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FDA 510(k)

SYNEPIX 4600 DETECTOR

K-Number: K070829 · 2007-05-09

ApplicantAnalogic Corporation
Decision Date2007-05-09
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SYNEPIX 4600 DETECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Analogic Corporation. It received FDA 510(k) clearance on 2007-05-09 under 510(k) number K070829. 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 SYNEPIX 4600 DETECTOR?

SYNEPIX 4600 DETECTOR is a medical device that received FDA 510(k) clearance on 2007-05-09. The listed applicant is Analogic Corporation. The 510(k) number is K070829.

When did SYNEPIX 4600 DETECTOR receive FDA 510(k) clearance?

SYNEPIX 4600 DETECTOR received FDA 510(k) clearance on 2007-05-09, under 510(k) number K070829.

Who is the listed applicant for SYNEPIX 4600 DETECTOR?

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

What is the FDA product code for SYNEPIX 4600 DETECTOR?

The FDA product code for SYNEPIX 4600 DETECTOR is MQB.

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Other records listing Analogic Corporation as applicant

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.

K201231CTxx85 CT ScannerK182147CTXX85K172058CT6485, CT12885K161342Sonic WindowK051903FETALGARD LITE-NIBP, MODEL FGL-NIBP

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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