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510(k) K072766

PVMED DDR 2520 DIGITAL IMAGING SYSTEM by Portavision Medical — Product Code IXK

K072766 is an FDA 510(k) premarket notification submitted by Portavision Medical for the device "PVMED DDR 2520 DIGITAL IMAGING SYSTEM". The FDA issued a decision of Substantially Equivalent on December 11, 2007. The device falls under product code IXK (System, Imaging, X-Ray, Electrostatic), a Class II device regulated under 21 CFR 892.1630. Portavision Medical has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 11, 2007
Date Received
September 28, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
System, Imaging, X-Ray, Electrostatic
Device Class
Class II
Regulation Number
892.1630
Review Panel
RA
Submission Type

Other clearances by Portavision Medical

  • K212557 — Virtual C DRF-NEO Digital Imaging System (September 24, 2021)
  • K211191 — Virtual C DRF Digital Imaging System (June 24, 2021)
  • K191503 — MobileRay Pulse SE Digital Imaging System (September 4, 2019)
  • K133524 — PVMED DDR 2430T (April 16, 2014)
  • K083048 — NEORAY DR 2520 DIGITAL IMAGING SYSTEM (November 21, 2008)

Other clearances for product code IXK

  • K093640 — DIGITAL X-RAY DETECTORS FAMILY KRC AND DIRA (April 29, 2011)
  • K042779 — RADIOTHERAPY SOLUTION BASED ON CR (October 21, 2004)
  • K032654 — PORT CASSETTE (October 9, 2003)
  • K003689 — CANON X-RAY DIGITAL CAMERA, MODEL CXDI-31 (January 2, 2002)
  • K000159 — AGFA DIAGNOSTIC CENTER ADC, ADC COMPACT, AND ADC SOLO (February 16, 2000)
  • K942561 — FUJI FCR IMAGE PROCESSING UNIT IP-U515 (December 23, 1994)
  • K934949 — DIGORA (February 10, 1994)
  • K931002 — FUJI COMPUTED RADIOGRAP HI-C654 DMS CRT IMAGE CONS (June 8, 1993)
  • K923990 — FUJI COMPUTED RADIOGRAPHY HI-C652B DMS CRT IMAGE (December 17, 1992)
  • K924459 — DIGISCAN 2 (December 17, 1992)

FDA data resources