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FDA 510(k)

PHANTOM

K-Number: K941363 · 1994-07-20

ApplicantDynarad Corp.
Decision Date1994-07-20
Product CodeIZL
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PHANTOM is the device name listed in this FDA 510(k) record. The listed applicant is Dynarad Corp.. It received FDA 510(k) clearance on 1994-07-20 under 510(k) number K941363. The device is classified under product code IZL. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PHANTOM?

PHANTOM is a medical device that received FDA 510(k) clearance on 1994-07-20. The listed applicant is Dynarad Corp.. The 510(k) number is K941363.

When did PHANTOM receive FDA 510(k) clearance?

PHANTOM received FDA 510(k) clearance on 1994-07-20, under 510(k) number K941363.

Who is the listed applicant for PHANTOM?

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

What is the FDA product code for PHANTOM?

The FDA product code for PHANTOM is IZL.

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Related PubMed Literature

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.

PMID: 27660042A medical device-grade T1 and ECV phantom for global T1 mapping quality assurance-the T1 Mapping and ECV Standardization in cardiovascular magnetic resonance (T1MES) program.Journal of cardiovascular magnetic resonance : official journal of the Society for Cardiovascular Magnetic Resonance ()

Other records listing Dynarad Corp. 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.

K000052X-RAY MONOBLOCK, MONOBLOCK XRS-60-330K981267FACTS MONOBLOCKK973833CONTROL, X-RAY DIAGNOSTIC, GENERATOR, HIGH VOLTAGE, ASSEMBLY, TUBE HOUSING DIAGNOSTIC, BEAM LIMITING DEVICE, MANUALK932356NOVA XM2K932353HF-110AK9323559150A, 1100F

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Related Devices (Code: IZL)

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.

K260236XLITEGEMSS HEALTHCARE CO., LTD.K253058Portable DR Imaging SystemShantou Institute of Ultrasonic Instruments Co., Ltd.K260085RAYMO Mobile X-ray System (Model: RAYMO)DRGEM CorporationK253185Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray SystemCarestream HealthK253244AirRay-mini 80A, AirRay-mini 90A, AirRay-mini 80F, AirRay-mini 90F (AirRay-mini)Poskom Co., Ltd.K250976Airbile-100Poskom Co., Ltd.

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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