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FDA 510(k)

PROSTATE SPECTROSCOPY AND IMAGING EXAM (PROSE) SOFTWARE OPTION FOR MRI

K-Number: K011604 · 2001-08-22

ApplicantGe Medical Systems, Inc.
Decision Date2001-08-22
Product CodeLNI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PROSTATE SPECTROSCOPY AND IMAGING EXAM (PROSE) SOFTWARE OPTION FOR MRI is the device name listed in this FDA 510(k) record. The listed applicant is Ge Medical Systems, Inc.. It received FDA 510(k) clearance on 2001-08-22 under 510(k) number K011604. The device is classified under product code LNI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROSTATE SPECTROSCOPY AND IMAGING EXAM (PROSE) SOFTWARE OPTION FOR MRI?

PROSTATE SPECTROSCOPY AND IMAGING EXAM (PROSE) SOFTWARE OPTION FOR MRI is a medical device that received FDA 510(k) clearance on 2001-08-22. The listed applicant is Ge Medical Systems, Inc.. The 510(k) number is K011604.

When did PROSTATE SPECTROSCOPY AND IMAGING EXAM (PROSE) SOFTWARE OPTION FOR MRI receive FDA 510(k) clearance?

PROSTATE SPECTROSCOPY AND IMAGING EXAM (PROSE) SOFTWARE OPTION FOR MRI received FDA 510(k) clearance on 2001-08-22, under 510(k) number K011604.

Who is the listed applicant for PROSTATE SPECTROSCOPY AND IMAGING EXAM (PROSE) SOFTWARE OPTION FOR MRI?

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

What is the FDA product code for PROSTATE SPECTROSCOPY AND IMAGING EXAM (PROSE) SOFTWARE OPTION FOR MRI?

The FDA product code for PROSTATE SPECTROSCOPY AND IMAGING EXAM (PROSE) SOFTWARE OPTION FOR MRI is LNI.

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Other records listing Ge Medical Systems, 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.

K091673GE LIGHTSPEED ACT FP16K082104GE LIGHTSPEED RT16 / LIGHTSPEED XTRA V2 CT SYSTEM (AKA GE LIGHTSPEED RT16 / LIGHTSPEED XTRA CT SYSTEMK042844GE SIGNA EXCITE 1.5T 6 CHANNEL PHASED ARRAY FLEX COIL, GE SIGNA EXCITE 3.0T 6 CHANNEL PHASED ARRAY FLEX COILK042053INNOVA 4100, INNOVA 3100K040125SENOGRAPHIC STEREOK033244DIGITAL FLUOROSCOPIC IMAGING SYSTEM, MODEL INNOVA 4100 WITH TILT TABLE OPTION

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Related Devices (Code: LNI)

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.

K093044OASIS MRI SYSTEMHitachi Medical Systems America, Inc.K071506ECHELON SPECTROSCOPY PACKAGEHitachi Medical Systems America, Inc.K010129EXCELART WITH PIANISSIMO, MODEL MRT-1500/P3Toshiba America Medical Systems, In.CK003575MODIFICATION TO 3.0T SIGNA VH/I MAGNETIC RESONANCE SYSTEMGE Medical SystemsK991568MR SPECTROSCOPY PACKAGEPhilips Medical Systems (Cleveland), Inc.K984167SAGE 7GE Medical Systems

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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