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510(k) K812088

POLAROID RADIOGRAPHIC FILM PROCESSOR by Polaroid Corp. — Product Code IXW

K812088 is an FDA 510(k) premarket notification submitted by Polaroid Corp. for the device "POLAROID RADIOGRAPHIC FILM PROCESSOR". The FDA issued a decision of Substantially Equivalent on August 31, 1981. The device falls under product code IXW (Processor, Radiographic-Film, Automatic), a Class II device regulated under 21 CFR 892.1900. Polaroid Corp. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 31, 1981
Date Received
July 22, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Processor, Radiographic-Film, Automatic
Device Class
Class II
Regulation Number
892.1900
Review Panel
RA
Submission Type

Other clearances by Polaroid Corp.

  • K812542 — POLAROID INSTANT ENDOCAMERA (October 19, 1981)
  • K812089 — POLAROID RADIOGRAPHIC FILM CASSETTE (August 31, 1981)
  • K811352 — POLAROID TPX RADIOGRAPHIC FILM (June 18, 1981)
  • K792512 — POLAROID LAND CAMERA FOR ENDOSCOPY (December 20, 1979)

Other clearances for product code IXW

  • K111167 — XTENDER FILM PROCESSOR, SPRINT FILM PROCESSOR MODEL XTENDER MODEL SPRINT (August 18, 2011)
  • K093503 — INTRAX FILM PROCESSOR (January 6, 2010)
  • K091628 — OPTIMAX, COMPACT 2, OPTIMAX 2010, ECOMAX (August 21, 2009)
  • K024342 — RADIOGRAPHIC FILM PROCESSOR, MODELS XP400 AND XP1000 (April 23, 2003)
  • K023825 — FILM PROCESSOR, MODEL LIFE RAY PRO 2500 (February 12, 2003)
  • K023801 — FILM PROCESSOR, MODEL LIFE RAY PRO 1000 (February 12, 2003)
  • K023613 — AX200 AUTOMATIC X-RAY FILM PROCESSOR, MODEL 6586.036 (January 23, 2003)
  • K022154 — LEVEL 356 X-RAY FILM PROCESSOR, MODELS MD & MD-D (September 30, 2002)
  • K002640 — FREEDOM AUTOMATIC FILM PROCESSOR (November 8, 2000)
  • K002404 — MICRO-MAX, MODEL 319 (August 30, 2000)

FDA data resources