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SRS MapCHECK 1179300Z

by Sun Nuclear Corporation

Ref 1179

SRS MapCHECK 1179300Z (1179000-0Z) is a device classified as Class IIb in the EU and Class II in the US made by Sun Nuclear Corporation, registered in EUDAMED on 27 Feb 2026 (Basic UDI-DI 506060888DASRSMPCHECK5V) with CE/MDR certificate 28620200479 valid until 6 Jan 2028, cleared under FDA 510(k) K131466 on 20 Aug 2013 and listed in FDA GUDID since 22 Jul 2020 (UDI-DI 05060608880188), active as of 24 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

6 Jan 2028

CE MDR certificate

FDA recalls

None found

in data synced 24 Oct 2026

Documents

1 certificate

Certifier Intertek Medical Notified Body AB

510(k) K131466

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number506060888DASRSMPCHECK5V Basic UDI-DI 05060608880188UDI-DIDate27 Feb 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05060608880188 UDI-DI Date22 Jul 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK131466 Date20 Aug 2013DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 506060888DASRSMPCHECK5V registered 27 Feb 2026 Active· +1 more in the status table
  • FDA 510(k) K131466 decided 20 Aug 2013 Active
  • FDA GUDID UDI-DI 05060608880188 listed 22 Jul 2020 Listed

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)

Timeline

5 dated events

  1. Cleared FDA 510(k) K131466
  2. Listed FDA GUDID 05060608880188
  3. Certificate issued EUDAMED 28620200479
  4. Registered EUDAMED 506060888DASRSMPCHECK5V
  5. Certificate expires EUDAMED 28620200479

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
SRS MapCHECK
Generic name
Accelerator system quality assurance device
Model / Ref / Catalog
1179 EUDAMED
1179300Z GUDID
1179000-0Z GUDID
Primary DI / UDI-DI
05060608880188
Basic UDI-DI
506060888DASRSMPCHECK5V
510(k) Number
FDA product code
IYE
EMDN code
Z11010180 Linear accelerators - hardware accessories
GMDN term
Accelerator system quality assurance device
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
892.5050
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
1179
GUDID
1179300Z
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

From the manufacturer

Manufacturer's product page: SRS MapCHECK SRS & SBRT QA, No Film

Related devices

Category: Accelerator system quality assurance device

Cleared under the same submission (K131466)

and 3 more cleared under K131466

Similar devices in this category

Other devices filed under LINEAR ACCELERATORS - HARDWARE ACCESSORIES.

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 (21, all answered No)