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510(k) K950288

AUTOLASER MULTI FORMAT CAMERA by Afp Imaging Corp. — Product Code LMC

K950288 is an FDA 510(k) premarket notification submitted by Afp Imaging Corp. for the device "AUTOLASER MULTI FORMAT CAMERA". The FDA issued a decision of Substantially Equivalent on April 4, 1995. The device falls under product code LMC (Camera, Multi Format, Radiological), a Class II device regulated under 21 CFR 892.2040. Afp Imaging Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 4, 1995
Date Received
January 25, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Camera, Multi Format, Radiological
Device Class
Class II
Regulation Number
892.2040
Review Panel
RA
Submission Type

Other clearances by Afp Imaging Corp.

  • K123419 — EVA SELECT DIGITAL DENTAL IMAGING SYSTEM (December 27, 2012)
  • K072357 — NEWTOM VG COMPUTED TOMOGRAPHY X-RAY SYSTEM (September 18, 2007)
  • K041120 — EV APAN DIGITAL, MODEL K1VSM2000 (August 30, 2004)
  • K030647 — EVA DIGITAL DENTAL X-RAY SYSTEM (March 20, 2003)
  • K014144 — EXTORAL/TESCERA GLAZING RESIN, MODEL T-1804 (February 7, 2002)
  • K013176 — MODIFICATION TO: SENS-A-RAY SYSTEM WITH PROIMAGE SOFTWARE (October 16, 2001)
  • K974619 — SCANARAY/CD-DENT ADVANCED COMPUTERIZED X-RAY SYSTEM (February 25, 1998)
  • K925885 — AFP 17 X 4 AUTOMATIC FILM PROCESSOR (June 9, 1993)
  • K930761 — IMAGE-X 70 INTRAORAL X-RAY SYSTEM (May 25, 1993)
  • K925684 — OLYMP-X,X-RAY GENERATOR (February 2, 1993)

Other clearances for product code LMC

  • K141454 — SONY DIGITAL PRINTER UP-D898MD/SONY HYBRID PRINTER UP-X898MD (June 26, 2014)
  • K141346 — SONY HYBIRD GRAPHIC UP-971AD, SONY HYBIRD GRAPHIC PRINTER UP-991AD (June 26, 2014)
  • K111566 — DRYVIEW CHROMA IMAGING SYSTEM (October 6, 2011)
  • K092280 — CYPHER DICOM PRINT SOLUTION (October 16, 2009)
  • K090469 — CARESTREAM DRYVIEW 5850 LASER IMAGER (May 22, 2009)
  • K083522 — SONY UP-DF750 DIGITAL FILM IMAGER (January 9, 2009)
  • K081637 — LASER IMAGER DRYPRO MODEL 873 (July 1, 2008)
  • K072680 — DRYSTAR AXYS, MODEL EYZ4E (October 25, 2007)
  • K061999 — DRY LASER IMAGER, DRYPRO MODEL 832 (August 15, 2006)
  • K061302 — DIGITAL PRINTER P6000D SERIES, MODEL P6000DU (June 23, 2006)

FDA data resources