Digital Diagnostic X-Ray System (Mak 1500 +2 more)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K082798

Identifiers

510(k) Number: K082798 FDA 510(k)
FDA Product Code: KPR FDA 510(k)
Models / Variants: Mak 1500 FDA 510(k)
Mak 2000 FDA 510(k)
Mak 3000 FDA 510(k)

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 892.1680 FDA 510(k)
Regulation Number: 892.1680 FDA 510(k)
Advisory Committee: Radiology FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

The Digital Diagnostic X-Ray System, Models Mak 1500, Mak 2000 And Mak 3000, is a stationary digital diagnostic X-ray system used for radiographic imaging. It is available in three models: Mak 1500, Mak 2000, and Mak 3000. Each model has distinct features, including ceiling-mounted tubehead/collimator and universal bucky for the Mak 1500, and vertical column mount with table for the Mak 2000. The Mak 3000 combines a ceiling mount, universal bucky, and table.

The system is supplied as a Class II X-ray system and has received FDA 510(k) clearance. It is used in the field of radiology and is manufactured by Medicatech USA. The system is identified by the product code KPR and regulation number 892.1680. The device has a specific registration number and fei number associated with it.

Frequently asked questions

What is the Digital Diagnostic X-Ray System used for?

The Digital Diagnostic X-Ray System is used for radiographic imaging in the field of radiology.

What are the different models of the Digital Diagnostic X-Ray System?

The Digital Diagnostic X-Ray System is available in three models: Mak 1500, Mak 2000, and Mak 3000, each with distinct features.

Is the Digital Diagnostic X-Ray System supplied sterile?

The description does not specify if the system is supplied sterile, but it is classified as a Class II X-ray system.

What is the regulatory status of the Digital Diagnostic X-Ray System?

The system has received FDA 510(k) clearance, indicated by the k_number K082798.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Digital Diagnostic X-ray System, Models Mak 1500, Mak 2000 and Mak 3000, Medicatech Digital X-Ray Models Mak 1500, Mak 2000 And…, www.accessdata.fda.gov, Medicatech USA® - Home - Radiology Manufacturers in Orange County

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K082798	Class II	Active

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Manufacturer

Manufacturer: Medicatech USA

Sources (1)

FDA 510(k) K082798 24 fields · synced Sep 28, 2026