LungPrint 1.x

by Vida Diagnostics

LungPrint 1.x is a Class II device made by Vida Diagnostics, cleared under FDA 510(k) K083227 on 18 Nov 2008 and listed in FDA GUDID since 14 Apr 2020 (UDI-DI 00852426007015), active as of 22 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 22 Oct 2026

Documents

FDA submission, from GUDID

Trust

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00852426007015 UDI-DI	Date14 Apr 2020Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK083227	Date18 Nov 2008Decided	StatusActive

Official records

AccessGUDID record UDI-DI 00852426007015
FDA 510(k) database 510(k) number K083227

Across registries

2 registries list this device

FDA 510(k) K083227 decided 18 Nov 2008 Active
FDA GUDID UDI-DI 00852426007015 listed 14 Apr 2020 Listed

Timeline

2 dated events

18 Nov 2008 Cleared FDA 510(k) K083227
14 Apr 2020 Listed FDA GUDID 00852426007015

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: LungPrint
Generic name: CT system application software
Model / reference: 1.x

Primary DI / UDI-DI: 00852426007015
510(k) Number: K083227
FDA product code: JAK
GMDN term: CT system application software

Device class: Class II
Regulation number: 892.1750
GUDID distribution status: In Commercial Distribution

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Class II

Properties

Prescription use
Lot / batch number

Other properties (13, all answered No)