Cleared Traditional

K991129 - HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERA SYSTEM WITH THICK NAL(TI) CRYSTAL

K991129 is an FDA 510(k) clearance for HITACHI SPECTRADIGITAL V250DSP GAMMA CA..., manufactured by Hitachi Medical Corp. of America. The device is a Class 2 Radiology device with product code KPS cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K991129 · Hitachi Medical Corp. of America · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1999
Decision
41d
Days
Class 2
Risk

K991129 is an FDA 510(k) clearance for the HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERA SYSTEM WITH THICK NAL(TI) CRYSTAL. 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 May 13, 1999 after a review of 41 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

FDA 510(k) Submission Details - K991129

510(k) Number K991129 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 1999
Decision Date May 13, 1999
Days to Decision 41 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
66d faster than avg
Panel avg: 107d · This submission: 41d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KPS Device Classification - Class 2, Special Controls

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 384
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K991129.
CONVERGENCE CDR FOR HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERAS
K991535 · Hitachi Medical Corp. of America · Jul 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
BEACON, MODEL 211060
K983948 · Philips Medical Systems (Cleveland), Inc. · Apr 1999
POSITRON OPTION, MODEL NSCO-050A
K983514 · Toshiba America Medical Systems, In.C · Dec 1998
TRANSMISSION KIT, TRANS-CT, MODEL NSTR-050A
K983516 · Toshiba America Medical Systems, In.C · Dec 1998