Rapid 6.x: FDA 510(k) K243350 cleared 2025

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	NumberB761R60 UDI-DI	Date7 May 2025Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK243350	Date22 Jan 2025Decided	StatusActive
United States	FDA 510(k) from GUDID	NumberK233582	Date22 Apr 2024Issued	StatusActive
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK232156	Date19 Jan 2024Decided	StatusActive
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Special	NumberK233512	Date16 Jan 2024Decided	StatusActive
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK232436	Date25 Oct 2023Decided	StatusActive
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK230074	Date27 Jul 2023Decided	StatusActive
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK223396	Date1 Feb 2023Decided	StatusActive
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK221456	Date12 Sep 2022Decided	StatusActive
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Special	NumberK221248	Date31 May 2022Decided	StatusActive
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK220499	Date17 May 2022Decided	StatusActive
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK200941	Date9 Jul 2020Decided	StatusActive
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK200760	Date26 Jun 2020Decided	StatusActive
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK193087	Date31 Mar 2020Decided	StatusActive

Official records

FDA 510(k) database 510(k) number K243350
FDA 510(k) database 510(k) number K233582
FDA 510(k) database 510(k) number K232156
FDA 510(k) database 510(k) number K233512
FDA 510(k) database 510(k) number K232436
FDA 510(k) database 510(k) number K230074
FDA 510(k) database 510(k) number K223396
FDA 510(k) database 510(k) number K221456
FDA 510(k) database 510(k) number K221248
FDA 510(k) database 510(k) number K220499

Across registries

2 registries list this device

FDA 510(k) K243350 decided 22 Jan 2025 Active· +12 more in the status table
FDA GUDID UDI-DI B761R60 listed 7 May 2025 Listed

Timeline

14 dated events

31 May 2022 Cleared FDA 510(k) K221248
12 Sep 2022 Cleared FDA 510(k) K221456
1 Feb 2023 Cleared FDA 510(k) K223396
27 Jul 2023 Cleared FDA 510(k) K230074
25 Oct 2023 Cleared FDA 510(k) K232436
16 Jan 2024 Cleared FDA 510(k) K233512
19 Jan 2024 Cleared FDA 510(k) K232156
22 Apr 2024 Cleared FDA 510(k) K233582
22 Jan 2025 Cleared FDA 510(k) K243350
7 May 2025 Listed FDA GUDID B761R60

4 earlier events are in the sections above.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Rapid
Generic name: Radiological PACS-dedicated management software
Model / reference: 6.x

Primary DI / UDI-DI: B761R60
FDA product code: QIH, POK, LLZ, QAS, QFM
GMDN term: Radiological PACS-dedicated management software

Device class: Class II
Regulation number: 892.2050, 892.2060, 892.2080
GUDID distribution status: In Commercial Distribution

Category: Radiological PACS software

Cleared under the same submission (K193087)

and 4 more cleared under K193087

Cleared under the same submission (K200760)

and 4 more cleared under K200760

Similar devices

Also classified as Radiological PACS software.

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Similar devices in this category

Other devices filed under Radiological PACS software.

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Properties

Single use
Prescription use

Other properties (13, all answered No)