042258) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K042258 · Syntermed, Inc. · Radiology device
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Oct 2004
Decision
45d
Days
Class 2
Risk

K042258 is an FDA 510(k) clearance for the BP-SPECT V1.O. Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by Syntermed, Inc. (Anaheim, US). The FDA issued a Cleared decision on October 4, 2004 after a review of 45 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1200 - 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: 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 Syntermed, Inc. devices

Submission Details

510(k) Number K042258 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 2004
Decision Date October 04, 2004
Days to Decision 45 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
62d faster than avg
Panel avg: 107d · This submission: 45d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KPS System, Tomography, Computed, Emission
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1200
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 - KPS System, Tomography, Computed, Emission

All 148
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K042258.
GEMINI GXL
K051170 · Philips Medical Systems (Cleveland), Inc. · May 2005
GEMINI GXL
K042935 · Philips Medical Systems (Cleveland), Inc. · Nov 2004
C-PET PLUS IMAGING SYSTEM
K042839 · Philips Medical Systems (Cleveland), Inc. · Oct 2004
DISCOVERY ST PET/CT IMAGING SYSTEM WITH AN ALTERNATE DETECTOR OPTION
K042257 · General Electric Co. · Sep 2004
GEMINI PET/CT IMAGING SYSTEM
K041955 · Philips Medical Systems (Cleveland), Inc. · Jul 2004
SIEMENS ENHANCED IMAGING SYSTEM
K041166 · Siemens Medical Solutions USA, Inc. · May 2004