PRO SERIES COUCH SOFTWARE, MODEL MT-PRO100

• K Number: K034054
• Device Name: PRO SERIES COUCH SOFTWARE, MODEL MT-PRO100
• Manufacturer: MED-TEC,INC.
• Date Cleared: 2004-02-20 ( 52 days)
• Product Code: JAI
• Regulation Number: 892.5770
• Type: Traditional
• Panel: RA
• Reference & Predicate Devices: N/A

Intended Use

Interface between treatment planning system and the MED-TEC Pro Series Couch; or: Software for MED-TEC Pro Series Couch (6 Degree Axis Couch) .

Device Description

Not Found

AI/ML Overview

This FDA 510(k) letter for the "Pro Series Couch Software" by MED-TEC, Inc. (K034054) is a regulatory clearance document. It does not contain the information required to describe the acceptance criteria and the study that proves the device meets those criteria.

The letter explicitly states that the device is determined to be "substantially equivalent" to legally marketed predicate devices. This means that the FDA has not conducted a de novo review of performance or efficacy in the way that would typically involve acceptance criteria and detailed study results. Instead, the focus is on whether the new device is as safe and effective as devices already on the market.

Therefore, I cannot provide answers to the requested points based on the provided document. The document pertains to regulatory clearance based on substantial equivalence, not a detailed performance study with acceptance criteria.

Regulation Number and Section

§ 892.5770 Powered radiation therapy patient support assembly.

(a)
Identification. A powered radiation therapy patient support assembly is an electrically powered adjustable couch intended to support a patient during radiation therapy.(b)
Classification. Class II.