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FDA 510(k)

PANTHER OIS/R & V MODEL VERSION 2.0

K-Number: K122616 · 2012-12-21

ApplicantProwess, Inc.
Decision Date2012-12-21
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PANTHER OIS/R & V MODEL VERSION 2.0 is the device name listed in this FDA 510(k) record. The listed applicant is Prowess, Inc.. It received FDA 510(k) clearance on 2012-12-21 under 510(k) number K122616. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PANTHER OIS/R & V MODEL VERSION 2.0?

PANTHER OIS/R & V MODEL VERSION 2.0 is a medical device that received FDA 510(k) clearance on 2012-12-21. The listed applicant is Prowess, Inc.. The 510(k) number is K122616.

When did PANTHER OIS/R & V MODEL VERSION 2.0 receive FDA 510(k) clearance?

PANTHER OIS/R & V MODEL VERSION 2.0 received FDA 510(k) clearance on 2012-12-21, under 510(k) number K122616.

Who is the listed applicant for PANTHER OIS/R & V MODEL VERSION 2.0?

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

What is the FDA product code for PANTHER OIS/R & V MODEL VERSION 2.0?

The FDA product code for PANTHER OIS/R & V MODEL VERSION 2.0 is IYE.

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Other records listing Prowess, 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.

K231825Panther TPSK211760Panther OISK193459Panther StereotacticK101076PROWESS PANTHER PROARC, MODEL VERSION 5.0K100801PUMA MODEL VERSION 1.0K083502PANTHER REALART, MODEL 4.7

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Related Devices (Code: IYE)

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.

K261865AerFrame™ Alignment Laser Box (LBV2)Stabilix, LLCK261718EZFluence (RADEZ V2)Radformation, Inc.K260733MRIA Radiation Therapy Information System (MRIA)Manteia Technologies Co., Ltd.K261856Halcyon, Ethos Radiotherapy System (5.0)Varian Medical Systems, Inc.K252937ThinkQA 3Dosisoft SAK253004LUNA 3DLap GmbH Laser Applikationen

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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