MapCHECK2 11770000Z

by Sun Nuclear Corporation

MapCHECK2 11770000Z is a Class II device made by Sun Nuclear Corporation, cleared under FDA 510(k) K131466 on 20 Aug 2013 and listed in FDA GUDID since 14 Jan 2017 (UDI-DI B01611770000Z0), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

FDA submission, from GUDID

Trust

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	NumberB01611770000Z0 UDI-DI	Date14 Jan 2017Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK131466	Date20 Aug 2013Decided	StatusActive

Official records

FDA 510(k) database 510(k) number K131466

Across registries

2 registries list this device

FDA 510(k) K131466 decided 20 Aug 2013 Active
FDA GUDID UDI-DI B01611770000Z0 listed 14 Jan 2017 Listed

Timeline

2 dated events

20 Aug 2013 Cleared FDA 510(k) K131466
14 Jan 2017 Listed FDA GUDID B01611770000Z0

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: MapCHECK2
Generic name: Accelerator system quality assurance device
Model / Ref / Catalog: 11770000Z

Primary DI / UDI-DI: B01611770000Z0
510(k) Number: K131466
FDA product code: IYE
GMDN term: Accelerator system quality assurance device

Device class: Class II
Regulation number: 892.5050
GUDID distribution status: In Commercial Distribution

Similar devices in this category

Other devices filed under Accelerator system quality assurance device.

Other devices from Sun Nuclear Corporation

See all devices from Sun Nuclear Corporation →

Properties

Prescription use
Lot / batch number
Serial number
Manufacturing date

Other properties (11, all answered No)