Bolus

Reusable non-sterile (15 x 15 x 2.0cm) bolus with skin

Registry build 21.09.26
1manufacturer
14catalogue numbers in this listing

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 Bolus
Listed by Medtec LLC, United States
FDA product code IXG
Device type Phantom, Anthropomorphic, Radiographic
Device class Class 1
Regulation 21 CFR 892.1950
Establishment Specification developer, Manufacturer
Premarket notification Exempt
Record published 2017-08-02
Record revised 2024-03-11 (version 7)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only
Label carries lot or batch number, manufacturing date
Storage Special storage condition: Keep away from sunlight; Storage environment temperature 52 to 85 °F
Sizes Length 15 to 50 cm; width 15 to 40 cm
Distribution end date 2025-10-13
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Bolus
Catalogue number Size Status
MTCB410S Length 30 cm Withdrawn
MTCB450S Length 15 cm Withdrawn
MTCB470S Width 15 cm Withdrawn
MTCB305005S Width 30 cm Withdrawn
MTCB404005S Length 40 cm Withdrawn
MTCB415S Width 30 cm Withdrawn
MTCB404010S Length 40 cm Withdrawn
MTCB420S Width 30 cm Withdrawn
MTCB405S Width 30 cm Withdrawn
MTCB430S Width 30 cm Withdrawn
MTCB465S Length 15 cm Withdrawn
MTCB403S Length 30 cm Withdrawn
MTCB305010S Length 50 cm Withdrawn
MTCB455S Width 15 cm Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
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
MapPHAN (10cm) Sun Nuclear Corporation 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