Cleared Traditional

K991535 - CONVERGENCE CDR FOR HITACHI SPECTRADIGI...

K991535 is the FDA 510(k) clearance for CONVERGENCE CDR FOR HITACHI SPECTRADIGI... by Hitachi Medical Corp. of America. It is a Class 2 Radiology device (product code KPS) cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K991535 · Hitachi Medical Corp. of America · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1999
Decision
88d
Days
Class 2
Risk

K991535 is an FDA 510(k) clearance for the CONVERGENCE CDR FOR HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERAS. Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by Hitachi Medical Corp. of America (Twinsburg, US). The FDA issued a Cleared decision on July 30, 1999 after a review of 88 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 Hitachi Medical Corp. of America devices

Submission Details

510(k) Number K991535 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 1999
Decision Date July 30, 1999
Days to Decision 88 days
Submission Type Traditional
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
19d faster than avg
Panel avg: 107d · This submission: 88d
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 247
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K991535.
BEACON-P, MODEL 211059
K992335 · Philips Medical Systems (Cleveland), Inc. · Oct 1999
AUTOSPECT PLUS WITH INSTILL MOTION CORRECTION
K992317 · Adac Laboratories · Oct 1999
VANTAGE EXSPECT II
K992078 · Adac Laboratories · Sep 1999
VANTAGE 2.5
K991607 · Adac Laboratories · Jul 1999
CONVERGENCE NUA FOR HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERAS
K991318 · Hitachi Medical Corp. of America · Jun 1999
HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERA SYSTEM WITH THICK NAL(TI) CRYSTAL
K991129 · Hitachi Medical Corp. of America · May 1999