Pentamax 1 Model B Table System

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K870707 ↗

FDA Product Code

IXR

Device Class

Class II

Regulation

21 CFR Part 892.1980

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Spectrum Automatic Chest Unit Model C

  Class II

  FDA 510(k) K791811 Active Cleared 26 Oct 1979

• Spectrum Pediatric Cardle Table

  Class I

  FDA 510(k) K813561 Active Cleared 29 Jan 1982

• Spectrum Emergency & Trauma Table System

  Class II

  FDA 510(k) K791812 Active Cleared 5 Nov 1979

• Spectrum Dg-P7000 Pediatric Cradle

  Class I

  FDA 510(k) K933134 Active Cleared 7 Oct 1993

• Digital Cradle

  Class I

  FDA 510(k) K840463 Active Cleared 21 Feb 1984

• Simplamatic III

  Not classified

  FDA 510(k) K827450 Active Cleared 19 May 1982

See all devices from Spectrum X-Ray Corp. →

• What is the Pentamax 1 Model B Table System used for?

  The Pentamax 1 Model B Table System is designed for use in radiology procedures and provides a stable platform for X-ray imaging, as it is a radiographic tilting table system intended to support patients during diagnostic imaging without requiring patient movement for positioning.

• Is the Pentamax 1 Model B Table System reusable or single-use?

  The Pentamax 1 Model B Table System is supplied as a reusable device, meaning it is designed for multiple uses after proper cleaning and maintenance between procedures, and is not intended to be discarded after a single use.

• Can the Pentamax 1 Model B Table System be used in MRI environments?

  The Pentamax 1 Model B Table System is not indicated for MRI use, as explicitly stated in the device description, meaning it should not be brought into or used within MRI scanner rooms due to potential safety risks from magnetic fields.

• How is the Pentamax 1 Model B Table System supplied and stored?

  The Pentamax 1 Model B Table System is supplied as a fully assembled reusable table system and is stored at the manufacturer's facility in Westville, New Jersey, when not in active clinical use, ensuring it remains under controlled conditions prior to deployment.