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.decimal P.D 5.1

by .Decimal, LLC

.decimal P.D 5.1 is a Class II device made by .Decimal, LLC, cleared under FDA 510(k) K151369 on 7 Aug 2015 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00851147007069), 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

510(k) K151369

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00851147007069 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK151369 Date7 Aug 2015DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K151369 decided 7 Aug 2015 Active
  • FDA GUDID UDI-DI 00851147007069 listed 24 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K151369
  2. Listed FDA GUDID 00851147007069

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
.decimal P.D
Generic name
Radiation therapy software
Model / reference
5.1
Primary DI / UDI-DI
00851147007069
510(k) Number
FDA product code
MUJ
GMDN term
Radiation therapy software
Device class
Class II
Regulation number
892.5050
GUDID distribution status
In Commercial Distribution

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Properties

  • Single use
  • Serial number
Other properties (13, all answered No)