CR Cassettes for Vita Systems

CARESTREAM CR Cassette 28x35 / 11x14

Registry build 21.09.26
3manufacturers in China registered for this device type
12catalogue numbers in this listing

Who Else Makes It

Concentrated in Shanghai (2), Guangdong (1).

Chinese manufacturers registered for FDA product code IXA
Manufacturer City Province Registered as Device types
Shanghai Jolly Industrial Co., Ltd. Shanghai Shanghai Contract manufacturer 99
Shanghai Lions Industrial Co., Ltd. Shanghai Shanghai Contract manufacturer 82
Guangdong Yuehua Medical Instrument Factory Co., Ltd. Shantou Guangdong Contract manufacturer 7

Record

Regulatory record for CR Cassettes for Vita Systems
Listed by Carestream Health, Inc., United States
FDA product code IXA
Device type Cassette, Radiographic Film
Device class Class 2
Regulation 21 CFR 892.1850
Establishment Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
510(k) K945039
Record published 2016-09-16
Record revised 2024-06-19 (version 5)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only
Label carries lot or batch number, serial number
Storage Storage environment temperature 10 to 24 °C

Catalogue Numbers

Catalogue numbers for CR Cassettes for Vita Systems
Catalogue number Size Status
CR Cassettes for Vita Systems In distribution
CR Cassettes for Vita Systems In distribution
CR Cassettes for Vita Systems In distribution
CR Cassettes for Vita Systems In distribution
CR Cassettes for Vita Systems In distribution
CR Cassettes for Vita Systems In distribution
CR Cassettes for Vita Systems In distribution
CR Cassettes for Vita Systems In distribution
CR Cassettes for Vita Systems In distribution
CR Cassettes for Vita Systems In distribution
CR Cassettes for Vita Systems In distribution
CR Cassettes for Vita Systems In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Medical X-ray Cassette with Green 400 Screens Carestream Health, Inc. 18
Directview CR Cassette with PQ Screen Carestream Health, Inc. 17
dose-map™ Ashland Specialty Ingredients, G.P. 17
Curix Ortho Regular Agfa Healthcare Inc. 12
Curix Ortho Fast Agfa Healthcare Inc. 11
Curix Ortho Medium Agfa Healthcare Inc. 11
Select Cassette with Lanex Fast Screens Carestream Health, Inc. 10
Select Cassette with Lanex Medium Screens Carestream Health, Inc. 8
Select Cassette with Lanex Regular Screens Carestream Health, Inc. 7
Huestis Medical Flexi-Holder Huestis Machine Corp. 7
Green RE 400 Speed Agfa Healthcare Inc. 6
Radiographic Film Cassette JPI Healthcare Co., Ltd. 5

Showing 12 of 31. All products under Cassette, Radiographic Film

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