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FDA 510(k)

KRYSTALRAD 660 DIGITAL RADIOGRAPHIC PORTABLE RETROFIT SYSTEM

K-Number: K112132 · 2011-11-18

ApplicantMedicatech USA
Decision Date2011-11-18
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

KRYSTALRAD 660 DIGITAL RADIOGRAPHIC PORTABLE RETROFIT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medicatech USA. It received FDA 510(k) clearance on 2011-11-18 under 510(k) number K112132. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KRYSTALRAD 660 DIGITAL RADIOGRAPHIC PORTABLE RETROFIT SYSTEM?

KRYSTALRAD 660 DIGITAL RADIOGRAPHIC PORTABLE RETROFIT SYSTEM is a medical device that received FDA 510(k) clearance on 2011-11-18. The listed applicant is Medicatech USA. The 510(k) number is K112132.

When did KRYSTALRAD 660 DIGITAL RADIOGRAPHIC PORTABLE RETROFIT SYSTEM receive FDA 510(k) clearance?

KRYSTALRAD 660 DIGITAL RADIOGRAPHIC PORTABLE RETROFIT SYSTEM received FDA 510(k) clearance on 2011-11-18, under 510(k) number K112132.

Who is the listed applicant for KRYSTALRAD 660 DIGITAL RADIOGRAPHIC PORTABLE RETROFIT SYSTEM?

The FDA 510(k) record lists Medicatech USA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KRYSTALRAD 660 DIGITAL RADIOGRAPHIC PORTABLE RETROFIT SYSTEM?

The FDA product code for KRYSTALRAD 660 DIGITAL RADIOGRAPHIC PORTABLE RETROFIT SYSTEM is MQB.

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Other records listing Medicatech USA as applicant

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Related Devices (Code: MQB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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