510(k) · Cleared

Cleared

Allegro Imaging System

K033782510(k) TraditionalCleared Dec 19, 200315-day reviewClass II21 CFR 892.1200

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Philips Medical Systems (Cleveland), Inc. · KPS System, Tomography, Computed, Emission

Cleared on Dec 19, 2003 as substantially equivalent to K003434 (Adac Laboratories, 2000) after a 15-day review. Its family tree reaches back 1 generation to 2000. 67 later devices descend from it.

Decided: Dec 19, 2003
Review: 15 days
Class: Class II
Product code: KPS
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K003434 (2000). 67 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK003434 Allegro TB, Allegro NAdac Laboratories · 2000
This deviceK033782 Allegro Imaging SystemPhilips Medical Systems (Cleveland), Inc. · 2003
Descendant · cites it directly · 65 of its ownK041955 Gemini Pet/CT Imaging SystemPhilips Medical Systems (Cleveland), Inc. · 2004 · Recalled
Descendant · 2 generations on · 49 of its ownK062650 EP Navigator SoftwarePhilips Medical Systems · 2006
Descendant · 3 generations on · 41 of its ownK101311 EP Navigator R3Philips Medical Systems North America Co. · 2010
Descendant · 4 generations on · 39 of its ownK111245 Heartnavigator Release 1Philips Medical Systems Nederland B.V. · 2011
Descendant · 5 generations on · 32 of its ownK121781 Echonavigator Release 1Philips Medical Systems Nederland B.V. · 2012

Showing 5 of 67 descendants. See all descendants

Descendants cleared per year

2004high 10 (2025) · low 0 (2007)2026

Most influential descendants

Showing 5 of 67 · See all

K041955Gemini Pet/CT Imaging SystemPhilips Medical Systems (Cleveland), Inc. · 2004 · cites it directly65descendants
K062650EP Navigator SoftwarePhilips Medical Systems · 2006 · 2 generations on49descendants
K101311EP Navigator R3Philips Medical Systems North America Co. · 2010 · 3 generations on41descendants
K111245Heartnavigator Release 1Philips Medical Systems Nederland B.V. · 2011 · 4 generations on39descendants
K121781Echonavigator Release 1Philips Medical Systems Nederland B.V. · 2012 · 5 generations on32descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K003434	Allegro TB, Allegro N	Adac Laboratories	2000	—
0 (this device)	K033782	Allegro Imaging System	Philips Medical Systems (Cleveland), Inc.	2003	—
+1	K041955	Gemini Pet/CT Imaging System	Philips Medical Systems (Cleveland), Inc.	2004	2
+2	K062650	EP Navigator Software	Philips Medical Systems	2006	—
+3	K101311	EP Navigator R3	Philips Medical Systems North America Co.	2010	—
+4	K111245	Heartnavigator Release 1	Philips Medical Systems Nederland B.V.	2011	—
+5	K121781	Echonavigator Release 1	Philips Medical Systems Nederland B.V.	2012	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	3	0
2005	2	0
2006	1	0
2008	2	0
2010	1	0
2011	2	0
2012	1	0
2013	2	0
2014	5	0
2017	4	0
2018	5	0
2020	4	0
2021	4	0
2022	5	0
2023	4	0
2024	5	0
2025	10	0
2026	7	0

FIG. 1 — Lineage of K033782, 2000–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in KPS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new KPS device

#1 K253564 uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI…score 18.6 · 17 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K003434	Allegro TB, Allegro N Summary page 1 …892.1200, Class II Product Code: 90 KPS C. Date prepared: November 24, 2003 D. Predicate Device: Allegro Imaging System (K003434, 11/16/2000) E. Performance Standards: NEMA NU-2 F. Intended Use: The device is a Positron Emission Tomography (PET) Im…	Adac Laboratories	2000	—

Also cleared against K003434: 1 other device →

What descends from it? (67)

See all 67

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K041955	Gemini Pet/CT Imaging System	Philips Medical Systems (Cleveland), Inc.	2004	65
K042839	C-Pet Plus Imaging System	Philips Medical Systems (Cleveland), Inc.	2004	0

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K041955 (Philips Medical Systems (Cleveland), Inc., 2004) has gone furthest, with 65 descendants of its own.
1 other device also cites its predicate K003434.

How does its category compare?

All KPS devices

KPS System, Tomography, Computed, Emission: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KPS

12in 2025

2007high 17 (2008) · low 3 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KPS

65in 2025

2007high 112 (2015) · low 25 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KPS

16in 2025

2007high 34 (2011) · low 4 (2010)2026

Class I (17 since 2007) Class II/III not classified

Adverse event reports per year · KPS

36in 2025

2007high 240 (2013) · low 10 (2016)2025

MAUDE reports naming product code KPS, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	8	38	22	38
2008	17	25	16	11
2009	9	42	14	15
2010	3	91	4	44
2011	7	28	34	56
2012	6	94	13	34
2013	11	84	13	240
2014	11	92	18	33
2015	3	112	5	24
2016	11	65	16	10
2017	11	104	11	31
2018	13	59	12 (3)	26
2019	3	60	5 (5)	105
2020	12	72	8	22
2021	15	66	4	10
2022	5	60	8 (6)	15
2023	12	63	6 (3)	22
2024	11	59	15	23
2025	12	65	16	36
2026	6	67	6	—

What is it indicated for?

The device is a Positron Emission Tomography (PET) Imaging System. It is intended to produce images depicting the anatomical distributions of single photon and positron emitting radioisotopes with the human body for interpretation by medical personnel.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K033782 · printed Nov 6, 2026

Cite this page

510(k) Report. “K033782: Allegro Imaging System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033782

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026