Home / 510(k) Clearances / K870707

510(k) K870707

PENTAMAX 1 MODEL B TABLE SYSTEM by Spectrum X-Ray Corp. — Product Code IXR

K870707 is an FDA 510(k) premarket notification submitted by Spectrum X-Ray Corp. for the device "PENTAMAX 1 MODEL B TABLE SYSTEM". The FDA issued a decision of Substantially Equivalent on May 14, 1987. The device falls under product code IXR (Table, Radiographic, Tilting), a Class II device regulated under 21 CFR 892.1980. Spectrum X-Ray Corp. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 14, 1987
Date Received
February 20, 1987
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 Spectrum X-Ray Corp.

  • K933134 — SPECTRUM DG-P7000 PEDIATRIC CRADLE (October 7, 1993)
  • K931563 — SPECTRUM MARK I SPECIAL PROCEDURES TABLE (August 23, 1993)
  • K834494 — SPECTRUM X-RAY CORP (February 21, 1984)
  • K840463 — DIGITAL CRADLE (February 21, 1984)
  • K827450 — SIMPLAMATIC III (May 19, 1982)
  • K813561 — SPECTRUM PEDIATRIC CARDLE TABLE (January 29, 1982)
  • K791812 — SPECTRUM EMERGENCY & TRAUMA TABLE SYSTEM (November 5, 1979)
  • K791811 — SPECTRUM AUTOMATIC CHEST UNIT MODEL C (October 26, 1979)

Other clearances for product code IXR

  • K000412 — VISION R/F TILTING TABLE (April 24, 2000)
  • K973039 — LEGACY/LEGACY-D TABLE (October 16, 1997)
  • K971128 — CAP-35B III/CINE 275 (April 28, 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)

FDA data resources