Stage 2

• FDA 510(k) K223079 decided 28 Oct 2022 Active
• FDA GUDID UDI-DI 00866463000441 listed 23 Feb 2023 Listed

1. 28 Oct 2022 Cleared FDA 510(k) K223079
2. 23 Feb 2023 Listed FDA GUDID 00866463000441

Trade name

Stage

Generic name

MRI system application software

Model / reference

2

Primary DI / UDI-DI

00866463000441

510(k) Number

K223079 ↗

FDA product code

LNH, LLZ

GMDN term

MRI system application software

Device class

Class II

Regulation number

892.1000, 892.2050

GUDID distribution status

Not in Commercial Distribution

Other devices filed under FDA product code LNH (System, Nuclear Magnetic Resonance Imaging).

• SIGNA Architect by Ge Healthcare (Ge Medical Systems, LLC)
• AIRIS by Hitachi Medical Systems America, Inc.
• GE QUADRATURE T/L SPINE SURF COIL, M1085AP/M1285AP by General Electric Co.
• GE 0.7T SIGNA OPENSPEED WITH EXCITE MR SYSTEM by GE Medical Systems, LLC
• NEURO II by Innovative Magnetic Resonance Imaging Systems, Inc.
• MATRIX 3000 FLEXIBLE SPINE COIL by Us Asia Instruments, Inc.
• InVision™ 1.5 Surgical Theatre by Deerfield Imaging, Inc.
• GE 0.2T SIGNA PROFILE EXCITE MR SYSTEM by General Electric Co.
• MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY by GE MEDICAL SYSTEMS, INC.
• Ingenia Elition R5.7.1 SP4 MR Systems by Philips Medical Systems Nederland B.V.

• Stage 2.4

  Class II

  FDA 510(k) K223079 Active Cleared 28 Oct 2022 GUDID on market

• Wand Plus

  Class II

  FDA 510(k) K992819 Active Cleared 11 May 2000

• Leaplaza Frame

  Class II

  FDA 510(k) K922238 Active Cleared 23 Dec 1992

• Spin Care Disposable Protective Mask Level 3

  Class II

  FDA 510(k) K212109 Active Cleared 14 Nov 2021

See all devices from Spintech, Inc. →