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510(k) K971128

CAP-35B III/CINE 275 by Jamieson Film Co. — Product Code IXR

K971128 is an FDA 510(k) premarket notification submitted by Jamieson Film Co. for the device "CAP-35B III/CINE 275". The FDA issued a decision of Substantially Equivalent on April 28, 1997. The device falls under product code IXR (Table, Radiographic, Tilting), a Class II device regulated under 21 CFR 892.1980. Jamieson Film Co. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 28, 1997
Date Received
March 27, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Table, Radiographic, Tilting
Device Class
Class II
Regulation Number
892.1980
Review Panel
RA
Submission Type

Other clearances by Jamieson Film Co.

  • K970738 — KODAK DIGITAL SCIENCE CARDIAC DIGITAL ACQUISITION UNIT (May 7, 1997)
  • K963334 — JAMIESON MODEL 2100 CINE FILM PROCESSOR AND KODAK CINEFLURE PROCESSOR MODEL 2100 (September 11, 1996)
  • K960043 — KODAK CARDIOLOGY DIGITAL ARCHIVE & REVIEW SYSTEM (March 27, 1996)
  • K953563 — VANGUARD XR-350 CINEANGIOGRAM PROJECTOR (October 5, 1995)
  • K913241 — JAMIESON JT-CRP CINE FILM PROCESSOR (September 24, 1991)

Other clearances for product code IXR

  • K000412 — VISION R/F TILTING TABLE (April 24, 2000)
  • K973039 — LEGACY/LEGACY-D TABLE (October 16, 1997)
  • K970640 — PHILIPS EASY DIAGNOST (March 21, 1997)
  • K965105 — ELECTROPHYSIOLOGY TILT TABLE MODEL #9660 (January 30, 1997)
  • K965096 — FLUOROVIEW SERIES FLUOROSCOPIC TABLES (January 27, 1997)
  • K963851 — TILTING RADIOGRAPHIC TABLE (REMOTE) (January 23, 1997)
  • K961022 — TANGENT VI TABLE (May 3, 1996)
  • K954356 — COMPAX 90/15E (October 7, 1995)
  • K953557 — SURGICAL C-ARM TABLE, 9610 (September 26, 1995)
  • K953556 — VACS TABLE, 9650 (September 26, 1995)

FDA data resources