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Found 9 results

510(k) Data Aggregation

K Number

Validate with FDA (Live)

Device Name

CRANIAL STEREOTACTIC EQUIPMENT

Manufacturer

ARPLAY MEDICAL S.A.

Date Cleared

2002-07-02

(540 days)

Product Code

Regulation Number

Type

Panel

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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K Number

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Device Name

INTRA OPERATIVE RADIATION THERAPY

Manufacturer

ARPLAY MEDICAL S.A.

Date Cleared

2001-09-21

(268 days)

Product Code

Regulation Number

Type

Panel

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

N/A

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

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K Number

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Device Name

IMMOBILIZATION SYSTEM FOR ENT

Manufacturer

ARPLAY MEDICAL S.A.

Date Cleared

2001-07-12

(217 days)

Product Code

Regulation Number

Type

Panel

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

N/A

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

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K Number

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Device Name

BREAST-BOARD (MULTIPLE)

Manufacturer

ARPLAY MEDICAL S.A.

Date Cleared

2001-06-08

(183 days)

Product Code

Regulation Number

Type

Panel

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

N/A

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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K Number

Validate with FDA (Live)

Device Name

Manufacturer

ARPLAY MEDICAL S.A.

Date Cleared

2001-04-18

(90 days)

Product Code

Regulation Number

Type

Panel

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

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K Number

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Device Name

TRAY ADAPTERS, MULTIPLE

Manufacturer

ARPLAY MEDICAL S.A.

Date Cleared

2001-04-18

(90 days)

Product Code

Regulation Number

Type

Panel

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

N/A

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

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K Number

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Device Name

COUCH FOR TOTAL BODY RADIATION

Manufacturer

ARPLAY MEDICAL S.A.

Date Cleared

2001-04-02

(84 days)

Product Code

Regulation Number

Type

Panel

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

N/A

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

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K Number

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Device Name

BEAM BLOCK TRAYS

Manufacturer

ARPLAY MEDICAL S.A.

Date Cleared

2001-03-13

(76 days)

Product Code

Regulation Number

Type

Panel

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

N/A

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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K Number

Validate with FDA (Live)

Device Name

STYROFOAM CUTTERS FOR BLOCK CASTING SYSTEM

Manufacturer

ARPLAY MEDICAL S.A.

Date Cleared

2001-03-13

(64 days)

Product Code

Regulation Number

Type

Panel

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

N/A

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

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