Ancoris

• FDA 510(k) K201807 decided 27 Aug 2020 Active
• FDA GUDID UDI-DI 04260484140067 listed 11 Jun 2021 Listed

1. 27 Aug 2020 Cleared FDA 510(k) K201807
2. 11 Jun 2021 Listed FDA GUDID 04260484140067

Generic name

PET system

Model / reference

ANCORIS

Primary DI / UDI-DI

04260484140067

510(k) Number

K201807 ↗

FDA product code

KPS

GMDN term

PET system

Device class

Class II

Regulation number

892.1200

GUDID distribution status

In Commercial Distribution

Category: PET system

Other devices filed under FDA product code KPS (System, Tomography, Computed, Emission).

• GE QUASAR NUCLEAR MEDICINE SYSTEM by Ge Medical Systems F.I. Haifa
• cNeuro cPET by Combinostics Oy
• DELTAMANAGER by Medimage, Inc.
• VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464) by Spectrum Dynamics Medical ltd
• BEACON-P, MODEL 211059 by Philips Medical Systems (Cleveland), Inc.
• GEMINI RAPTOR by Philips Medical Systems (Cleveland), Inc.
• MODIFIED POSICAM SYSTEM MODEL 6.5 by Positron Corp.
• DIACAM GAMMA CAMERA SYSTEM by Siemens Gammasonics, Inc.
• BIOGRAPH MCT FAMILY by SIEMENS MEDICAL SOLUTIONS USA, INC.
• HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERA SYSTEM WITH THICK NAL(TI) CRYSTAL by Hitachi Medical Corp. of America

• Ecam-Scintron

  Class II

  FDA 510(k) K101768 Active Cleared 5 Oct 2010 GUDID on market

• ECAT Scintron PET

  Class II

  FDA 510(k) K130269 Active Cleared 19 Apr 2013 GUDID on market

• Scintron

  Class II

  FDA 510(k) K101013 Active Cleared 7 Jun 2010 GUDID on market

• MiE - Gamma Camera Systems PICOLA-SCINTRON

  Class I

  FDA 510(k) K053086 Active Cleared 27 Jan 2006 GUDID on market

See all devices from MiE medical imaging electronics GmbH →