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510(k) K864854

VIEW(TM) IMAGE PROCESSING AND VIEWING STATION by Virtual Imaging — Product Code LLZ

K864854 is an FDA 510(k) premarket notification submitted by Virtual Imaging for the device "VIEW(TM) IMAGE PROCESSING AND VIEWING STATION". The FDA issued a decision of Substantially Equivalent on February 26, 1987. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Virtual Imaging has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 26, 1987
Date Received
December 11, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Image Processing, Radiological
Device Class
Class II
Regulation Number
892.2050
Review Panel
RA
Submission Type

Other clearances by Virtual Imaging

  • K093688 — CANON, MODEL URS-50RF (February 4, 2010)
  • K092439 — CANON DIGITAL FLUOROSCOPY AND RADIOGRAPHY, MODEL CXDI-50RF (November 30, 2009)
  • K092280 — CYPHER DICOM PRINT SOLUTION (October 16, 2009)
  • K083725 — RADPRO ION (January 22, 2009)
  • K070390 — FLUOROPRO RF DIGITAL IMAGING SYSTEM (April 5, 2007)
  • K063262 — AMX4-50 AND AMX4-31 MOBILE DIGITAL DIAGNOSTIC RADIOGRAPHIC SYSTEMS (December 26, 2006)
  • K922313 — P-LINK (July 10, 1992)
  • K891695 — VIEW 1000 (October 27, 1989)

Other clearances for product code LLZ

  • K261855 — Elucid PlaqueIQ (September 18, 2026)
  • K261861 — SPINEsim v1.0 (September 15, 2026)
  • K254214 — OOOPDS (September 15, 2026)
  • K262060 — 3D-RD-S (September 4, 2026)
  • K261500 — KBA3D (v2.4.0) (August 17, 2026)
  • K262449 — AdvaView (August 14, 2026)
  • K261916 — NeuroQuant PET (August 12, 2026)
  • K260936 — RadioViewAI (July 31, 2026)
  • K260588 — Cleerly LABS (July 29, 2026)
  • K262462 — TheraSphere 360™ Y-90 Management Platform (July 24, 2026)

FDA data resources