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FDA 510(k)

IMASIGHT 4600 DIGITAL RADIOGRAPHY SENSOR

K-Number: K092307 · 2009-08-25

ApplicantImasight, Inc.
Decision Date2009-08-25
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

IMASIGHT 4600 DIGITAL RADIOGRAPHY SENSOR is the device name listed in this FDA 510(k) record. The listed applicant is Imasight, Inc.. It received FDA 510(k) clearance on 2009-08-25 under 510(k) number K092307. The device is classified under product code KPR. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMASIGHT 4600 DIGITAL RADIOGRAPHY SENSOR?

IMASIGHT 4600 DIGITAL RADIOGRAPHY SENSOR is a medical device that received FDA 510(k) clearance on 2009-08-25. The listed applicant is Imasight, Inc.. The 510(k) number is K092307.

When did IMASIGHT 4600 DIGITAL RADIOGRAPHY SENSOR receive FDA 510(k) clearance?

IMASIGHT 4600 DIGITAL RADIOGRAPHY SENSOR received FDA 510(k) clearance on 2009-08-25, under 510(k) number K092307.

Who is the listed applicant for IMASIGHT 4600 DIGITAL RADIOGRAPHY SENSOR?

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

What is the FDA product code for IMASIGHT 4600 DIGITAL RADIOGRAPHY SENSOR?

The FDA product code for IMASIGHT 4600 DIGITAL RADIOGRAPHY SENSOR is KPR.

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Related Devices (Code: KPR)

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.

K260227EXSYS DEXi (EXSYS DEXi-S40S); EXSYS DEXi (EXSYS DEXi-S40P); EXSYS DEXi (EXSYS DEXi-S40T); EXSYS DEXi (EXSYS DEXi-S50HDRTECH CorporationK260488MULTIX Impact; MULTIX Impact CSiemens Medical Solutions USA, Inc.K260481GC85ASamsung Electronics Co., Ltd.K260482DRE DuoJpi Healthcare Co, Ltd.K253446AeroDR TX c02Dk Medical Systems Co., Ltd.K250954DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector, Lux HD 43 detectorCarestream Health

Official Source

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

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