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FDA 510(k)

IODR1717 / IODR1417 / IODR1417-GF (Digital Flat Panel X-ray Detector)

K-Number: K241346 · 2024-11-07

ApplicantAspen Imaging Healthcare, Inc.
Decision Date2024-11-07
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

IODR1717 / IODR1417 / IODR1417-GF (Digital Flat Panel X-ray Detector) is the device name listed in this FDA 510(k) record. The listed applicant is Aspen Imaging Healthcare, Inc.. It received FDA 510(k) clearance on 2024-11-07 under 510(k) number K241346. 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 IODR1717 / IODR1417 / IODR1417-GF (Digital Flat Panel X-ray Detector)?

IODR1717 / IODR1417 / IODR1417-GF (Digital Flat Panel X-ray Detector) is a medical device that received FDA 510(k) clearance on 2024-11-07. The listed applicant is Aspen Imaging Healthcare, Inc.. The 510(k) number is K241346.

When did IODR1717 / IODR1417 / IODR1417-GF (Digital Flat Panel X-ray Detector) receive FDA 510(k) clearance?

IODR1717 / IODR1417 / IODR1417-GF (Digital Flat Panel X-ray Detector) received FDA 510(k) clearance on 2024-11-07, under 510(k) number K241346.

Who is the listed applicant for IODR1717 / IODR1417 / IODR1417-GF (Digital Flat Panel X-ray Detector)?

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

What is the FDA product code for IODR1717 / IODR1417 / IODR1417-GF (Digital Flat Panel X-ray Detector)?

The FDA product code for IODR1717 / IODR1417 / IODR1417-GF (Digital Flat Panel X-ray Detector) is MQB.

Related Clinical Trials

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.

NCT07092553Evaluation of C-arm PCD-CBCT for Image-Guided InterventionsNOT_YET_RECRUITING

Other records listing Aspen Imaging Healthcare, Inc. 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.

K241425AspenView

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.

K2538000909FCE, 0909FCE-HSRayence Co., Ltd.K260820VIVIX-S 4386W (FXRD-4386WA)Vieworks Co., Ltd.K252996Universal 1417PIKonica Minolta Healthcare Americas, Inc.K252911Lux HD 2530 detector (Lux HD 2530)Iray Imaging Technology (Haining) LimitedK250211Yushan X-Ray Flat Panel DetectorInnocare Optoelectronics Corp.K250665SKR 3000Konica Minolta, Inc.

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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