Cleared Traditional

GYROSCAN INTERA (R7.5)

K001796 · Philips Medical Systems North America, Inc. · Radiology
Sep 2000
Decision
84d
Days
Class 2
Risk

About This 510(k) Submission

K001796 is an FDA 510(k) clearance for the GYROSCAN INTERA (R7.5), a System, Nuclear Magnetic Resonance Imaging (Class II — Special Controls, product code LNH), submitted by Philips Medical Systems North America, Inc. (Shelton, US). The FDA issued a Cleared decision on September 6, 2000, 84 days after receiving the submission on June 14, 2000. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1000.

Submission Details

510(k) Number K001796 FDA.gov
FDA Decision Cleared SESE
Date Received June 14, 2000
Decision Date September 06, 2000
Days to Decision 84 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code LNH — System, Nuclear Magnetic Resonance Imaging
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1000

Similar Devices — LNH System, Nuclear Magnetic Resonance Imaging

All 1093
Embrace Neonatal MRI System
K254277 · Aspect Imaging, Ltd. · Mar 2026
LiverMultiScan (v6.0)
K253413 · Perspectum, Ltd. · Mar 2026
Magnifico Open (100009900)
K251901 · Esaote, S.P.A. · Mar 2026
MAGNETOM Flow.Ace; MAGNETOM Flow.Plus
K260265 · Siemens Shenzhen Magnetic Resonance , Ltd. · Feb 2026
Ingenia, Ingenia CX, Ingenia Elition S/X, Ingenia Ambition S/X, BlueSeal SE/XE/QE, MR 5300 and MR 7700 MR Systems including Upgrades
K253648 · Philips Medical Systems Nederland B.V. · Feb 2026
SIGNA? Bolt
K253780 · Ge Medical Systems, LLC · Feb 2026