MapPHAN (5cm)

Accessory to Model 1177 MapCHECK 2.

Registry build 21.09.26
1manufacturer
1catalogue number

Who Else Makes It

Registered in Guangdong.

Chinese manufacturers registered for FDA product code IXG
Manufacturer City Province Registered as Device types
Guangdong Meicen Medical Equipment Co., Ltd. Foshan Guangdong Manufacturer 7

Record

Regulatory record for MapPHAN (5cm)
Listed by Sun Nuclear Corporation, United States
FDA product code IXG
Device type Phantom, Anthropomorphic, Radiographic
Device class Class 1
Regulation 21 CFR 892.1950
Establishment Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
Record published 2017-01-14
Record revised 2018-03-29 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only
Label carries lot or batch number, manufacturing date, serial number
Storage Special storage condition: Avoid wearing jewelry on hands when handling the phantoms.; Special storage condition: The phantoms are fragile. Handle gently and avoid bumping against other objects.; Special storage condition: MapPHAN is constructed from water equivalent material, which must be handled carefully to prevent damage such as scratch; Special storage condition: Before handling the phantoms, wash hands thoroughly to prevent fingerprints, which cannot be removed. Fingerprints can b; Special storage condition: To prevent warping or breaking of thinner phantoms, do not place a thicker phantom on top of a thinner phantom. For exam; Special storage condition: Do not store anything on top of the phantom.

Catalogue Numbers

Catalogue numbers for MapPHAN (5cm)
Catalogue number Size Status
10830000 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Bolus Medtec LLC 14
LiquiPhil™ Providus Holdings, Inc. 14
Rando® Providus Holdings, Inc. 8
Clearsight Bolus Clearsight RT LLC 2
miniPhantom R IBA Dosimetry GmbH 2
Gafchromic™ Ashland Specialty Ingredients, G.P. 2
StereoPHAN Sun Nuclear Corporation 1
myQA® SRS Phantom IBA Dosimetry GmbH 1
SNC Phantom (MV-QA) Sun Nuclear Corporation 1
R2*/T2* Phantom Resonance Health Analysis Services PTY Ltd 1
myQA® SRS Phantom Cyberknife IBA Dosimetry GmbH 1
Alignment Block Medtec LLC 1

Showing 12 of 33. All products under Phantom, Anthropomorphic, Radiographic

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer